Teva 5728

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If you are a consumer or patient please visit this version. Famotidine tablets are a histamine-2 H 2 receptor antagonist indicated 1 :. Administration 2. Tablets: 20 mg, 40 mg 3. History of serious hypersensitivity reactions e.

Teva 5728

The active ingredient in famotidine tablets USP is a histamine H 2 -receptor antagonist. Famotidine, USP is [1-Amino[[[2-[ diaminomethylene amino]thiazolyl]methyl]thio] propylidene] sulfamide and has the following structural formula:. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Each tablet for oral administration contains either 20 mg or 40 mg of famotidine, USP and has the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. Famotidine is a competitive inhibitor of histamine H 2 -receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output. In normal volunteers and hypersecretors, famotidine inhibited basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 and 40 mg was 10 to 12 hours. The same doses given in the morning suppressed food-stimulated acid secretion in all subjects. In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within 6 to 8 hours. There was no cumulative effect with repeated doses.

Specific Populations Pediatric Patients Bioavailability studies of 8 pediatric patients 11 to 15 years of age showed a mean teva 5728 bioavailability of 0, teva 5728. Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 to 13 years of age using the sigmoid Emax model.

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If you are a consumer or patient please visit this version. Famotidine tablets are a histamine-2 H 2 receptor antagonist indicated 1 :. A d m inistration 2. Tablets: 20 mg 3. History of serious hypersensitivity reactions e. The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:.

Teva 5728

If you are a consumer or patient please visit this version. Famotidine tablets are a histamine-2 H 2 receptor antagonist indicated 1 :. A d m inistration 2.

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Famotidine is incompletely absorbed. No drug interactions have been identified. The types of adverse reactions in overdosage of famotidine tablets are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions 6. In elderly patients, there are no clinically significant age-related changes in the pharmacokinetics of famotidine. The clinical relevance of this interaction is unknown. Use another famotidine formulation for pediatric patients weighing less than 40 kg. Treatment of pathological hypersecretory conditions e. International Study. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e. View Package Photos. Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth. Prolonged QT interval, in patients with impaired renal function, has been reported very rarely.

Famotidine belongs to a class of medications called H2 antagonists. It is used to treat stomach and duodenal intestinal ulcers, gastroesophageal reflux disease GERD , and conditions where too much stomach acid is secreted, such as Zollinger-Ellison syndrome.

The use of famotidine 20 mg and 40 mg tablets is not recommended in pediatric patients weighing less than 40 kg because the lowest available strength 20 mg exceeds the recommended dose for these patients. Other Effects Systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted in clinical pharmacology studies. Arrhythmia, AV block, palpitation. Limited published studies also suggest that the relationship between serum concentration and acid suppression is similar in pediatric patients 1 to 15 years of age as compared with adults. While each study had a different design, acid suppression data over time are summarized as follows:. In some patients, a higher starting dose may be required. Famotidine, 20 mg p. As shown in Table 2 , the incidence of ulcer healing dropouts counted as unhealed with famotidine was statistically significantly better than placebo at weeks 6 and 8 in the U. Hypersensitivity to any component of this product. Effect a.