Teva 5728

If you are a consumer or patient please visit this version.

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.

Teva 5728

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Two patients discontinued famotidine due to adverse events. Teva 5728 Teva we believe that every one of us should have access to quality medicine that helps manage disease, fight infection, or simply improves overall health.

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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. 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:. Table 1 shows the recommended dosage of famotidine 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. 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.

Teva 5728

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. It is also used to prevent duodenal ulcers and prevent GERD symptoms from coming back. It works by reducing the amount of acid secreted by the stomach. The over-the-counter form of famotidine is used to treat conditions where a reduction of stomach acid is needed, such as acid indigestion, heartburn, or sour or upset stomach. It can also be used to prevent these symptoms when they are associated with eating food or drinking beverages, including nighttime symptoms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

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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. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure as required. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence. Famotidine Famotidine 40 mg b. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. NDC 1 2 3 4 5 6 Convulsions, in patients with impaired renal function, have been reported very rarely. Print Page. In the U. Famotidine is incompletely absorbed. At Teva we believe that every one of us should have access to quality medicine that helps manage disease, fight infection, or simply improves overall health. Version Files Jul 11, 5 current download Jul 15, 4 download Jan 13, 3 download Oct 10, 2 download Jun 7, 1 download. Drug Label Info. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.

Teva Pill is determined as an antacid pill containing Famotidine 20 mg as an active ingredient which reduces the amount of acid produced in the stomach.

In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine tablets [see Warnings and Precautions 5. In the event of overdosage, treatment should be symptomatic and supportive. CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [see Warnings and Precautions 5. In some patients, a higher starting dose may be required. The duration of effect of famotidine I. Effect a. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer Controlled studies in adults have not extended beyond one year. In contrast, pediatric patients 0 to 3 months of age had famotidine clearance values that were 2 to 4 fold less than those in older pediatric patients and adults. Marketing Information. Product Information. There are, however, no adequate or well-controlled studies in pregnant women. Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. Our mission is to be a global leader in generics and biopharmaceuticals, improving the lives of patients around the globe. Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine tablets may be greater in elderly patients, particularly those with impaired renal function [see Use in Specific Populations 8. The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.