Famotidine
FDA Drug Information • Also known as: Acid Controller, Acid Controller Original Strength, Acid Reducer, Acid Reducer Maximum Strength,...
- Brand Names
- Acid Controller, Acid Controller Original Strength, Acid Reducer, Acid Reducer Maximum Strength, Acid Reducer Original Strength, Acid Relief, Amazon Basic Care Acid Reducer, Basic Care Acid Reducer, Basic Care Heartburn Prevention, Berkley And Jensen Famotidine, Calmicid Ac Acid Reducer, Careone Acid Relief, Dg Health Acid Reducer, Dg Health Heartburn Prevention, Dg Health Heartburn Prevention Original Strength, Equaline Heartburn Prevention, Equate Famotidine, Famotidine, Foster And Thrive Acid Reducer, Good Sense Acid Reducer, Heartburn Prevention, Heartburn Relief, Heartburn Relief Original Strength, Kirkland Signature Acid Controller, Leader Acid Reducer, Major Heartburn Relief Maximum Strength, Maximum Strength, Maximum Strength Acid Controller, Maximum Strength Acid Reducer, Maximum Strength Pepcid Ac Icy Cool Mint, Members Mark Acid Pep, Original Strength Heartburn Prevention, Pepcid, Pepcid Ac, Pepcid Ac Maximum Strength, Pepcid Ac Original Strength, Rugby Famotidine, Signature Care Acid Controller, Signature Care Acid Controller Maximum Strength, Topcare Acid Reducer, Up And Up Famotidine, Zantac 360, Zantac 360 1 Per Blister 6 Blisters, Zantac 360 2 Per Blister 6 Blisters, Zantac 360 Cool Mint
- Drug Class
- Histamine-2 Receptor Antagonist [EPC]
- Route
- ORAL
- Dosage Form
- TABLET, FILM COATED
- Product Type
- HUMAN OTC DRUG
Description
11 DESCRIPTION The active ingredient in famotidine tablets, USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl] thio]propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45. Its structural formula is: Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and film coating contains carnauba wax, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide; and additionally 20 mg contains iron oxide red and iron oxide yellow. Famotidine, USP is a white to pale yellowish white crystalline powder that is freely soluble in dimethyl formamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and ethyl acetate. famotabstructure
What Is Famotidine Used For?
1 INDICATIONS AND USAGE Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Indication Recommended Dosage ( 2.1 ) Adult and Pediatric Patients 40 kg and greater Active DU 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily Adults Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2500 patients [see Clinical Studies ( 14 )]. A total of 1442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily. The population was 17 to 91 years old, fairly well distributed between gender and race; however, the predominant race treated was Caucasian. The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients: headache, dizziness and constipation. The following other adverse reactions were reported in less than 1% of patients in clinical trials: Body as a Whole: fever, asthenia, fatigue Cardiovascular: palpitations Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: thrombocytopenia Hypersensitivity: orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal: musculoskeletal pain, arthralgia Nervous System/Psychiatric: seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin: pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: impotence 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, AV block, prolonged QT interval Gastrointestinal: cholestatic jaundice, hepatitis Hematologic : agranulocytosis, pancytopenia, leukopenia Hypersensitivity: anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal : rhabdomyolysis, muscle cramps Nervous System/Psychiatric: confusion, agitation, paresthesia Respiratory: interstitial pneumonia Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome
Drug Interactions
7 DRUG INTERACTIONS
Contraindications
4 CONTRAINDICATIONS Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data). The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine. While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Overdosage
10 OVERDOSAGE The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions ( 6.1 )]. 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. Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for famotidine overdosage.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine Tablets USP, 20 mg, are light yellow, round, biconvex, film-coated tablets debossed with “T” on one side and “11” on the other side. They are supplied as follows: Bottles of 2 NDC 72789-331-02 Bottles of 20 NDC 72789-331-20 Bottles of 30 NDC 72789-331-30 Bottles of 60 NDC 72789-331-60 Bottles of 90 NDC 72789-331-90 Bottles of 180 NDC 72789-331-93 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.