Linked Life Data

Famotidine (Tablet)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4049

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Famotidine (Tablet)
dailymed-instance:dosage
Duodenal Ulcer:<br/>Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.<br/>Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.<br/>Benign Gastric Ulcer:<br/>Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.<br/>Gastroesophageal Reflux Disease (GERD): The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks .<br/>Dosage for Pediatric Patients<1 Year of Age:<br/>Gastroesophageal Reflux Disease (GERD): The studies described in PRECAUTIONS: Pediatric Patients<1 Year of Age suggest the following starting doses in pediatric patients<1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients<3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to<1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients<1 year of age with GERD has not been adequately studied.<br/>Dosage for Pediatric Patients 1 to 16 Years of Age: The studies described in PRECAUTIONS: Pediatric Patients 1 to 16 Years of Age suggest the following starting doses in pediatric patients 1 to 16 years of age: While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.<br/>Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas): The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q6h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q6h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.<br/>Oral Suspension: Famotidine for oral suspension may be substituted for famotidine tablets in any of the above indications.<br/>Orally Disintegrating Tablets: Famotidine orally disintegrating tablets may be substituted for famotidine tablets in any of the above indications at the same recommended dosages.<br/>Concomitant Use of Antacids: Antacids may be given concomitantly if needed.<br/>Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency: In adult patients with moderate (creatinine clearance<50 mL/min) or severe (creatinine clearance<10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient's clinical response. Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.<br/>HOW SUPPLIED: Famotidine Tablets, USP are available containing either 20 mg or 40 mg of famotidine, USP. The 20 mg tablets are yellow film-coated, round, unscored tablets debossed with M over F1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3020-01bottles of 100 tablets NDC 0378-3020-05bottles of 500 tablets The 40 mg tablets are green film-coated, round, unscored tablets debossed with M over F2 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3040-01bottles of 100 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
dailymed-instance:descripti...
Famotidine is a histamine H-receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is CHNOSand its molecular weight is 337.45. Its structural formula is: Famotidine 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. Each tablet also contains the following inactive ingredients: D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. In addition the 20 mg tablet contains triacetin and FD&C Blue No. 2 aluminum lake and the 40 mg tablet contains FD&C Blue No. 1 aluminum lake and glyceryl triacetate.
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Hypersensitivity to any component of this product. Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H-receptor antagonists.
dailymed-instance:supply
Famotidine Tablets, USP are available containing either 20 mg or 40 mg of famotidine, USP. The 20 mg tablets are yellow film-coated, round, unscored tablets debossed with M over F1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3020-01bottles of 100 tablets NDC 0378-3020-05bottles of 500 tablets The 40 mg tablets are green film-coated, round, unscored tablets debossed with M over F2 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3040-01bottles of 100 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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dailymed-instance:overdosag...
There is no experience to date with deliberate overdosage. Oral doses of up to 640 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed. The oral LDof famotidine in male and female rats and mice was greater than 3000 mg/kg and the minimum lethal acute oral dose in dogs exceeded 2000 mg/kg. Famotidine did not produce overt effects at high oral doses in mice, rats, cats and dogs, but induced significant anorexia and growth depression in rabbits starting with 200 mg/kg/day orally. The intravenous LDof famotidine for mice and rats ranged from 254 to 563 mg/kg and the minimum lethal single I.V. dose in dogs was approximately 300 mg/kg. Signs of acute intoxication in I.V. treated dogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension, tachycardia and collapse.
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Famotidine
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Famotidine (Tablet)
dailymed-instance:adverseRe...
The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which famotidine tablets were compared to placebo, the incidence of adverse experiences in the group which received famotidine tablets, 40 mg at bedtime, was similar to that in the placebo group. The following adverse reactions have been reported to occur in more than 1% of patients on therapy with famotidine in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%). The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity: Body as a Whole: fever, asthenia, fatigue Cardiovascular: arrhythmia, AV block, palpitation Gastrointestinal: cholestatic jaundice, liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: rare cases of agranulocytosis, pancytopenia, leukopenia, thrombocytopenia Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival infection Musculoskeletal: musculoskeletal pain including muscle cramps, arthralgia Nervous System/Psychiatric: grand mal seizure; psychic disturbances, which were reversible in cases for which follow up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence Respiratory: bronchospasm Skin: toxic epidermal necrolysis (very rare), alopecia, acne, pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: Rare cases of impotence and rare cases of gynecomastia have been reported; however, in controlled clinical trials, the incidences were not greater than those seen with placebo. The adverse reactions reported for famotidine tablets may also occur with famotidine for oral suspension and famotidine orally disintegrating tablets.<br/>Pediatric Patients: In a clinical study in 35 pediatric patients<1 year of age with GERD symptoms [e.g., vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.
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Famotidine is indicated in:
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Famotidine