Sucralfate

Dosage Form: tablet
Sucralfate TABLETS, USP

2210

Rx only

Sucralfate Description

Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex.

R = SO3Al(OH)2

Tablets for oral administration contain 1 g of Sucralfate.

Inactive Ingredients

Corn starch, magnesium stearate, and microcrystalline cellulose

Therapeutic Category

antiulcer

Sucralfate - Clinical Pharmacology

Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.

Although the mechanism of Sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:

1. Studies in human subjects and with animal models of ulcer disease have shown that Sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.


2. In vitro, a Sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.


3. In human subjects, Sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.


4. In vitro, Sucralfate absorbs bile salts.

These observations suggest that Sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of Sucralfate.

Clinical Trials

Acute Duodenal Ulcer

Over 600 patients have participated in well-controlled clinical trials worldwide. Multicenter trials conducted in the United States, both of them placebo-controlled studies with endoscopic evaluation at 2 and 4 weeks, showed:

STUDY 1

Treatment Groups	Ulcer Healing/No. Patients
	2 wk	4 wk (Overall)
Sucralfate	37/105 (35.2%)	82/109 (75.2%)
Placebo	26/106 (24.5%)	68/107 (63.6%)

STUDY 2

Treatment Groups	Ulcer Healing/No. Patients
	2 wk	4 wk (Overall)
Sucralfate	8/24 (33%)	22/24 (92%)
Placebo	4/31 (13%)	18/31 (58%)

The Sucralfate-placebo differences were statistically significant in both studies at 4 weeks but not at 2 weeks. The poorer result in the first study may have occurred because Sucralfate was given 2 hours after meals and at bedtime rather than 1 hour before meals and at bedtime, the regimen used in international studies and in the second United States study. In addition, in the first study liquid antacid was utilized as needed, whereas in the second study antacid tablets were used.

Maintenance Therapy After Healing of Duodenal Ulcer

Two double-blind randomized placebo-controlled U.S. multicenter trials have demonstrated that Sucralfate (1 g bid) is effective as maintenance therapy following healing of duodenal ulcers.

In one study, endoscopies were performed monthly for 4 months. Of the 254 patients who enrolled, 239 were analyzed in the intention-to-treat life table analysis presented below.

Duodenal Ulcer Recurrence Rate (%)

* p < 0.05 † p < 0.01
Months of Therapy
Drug	n	1	2	3	4
Sucralfate	122	20*	30*	38†	42†
Placebo	117	33	46	55	63

In this study, prn antacids were not permitted.

In the other study, scheduled endoscopies were performed at 6 and 12 months, but for-cause endoscopies were permitted as symptoms dictated. Median symptom scores between the Sucralfate and placebo groups were not significantly different. A life table intention-to-treat analysis for the 94 patients enrolled in the trial had the following results:

Duodenal Ulcer Recurrence Rate (%)

* p < 0.002
Drug	n	6 months	12 months
Sucralfate	48	19*	27*
Placebo	46	54	65

In this study, prn antacids were permitted.

Data from placebo-controlled studies longer than 1 year are not available.

Indications and Usage for Sucralfate

Sucralfate is indicated in:

• Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with Sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.


• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

Contraindications

There are no known contraindications to the use of Sucralfate.

Precautions

Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with Sucralfate can result in complete healing of the ulcer, a successful course of treatment with Sucralfate should not be expected to alter the posthealing frequency or severity of duodenal ulceration.

Special Populations

Chronic Renal Failure and Dialysis Patients

When Sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of Sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of Sucralfate and aluminum-containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.

Drug Interactions

Some studies have shown that simultaneous Sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and Sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of Sucralfate to chronic warfarin therapy.

The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from Sucralfate binding to the concomitant agent in the gastrointestinal tract. In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before Sucralfate eliminated the interaction. Because of the potential of Sucralfate to alter the absorption of some drugs, Sucralfate should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose).

There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.

Pregnancy

Teratogenic Effects

Pregnancy category B

Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to Sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sucralfate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of Sucralfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See DOSAGE ANDADMINISTRATION.)

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. (See PRECAUTIONS, SpecialPopulations, Chronic Renal Failureand Dialysis Patients.) Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Adverse reactions to Sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Sucralfate tablets, adverse effects were reported in 129 (4.7%).

Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:

Gastrointestinal

diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth

Dermatological

pruritus, rash

Nervous System

dizziness, insomnia, sleepiness, vertigo

Other

back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Sucralfate tablets. Similar events were reported with Sucralfate suspension. However, a causal relationship has not been established.

Bezoars have been reported in patients treated with Sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Inadvertent injection of insoluble Sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

Overdosage

Due to limited experience in humans with overdosage of Sucralfate, no specific treatment recommendations can be given. Acute oral toxicity studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing Sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

Sucralfate Dosage and Administration

Active Duodenal Ulcer

The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.

Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate.

While healing with Sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

Maintenance Therapy

The recommended adult oral dosage is 1 g twice a day.

Elderly

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See PRECAUTIONS, Geriatric Use.)

How is Sucralfate Supplied

Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of Sucralfate. Available in bottles of 90, 100 and 500 and in unit-dose boxes of 100 (10 x 10s). Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. H 12/2009

Principal Display Panel

Sucralfate Tablets 1 gram 90s Label Text

NDC 0093-2210-98

Sucralfate

Tablets, USP

1 gram

Rx only

90 TABLETS

TEVA

Sucralfate  Sucralfate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0093-2210 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sucralfate (Sucralfate) Sucralfate 1 g

Inactive Ingredients Ingredient Name Strength STARCH, CORN   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color WHITE Score 2 pieces Shape OVAL (capsule-shaped) Size 19mm Flavor Imprint Code BIOCRAFT;105;105 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0093-2210-98 90 TABLET In 1 BOTTLE None 2 0093-2210-01 100 TABLET In 1 BOTTLE None 3 0093-2210-05 500 TABLET In 1 BOTTLE None 4 0093-2210-93 100 BLISTER PACK In 1 BOX contains a BLISTER PACK (0093-2210-19) 4 0093-2210-19 1 TABLET In 1 BLISTER PACK This package is contained within the BOX (0093-2210-93)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA070848	07/27/2010

Labeler - TEVA Pharmaceuticals USA Inc (118234421)

Revised: 07/2010TEVA Pharmaceuticals USA Inc

More Sucralfate resources

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

• Sucralfate Professional Patient Advice (Wolters Kluwer)


• Sucralfate MedFacts Consumer Leaflet (Wolters Kluwer)


• Sucralfate Monograph (AHFS DI)


• sucralfate Advanced Consumer (Micromedex) - Includes Dosage Information


• Carafate Consumer Overview

Compare Sucralfate with other medications

• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• GERD
• Hyperphosphatemia of Renal Failure
• Stomach Ulcer
• Stomatitis
• Stress Ulcer Prophylaxis

TL-Hist CD

Generic Name: brompheniramine, codeine, and phenylephrine (BROM fen IR a meen, KOE deen, FEN il EFF rin)

Brand Names: M-End PE, Poly-Tussin AC, TL-Hist CD

What is TL-Hist CD (brompheniramine, codeine, and phenylephrine)?

Brompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine, codeine, and phenylephrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

Brompheniramine, codeine, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about TL-Hist CD (brompheniramine, codeine, and phenylephrine)?

You should not use this medication if you have severe liver disease, severe constipation, severe colitis or toxic megacolon, if you are unable to urinate, if you have been sick with diarrhea, if you recently drank large amounts of alcohol, or if you have a head injury or brain tumor. Do not use cough and cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking TL-Hist CD (brompheniramine, codeine, and phenylephrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you have severe liver disease, severe constipation, severe colitis or toxic megacolon, if you are unable to urinate, if you have been sick with diarrhea, if you recently drank large amounts of alcohol, or if you have a head injury or brain tumor. Do not use cough and cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid.

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

• 
  

  a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

  
  


• 
  

  diabetes;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  an adrenal gland tumor or disorder (such as Addison's disease); or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

Codeine may be habit forming and should be used only by the person it was prescribed for. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. FDA pregnancy category C. Codeine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take TL-Hist CD (brompheniramine, codeine, and phenylephrine)?

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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not freeze. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

See also: TL-Hist CD dosage (in more detail)

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. An overdose of codeine can be fatal.

Overdose symptoms may include confusion, extreme weakness, pinpoint pupils, cold and clammy skin, weak pulse, slow breathing, fainting, or breathing that stops. Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking TL-Hist CD (brompheniramine, codeine, and phenylephrine)?

Do not drink alcohol while you are taking medicine that contains codeine. Dangerous side effects or death can occur when alcohol is combined with a narcotic medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines, decongestants, and cough suppressants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, decongestant, or cough suppressant. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

TL-Hist CD (brompheniramine, codeine, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking the medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, problems with memory or concentration;

  
  


• 
  

  dry mouth, nose, or throat, increased sweating or urination;

  
  


• 
  

  mild stomach pain, diarrhea or constipation;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  blurred vision; or

  
  


• 
  

  flushing (warmth, redness, or tingly 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 TL-Hist CD (brompheniramine, codeine, and phenylephrine)?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicines, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by brompheniramine or codeine.

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

• 
  

  naloxone (Narcan, Suboxone);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  tramadol (Ultram, Ultracet);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;

  
  


• 
  

  anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

  
  


• 
  

  bowel cleansing preparations (Half Lytely, Fleet Prep Kit, Evac-Q-Kwik, GoLytely, Supraprep, and others);

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

  
  


• 
  

  ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

  
  

This list is not complete and other drugs may interact with brompheniramine, codeine, and phenylephrine. 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 TL-Hist CD resources

• TL-Hist CD Side Effects (in more detail)
• TL-Hist CD Dosage
• TL-Hist CD Use in Pregnancy & Breastfeeding
• TL-Hist CD Drug Interactions
• 0 Reviews for TL-Hist CD - Add your own review/rating

• Brompheniramine/Codeine/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare TL-Hist CD with other medications

• Cold Symptoms
• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine, codeine, and phenylephrine.

See also: TL-Hist CD side effects (in more detail)

Tegrin-LT Shampoo

Generic Name: piperonyl butoxide and pyrethrins topical (pi PER o nil bue TOX ide and pye RETH rins)

Brand Names: A-200 Lice Control, A-200 Lice Treatment, Good Sense Lice Killing Shampoo, Step 1, Lice Treatment Maximum Strength, Pronto Lice Kill System, Pronto Shampoo & Cream Rinse, Pronto Shampoo Kit, Pronto Spray, Pronto with Metal Comb, R & C Lice Treatment Kit, Rid Pediculicide, Tegrin-LT Lice Spray, Tegrin-LT Lice Treatment Kit, Tegrin-LT Shampoo, Triple X Pediculicide

What is Tegrin-LT Shampoo (piperonyl butoxide and pyrethrins topical)?

Piperonyl butoxide and pyrethrins are insecticide chemicals.

Piperonyl butoxide and pyrethrins topical (for the skin) is used to treat lice.

Piperonyl butoxide and pyrethrins topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Tegrin-LT Shampoo (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins, or if you have an allergy to chrysanthemums or ragweed.

Check all household members for signs of lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

What should I discuss with my healthcare provider before using Tegrin-LT Shampoo (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins topical, or if you have an allergy to chrysanthemums or ragweed. It is not known whether piperonyl butoxide and pyrethrins topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Piperonyl butoxide and pyrethrins can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Tegrin-LT Shampoo (piperonyl butoxide and pyrethrins topical)?

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

Check for signs of lice on all household members. They may also need to be treated for lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Apply the shampoo form of this medication to dry hair. Wetting the hair first may make the medication less effective. Apply the shampoo to all areas of the scalp, including behind the ears and neck. Treat hair from the roots to the ends and leave the shampoo in the hair for 10 minutes. Add warm water to form a lather and shampoo. Then rinse thoroughly with warm water. Piperonyl butoxide and pyrethrins shampoo is usually used once every 7 to 10 days.

You may need to use a larger amount of the shampoo if you have long hair. Follow the directions on the product label.

Keep your eyes tightly closed while using the shampoo, foam, or spray, and while rinsing it out of your hair. You may use a washcloth or towel to protect your eyes while applying the medication to your head.

Do not apply this medication to your eyebrows or eyelashes. Call your doctor if these areas become infected with lice.

Avoid inhaling the vapors from this medication. Use in a well-ventilated area.

You will need to remove any eggs (nits) from the hair shafts with a special comb. Some piperonyl butoxide and pyrethrins products come provided with a nit comb. If you do not have such a comb, ask your pharmacist where you can get one. Nits may not be removed effectively with a regular fine-tooth comb.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

Store this medication at room temperature away from moisture and heat. Keep the medicine canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or incinerate the can, the contents are under pressure.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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.

What should I avoid while using Tegrin-LT Shampoo (piperonyl butoxide and pyrethrins topical)?

Avoid using other medications or skin products on the areas you treat with piperonyl butoxide and pyrethrins topical, unless you doctor tells you to.

Avoid getting this medication in your eyes, nose, mouth, or vagina. If this does happen, rinse with water. Do not use piperonyl butoxide and pyrethrins topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid close contact with others until the infection has been cured. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, pillows, and other items of personal use. Lice infestations are highly contagious.

Tegrin-LT Shampoo (piperonyl butoxide and pyrethrins topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

Less serious side effects may include:

• 
  

  mild itching, burning, or stinging;

  
  


• 
  

  mild skin rash; or

  
  


• 
  

  numbness or tingly 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 Tegrin-LT Shampoo (piperonyl butoxide and pyrethrins topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied piperonyl butoxide and pyrethrins. But many drugs can interact with each other. 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 Tegrin-LT Shampoo resources

• Tegrin-LT Shampoo Use in Pregnancy & Breastfeeding
• Tegrin-LT Shampoo Support Group
• 0 Reviews for Tegrin-LT - Add your own review/rating

Compare Tegrin-LT Shampoo with other medications

• Head Lice

Where can I get more information?

• Your pharmacist can provide more information about piperonyl butoxide and pyrethrins.

Thorazine Suppositories

Pronunciation: klor-PROE-ma-zeen
Generic Name: Chlorpromazine
Brand Name: Thorazine

Thorazine Suppositories are an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Thorazine Suppositories are not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.

Thorazine Suppositories are used for:

Treating certain mental or mood disorders (eg, schizophrenia), the manic phase of manic-depressive disorder, anxiety and restlessness before surgery, the blood disease porphyria, severe behavioral and conduct disorders in children, nausea and vomiting, and severe hiccups. It is also used with other medicines to treat symptoms associated with tetanus. It may be used for other conditions as determined by your doctor.

Thorazine Suppositories are a phenothiazine. Exactly how it works is not known.

Do NOT use Thorazine Suppositories if:

• you are allergic to any ingredient in Thorazine Suppositories or to other phenothiazines (eg, thioridazine)


• you have severe drowsiness


• you have recently taken large amounts of alcohol or medicines that may cause drowsiness, such as barbiturates (eg, phenobarbital) or narcotic pain medicines (eg, codeine)


• you are taking certain antiarrhythmic medicines (eg, amiodarone, dofetilide, dronedarone, quinidine, sotalol), cisapride, pergolide, pimozide, quetiapine, or ziprasidone

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

Before using Thorazine Suppositories:

Some medical conditions may interact with Thorazine Suppositories. 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 alcohol abuse or you consume more than 3 alcoholic drinks per day


• if you have asthma, lung infection, or other lung problems (eg, emphysema); increased pressure in the eyes; glaucoma; or if you are at risk for glaucoma


• if you have a history of blood problems, enlargement of the prostate gland, epilepsy or seizures, heart problems, low blood pressure, liver problems (eg, cirrhosis), bone marrow problems, low white blood cell count, diabetes, kidney problems, neuroleptic malignant syndrome (NMS), or an adrenal gland tumor (pheochromocytoma)


• if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome


• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer


• if you are regularly exposed to extreme heat or organophosphate insecticides

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

• Lithium because the risk of a severe and sometimes permanent nervous system problem (encephalopathic syndrome) characterized by weakness, lethargy, fever, tremor, confusion, or uncontrolled muscle movements may be increased


• Certain antiarrhythmic medicines (eg, amiodarone, dofetilide, dronedarone, quinidine, sotalol), cisapride, pergolide, pimozide, quetiapine, or ziprasidone because the risk of side effects, such as racing heartbeat, dizziness, fainting, and life-threatening irregular heartbeat leading to unconsciousness, may be increased by Thorazine Suppositories


• Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Thorazine Suppositories, increasing the risk of side effects

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

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

• Wash your hands before and after using Thorazine Suppositories. If the suppository is too soft to use, put it in the refrigerator for about 15 minutes. You may also run cold water over it. Remove the wrapper. Moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum. Use your finger to push it in completely.


• Wash your hands immediately after using Thorazine Suppositories.


• If you miss a dose of Thorazine Suppositories, 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 Thorazine Suppositories.

Important safety information:

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


• Do not drink alcohol while you are using Thorazine Suppositories.


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


• Thorazine Suppositories may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


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


• Thorazine Suppositories may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Thorazine Suppositories. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Thorazine Suppositories may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


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


• Some patients who take Thorazine Suppositories may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Thorazine Suppositories in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Thorazine Suppositories.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Thorazine Suppositories. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Thorazine Suppositories may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.


• Thorazine Suppositories may raise or lower your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Thorazine Suppositories may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.


• Thorazine Suppositories may interfere with certain lab tests, including phenylketonuria (PKU) tests. Be sure your doctor and lab personnel know you are taking Thorazine Suppositories.


• Lab tests, including liver function, complete blood cell counts, and eye exams, may be performed while you use Thorazine Suppositories. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Thorazine Suppositories with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, light-headedness (especially upon standing), rapid heartbeat, breathing problems, urinary retention, and constipation.


• Thorazine Suppositories 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 Thorazine Suppositories while you are pregnant. Using Thorazine Suppositories during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Thorazine Suppositories are found in breast milk. Do not breast-feed while taking Thorazine Suppositories.

If you stop taking Thorazine Suppositories suddenly, you may have WITHDRAWAL symptoms. These may include nausea, vomiting, dizziness, and tremors.

Possible side effects of Thorazine Suppositories:

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:

Agitation; constipation; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose.

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); changes in menstrual period; changes in sexual ability; confusion; dark urine; difficulty swallowing; drooling; fainting; fast or irregular heartbeat; fever, chills, or sore throat; inability to move eyes; involuntary movements or spasms of the arms and legs; involuntary movements of tongue, face, mouth, or jaw (eg, sticking out of tongue, puffing of cheeks, puckering of mouth, lip-smacking, chewing movements); mask-like face; mental or mood changes, including lack of response to your surroundings; muscle restlessness; prolonged or painful erection; restlessness; seizures; severe constipation; severe or persistent dizziness; shuffling walk; sleeplessness; stiff or rigid muscles; stomach pain; sweating; tremor; trouble urinating; unusual bruising or bleeding; unusual eye movements; unusual tiredness or weakness; unusually pale skin; vision changes; yellowing of the 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: Thorazine 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 agitation; fainting; involuntary movements or muscle spasms; irregular heartbeat; light-headedness; loss of consciousness; restlessness; seizures; severe drowsiness or dizziness; tremors; twitching.

Proper storage of Thorazine Suppositories:

Store Thorazine Suppositories 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 Thorazine Suppositories out of the reach of children and away from pets.

General information:

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


• Thorazine Suppositories 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 Thorazine Suppositories. 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 Thorazine resources

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

Compare Thorazine with other medications

• Hiccups
• Light Sedation
• Mania
• Nausea/Vomiting
• Opiate Withdrawal
• Porphyria
• Psychosis
• Schizophrenia
• Tetanus

Sumatriptan and naproxen

soo-ma-TRIP-tan SUX-i-nate, na-PROX-en SOE-dee-um

Oral route(Tablet)

Naproxen sodium/sumatriptan may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased with extended duration of use or in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen sodium/sumatriptan contains an NSAID. NSAID-containing products can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Treximet

Available Dosage Forms:

• Tablet

Therapeutic Class: Antimigraine

Pharmacologic Class: Sumatriptan

Chemical Class: Naproxen

Uses For sumatriptan and naproxen

Sumatriptan and naproxen combination is used to treat acute migraine attacks in adults. It does not prevent migraine attacks nor treat certain types of migraine headaches (e.g., hemiplegic or basilar type).

Many people find that their headaches go away completely after they take sumatriptan and naproxen. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. sumatriptan and naproxen often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan and naproxen combination is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. sumatriptan and naproxen is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan and naproxen combination has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using sumatriptan and naproxen as well as the benefits that it can do.

sumatriptan and naproxen is available only with your doctor's prescription.

Before Using sumatriptan and naproxen

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 sumatriptan and naproxen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sumatriptan and naproxen 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 have not been performed on the relationship of age to the effects of sumatriptan and naproxen combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Use of sumatriptan and naproxen combination is not recommended in elderly patients with kidney problems, heart and blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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 sumatriptan and naproxen, 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 sumatriptan and naproxen with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Almotriptan


• Dihydroergotamine


• Eletriptan


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Frovatriptan


• Isocarboxazid


• Ketorolac


• Linezolid


• Methylergonovine


• Methysergide


• Naratriptan


• Pentoxifylline


• Phenelzine


• Procarbazine


• Rizatriptan


• Tranylcypromine


• Zolmitriptan

Using sumatriptan and naproxen 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.

• Abciximab


• Ardeparin


• Argatroban


• Aspirin


• Beclamide


• Beta Glucan


• Bivalirudin


• Caramiphen


• Carbamazepine


• Certoparin


• Chlormethiazole


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Desvenlafaxine


• Dexfenfluramine


• Diazepam


• Dipyridamole


• Duloxetine


• Enoxaparin


• Escitalopram


• Ethotoin


• Felbamate


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Fosphenytoin


• Gabapentin


• Ginkgo


• Heparin


• Lacosamide


• Lepirudin


• Mephenytoin


• Mephobarbital


• Methotrexate


• Milnacipran


• Nadroparin


• Nefazodone


• Oxcarbazepine


• Paraldehyde


• Paramethadione


• Parnaparin


• Paroxetine


• Pemetrexed


• Phenacemide


• Phenobarbital


• Phenytoin


• Piracetam


• Pregabalin


• Protein C


• Reboxetine


• Reviparin


• Rivaroxaban


• Rufinamide


• Sertraline


• Sibutramine


• Stiripentol


• St John's Wort


• Tacrolimus


• Tapentadol


• Tiagabine


• Ticlopidine


• Tinzaparin


• Tirofiban


• Topiramate


• Trimethadione


• Valproic Acid


• Venlafaxine


• Vigabatrin


• Vilazodone


• Warfarin


• Zimeldine


• Zonisamide

Using sumatriptan and naproxen 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.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

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 sumatriptan and naproxen. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Asthma or


• Bleeding problems or


• Blurred vision or


• Congestive heart failure or


• Dehydration or


• Edema (fluid retention or body swelling) or


• Hypertension (high blood pressure), controlled or


• Kidney disease or


• Seizures, or history of or


• Stomach or intestinal ulcers or bleeding, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history of or


• Cerebrovascular disease (e.g., stroke, transient ischemic attack), or history of or


• Heart attack, history of or


• Heart disease (e.g., angina) or


• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery) or


• Hemiplegic or basilar types of migraine or


• Hypertension (high blood pressure), uncontrolled or


• Ischemic bowel disease or


• Liver disease—Should not be used in patients with these conditions.

• Coronary artery disease, history of or


• Diabetes or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertension (high blood pressure), controlled or


• Obesity or


• Raynaud's syndrome—Use with caution. The chance of side effects may be increased.1

Proper Use of sumatriptan and naproxen

Do not use sumatriptan and naproxen for a headache that is different from your usual migraines. Instead, check with your doctor.

If your headache comes back or does not go away after taking sumatriptan and naproxen, wait at least 2 hours before taking another dose. However, use sumatriptan and naproxen only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much of sumatriptan and naproxen may increase the chance of side effects. Do not take more than two tablets in 24 hours.

You may take the tablet with or without food. Swallow the tablet whole. Do not crush, break, or chew it.

Use sumatriptan and naproxen for the shortest time possible and in the smallest dose possible. This will help lower the risk of side effects.

sumatriptan and naproxen comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of sumatriptan and naproxen 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 sumatriptan and naproxen. 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 (tablets):
  
  • For migraine headaches:
    
    • Adults—One tablet once a day. Your doctor may increase your dose if needed. Do not take more than two tablets in any 24-hour period.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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 sumatriptan and naproxen

Check with your doctor if you have used sumatriptan and naproxen and have not had good relief. Also, check with your doctor if your migraine headaches are worse, or if they are occurring more often, than before you started using sumatriptan and naproxen.

Make sure your doctor knows if you are pregnant. You should not use sumatriptan and naproxen during the later part of pregnancy unless your doctor tells you to. Your doctor may want you to join a pregnancy registry for patients taking sumatriptan and naproxen.

sumatriptan and naproxen may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, if you smoke, are over 40 years of age, or if you have gone through menopause. People who use sumatriptan and naproxen for a long time might also have a higher risk.

sumatriptan and naproxen might cause bleeding or ulcers in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Do not use sumatriptan and naproxen if you are also using other medicines containing naproxen. Using these medicines together may cause serious unwanted effects.

You should not take sumatriptan and naproxen if you have used an MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past two weeks. Do not use sumatriptan and naproxen if you have taken other migraine medicines (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (e.g., dihydroergotamine, methysergide, Cafergot®, D.H.E. 45®, Ergomar®, or Migranal®) within the past 24 hours.

Make sure your doctor knows about all the other medicines you are using. Sumatriptan and naproxen combination may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Lexapro®, Cymbalta®, Effexor®, Paxil®, Prozac®, or Zoloft®. Check with your doctor first before taking any other medicines.

sumatriptan and naproxen may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in the color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Serious skin reactions may also occur during treatment with sumatriptan and naproxen. Check with your doctor right away if you have any of the following symptoms while taking sumatriptan and naproxen: blistering, peeling, or loosening of skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using sumatriptan and naproxen. Also, tell your doctor if you have sudden or severe abdominal or stomach pain after taking sumatriptan and naproxen.

Stop using sumatriptan and naproxen and check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.

Using too much of sumatriptan and naproxen or any other migraine medicines (e.g., ergotamine, triptans, opioids, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

sumatriptan and naproxen may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert while you are taking sumatriptan and naproxen.

sumatriptan and naproxen 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 common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest discomfort or pain


• fast, irregular, pounding, or racing heartbeat or pulse


• jaw, neck, or throat pain

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

• Acid or sour stomach


• belching


• dizziness


• dry mouth


• feeling hot


• heartburn


• indigestion


• lack or loss of strength


• muscle tightness


• nausea


• sleepiness or unusual drowsiness


• stomach discomfort, upset, or pain

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 sumatriptan and naproxen resources

• Sumatriptan and naproxen Dosage
• Sumatriptan and naproxen Use in Pregnancy & Breastfeeding
• Sumatriptan and naproxen Drug Interactions
• Sumatriptan and naproxen Support Group
• 58 Reviews for Sumatriptan and naproxen - Add your own review/rating

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• Migraine

Tofranil injection

imipramine hydrochloride USP

Dosage Form: injection

Tofranil®

imipramine hydrochloride USP

Ampuls

For intramuscular administration

Prescribing Information

DESCRIPTION

Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is available in ampuls for intramuscular administration. Each 2 mL ampul contains imipramine hydrochloride USP, 25 mg; ascorbic acid, 2 mg; sodium bisulfite, 1 mg; sodium sulfite, anhydrous, 1 mg. Tofranil is a member of the dibenzazepine group of compounds. It is designated 5-[3- (dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is

Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Its molecular weight is 316.87.

CLINICAL PHARMACOLOGY

The mechanism of action of Tofranil is not definitely known. However, it does not act primarily by stimulation of the central nervous system. The clinical effect is hypothesized as being due to potentiation of adrenergic synapses by blocking uptake of norepinephrine at nerve endings. The mode of action of the drug in controlling childhood enuresis is thought to be apart from its antidepressant effect.

INDICATIONS AND USAGE

Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.

CONTRAINDICATIONS

The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of adverse effects can be serious, or even fatal. When it is desired to substitute Tofranil in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. Initial dosage should be low and increases should be gradual and cautiously prescribed.

The drug is contraindicated during the acute recovery period after a myocardial infarction. Patients with a known hypersensitivity to this compound should not be given the drug. The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind.

WARNINGS

Children: A dose of 2.5 mg/kg/day of imipramine hydrochloride should not be exceeded in childhood. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.

Extreme caution should be used when this drug is given to: patients with cardiovascular disease because of the possibility of conduction defects, arrhythmias, congestive heart failure, myocardial infarction, strokes and tachycardia. These patients require cardiac surveillance at all dosage levels of the drug; patients with increased intraocular pressure, history of urinary retention, or history of narrow-angle glaucoma because of the drug's anti-cholinergic properties; hyperthyroid patients or those on thyroid medication because of the possibility of cardiovascular toxicity; patients with a history of seizure disorder because this drug has been shown to lower the seizure threshold; patients receiving guanethidine, clonidine, or similar agents, since imipramine hydrochloride may block the pharmacologic effects of these drugs; patients receiving methylphenidate hydrochloride. Since methylphenidate hydrochloride may inhibit the metabolism of imipramine hydrochloride, downward dosage adjustment of imipramine hydrochloride may be required when given concomitantly with methylphenidate hydrochloride.

Tofranil may enhance the CNS depressant effects of alcohol. Therefore, it should be borne in mind that the dangers inherent in a suicide attempt or accidental overdosage with the drug may be increased for the patient who uses excessive amounts of alcohol. (See PRECAUTIONS.)

Since imipramine hydrochloride may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly.

Contains sodium sulfite and sodium bisulfite, that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably 1ow. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS

General

An ECG recording should be taken prior to the initiation of larger-than-usual doses of imipramine hydrochloride and at appropriate intervals thereafter until steady state is achieved. (Patients with any evidence of cardiovascular disease require cardiac surveillance at all dosage levels of the drug. See WARNINGS.) Elderly patients and patients with cardiac disease or a prior history of cardiac disease are at special risk of developing the cardiac abnormalities associated with the use of imipramine hydrochloride.

It should be kept in mind that the possibility of suicide in seriously depressed patients is inherent in the illness and may persist until significant remission occurs. Such patients should be carefully supervised during the early phase of treatment with imipramine hydrochloride, and may require hospitalization. Prescriptions should be written for the smallest amount feasible.

Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders.

Such reactions may necessitate discontinuation of the drug. If needed, imipramine hydrochloride may be resumed in lower dosage when these episodes are relieved.

Administration of a tranquilizer may be useful in controlling such episodes.

An activation of the psychosis may occasionally be observed in schizophrenic patients and may require reduction of dosage and the addition of a phenothiazine.

Concurrent administration of imipramine hydrochloride with electroshock therapy may increase the hazards; such treatment should be limited to those patients for whom it is essential, since there is limited clinical experience.

Patients taking imipramine hydrochloride should avoid excessive exposure to sunlight since there have been reports of photosensitization.

Both elevation and lowering of blood sugar levels have been reported with imipramine hydrochloride use.

Imipramine hydrochloride should be used with caution in patients with significantly impaired renal or hepatic function.

Patients who develop a fever and a sore throat during therapy with imipramine hydrochloride should have leukocyte and differential blood counts performed. Imipramine hydrochloride should be discontinued if there is evidence of pathologic neutrophil depression.

Prior to elective surgery, imipramine hydrochloride should be discontinued for as long as the clinical situation will allow.

Drug Interactions

Drugs Metabolized by P450 2D6

The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7%-10% of Caucasians are so-called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TGAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA).

In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

The plasma concentration of imipramine may increase when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decrease by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), and adjustment of the dosage of imipramine may therefore be necessary.

In occasional susceptible patients or in those receiving anticholinergic drugs (including antiparkinsonism agents) in addition, the atropine-like effects may become more pronounced (e.g., paralytic ileus). Close supervision and careful adjustment of dosage is required when imipramine hydrochloride is administered concomitantly with anticholinergic drugs.

Avoid the use of preparations, such as decongestants and local anesthetics, that contain any sympathomimetic amine (e.g., epinephrine, norepinephrine), since it has been reported that tricyclic antidepressants can potentiate the effects of catecholamines.

Caution should be exercised when imipramine hydrochloride is used with agents that lower blood pressure. Imipramine hydrochloride may potentiate the effects of CNS depressant drugs.

Patients should be warned that imipramine hydrochloride may enhance the CNS depressant effects of alcohol (See WARNINGS.)

Usage During Pregnancy and Lactation

Animal reproduction studies have yielded inconclusive results. (See also ANIMAL PHARMACOLOGY & TOXICOLOGY.)

There have been no well-controlled studies conducted with pregnant women to determine the effect of imipramine hydrochloride on the fetus. However, there have been clinical reports of congenital malformations associated with the use of the drug. Although a causal relationship between these effects and the drug could not be established, the possibility of fetal risk from the maternal ingestion of imipramine hydrochloride cannot be excluded. Therefore, imipramine hydrochloride should be used in women who are or might become pregnant only if the clinical condition clearly justifies potential risk to the fetus.

Limited data suggest that imipramine hydrochloride is likely to be excreted in human breast milk. As a general rule, a woman taking a drug should not nurse since the possibility exists that the drug may be excreted in breast milk and be harmful to the child.

Usage in Children

The effectiveness of the drug in children for conditions other than nocturnal enuresis given orally has not been established.

ADVERSE REACTIONS

Note: Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when imipramine is administered.

Cardiovascular

Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction. arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke.

Psychiatric

Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.

Neurological

Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus.

Anticholinergic

Dry mouth, and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

Allergic

Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue); drug fever; cross sensitivity with desipramine.

Hematologic

Bone marrow depression including agranulotosis; eosinophilia; purpura; thrombocytopenia.

Gastrointestinal

Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue.

Endocrine

Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; inappropriate antidiuretic hormone (ADH) secretion syndrome.

Other

Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness and fatigue; headache; parotid swelling; alopecia; proneness to falling.

Withdrawal Symptoms

Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache and malaise.

DOSAGE AND ADMINISTRATION

Initially, up to 100 mg/day intramuscularly in divided doses.

Parenteral administration should be used only for starting therapy in patients unable or unwilling to use oral medication. The oral form should supplant the injectable as soon as possible.

Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, oral maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission.

OVERDOSAGE

Children have been reported to be more sensitive than adults to an acute overdosage of imipramine hydrochloride. An acute overdose of any amount in infants or young children, especially, must be considered serious and potentially fatal.

Signs and Symptoms

These may vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient, and the interval between drug ingestion and the start of treatment. Blood and urine levels of imipramine may not reflect the severity at poisoning; they have chiefly a qualitative rather than quantitative value, and are unreliable indicators in the clinical management of the patient.

CNS abnormalities may include drowsiness, stupor, coma, ataxia, restlessness, agitation, hyperactive reflexes, muscle rigidity, athetoid and choreiform movements, and convulsions.

Cardiac abnormalities may include arrhythmia, tachycardia, ECG evidence of impaired conduction, and signs of congestive failure. Respiratory depression, cyanosis, hypotension, shock, vomiting, hyperpyrexia, mydriasis, and diaphoresis may also be present.

Treatment

The recommended treatment for overdosage with tricyclic antidepressants may change periodically. Therefore, it is recommended that the physician contact a poison control center for current information on treatment. Because CNS involvement, respiratory depression and cardiac arrhythmia can occur suddenly, hospitalization and close observation may be necessary, even when the amount ingested is thought to be small or the initial degree of intoxication appears slight or moderate. All patients with ECG abnormalities should have continuous cardiac monitoring and be closely observed until well after cardiac status has returned to normal; relapses may occur after apparent recovery.

In the alert patient, empty the stomach promptly by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Instillation of activated charcoal slurry may help reduce absorption of imipramine.

Minimize external stimulation to reduce the tendency to convulsions. If anticonvulsants are necessary, diazepam and phenytoin may be useful.

Maintain adequate respiratory exchange. Do not use respiratory stimulants.

Shock should be treated with supportive measures, such as appropriate position, intravenous fluids, and, if necessary, a vasopressor agent. The use of corticosteroids in shock is controversial and may be contraindicated in cases of overdosage with tricyclic antidepressants. Digitalis may increase conduction abnormalities and further irritate an already sensitized myocardium. If congestive heart failure necessitates rapid digitalization, particular care must be exercised.

Hyperpyrexia should be controlled by whatever external means are available, including ice packs and cooling sponge baths, if necessary.

Hemodialysis, peritoneal dialysis, exchange transfusions and forced diuresis have been generally reported as ineffective because of the rapid fixation of imipramine in tissues. Blood and urine levels of imipramine may not correlate with the degree of intoxication, and are unreliable indicators in the clinical management of the patient.

The slow intravenous administration of physostigmine salicylate has been used as a last resort to reverse severe CNS anticholinergic manifestations of overdosage with tricyclic anti- depressants; however, it should not be used routinely, since it may induce seizures and cholinergic crises.

HOW SUPPLIED

Ampuls 2 mL – For intramuscular administration only

25 mg imipramine hydrochloride, 2 mg ascorbic acid, 1 mg sodium bisulfite, 1 mg sodium sulfite, anhydrous

Boxes of 10 ........................................................................................ NDC 0028-0065-23

Store between 59º-86ºF (15º-30ºC).

Note: Upon storage, minute crystals may form in some ampuls. This has no influence on the therapeutic efficacy of the preparation, and the crystals redissolve when the affected ampuls are immersed in hot tap water for 1 minute.

ANIMAL PHARMACOLOGY & TOXICOLOGY

A. Acute: Oral LD50 ranges are as follows:

Rat 355 to 682 mg/kg

Dog 100 to 215 mg/kg

Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death.

B. Reproduction/Teratogenic: The overall evaluation may be summed up in the following manner:

Oral: Independent studies in three species (rat, mouse, and rabbit) revealed that when Tofranil is administered orally in doses up to approximately 2 ½ times the maximum human dose in the first 2 species and up to 25 times the maximum human dose in the third species, the drug is essentiality free from teratogenic potential. In the three species studied, only one instance of fetal abnormality occurred (in the rabbit) and in that study there was likewise an abnormality in the control group. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. This is manifested by reduced litter size, a slight increase in the stillborn rate and a reduction in the mean birth weight.

Parenteral: In contradistinction to the oral data, Tofranil does exhibit a slight but definite teratogenic potential when administered by the subcutaneous route. Drug effects on both the mother and fetus in the rabbit are manifested in higher resorption rates and decrease in mean fetal birth weights, while teratogenic findings occurred at a level of 5 times the maximum human dose. In the mouse, teratogenicity occurred at 1 ½ and 6 ½ times the maximum human dose, but no teratogenic effects were seen at levels 3 times the maximum human dose. Thus, in the mouse, the findings are equivocal.

667764 

C94-15 (Rev. 7/94)

Geigy

Dist. by: Geigy Pharmaceuticals

Ciba-Geigy Corporation

Ardsley, New York 10502

Tofranil  imipramine hydrochloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0028-0065 Route of Administration INTRAMUSCULAR DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength imipramine hydrochloride (imipramine) Active 25 MILLIGRAM  In 2 MILLILITER ascorbic acid Inactive 2 MILLIGRAM  In 2 MILLILITER sodium bisulfite Inactive 1 MILLIGRAM  In 2 MILLILITER sodium sulfite, anhydrous Inactive 1 MILLIGRAM  In 2 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0028-0065-23 10 AMPULE In 1 BOX contains a AMPULE 1 2 mL (MILLILITER) In 1 AMPULE This package is contained within the BOX (0028-0065-23)

Revised: 10/2006Geigy Pharmaceuticals

More Tofranil resources

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

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