Sunday, April 29, 2012

Teveten


Generic Name: eprosartan (EP roe SAR tan)

Brand Names: Teveten


What is Teveten (eprosartan)?

Eprosartan is in a group of drugs called angiotensin II receptor antagonists. Eprosartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.


Eprosartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.


Eprosartan may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Teveten (eprosartan)?


Stop using this medication and tell your doctor right away if you become pregnant. Eprosartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. You should not use this medication if you are allergic to eprosartan. Drinking alcohol can further lower your blood pressure and may increase certain side effects of eprosartan. Do not use potassium supplements or salt substitutes while you are taking eprosartan, unless your doctor has told you to.

Your blood pressure will need to be checked often. Visit your doctor regularly.


Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.


In rare cases, eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

What should I discuss with my healthcare provider before taking Teveten (eprosartan)?


You should not use this medication if you are allergic to eprosartan.

To make sure you can safely take eprosartan, tell your doctor if you have any of these other conditions:


  • kidney disease;

  • liver disease;


  • congestive heart failure; or




  • if you are dehydrated.




FDA pregnancy category D. Do not use eprosartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Eprosartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking eprosartan. It is not known whether eprosartan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Teveten (eprosartan)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Your doctor may occasionally change your dose to make sure you get the best results.


You may take eprosartan with or without food.


Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking eprosartan. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Visit your doctor regularly.


It may take 2 to 3 weeks of using this medicine before your blood pressure is under control. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 weeks of treatment.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.


Store eprosartan at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness or feeling like you might pass out.


What should I avoid while taking Teveten (eprosartan)?


Drinking alcohol can further lower your blood pressure and may increase certain side effects of eprosartan. Do not use potassium supplements or salt substitutes while you are taking eprosartan, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.


Teveten (eprosartan) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. In rare cases, eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;




  • urinating less than usual or not at all;




  • chest pain, fast heart rate; or




  • swelling in your hands or feet.



Less serious side effects may include:



  • runny or stuffy nose, sore throat, cough;




  • joint pain;




  • nausea, stomach pain, diarrhea;




  • headache, dizziness; or




  • tired feeling.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Teveten (eprosartan)?


Tell your doctor about all other medicines you use, especially:



  • a diuretic (water pill); or




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.



This list is not complete and other drugs may interact with eprosartan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Teveten resources


  • Teveten Side Effects (in more detail)
  • Teveten Use in Pregnancy & Breastfeeding
  • Drug Images
  • Teveten Drug Interactions
  • Teveten Support Group
  • 0 Reviews for Teveten - Add your own review/rating


  • Teveten Prescribing Information (FDA)

  • Teveten MedFacts Consumer Leaflet (Wolters Kluwer)

  • Teveten Monograph (AHFS DI)

  • Teveten Advanced Consumer (Micromedex) - Includes Dosage Information

  • Eprosartan Prescribing Information (FDA)



Compare Teveten with other medications


  • High Blood Pressure


Where can I get more information?


  • Your pharmacist can provide more information about eprosartan.

See also: Teveten side effects (in more detail)



Saturday, April 28, 2012

Scorpion (centruroides) immune f(ab)2 Intravenous


SKOR-pee-on SEN-troo-roy-deez i-MUNE fab-too


Commonly used brand name(s)

In the U.S.


  • Anascorp

Available Dosage Forms:


  • Powder for Solution

Therapeutic Class: Antivenom


Uses For scorpion (centruroides) immune f(ab)2


Scorpion (Centruroides) immune F(ab)2 injection is used to treat scorpion stings. A scorpion sting may cause abnormal eye movements, increased watering of the mouth, loss of muscle control, shortness of breath, slurred speech, troubled breathing, or vomiting. scorpion (centruroides) immune f(ab)2 is made from horse proteins that have been immunized with the scorpion’s venom.


scorpion (centruroides) immune f(ab)2 is to be given only by or under the direct supervision of a doctor.


Before Using scorpion (centruroides) immune f(ab)2


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For scorpion (centruroides) immune f(ab)2, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to scorpion (centruroides) immune f(ab)2 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of scorpion (Centruroides) immune F(ab)2 injection in children.


Geriatric


Although appropriate studies on the relationship of age to the effects of scorpion (Centruroides) immune F(ab)2 injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of scorpion (centruroides) immune f(ab)2. Make sure you tell your doctor if you have any other medical problems, especially:


  • Allergy to horse protein or

  • Prior use of an antivenom containing horse protein—Use with caution. May increase the likelihood for an allergic reaction.

Proper Use of scorpion (centruroides) immune f(ab)2


A nurse or other trained health professional will give you scorpion (centruroides) immune f(ab)2 in a hospital. scorpion (centruroides) immune f(ab)2 is given through a needle placed in one of your veins.


Precautions While Using scorpion (centruroides) immune f(ab)2


Your doctor will check your or your child's progress closely while you are receiving scorpion (centruroides) immune f(ab)2. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.


scorpion (centruroides) immune f(ab)2 may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are receiving scorpion (centruroides) immune f(ab)2.


Call your doctor or the emergency department right away if you or your child have a delayed allergic reaction or serum sickness, which may occur up to 14 days after receiving scorpion (centruroides) immune f(ab)2. The symptoms may include a rash, itching skin, fever, general feeling of discomfort or illness, joint or muscle pain, unusual tiredness or weakness, or swollen, painful, or tender lymph glands in the neck, armpit, or groin.


scorpion (centruroides) immune f(ab)2 is made from horse blood. Some horse blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from horse blood has been greatly reduced in recent years. This is the result of required testing of horses for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.


scorpion (centruroides) immune f(ab)2 Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor or nurse immediately if any of the following side effects occur:


Less common
  • Chest pain

  • confusion

  • cough

  • dizziness

  • fast heartbeat

  • feeling of discomfort

  • fever or chills

  • inflammation of the joints

  • itching

  • muscle aches

  • rash

  • shakiness and unsteady walk

  • shortness of breath

  • sneezing

  • sore throat

  • swelling of the eye

  • swollen lymph glands

  • tightness in the chest

  • troubled breathing

  • unsteadiness, trembling, or other problems with muscle control or coordination

  • weakness

  • wheezing

Incidence not known
  • Fast, irregular, pounding, or racing heartbeat or pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Diarrhea

  • difficulty with moving

  • headache

  • joint pain

  • muscle cramping

  • muscle pains or stiffness

  • nausea

  • runny nose

  • swollen joints

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


Nicotinex


Generic Name: niacin (Oral route)

NYE-a-sin

Commonly used brand name(s)

In the U.S.


  • Niacinol

  • Niacor

  • Niaspan

  • Nicotinex

  • Slo-Niacin

Available Dosage Forms:


  • Tablet

  • Tablet, Extended Release

  • Capsule

  • Capsule, Extended Release

  • Elixir

Therapeutic Class: Antihyperlipidemic


Pharmacologic Class: Vitamin B


Chemical Class: Nicotinic Acid (class)


Uses For Nicotinex


Niacin is used to help lower high cholesterol and fat levels in the blood. This may help prevent medical problems caused by cholesterol and fat clogging the blood vessels.


Some strengths of niacin are available only with your doctor's prescription.


Importance of Diet


Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.


Also, Nicotinex is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.


Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.


Before Using This Medicine


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


There is no specific information comparing the use of niacin for high cholesterol in children with use in other age groups. However, use is not recommended in children under 2 years of age since cholesterol is needed for normal development.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing the use of niacin for high cholesterol in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Atorvastatin

  • Cerivastatin

  • Lovastatin

  • Pitavastatin

  • Rosuvastatin

  • Simvastatin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Bleeding problems or

  • Diabetes mellitus (sugar diabetes) or

  • Glaucoma or

  • Gout or

  • Liver disease or history of jaundice

  • Low blood pressure or

  • Stomach ulcer—Niacin may make these conditions worse

  • Kidney problems—Niacin (extended release tablets) may make your kidney problems worse.

Proper Use of niacin

This section provides information on the proper use of a number of products that contain niacin. It may not be specific to Nicotinex. Please read with care.


Use this medicine only as directed by your doctor. Do not use more or less of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.


Remember that niacin will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.


Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly.


If this medicine upsets your stomach, it may be taken with meals or milk. If stomach upset (nausea or diarrhea) continues, check with your doctor.


For patients taking the extended-release capsule form of this medicine:


  • Swallow the capsule whole. Do not crush, break, or chew before swallowing. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

For patients taking the extended-release tablet form of this medicine:


  • Swallow the tablet whole. If the tablet is scored, it may be broken, but not crushed or chewed, before being swallowed.

  • Tablet (Niaspan) should be taken at bedtime after a low-fat snack.

  • To decrease flushing of your face (redness), take aspirin or ibuprofen (e.g., Advil, Motrin) 30 minutes before taking tablet (Niaspan).

  • Avoid drinking alcohol or hot drinks around the time you take your tablet (Niaspan). This helps decrease flushing of your face (redness).

  • Take this medication exactly as your doctor ordered. If you stop taking this medication for any period of time, contact your doctor prior to restarting taking niacin.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (extended-release capsules, extended-release tablets, oral solution, or regular tablets):
    • For treatment of high cholesterol:
      • Adults and teenagers—500 milligrams to 2 grams one to three times a day: use and dose will be determined by your doctor. Do not exceed the amount the doctor prescribes.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Nicotinex


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and if you should continue to take it.


Do not stop taking niacin without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.


Do not take vitamins or other dietary supplements unless they have been discussed with your doctor. This especially includes vitamins or dietary supplements that contain niacin or similar ingredients.


This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.


This medicine may cause you to feel dizzy or faint, especially when you get up from a lying or sitting position. Getting up slowly may help. This effect should lessen after a week or two as your body gets used to the medicine. However, if the problem continues or gets worse, check with your doctor.


Nicotinex Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less commonWith prolonged use of extended-release niacin
  • Darkening of urine

  • light gray-colored stools

  • loss of appetite

  • severe stomach pain

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Abdominal pain

  • feeling of warmth

  • flushing or redness of skin, especially on face and neck

  • headache

  • rash

  • runny nose

  • sneezing

  • stuffy nose

With high doses
  • Diarrhea

  • dizziness or faintness

  • dryness of skin

  • fever

  • frequent urination

  • itching of skin

  • joint pain

  • muscle aching or cramping

  • nausea or vomiting

  • side, lower back, or stomach pain

  • swelling of feet or lower legs

  • unusual thirst

  • unusual tiredness or weakness

  • unusually fast, slow, or irregular heartbeat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Nicotinex side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Nicotinex resources


  • Nicotinex Side Effects (in more detail)
  • Nicotinex Use in Pregnancy & Breastfeeding
  • Nicotinex Drug Interactions
  • Nicotinex Support Group
  • 0 Reviews for Nicotinex - Add your own review/rating


  • Niacin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Niacin Monograph (AHFS DI)

  • B-3-50 nicotinic acid Concise Consumer Information (Cerner Multum)

  • Niacor Prescribing Information (FDA)

  • Slo-Niacin Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Nicotinex with other medications


  • High Cholesterol
  • Hyperlipoproteinemia
  • Hyperlipoproteinemia Type IV, Elevated VLDL
  • Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
  • Niacin Deficiency
  • Pellagra


Triamcinolone Aerosol



Pronunciation: TRYE-am-SIHN-oh lohn
Generic Name: Triamcinolone
Brand Name: Azmacort


Triamcinolone Aerosol is used for:

Preventing or reducing the frequency and severity of bronchial asthma attacks. It will not stop an asthma attack once it has started. It may also be used for other conditions as determined by your doctor.


Triamcinolone Aerosol is a corticosteroid. It works by decreasing the irritation and swelling of the airways of the lung. This helps to control or prevent asthma symptoms.


Do NOT use Triamcinolone Aerosol if:


  • you are allergic to any ingredient in Triamcinolone Aerosol

  • you are currently taking mifepristone

  • you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.



Before using Triamcinolone Aerosol:


Some medical conditions may interact with Triamcinolone Aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have or have been recently exposed to a bacterial, fungal, parasitic, or viral infection, especially measles, chickenpox, tuberculosis (TB), or herpes simplex of the eye

  • if you have been recently vaccinated with a live or inactivated vaccine, or have had a positive TB skin test

  • if you are having an attack of bronchospasm (tightening of the airway, difficulty breathing), or have diarrhea

Some MEDICINES MAY INTERACT with Triamcinolone Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Barbiturates (eg, phenobarbital), carbamazepine, fluconazole, hydantoins (eg, phenytoin), lithium, rifampin, or thioamines (eg, propylthiouracil) because they may decrease Triamcinolone Aerosol's effectiveness

  • Clarithromycin, itraconazole, oral contraceptives (birth control pills), or midazolam because the risk of side effects, such as nervous system or adrenal gland problems, may be increased

  • Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), mifepristone, nondepolarizing muscle relaxants (eg, vecuronium), ritodrine, sympathomimetics (eg, albuterol, amphetamine, pseudoephedrine), or live vaccines because the risk of their side effects may be increased by Triamcinolone Aerosol

  • Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), interleukin-2, or nondepolarizing muscle relaxants (eg, vecuronium) because their effectiveness may be decreased by Triamcinolone Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triamcinolone Aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Triamcinolone Aerosol:


Use Triamcinolone Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Triamcinolone Aerosol. Talk to your pharmacist if you have questions about this information.

  • Before using Triamcinolone Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Triamcinolone Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes.

  • Rinse your mouth or gargle with water after using Triamcinolone Aerosol to prevent mouth sores or bad taste.

  • Each time a new inhaler is used, turn the canister away from the face and press down into the mouthpiece to release test sprays into the air. This process is called priming and will allow you to be sure the inhaler is working properly and will provide a full dose of medicine.

  • Keep track of the number of sprays you use and subtract this number from the number of doses in the container. This will help you know when the container is becoming empty.

  • If you miss a dose of Triamcinolone Aerosol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Triamcinolone Aerosol.



Important safety information:


  • Triamcinolone Aerosol will not stop an asthma attack once it has started

  • If you are also using a bronchodilator inhaler, be sure to always carry the inhaler with you to use during asthma attacks.

  • After you begin using Triamcinolone Aerosol, a few weeks may pass before the full benefit is obtained. Continue to use it as directed during this time.

  • Use caution if you switch from an oral steroid (eg, prednisone) to Triamcinolone Aerosol. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.

  • Tell your doctor or dentist that you take Triamcinolone Aerosol before you receive any medical or dental care, emergency care, or surgery.

  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.

  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Triamcinolone Aerosol.

  • Use Triamcinolone Aerosol with extreme caution in CHILDREN. Triamcinolone Aerosol should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Triamcinolone Aerosol while you are pregnant. It is not known if Triamcinolone Aerosol is found in breast milk. If you are or will be breast-feeding while you use Triamcinolone Aerosol, check with your doctor. Discuss any possible risks to your baby.

You may experience WITHDRAWAL when switching from an oral steroid medicine to an inhaled one. Contact your health care provider at once if the following symptoms occur: muscle and joint pain, exhaustion, depression.



Possible side effects of Triamcinolone Aerosol:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Back pain; dry mouth; flu-like symptoms; headache, hoarseness; irritated or sore throat; sinus inflammation.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest congestion; depression; exhaustion; fainting; muscle and joint pain; severe dizziness; sudden weight loss; unusual weakness; white, curd-like patches in mouth.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Triamcinolone Aerosol:

Store Triamcinolone Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Triamcinolone Aerosol out of the reach of children and away from pets.


General information:


  • If you have any questions about Triamcinolone Aerosol, please talk with your doctor, pharmacist, or other health care provider.

  • Triamcinolone Aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Triamcinolone Aerosol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Triamcinolone resources


  • Triamcinolone Use in Pregnancy & Breastfeeding
  • Drug Images
  • Triamcinolone Drug Interactions
  • Triamcinolone Support Group
  • 24 Reviews for Triamcinolone - Add your own review/rating


Compare Triamcinolone with other medications


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  • Thrombocytopenia Idiopathic
  • Uveitis


Sunday, April 22, 2012

Tri-Vit with Fluoride





Dosage Form: oral solution
Tri-Vit with Fluoride 0.25 mg DROPS


Rx only































 Supplement Facts   
 Dosage Size 1 mL (Mark on Dropper)  
 Amount Per  % Daily Value 
 1 mL   Infants Children Under
   Age 4 Years
 Vitamin A 1500 IU 100% 60%
 Vitamin C 35 mg 100% 88%
 Vitamin D 400 IU 100% 100%
 Fluoride 0.25 mg * *
 *Daily Value (DV) not established  

Active ingredient for caries prophylaxis:

Each 1 mL contains 0.25 mg fluoride as sodium fluoride.



Other ingredients:


ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D3), flavor, glycerin, polysorbate 80, purified water, sodium hydroxide, vitamin A palmitate.



CLINICAL PHARMACOLOGY:


It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. Three stages of fluoride deposition in tooth enamel can be distinguished:1 1) Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. 2) After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted. 3) After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride, and smaller amounts from saliva



INDICATIONS AND USAGE:


Tri-Vit with Fluoride 0.25 mg drops may be useful for infants whose diets are lacking in vitamins A, D and C. Tri-Vit with Fluoride 0.25 mg drops also provide fluoride for caries prophylaxis. Tri-Vit with Fluoride 0.25 mg (vitamins A, D, C, and fluoride) drops were developed to provide fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2,3 Each 1 mL supplies sodium fluoride (0.25 mg fluoride) plus three basic vitamins.



WARNING:


As with all medicines, keep out of the reach of children.



PRECAUTIONS:


The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing Tri-Vit with Fluoride 0.25 mg drops: 1) Determine the fluoride content of the drinking water from all major sources. 2) Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. 3) Periodically check to make sure that the child does not develop significant dental fluorosis.

Tri-Vit with Fluoride 0.25 mg drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)



ADVERSE REACTIONS:


Allergic rash and other idiosyncrasies have been rarely reported.



DOSAGE AND ADMINISTRATION:


1 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with fruit juice, cereal or other food. USE FULL DOSAGE.


DISPENSE in original container



Occasional deepening of color has no significant effect on vitamin potency.


After opening, store away from direct light.


Your doctor or dentist is the best source of counsel and guidance in your child’s fluoride supplementation.



REFERENCES


  1. Brudevold F, McCann HG. Fluoride and caries control - Mechanism of action. In: Nizel AE, ed. The Science of Nutrition and Its Application in Clinical Dentistry. Philadelphia: WB Saunders Co.; 1966;331-347.

  2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995;95(5):777.

  3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994;12-14.


Manufactured for:

QUALITEST PHARMACEUTICALS

130 VINTAGE DRIVE

HUNTSVILLE, AL 35811


R6/08-R5

8277530



PRINCIPAL DISPLAY PANEL



 

PRINCIPAL DISPLAY PANEL



 






Tri-Vit with Fluoride DROPS 
ascorbic acid and cholecalciferol and sodium fluoride and vitamin a palmitate  solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0603-1785
Route of AdministrationORALDEA Schedule    

















Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A PALMITATE (VITAMIN A PALMITATE)VITAMIN A PALMITATE1500 [iU]  in 1 mL
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID35 mg  in 1 mL
CHOLECALCIFEROL (CHOLECALCIFEROL)CHOLECALCIFEROL400 [iU]  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION)SODIUM FLUORIDE0.25 mg  in 1 mL














Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYSORBATE 80 
WATER 
SODIUM HYDROXIDE 
ANHYDROUS CITRIC ACID 


















Product Characteristics
ColorBROWN (Clear-Brown)Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10603-1785-471 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
150 mL In 1 BOTTLE, PLASTICThis package is contained within the CARTON (0603-1785-47)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/1995


Labeler - Qualitest Pharmaceuticals (011103059)









Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE
Revised: 07/2011Qualitest Pharmaceuticals




Friday, April 20, 2012

Trimox


Generic Name: amoxicillin (Oral route)

a-mox-i-SIL-in

Commonly used brand name(s)

In the U.S.


  • Amoxicot

  • Amoxil

  • DisperMox

  • Moxatag

  • Moxilin

  • Trimox

In Canada


  • Amoxil Pediatric

  • Apo-Amoxi

  • Apo-Amoxi Sugar-Free

  • Gen-Amoxicillin

  • Med Amoxicillin

  • Novamoxin

  • Novamoxin Reduced Sugar

  • Nu-Amoxi

  • Riva-Amoxicillin

  • Scheinpharm Amoxicillin

  • Zimamox

Available Dosage Forms:


  • Tablet

  • Tablet, Chewable

  • Tablet for Suspension

  • Powder for Suspension

  • Tablet, Extended Release

  • Capsule

Therapeutic Class: Antibiotic


Pharmacologic Class: Penicillin, Aminopenicillin


Uses For Trimox


Amoxicillin is used to treat bacterial infections in many different parts of the body. It is also used with other medicines (e.g., clarithromycin, lansoprazole) to treat H. pylori infection and duodenal ulcers.


Amoxicillin belongs to the group of medicines known as penicillin antibiotics. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.


This medicine is available only with your doctor's prescription.


Before Using Trimox


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin in children. However, newborns and infants 3 months of age and younger have incompletely developed kidney functions, which may need a lower dose of this medicine.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxicillin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving amoxicillin.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Methotrexate

  • Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acenocoumarol

  • Desogestrel

  • Dienogest

  • Drospirenone

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Khat

  • Levonorgestrel

  • Medroxyprogesterone Acetate

  • Mestranol

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Probenecid

  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Allergy to penicillins or cephalosporin antibiotics (e.g., cefaclor, cefadroxil, cephalexin, Ceftin®, or Keflex®) or

  • Mononucleosis (viral infection)—Should not be used in patients with these conditions.

  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can make this condition worse.

Proper Use of amoxicillin

This section provides information on the proper use of a number of products that contain amoxicillin. It may not be specific to Trimox. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


You may take this medicine with or without food.


For patients using the oral liquid:


  • Shake the bottle well before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

  • You may mix the oral liquid with a baby formula, milk, fruit juice, water, ginger ale, or another cold drink. Be sure the child drinks all of the mixture immediately.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage forms (capsules, powder for suspension, and tablets):
    • For bacterial infections:
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours.

      • Children and infants older than 3 months of age weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 8 hours, or 25 to 45 mg per kg of body weight per day, divided and given every 12 hours.

      • Infants 3 months of age and younger—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 mg per kg of body weight per day, divided and given every 12 hours.


    • For treatment of gonorrhea:
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—3-grams (g) taken as a single dose.

      • Children 2 years of age and older weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, combined with 25 mg per kg of probenecid, taken as a single dose.

      • Children younger than 2 years of age—Use is not recommended.


    • For treatment of H. pylori infection:
      • Adults—
        • Dual therapy: 1000 milligrams (mg) of amoxicillin and 30 mg of lansoprazole, each given three times a day (every 8 hours) for 14 days.

        • Triple therapy: 1000 mg of amoxicillin, 500 mg of clarithromycin, and 30 mg of lansoprazole, all given two times a day (every 12 hours) for 14 days.


      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


You may store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days. Do not freeze.


Precautions While Using Trimox


If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.


This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a skin rash; itching; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, mouth, or throat after you or your child receive this medicine.


Amoxicillin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.


Before you have any medical tests, tell the doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.


In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.


Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include a condom, a diaphragm, or a contraceptive foam or jelly.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Trimox Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Incidence not known
  • Abdominal or stomach cramps or tenderness

  • back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • blistering, peeling, or loosening of the skin

  • bloating

  • blood in the urine

  • bloody nose

  • chest pain

  • chills

  • clay-colored stools

  • cough

  • dark urine

  • diarrhea

  • diarrhea, watery and severe, which may also be bloody

  • difficulty with breathing

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • feeling of discomfort

  • fever

  • general body swelling

  • headache

  • heavier menstrual periods

  • hives or welts

  • increased thirst

  • inflammation of the joints

  • itching

  • joint or muscle pain

  • loss of appetite

  • muscle aches

  • nausea or vomiting

  • nosebleeds

  • pain

  • pain in the lower back

  • pain or burning while urinating

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • rash

  • red, irritated eyes

  • redness, soreness, or itching skin

  • shortness of breath

  • sore throat

  • sores, ulcers, or white spots in the mouth or on the lips

  • sores, welting, or blisters

  • sudden decrease in the amount of urine

  • swollen, lymph glands

  • tenderness

  • tightness in the chest

  • unpleasant breath odor

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • unusual weight loss

  • vomiting of blood

  • watery or bloody diarrhea

  • wheezing

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Bad, unusual, or unpleasant (after) taste

  • change in taste

Incidence not known
  • Agitation

  • black, hairy tongue

  • changes in behavior

  • confusion

  • convulsions

  • discoloration of the tooth (brown, yellow, or gray staining)

  • dizziness

  • sleeplessness

  • trouble with sleeping

  • unable to sleep

  • white patches in the mouth or throat or on the tongue

  • white patches with diaper rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


Wednesday, April 18, 2012

Typhim Vi


Generic Name: typhoid vi polysaccharide vaccine (Intramuscular route)


TYE-foid Vi pol-ee-SAK-a-ride VAX-een


Commonly used brand name(s)

In the U.S.


  • Typhim Vi

  • Typhoid Vi Polysaccharide Vaccine

Available Dosage Forms:


  • Solution

  • Injectable

Therapeutic Class: Vaccine


Uses For Typhim Vi


Typhoid fever is a serious disease that can cause death. It is caused by a germ called Salmonella typhi, and is spread most often through infected food or water. Typhoid may also be spread by close person-to-person contact with infected persons (such as occurs with persons living in the same household). Some infected persons do not appear to be sick, but they can still spread the germ to others.


Typhoid fever is very rare in the U.S. and other areas of the world that have good water and sewage (waste) systems. However, it is a problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote, out-of-the-way areas, typhoid vaccine will help protect you from typhoid fever. The U.S. Centers for Disease Control (CDC) currently recommend caution in the following areas of the world:


  • Africa

  • Asia

  • Latin America

Typhoid vaccine given by injection helps prevent typhoid fever, but does not provide 100% protection. Therefore, it is very important to avoid infected persons and food and water that may be infected, even if you have received the vaccine.


To get the best possible protection against typhoid, you should receive the vaccine at least 1 week before you travel to areas where you may be exposed to typhoid.


If you will be traveling regularly to parts of the world where typhoid is a problem, you should get a booster (repeat) dose of the vaccine every 2 years.


Typhoid vaccine is to be used only by or under the supervision of a doctor.


Before Using Typhim Vi


In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Typhoid Vi polysaccharide vaccine is not recommended for infants and children younger than 2 years of age. For children 2 years of age and over, this vaccine is not expected to cause different side effects or problems than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of typhoid vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Tacrolimus

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Previous sensitivity reaction to typhoid vaccine—Use of typhoid vaccine is not recommended

  • Severe illness with fever—The symptoms of the condition may be confused with the side effects of the vaccine

Proper Use of Typhim Vi


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


The dose of typhoid Vi polysaccharide vaccine is the same for all patients 2 years of age and older. For infants and children up to two years of age, the use of typhoid Vi polysaccharide vaccine is not recommended.


  • For injection dosage form:
    • For prevention of typhoid fever:
      • Adults and children 2 years of age and older—One dose injected into a muscle.

      • Children up to 2 years of age—Use is not recommended.



Typhim Vi Side Effects


Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effects that occur after a dose of typhoid vaccine, even though the side effect may have gone away without treatment. Some types of side effects may mean that you should not receive any more doses of typhoid vaccine.


Check with your doctor immediately if any of the following side effects occur:


Rare
  • Difficulty in breathing or swallowing

  • hives

  • itching, especially of feet or hands

  • reddening of skin, especially around ears

  • swelling of eyes, face, or inside of nose

  • unusual tiredness or weakness (sudden and severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Fever

  • general feeling of discomfort or illness

  • headache

  • muscle pain

  • pain, redness, or swelling at place of injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Typhim Vi side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Typhim Vi resources


  • Typhim Vi Side Effects (in more detail)
  • Typhim Vi Use in Pregnancy & Breastfeeding
  • Typhim Vi Drug Interactions
  • Typhim Vi Support Group
  • 0 Reviews for Typhim Vi - Add your own review/rating


  • Typhim Vi MedFacts Consumer Leaflet (Wolters Kluwer)

  • Typhim VI Concise Consumer Information (Cerner Multum)

  • Typhoid Vaccine Monograph (AHFS DI)



Compare Typhim Vi with other medications


  • Typhoid Prophylaxis


Tisseel VH Kit


Generic Name: fibrin sealant topical (FYE brin SEE lant TOP i kal)

Brand Names: Artiss, Artiss Duo Set, Artiss Duploject, Tisseel, Tisseel Duploject Kit, Tisseel Valupak Kit


What is Tisseel VH Kit (fibrin sealant topical)?

Fibrinolysis inhibitor and thrombin are agents that are involved in blood clotting.


Fibrin sealant topical is used to cause blood clotting during surgery or due to trauma when natural blood clotting processes are deficient.


Fibrin sealant topical may also be used for purposes other than those listed here.


What is the most important information I should know about Tisseel VH Kit (fibrin sealant topical)?


Fibrin sealant topical is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although fibrin sealant topical is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using fibrin sealant topical.


Contact your doctor if you develop fever, drowsiness, chills, runny nose, rash, joint pain, poor appetite, tiredness, nausea, vomiting, abdominal pain, dark-colored urine, or yellowing of the skin or eyes following treatment with fibrin sealant topical. These may be symptoms of infections that may occur due to use of this product.


What should I discuss with my healthcare provider before using Tisseel VH Kit (fibrin sealant topical)?


Do not use fibrin sealant topical without first talking to your doctor if you are allergic to cows or products derived from cows. Fibrin sealant topical is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use fibrin sealant topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether fibrin sealant topical will be harmful to a nursing baby. Do not use fibrin sealant topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Tisseel VH Kit (fibrin sealant topical)?


Fibrin sealant topical will be administered by a healthcare professional as a topical application.


What happens if I miss a dose?


Due to the indications for use and the method of application of fibrin sealant topical, missing a dose is not likely to occur.


What happens if I overdose?


Due to the indications for use and the method of application of fibrin sealant topical, an overdose of the medication is unlikely to occur. Contact your doctor or a poison control center for advice if an overdose is suspected.


What should I avoid while taking Tisseel VH Kit (fibrin sealant topical)?


There are no restrictions on food, beverages, or activity following the use of fibrin sealant topical, unless otherwise directed by your doctor.


Tisseel VH Kit (fibrin sealant topical) side effects


Fibrin sealant topical is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although fibrin sealant topical is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using fibrin sealant topical.


Contact your doctor if you develop fever, drowsiness, chills, runny nose, rash, joint pain, poor appetite, tiredness, nausea, vomiting, abdominal pain, dark-colored urine, or yellowing of the skin or eyes following treatment with fibrin sealant topical. These may be symptoms of infections that may occur due to use of this product.


Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to fibrin sealant topical.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect fibrin sealant topical


It is not known whether other medications will interact with fibrin sealant topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with fibrin sealant topical.



More Tisseel VH Kit resources


  • Tisseel VH Kit Use in Pregnancy & Breastfeeding
  • Tisseel VH Kit Support Group
  • 0 Reviews for Tisseel VH - Add your own review/rating


  • Artiss Prescribing Information (FDA)

  • Artiss Consumer Overview



Compare Tisseel VH Kit with other medications


  • Closure of Colostomy
  • Hemostasis


Where can I get more information?


  • Your pharmacist has additional information about fibrin sealant topical written for health professionals that you may read.



Sunday, April 15, 2012

Sumatriptan Succinate



Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: C14H21N3O2S
Molecular Formula: C14H21N3O2S•C4H6O4
CAS Number: 103628-46-2
Brands: Imitrex


REMS:


FDA approved a REMS for sumatriptan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of sumatriptan and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1-like receptor agonist (“triptan”).1 2 3 4 5 6 7 8 223 224 268


Uses for Sumatriptan Succinate


Vascular Headaches


Acute treatment of migraine attacks with or without aura.1 2 3 6 7 8 9 10 13 48 80 145 148 184 195 214 217 225 249


Sub-Q for acute treatment of cluster headache episodes.1 2 49 75 183 184 185 210 214 Safety and efficacy of oral or intranasal sumatriptan for this use not established.148 249


Not recommended for management of hemiplegic or basilar migraine or for prophylaxisof migraine or cluster headache.1 7 114 158


Sumatriptan Succinate Dosage and Administration


Administration


Administer orally, intranasally, or by sub-Q injection. Do not administer IM or IV; IV administration may induce coronary vasospasm.1 148 249


To achieve maximum relief, initiate therapy as soon as possible after onset of migraine attack.50 92 108 124 148 180 237


Oral Administration


Administer orally with fluids; swallow tablet whole.148


Intranasal Administration


Administer intranasally as a single spray into 1 nostril.249


Nasal solution unit contains only 1 spray; do not test before use.249


To administer, remove unit from package just before use.249 While sitting down, gently blow nose to clear nasal passages.249 Keep head in upright position and gently close 1 nostril with index finger; exhale gently through mouth.249 With other hand, hold unit with thumb supporting at bottom and index and middle fingers on either side of nozzle.249 Insert nozzle into open nostril about ½ inch.249 While gently inhaling through nose (with closed mouth), release spray by firmly pressing plunger.249 Remove nozzle from nostril while keeping head level for 10–20 seconds and gently inhaling through nose and exhaling through mouth; do not inhale deeply.249 Consult administration instructions provided by manufacturer before use.249


Sub-Q Administration


Administer only by sub-Q injection, preferably into lateral aspect of thigh or deltoid.1 12


Do not administer IM or IV; IV administration may induce coronary vasospasm.1


Autoinjection device available for use with prefilled syringes (each containing a 4- or 6-mg dose) to facilitate self-administration.1 273 Needles with this device penetrate approximately 5–6 mm (¼ inch); use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length.1 273


Dosage


Available as sumatriptan (nasal solution) and sumatriptan succinate (tablets and injection); dosage expressed in terms of sumatriptan.1 148 249


Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.1 148 249


Adults


Vascular Headaches

Migraine

Oral

25, 50, or 100 mg as a single dose.148 274 Individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 50- or 100-mg dose; 100-mg dose may not provide substantially greater effect than 50-mg dose.148 274


If headache recurs or partial response occurs after initial dose, additional oral doses may be administered at intervals of ≥2 hours, up to a maximum oral dosage of 200 mg daily.274


If headache recurs after an initial sub-Q dose, additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.274


Intranasal

5, 10, or 20 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 20-mg dose.249 Doses >20 mg provide no additional benefit.249


To achieve a 10-mg dose, administer a single 5-mg dose into each nostril.249


If headache recurs, dose may be repeated once after 2 hours, up to a maximum dosage of 40 mg daily.249


Sub-Q

≤6 mg as a single dose.1 If dose-limiting adverse effects occur with 6-mg dose, lower doses (e.g., 4 mg) may be given.1 273 In patients receiving doses other than 4 or 6 mg, only the single-dose vials containing 6 mg/0.5 mL should be used to provide the desired dose.1 273


If headache recurs, a 6-mg sub-Q dose may be repeated once after ≥1 hour or additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.273


If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.1 2 3 6 7 8 9 174 176 181 236 237


Cluster Headache

Sub-Q

≤6 mg as a single dose.1 If dose-limiting adverse effects occur with 6-mg dose, lower doses may be administered using only single-dose vials; use autoinjection device only with prefilled, unit-of-use syringes containing 6 mg.1


If headache recurs, 6-mg dose may be repeated once after ≥1 hour, up to a maximum dosage of 12 mg in any 24-hour period.1


If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.1 2 3 6 7 8 9 174 176 181 236 237


Prescribing Limits


Adults


Vascular Headaches

Migraine

Oral

Maximum 200 mg daily; do not exceed 100 mg daily if following an initial sub-Q dose.273


Safety of treating an average of >4 headaches per 30-day period has not been established.148


Intranasal

Maximum 40 mg daily.249


Safety of treating an average of >4 headaches per 30-day period has not been established.249


Sub-Q

Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1


Cluster Headache

Sub-Q

Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1


Special Populations


Hepatic Impairment


Contraindicated in patients with severe hepatic impairment.1 148 249 Unpredictable increases in bioavailability following oraladministration in patients with hepatic impairment.148 If oral therapy is deemed advisable in these patients, do not exceed 50 mg as a single dose.148


Patients Receiving MAO-A Inhibitors


Concurrent or recent (within 2 weeks) use of MAO-A inhibitor and oral or intranasal sumatriptan is contraindicated;148 249 sub-Qsumatriptan is not generally recommended, but if concomitant use is clinically warranted, decrease sumatriptan sub-Q dosage and administer under careful medical supervision.1 237


Cautions for Sumatriptan Succinate


Contraindications



  • Known or suspected ischemic heart disease (e.g., angina pectoris, MI, silent ischemia).1 148 249




  • Coronary artery vasospasm (e.g., Prinzmetal variant angina).1 148 249




  • Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).1 148 249




  • Cerebrovascular syndromes (e.g., stroke syndrome, TIAs).1 148 249




  • Peripheral vascular ischemia (e.g., ischemic bowel disease).1 148 249




  • Hemiplegic or basilar migraine.1 148 249




  • Treatment within previous 24 hours with another 5-HT1 receptor agonist or an ergot alkaloid.1 148 249 (See Specific Drugs under Interactions.)




  • Concurrent or recent (within 2 weeks) treatment with an MAO-A inhibitor (oral and nasal sumatriptan formulations).1 148 249




  • Severe hepatic impairment.1 148 249




  • Known hypersensitivity to sumatriptan or any ingredient in the formulation.1 148 249



Warnings/Precautions


Warnings


Use oral or intranasal sumatriptan only in patients in whom a clear diagnosis of migraine has been established.148 249 Use sub-Q sumatriptan only in patients in whom a clear diagnosis of migraine or cluster headache has been established.1


Exclude other potentially serious neurologic disorders before administering sumatriptan to patients not previously diagnosed with migraine or cluster headache or to those with atypical symptoms.1 61 148 236 237


Cardiac Effects

Risk of myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbances, and death.1 148 249


Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.1 148 249


Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.1 148 249


Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy, including patients with cluster headache (predominantly males >40 years of age).1 148 249


Patients with symptoms suggestive of angina after receiving sumatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration resumed and such signs or symptoms recur, ECG evaluation recommended.1 148 249


Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal.1 148 249


Risk of certain cerebrovascular events (e.g., stroke, TIA) may be increased in patients with migraine.1 148 249


Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported.1 148 249 Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic bowel syndrome, Raynaud’s syndrome) occur following administration.1 6 8


Substantial increases in BP, including hypertensive crises, reported rarely in patients with or without history of hypertension; administer with caution in patients with controlled hypertension as transient increases in BP and peripheral vascular resistance are possible.1 148 249 (See Contraindications under Cautions.)


Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT1 receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).272 273 274 275 Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).272 273 274 275


Local Effects

Possible transient irritation in nose and throat (e.g., burning, numbness, paresthesia, discharge, pain/soreness), sometimes severe, after intranasal administration; symptoms usually resolve in <2 hours.249 Effects of extended and repeated use on nasal and/or respiratory mucosa not systematically evaluated.249


Sensitivity Reactions


Hypersensitivity

Hypersensitivity reactions (e.g., anaphylaxis/anaphylactoid reactions), possibly life-threatening or fatal, reported rarely; increased risk in patients with history of sensitivity to multiple allergens.1 148 249


General Precautions


Seizures

Seizures reported rarely; use with caution in patients with a history of seizures or with conditions associated with a lowered seizure threshold.273 274 275


Ocular Effects

Possible accumulation of sumatriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.1 148 249


Corneal opacities and corneal epithelial defects reported in dogs. No specific recommendations for monitoring.


Specific Populations


Pregnancy

Category C.1 148 249 Sumatriptan Pregnancy Registry at 800-336-2176.1 148 249


Lactation

Distributed into human milk.1 148 249 The manufacturer recommends avoiding breast-feeding for 12 hours after receiving sumatriptan oral tablets, sub-Q injection, or nasal spray.273 274 275


Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.1 148 249


Geriatric Use

Use not recommended due to possible decreased hepatic function, potential for more pronounced increases in BP, and increased risk for CAD in geriatric patients.1 148 249


Hepatic Impairment

Contraindicated in patients with severe hepatic impairment.1 148 249 Due to important role of the liver in presystemic clearance of oral sumatriptan, dosage adjustment recommended if oral therapy is deemed advisable in patients with hepatic impairment.148 (See Special Populations under Dosage and Administration.)


Common Adverse Effects


With oral therapy, pain/pressure sensations in chest/neck/throat/jaw, paresthesia, warm or cold sensation, malaise/fatigue, vertigo.148


With intranasal therapy, taste disturbances, nausea, vomiting, disorder/discomfort of nasal cavity or sinuses.249


With sub-Q therapy, injection site reaction, atypical sensations (e.g., tingling, warm/hot sensation, burning, feeling of heaviness, pressure, tightness, numbness), dizziness/vertigo, flushing, mouth/tongue discomfort, weakness, neck pain/stiffness, chest discomfort.1


Interactions for Sumatriptan Succinate


Metabolized principally by MAO-A isoenzyme in vitro.148


Protein-bound Drugs


Effect on protein binding of other drugs has not been evaluated,1 but expected to be minor due to low-level protein binding of sumatriptan.148 249


Specific Drugs




































Drug



Interaction



Comments



Acetaminophen



Pretreatment with oral sumatriptan followed by acetaminophen affected rate, but not extent of acetaminophen absorption over 8 hours187



Alcohol



Administration of alcohol 30 minutes prior to oral sumatriptan did not affect sumatriptan pharmacokinetics44 45 148 236



Amitriptyline



Concomitant use did not affect sumatriptan efficacy1 40 62



Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)



Potentially life-threatening serotonin syndrome272 273 274 275



Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated272 273 274 275



Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)



Additive vasospastic effects1 148 249



Use within 24 hours contraindicated1 148 249



5-HT1receptor agonists



Additive vasospastic effects1 148 249



Use within 24 hours contraindicated1 148 249



MAO inhibitors



MAO-A inhibitors decrease sumatriptan clearance, resulting in substantially increased systemic exposure; no substantial effect on sumatriptan metabolism seen with an MAO-B inhibitor1 148 249



Use of nasal or oralsumatriptan within 2 weeks of MAO-A inhibitor contraindicated; although not generally recommended, if clinically warranted, sub-Q sumatriptan may be used concurrently with MAO-A inhibitors with appropriate dosage adjustment and careful monitoring1 237



Propranolol



Concomitant use did not affect sumatriptan efficacy;1 40 62 pretreatment with propranolol did not alter pharmacokinetics or pharmacodynamics of oral sumatriptan62



Verapamil



Concomitant use did not affect sumatriptan efficacy1 40 62



Xylometazoline



Topical application of xylometazoline to nasal mucosa 15 minutes prior to intranasal sumatriptan did not affect sumatriptan pharmacokinetics249


Sumatriptan Succinate Pharmacokinetics


Absorption


Bioavailability


Absorbed rapidly after oral, intranasal, or sub-Q administration, with peak plasma concentrations attained within approximately 0.5–5 hours, 0.8–1.8 hours, or 5–20 minutes, respectively.1 2 3 13 45 61 78 79 89 96 123 146 148 166 168 236 Bioavailability after sub-Q administration averages 97% of that obtained with IV administration1 44 ; bioavailability after oral or intranasal administration averages only about 15 or 17%, respectively, principally due to presystemic metabolism and in part due to incomplete absorption.2 13 14 44 45 61 89 146 148 166 168 249


Oral absorption is not appreciably affected by gastric stasis that may occur during migraine attack,3 13 45 146 but time to peak concentration is prolonged by about 30 minutes;3 13 45 96 146 148 pharmacokinetics after sub-Q injection appear to be similar during migraine attacks and pain-free periods.1


Special Populations


In patients with hepatic impairment, bioavailability after oral administration may be markedly increased.148 In a small study, AUC and peak plasma concentrations increased approximately 70% and time to peak plasma concentrations occurred 40 minutes earlier after oral administration compared with such values in healthy adults.148


Onset


After oral administration, onset of relief of migraine symptoms generally occurs within 1–3 hours after single doses (25–100 mg),92 148 162 178 191 with maximum pain relief attained within 3–6 hours.148 178 191


After intranasal administration, onset of headache relief occurs within 30 minutes following a 10-, 20-, or 40-mg dose.123 243


After sub-Q administration, onset of pain relief usually occurs within 10–34 minutes in patients with moderate to severe migraine headache pain, with maximum relief attained within 1–2 hours;1 8 9 13 47 56 162 176 181 onset of pain relief generally occurs within 4–7 minutes in patients with cluster headache, with headache resolution shortly thereafter.40 49 75 184


Food


Food does not appreciably affect oral bioavailability, but prolongs time to peak concentration.2 13 44 148


Distribution


Extent


Rapidly and widely distributed into body tissues after sub-Q administration.1 14 146 148 168


Distributed into human milk;1 148 only small amounts cross placenta by passive transport in vitro.235


Plasma Protein Binding


Approximately 14–21%.1 14 45 148


Elimination


Metabolism


Metabolized in the liver and possibly in the GI tract principally to inactive indole acetic acid metabolite and other minor metabolites;1 2 3 13 14 104 148 166 metabolized principally by MAO-A isoenzyme in vitro.1 37 48 148


Elimination Route


After oral administration, excreted in urine (57–60%) and feces (37–40%); only 3 and 9% of dose is excreted as unchanged drug in urine and feces, respectively.14 45 148 13 45 148 166 168 After sub-Q administration, approximately 22 or 38–53% of dose is excreted in urine unchanged or as indole acetic acid metabolite, respectively;1 45 168 0.6 and 3.3% of dose is excreted in feces as unchanged drug and indole acetic acid metabolite, respectively.2 13 14 45


Half-life


1.5–2.6 hours.1 6 44 45 78 79 89 91 148 166 168 249


Special Populations


In patients with renal impairment, pharmacokinetics not evaluated, but little clinical effect expected since drug is largely metabolized to an inactive metabolite.1 148 249


Stability


Storage


Oral


Tablets

2–30°C.148


Intranasal


Solution

2–30°C; protect from light.249


Parenteral


Injection

2–30°C; protect from light.1


Actions



  • Binds with high affinity to 5-HT type 1-like receptors, probably 5-HT1B and 5-HT1D subtypes.1 2 3 4 5 6 7 8 223 224




  • Precise mechanism of action not established;4 6 9 13 77 87 may ameliorate migraine and cluster headache through selective constriction of certain large cranial blood vessels and/or inhibition of neurogenic inflammatory processes in the CNS.1 2 3 6 7 9 10 13 47 66 73 77 88 110 119 131 177 184 186 217 236 237



Advice to Patients



  • Importance of immediately informing a clinician of any tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck, as well as sudden and/or severe abdominal pain, shortness of breath, wheezing, heart throbbing, facial swelling (e.g., eyelids, face, lips), rash, or hives after taking sumatriptan and of not taking sumatriptan again until evaluated by a clinician.1




  • Importance of taking sumatriptan exactly as prescribed.1 148 249




  • Importance of providing patient a copy of manufacturer’s patient information.1 148 249 Importance of clinician providing adequate instructions, as well as the written administration instructions supplied with the autoinjection device or nasal spray, before first use.1 171 249




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).1 148 249




  • Importance of informing patients of risk of serotonin syndrome with concurrent use of sumatriptan and an SSRI or SNRI.272 273 274 275 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.272 273 274 275




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 148 249




  • Importance of informing patients of other important precautionary information.1 148 249 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


















Sumatriptan

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Nasal



Solution



5 mg/0.1 mL



Imitrex Nasal Spray



GlaxoSmithKline



20 mg/0.1 mL



Imitrex Nasal Spray



GlaxoSmithKline

































Sumatriptan Succinate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



25 mg (of sumatriptan)



Imitrex



GlaxoSmithKline



50 mg (of sumatriptan)



Imitrex



GlaxoSmithKline



100 mg (of sumatriptan)



Imitrex



GlaxoSmithKline



Parenteral



Injection, for sub-Q use only



4 mg/0.5 mL (of sumatriptan)



Imitrex (available in 0.5-mL [4-mg] unit-of-use syringes)



GlaxoSmithKline



6 mg/0.5 mL (of sumatriptan)



Imitrex (available in 0.5-mL [6-mg] unit-of-use syringes and as 0.5 mL [6-mg] single-dose vials)



GlaxoSmithKline


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Imitrex 100MG Tablets (GLAXO SMITH KLINE): 9/$250.99 or 27/$743.93


Imitrex 20MG/ACT Solution (GLAXO SMITH KLINE): 6/$270.98 or 18/$790.96


Imitrex 25MG Tablets (GLAXO SMITH KLINE): 9/$272.65 or 27/$791.50


Imitrex 5MG/ACT Solution (GLAXO SMITH KLINE): 1/$55.49 or 3/$136.30


Imitrex 50MG Tablets (GLAXO SMITH KLINE): 9/$266.99 or 27/$774.99


Imitrex STATdose Refill 6MG/0.5ML Solution (GLAXO SMITH KLINE): 1/$217.16 or 3/$603.25


Imitrex STATdose System 6MG/0.5ML Solution (GLAXO SMITH KLINE): 1/$217.16 or 3/$628.59


SUMAtriptan 20MG/ACT Solution (SANDOZ): 1/$45.99 or 3/$119.96


SUMAtriptan 5MG/ACT Solution (SANDOZ): 1/$45.99 or 3/$125.97


SUMAtriptan Succinate 100MG Tablets (SUN PHARMACEUTICAL): 9/$199.97 or 27/$569.98


SUMAtriptan Succinate 25MG Tablets (SUN PHARMACEUTICAL): 9/$219.99 or 27/$619.95


SUMAtriptan Succinate 50MG Tablets (SUN PHARMACEUTICAL): 9/$199.99 or 27/$569.97


Sumavel DosePro 6MG/0.5ML Device (ZOGENIX): 1/$101.99 or 2/$291.97


Treximet 85-500MG Tablets (GLAXO SMITH KLINE): 9/$216.99 or 27/$607.99



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Glaxo Wellcome. Imitrex (sumatriptan succinate) injection prescribing information. Research Triangle Park, NC; 2001 Mar.



2. Hsu VD. Sumatriptan: a new drug for vascular headache. Clin Pharm. 1992; 11:919-29. [IDIS 303852] [PubMed 1334452]



3. Bateman DN. Sumatriptan. Lancet. 1993; 341:221-4. [IDIS 308640] [PubMed 8093509]



4. Peroutka SJ. Serotonin receptor subtypes and neuropsychiatric diseases: focus on 5-HT1D and 5-HT3 receptor agents. Pharmacol Rev. 1991; 43:579-86. [IDIS 296518] [PubMed 1663621]



5. MacIntyre PD, Bhargava B, Hogg KJ et al. Effect of subcutaneous sumatriptan, a selective 5HT1 agonist, on the systemic, pulmonary, and coronary circulation. Circulation. 1993; 87:401-5. [IDIS 309421] [PubMed 8381056]



6. Fullerton T, Gengo FM. Sumatriptan: a selective 5-hydroxytryptamine receptor agonist for the acute treatment of migraine. Ann Pharmacother. 1992; 26:800-8. [IDIS 298261] [PubMed 1319244]



7. Anon. Sumatriptan for migraine. Med Lett Drugs Ther. 1992; 34:91-3. [PubMed 1326077]



8. Ferrari MD and the Subcutaneous Sumatriptan International Study Group. Treatment of migraine attacks with sumatriptan. N Engl J Med. 1991; 325:316-21. [IDIS 283296] [PubMed 1647495]



9. Cady RK, Wendt JK, Kirchner JR et al. Treatment of acute migraine with subcutaneous sumatriptan. JAMA. 1991; 265:2831-5. [IDIS 281579] [PubMed 1851894]



10. Friberg L, Olesen J, Iversen HK et al. Migraine pain associated with middle cerebral artery dilatation: reversal by sumatriptan. Lancet. 1991; 338:13-7. [IDIS 282832] [PubMed 1676084]



11. Fox AW, Poe TE. Use and safety of sumatriptan. Clin Pharm. 1993; 12:258. [IDIS 311529] [PubMed 8384541]



12. Glaxo, Research Triangle Park, NC: Personal communication.



13. Plosker GL, McTavish D. Sumatriptan: a reappraisal of its pharmacology and therapeutic efficacy in the acute treatment of migraine and cluster headache. Drugs. 1994; 47:622-51. [PubMed 7516861]



14. Dixon CM, Saynor DA, Andrew PD et al. Disposition of sumatriptan in laboratory animals and humans. Drug Metabol Disp. 1993; 21:761-9.



15. Dechant KL, Clissold SP. Sumatriptan: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the acute treatment of migraine and cluster headache. Drugs. 1992; 43:776-98. [PubMed 1379152]



16. D’Arcy PF. Adverse drug reaction (ADR) problems with sumatriptan. Intl Pharm J. 1992; 6:264-5.



17. D’Arcy PF. Warnings from the UK committee on safety of medicines: chest pain with sumatriptan. Intl Pharm J. 1992; 6:217-8.



18. Willett F, Curzen N, Adams J et al. Coronary vasospasm induced by subcutaneous sumatriptan. BMJ. 1992; 304:1415. [IDIS 297248] [PubMed 1320974]



19. Price LH, Charney DS, Delgado PL et al. Lithium treatment and serotoninergic function. Arch Gen Psych. 1989; 46:13-9.



20. Castle WM, Simmons VE. Coronary vasospasm and sumatriptan. BMJ. 1992; 305:117-8. [IDIS 299098] [PubMed 1322216]