Therasoft Anti-Itch & Dermatitis

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Ala-Cort


• Ala-Scalp HP


• Anusol HC


• Aquanil HC


• Beta HC


• Caldecort


• Cetacort


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Locoid Lipocream


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Liquid


• Gel/Jelly


• Kit


• Foam


• Stick


• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Therasoft Anti-Itch & Dermatitis

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Therasoft Anti-Itch & Dermatitis

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 hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Therasoft Anti-Itch & Dermatitis. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more 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 cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, shake it well before using.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two to four times per day.
    
    
    • Children—Apply to the affected area of the skin two to four times per day.
    
    
  
  
  • For topical dosage form (ointment):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

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

Precautions While Using Therasoft Anti-Itch & Dermatitis

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

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

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Therasoft Anti-Itch & Dermatitis 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

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the 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:

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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.

More Therasoft Anti-Itch & Dermatitis resources

• Therasoft Anti-Itch & Dermatitis Use in Pregnancy & Breastfeeding
• Therasoft Anti-Itch & Dermatitis Drug Interactions
• Therasoft Anti-Itch & Dermatitis Support Group
• 15 Reviews for Therasoft Anti-Itch & Dermatitis - Add your own review/rating

Compare Therasoft Anti-Itch & Dermatitis with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Triaminic Cough/Sore Throat Chewable Tablets

Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Pseudoephedrine
Brand Name: Triaminic Cough/Sore Throat

Triaminic Cough/Sore Throat Chewable Tablets are used for:

Relieving pain, congestion, and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Triaminic Cough/Sore Throat Chewable Tablets are an analgesic, decongestant, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you breathe more easily. The analgesic and cough suppressant work in the brain to decrease pain and reduce the cough reflex.

Do NOT use Triaminic Cough/Sore Throat Chewable Tablets if:

• you are allergic to any ingredient in Triaminic Cough/Sore Throat Chewable Tablets


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Triaminic Cough/Sore Throat Chewable Tablets:

Some medical conditions may interact with Triaminic Cough/Sore Throat Chewable Tablets. 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 a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day


• if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Triaminic Cough/Sore Throat Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Triaminic Cough/Sore Throat Chewable Tablets may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine because the risk of side effects may be increased by Triaminic Cough/Sore Throat Chewable Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Triaminic Cough/Sore Throat Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triaminic Cough/Sore Throat Chewable Tablets 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 Triaminic Cough/Sore Throat Chewable Tablets:

Use Triaminic Cough/Sore Throat Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Triaminic Cough/Sore Throat Chewable Tablets may be taken with or without food.


• Chew thoroughly before swallowing.


• If you miss a dose of Triaminic Cough/Sore Throat Chewable Tablets, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Triaminic Cough/Sore Throat Chewable Tablets.

Important safety information:

• Triaminic Cough/Sore Throat Chewable Tablets may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Triaminic Cough/Sore Throat Chewable Tablets. Using Triaminic Cough/Sore Throat Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take appetite suppressants while you are taking Triaminic Cough/Sore Throat Chewable Tablets without checking with your doctor.


• Triaminic Cough/Sore Throat Chewable Tablets contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Triaminic Cough/Sore Throat Chewable Tablets for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Triaminic Cough/Sore Throat Chewable Tablets may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Triaminic Cough/Sore Throat Chewable Tablets or other pain relievers/fever reducers. Alcohol use combined with Triaminic Cough/Sore Throat Chewable Tablets may increase your risk for liver damage.


• Triaminic Cough/Sore Throat Chewable Tablets may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Triaminic Cough/Sore Throat Chewable Tablets.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Triaminic Cough/Sore Throat Chewable Tablets.


• Use Triaminic Cough/Sore Throat Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Triaminic Cough/Sore Throat Chewable Tablets in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Triaminic Cough/Sore Throat Chewable Tablets, discuss with your doctor the benefits and risks of using Triaminic Cough/Sore Throat Chewable Tablets during pregnancy. It is unknown if Triaminic Cough/Sore Throat Chewable Tablets are excreted in breast milk. Do not breast-feed while taking Triaminic Cough/Sore Throat Chewable Tablets.

Possible side effects of Triaminic Cough/Sore Throat Chewable Tablets:

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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

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.

See also: Triaminic Cough/Sore Throat side effects (in more detail)

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. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Triaminic Cough/Sore Throat Chewable Tablets:

Store Triaminic Cough/Sore Throat Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Triaminic Cough/Sore Throat Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Triaminic Cough/Sore Throat Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Triaminic Cough/Sore Throat Chewable Tablets are 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 Triaminic Cough/Sore Throat Chewable Tablets. 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 Triaminic Cough/Sore Throat resources

• Triaminic Cough/Sore Throat Side Effects (in more detail)
• Triaminic Cough/Sore Throat Use in Pregnancy & Breastfeeding
• Triaminic Cough/Sore Throat Drug Interactions
• Triaminic Cough/Sore Throat Support Group
• 1 Review for Triaminic Cough/Sore Throat - Add your own review/rating

Compare Triaminic Cough/Sore Throat with other medications

• Cold Symptoms

Solaraze Gel

Pronunciation: dye-KLOE-fen-ak
Generic Name: Diclofenac
Brand Name: Solaraze

Solaraze Gel is used for:

Treating actinic keratoses, a precancerous skin growth usually caused by sun exposure. It may also be used for other conditions as determined by your doctor.

Solaraze Gel is a nonsteroidal anti-inflammatory drug (NSAID). The way Solaraze Gel works to treat actinic keratoses is not fully understood.

Do NOT use Solaraze Gel if:

• you are allergic to any ingredient in Solaraze Gel, including benzyl alcohol, polyethylene glycol, or hyaluronate sodium

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

Before using Solaraze Gel:

Some medical conditions may interact with Solaraze Gel. 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 had a severe allergic reaction (eg, a severe rash, hives, difficulty breathing, dizziness) to aspirin or an NSAID (eg, ibuprofen, naproxen, celecoxib)


• if you have growths in the nose (nasal polyps), kidney or liver problems, the blood disease porphyria, asthma, or stomach or bowel ulcers or bleeding

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

• Aspirin or NSAIDs (eg, ibuprofen) because the risk of their side effects may be increased by Solaraze Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Solaraze Gel 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 Solaraze Gel:

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

• Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed. Make sure you use enough medicine to cover the entire treated area.


• Do not cover the skin being treated with bandages, dressings, or wraps, unless directed otherwise by your doctor.


• Unless you are treating your hands, wash your hands with soap and water after applying Solaraze Gel to remove any medicine on the hands.


• Do not apply Solaraze Gel to open skin wounds or infected skin. Do not apply to red or irritated skin without first checking with your doctor.


• If you miss a dose of Solaraze Gel, 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 Solaraze Gel.

Important safety information:

• Solaraze Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get Solaraze Gel in any of these areas, rinse well with cool tap water.


• Solaraze Gel has diclofenac in it. Before you start any new medicine, check the label to see if it has diclofenac or another NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Avoid the sun, sunlamps, or tanning booths while you are using Solaraze Gel. Discuss any questions or concerns with your doctor.


• Improvement of your condition may not be obvious for up to 30 days after you stop using Solaraze Gel. If no improvement is seen, contact your doctor.


• Do not use other skin products (eg, cosmetics, lotions, sunscreens) on the treated area without checking with your doctor.


• Solaraze Gel should not be used in CHILDREN; safety and effectiveness in 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 Solaraze Gel while you are pregnant. Solaraze Gel is not recommended during the last 3 months of pregnancy. It may cause harm to the fetus. It is not known if Solaraze Gel is found in breast milk. Do not breast-feed while taking Solaraze Gel.

Possible side effects of Solaraze Gel:

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:

Dry skin; flu-like symptoms; peeling, scaling, or flaking of the skin.

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); abnormal skin sensations; chest pain; eye redness or swelling (conjunctivitis); inflammation, swelling, or severe irritation of the skin; muscle pain; open sores on the skin (ulcers); shortness of breath.

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.

See also: Solaraze side effects (in more detail)

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. Symptoms may include decreased urination; seizures; stomach irritation; trouble breathing.

Proper storage of Solaraze Gel:

Store Solaraze Gel at controlled room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Solaraze Gel out of the reach of children and away from pets.

General information:

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


• Solaraze Gel 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 Solaraze Gel. 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 Solaraze resources

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

Compare Solaraze with other medications

• Actinic Keratosis

TobraDex ST

tobramycin and dexamethasone

Dosage Form: ophthalmic suspension
FULL PRESCRIBING INFORMATION

Indications and Usage for TobraDex ST

TOBRADEX® ST ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci, including some Group A and other beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris isolates, Haemophilus influenzae, H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

TobraDex ST Dosage and Administration

Recommended Dosing

Instill one drop into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Prescription Guideline

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in WARNINGS AND PRECAUTIONS (5).

Dosage Forms and Strengths

TobraDex ST ophthalmic suspension contains 3 mg/mL tobramycin and 0.5 mg/mL dexamethasone.

Contraindications

Nonbacterial Etiology

TobraDex ST, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. (4.1)

Hypersensitivity

Hypersensitivity to a component of the medication.

Warnings and Precautions

IOP increase

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.

Aminoglycoside sensitivity

Sensitivity to topically applied aminoglycosides may occur.

Cataracts

Use of corticosteroids may result in posterior subcapsular cataract formation.

Delayed Healing

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Bacterial infections

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

Viral infections

Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal infections

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

Use with systemic aminoglycosides

If product is used in combination with systemic aminoglycoside antibiotics the patient should be monitored for total serum concentration.

Adverse Reactions

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available.

The most frequent adverse reactions to topical ocular tobramycin (TOBREX®) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.

The reactions due to the steroid component are: increased intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing.

Secondary Infection.

The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnanacy Category C. Corticosteroids have been shown to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day (equivalent to human doses of 16 and 32 mg/kg/day, respectively) and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. TOBRADEX® ST ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TOBRADEX® ST is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

TobraDex ST Description

TOBRADEX® ST (tobramycin / dexamethasone ophthalmic suspension) 0.3%/0.05% is a sterile, isotonic, white, aqueous antibiotic and steroid suspension with a pH of approximately 5.7 and an osmolality of approximately 290 mOsm/kg.

The chemical name of tobramycin is O - 3 - amino - 3 - deoxy - α - D - glucopyranosyl - (14) - O - [2,6 - diamino - 2,3,6 - trideoxy - α - D - ribo - hexopyranosyl - (16)] - 2 - deoxy - L-streptamine. It has a molecular formula of C18H37N5O9 and a molecular weight of 467.52. The chemical structure is:

The chemical name of dexamethasone is 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of C22H29FO5 and a molecular weight of 392.47. The chemical structure is:

Each mL of TOBRADEX® ST contains: Actives: tobramycin 3 mg and dexamethasone 0.5 mg. Preservative: benzalkonium chloride 0.1 mg. Inactives: xanthan gum, tyloxapol, edetate disodium, sodium chloride, propylene glycol, sodium sulfate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.

TobraDex ST - Clinical Pharmacology

Mechanism of Action

Dexamethasone is a potent corticoid. Corticoids suppress the inflammatory response to a variety of agents and they can delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.

Tobramycin is an antibacterial drug. It inhibits the growth of bacteria by inhibiting protein synthesis. Tobramycin is included in this combination product to provide action against susceptible bacteria.

Pharmacokinetics

In a multi-center, double-masked, parallel-group, randomized, single-dose pharmacokinetic study in male and female cataract surgery patients, mean dexamethasone concentrations following administration of TobraDex ST were similar to dexamethasone concentrations following administration of TOBRADEX (tobramycin /dexamethasone ophthalmic suspension) 0.3%/0.1%. Aqueous humor concentrations reached a mean peak of 33.7 ng/mL 2 hours following single-dose administration of TobraDex ST.

No data are available on the extent of systemic absorption of dexamethasone or tobramycin from TobraDex ST ophthalmic suspension. Following multiple-dose (QID for 2 days) bilateral ocular administration of TOBRADEX (Tobramycin 0.3%/Dexamethasone 0.1% ophthalmic suspension) in healthy male and female volunteers, peak plasma concentrations of dexamethasone were less than 1 ng/mL and occurred within 2 hours post-dose across all subjects.

Microbiology

The antibiotic component (tobramycin) in the combination is included to provide action against susceptible bacteria. In vitro studies have demonstrated that tobramycin is active against susceptible isolates of the following bacteria: Staphylococcus aureus (includes penicillin-resistant isolates), Staphylococcus epidermidis (includes penicillin-resistant isolates), Streptococci, including some Group A other beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Haemophilus aegypticus, Klebsiella pneumoniae, Moraxella lacunata, Morganella morganii, Neisseria perflava, Neisseria sicca, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa.

In vitro bacterial studies demonstrate that in some cases bacteria resistant to gentamicin are susceptible to tobramycin.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day (equivalent to human doses of 8 and 16 mg/kg/day, at least 2 orders of magnitude greater than the topical ocular dose).

How Supplied/Storage and Handling

TOBRADEX® ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER® bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.

NDC 0065-0652-25: 2.5 mL

NDC 0065-0652-05: 5 mL

NDC 0065-0652-10: 10 mL

Storage

Store at 2° to 25°C (36° to 77°F).

Protect from light.

Patient Counseling Information

Storage and Handling

Patients should be instructed to store the bottle upright and away from light. Shake well before using.

Avoid Contamination

Patients should be instructed not to touch dropper tip to any surface, as this may contaminate the contents.

Contact Lens Wear

Contact lenses should not be worn during the use of this product.

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

Printed in USA

U.S. Patent No. 7,795,316

©2008, 2011 Alcon, Inc.

        

9006383-0111

PRINCIPAL DISPLAY PANEL

NDC 0065-0652-05

     

TobraDex®ST

(tobramycin/dexamethasone

ophthalmic suspension)

0.3%/0.5%

     

STERILE

5 mL

Alcon®

TobraDex ST  tobramycin / dexamethasone  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0652 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 mL DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 0.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   XANTHAN GUM   TYLOXAPOL   EDETATE DISODIUM   SODIUM CHLORIDE   PROPYLENE GLYCOL   SODIUM SULFATE   HYDROCHLORIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0652-25 2.5 mL In 1 BOTTLE None 2 0065-0652-05 5 mL In 1 BOTTLE None 3 0065-0652-10 10 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050818	09/07/2010

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 07/2011Alcon Laboratories, Inc.

More TobraDex ST resources

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

• TobraDex ST Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• TobraDex Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Tobradex Consumer Overview


• Tobradex ST Advanced Consumer (Micromedex) - Includes Dosage Information

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• Conjunctivitis, Bacterial
• Keratitis
• Uveitis

Tinactin Plus Aerosol Powder Topical

Generic Name: tolnaftate (Topical route)

tol-NAF-tate

Commonly used brand name(s)

In the U.S.

• Absorbine Jr. Antifungal


• Aftate


• Blis-To-Sol


• Dermasept Antifungal


• Fungi-Guard


• Podactin


• Q-Naftate


• Tinactin


• Tinaderm


• Ting

In Canada

• Athlete's Foot Gel


• Dr. Scholl's Athlete's Foot


• Pitrex


• Scholl's Athlete's Foot Spray


• Scholl Tritin Antifungal Powder


• Scholl Tritin Antifungal Spray Powder


• Tinactin Aerosol Liquid


• Tinactin Aerosol Powder


• Tinactin Jock Itch


• Tinactin Plus


• Tinactin Plus Aerosol Powder

Available Dosage Forms:

• Ointment


• Spray


• Cream


• Lotion


• Gel/Jelly


• Powder


• Solution

Therapeutic Class: Antifungal

Uses For Tinactin Plus Aerosol Powder

Tolnaftate belongs to the group of medicines called antifungals. It is used to treat some types of fungus infections. It may also be used together with medicines taken by mouth for fungus infections.

Tolnaftate is available without a prescription.

Before Using Tinactin Plus Aerosol Powder

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

Tolnaftate should not be used on children up to 2 years of age, unless otherwise directed by your doctor. Although there is no specific information comparing use of tolnaftate in children 2 years of age and older with use in other age groups, this medicine is not expected to cause different side effects or problems in children 2 years of age and older 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 or if they cause different side effects or problems in older people. There is no specific information comparing use of tolnaftate in the elderly with use in other age groups.

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.

Proper Use of tolnaftate

This section provides information on the proper use of a number of products that contain tolnaftate. It may not be specific to Tinactin Plus Aerosol Powder. Please read with care.

Before applying tolnaftate, wash the affected area and dry thoroughly. Then apply enough medicine to cover the affected area.

Keep this medicine away from the eyes.

For patients using the powder form of this medicine:

• If the powder is used on the feet, sprinkle it between toes, on feet, and in socks and shoes.

For patients using the aerosol powder form of this medicine:

• Shake well before using.


• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between toes, on feet, and in socks and shoes.


• Do not inhale the powder.


• Do not use near heat, near open flame, or while smoking.

For patients using the solution form of this medicine:

• If tolnaftate solution becomes a solid, it may be dissolved by warming the closed container of medicine in warm water.

For patients using the aerosol solution form of this medicine:

• Shake well before using.


• From a distance of 6 inches, spray the solution on the affected areas. If it is used on the feet, spray between toes and on feet.


• Do not inhale the vapors from the spray.


• Do not use near heat, near open flame, or while smoking.

To help clear up your infection completely, keep using this medicine for 2 weeks after burning, itching, or other symptoms have disappeared , unless otherwise directed by your doctor. Do not miss any doses.

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 topical dosage forms (aerosol powder, aerosol solution, cream, gel, powder, or topical solution):
  
  • For fungus infections:
    
    • Adults and children 2 years of age and over—Apply to the affected area(s) of the skin two times a day.
    
    
    • Children up to 2 years of age—Use is not recommended except under the advice and supervision of your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tinactin Plus Aerosol Powder

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

To help prevent reinfection after the period of treatment with this medicine, the powder or spray powder form of this medicine may be used each day after bathing and carefully drying the affected area.

Tinactin Plus Aerosol Powder 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 as soon as possible if any of the following side effects occur:

• Skin irritation not present before use of this medicine

When you apply the aerosol solution form of this medicine, a mild temporary stinging may be expected.

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: Tinactin Plus Topical 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 Tinactin Plus Aerosol Powder Topical resources

• Tinactin Plus Aerosol Powder Topical Side Effects (in more detail)
• Tinactin Plus Aerosol Powder Topical Use in Pregnancy & Breastfeeding
• Tinactin Plus Aerosol Powder Topical Support Group
• 0 Reviews for Tinactin Plus Topical - Add your own review/rating

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• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Triactin

Pronunciation: dye-SYE-kloe-meen
Generic Name: Dicyclomine
Brand Name: Examples include Bentyl and Triactin

Triactin is used for:

Treatment of the symptoms of irritable bowel syndrome. It may also be used for other conditions as determined by your doctor.

Triactin is an anticholinergic. It works by blocking a chemical in the smooth muscle of the stomach and intestines causing them to relax, which reduces cramping.

Do NOT use Triactin if:

• you are allergic to any ingredient in Triactin


• you have blockage of the esophagus, stomach, intestine, or urinary tract


• you have heart problems due to severe bleeding


• you have glaucoma


• you have inflammation of the esophagus due to acid reflux, loss of strength in the intestinal muscles, or chronic inflammation and ulceration of the bowels


• you have myasthenia gravis (a condition in which the muscles become progressively paralyzed)


• you are breast-feeding

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

Before using Triactin:

Some medical conditions may interact with Triactin. 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 chronic inflammation or ulcers of the bowel, diarrhea, enlargement of the prostate, hiatal hernia, kidney or liver disease, a nervous system disease, overactive thyroid, or urinary blockage or retention


• if you have heart disease, heart failure, a history of rapid heartbeat, or high blood pressure


• if you are at risk for glaucoma

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

• Amantadine, antiarrhythmics (eg, quinidine), antihistamines (eg, diphenhydramine), benzodiazepines (eg, diazepam), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic pain medicine (eg, meperidine), nitrates (eg, nitroglycerin, isosorbide), nitrites (eg, sodium nitrite), phenothiazines (eg, chlorpromazine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Triactin's side effects


• Metoclopramide or phenothiazines (eg, chlorpromazine) because their effectiveness may be decreased by Triactin


• Digoxin because the risk of its side effects may be increased by Triactin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triactin 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 Triactin:

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

• Take Triactin by mouth on an empty stomach at least 30 minutes before eating unless otherwise directed by your doctor.


• If you are also taking antacids, you may need to separate them from Triactin. Ask your doctor or pharmacist for more information.


• Take Triactin on a regular schedule around the clock, unless your doctor tells you otherwise.


• If you miss a dose of Triactin, take 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 take 2 doses at once.

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

Important safety information:

• Triactin may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Triactin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Triactin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Triactin may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Use Triactin with caution in the ELDERLY; they may be more sensitive to its effects.


• Triactin should not be used in CHILDREN younger than 6 months 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 Triactin while you are pregnant. Triactin is found in breast milk. Do not breast-feed while taking Triactin.

Possible side effects of Triactin:

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:

Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth; headache; lightheadedness; loss of taste; nausea; nervousness.

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); agitation; confusion; diarrhea; difficulty focusing your eyes; difficulty moving; difficulty speaking; difficulty urinating; disorientation; exaggerated sense of well-being; fainting; hallucinations; pounding in the chest, rapid heartbeat; short-term memory loss; unusual weakness; vomiting.

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.

See also: Triactin side effects (in more detail)

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. Symptoms may include blurred vision; convulsions (seizures); difficulty breathing; dilated pupils; disorientation; excessive thirst; flushed, hot, dry skin; hallucinations or unusual behavior; muscle weakness; nausea; rapid heartbeat and breathing; restlessness; unusual dizziness or drowsiness; unusually dry mouth; vomiting.

Proper storage of Triactin:

Store at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Triactin out of the reach of children and away from pets.

General information:

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


• Triactin 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 Triactin. 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 Triactin resources

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

• Triactin Concise Consumer Information (Cerner Multum)

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• Colitis
• Irritable Bowel Syndrome

Tetterine Topical

Generic Name: miconazole (Topical route)

mye-KON-a-zole

Commonly used brand name(s)

In the U.S.

• Aloe Vesta 2-N-1 Antifungal


• Aloe Vesta Antifungal


• Baza Antifungal


• Carrington Antifungal


• Derma Gran AF


• DiabetAid Antifungal Foot Bath


• Fungoid


• Lotrimin AF


• Micatin


• Micro-Guard


• Mitrazol


• Monistat 1


• Monistat Derm


• Neosporin AF


• QC Miconazole Nitrate


• Secura Antifungal


• Soothe & Cool Inzo Antifungal


• Tetterine


• Therasoft Antifungal


• Triple Care Antifungal


• Triple Care EPC


• Zeasorb-AF

Available Dosage Forms:

• Lotion


• Tablet, Effervescent


• Cream


• Ointment


• Powder


• Kit


• Gel/Jelly


• Tincture


• Spray

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Tetterine

Miconazole belongs to the group of medicines called antifungals. Topical miconazole is used to treat some types of fungus infections.

Some of these preparations may be available without a prescription.

Before Using Tetterine

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

Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 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 topical miconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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.

Proper Use of miconazole

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

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

• Shake well before using.


• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes.


• Do not inhale the powder.


• Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

• Shake well before using.


• From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet.


• Do not inhale the vapors from the spray.


• Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

• If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

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 aerosol powder, aerosol solution, cream , and powder dosage forms:
  
  • For fungus infections:
    
    • Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening.
    
    
  
  


• For cream and lotion dosage forms:
  
  • For sun fungus:
    
    • Adults and children—Apply to the affected area(s) of the skin once a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tetterine

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

Tetterine 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 as soon as possible if any of the following side effects occur:

• Blistering, burning, redness, skin rash, or other sign of skin irritation not present before use of this medicine

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: Tetterine Topical side effects (in more detail)

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More Tetterine Topical resources

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

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