Famotidine

Special Alerts

Fluxid™, Orally-disintegrating Famotidine Tablet, FDA-approved September, 2004 - Release Date Has Not Been Announced

Pronunciation

(fa MOE ti deen)

U.S. Brand Names

Fluxid™; Pepcid®; Pepcid® AC [OTC]

Generic Available

Yes: Injection, tablet

Canadian Brand Names

Apo-Famotidine®; Gen-Famotidine; Novo-Famotidine; Nu-Famotidine; Pepcid®; Pepcid® AC; Pepcid® I.V.; ratio-Famotidine; Rhoxal-famotidine; Riva-Famotidine

Use

Therapy and treatment of duodenal ulcer, gastric ulcer, control gastric pH in critically-ill patients, symptomatic relief in gastritis, gastroesophageal reflux, active benign ulcer, and pathological hypersecretory conditions

OTC labeling: Relief of heartburn, acid indigestion, and sour stomach

Use - Unlabeled/Investigational

Part of a multidrug regimen for H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Pregnancy Risk Factor

Pregnancy Implications

Crosses the placenta; insufficient data concerning effects on the fetus

Lactation

Enters breast milk/not recommended

Contraindications

Hypersensitivity to famotidine, other H2 antagonists, or any component of the formulation

Warnings/Precautions

Modify dose in patients with renal impairment; chewable tablets contain phenylalanine; multidose vials contain benzyl alcohol

OTC labeling: When used for self-medication, patients should be instructed not to use if they have difficulty swallowing, have vomiting with blood, or bloody or black stools. Not for use with other acid reducers.

Adverse Reactions

Note: Agitation and vomiting have been reported in up to 14% of pediatric patients <1 year of age.

1% to 10%:

Central nervous system: Dizziness (1%), headache (5%)

Gastrointestinal: Constipation (1%), diarrhea (2%)

<1% (Limited to important or life-threatening): Abdominal discomfort, acne, agranulocytosis, allergic reaction, alopecia, anaphylaxis, angioedema, anorexia, arrhythmia, AST/ALT increased, bradycardia, bronchospasm, BUN/creatinine increased, drowsiness, fatigue, fever, hypertension, insomnia, jaundice, neutropenia, palpitation, paresthesia, proteinuria, pruritus, psychic disturbances, rash, seizure, tachycardia, thrombocytopenia, toxic epidermal necrolysis, urticaria, vomiting, weakness

Overdosage/Toxicology

Symptoms of overdose include hypotension, tachycardia, vomiting, and drowsiness. Treatment is symptomatic and supportive.

Drug Interactions

Cefpodoxime: Histamine H2 antagonists may decrease the absorption of cefpodoxime; separate oral doses by at least 2 hours. Risk: Moderate

Cefuroxime: Histamine H2 antagonists may decrease the absorption of cefuroxime; separate oral doses by at least 2 hours. Risk: Moderate

Cyclosporine: Histamine H2 antagonists may increase the serum concentration of cyclosporine; monitor

Delavirdine: Delavirdine's absorption is decreased; avoid concurrent use with H2 antagonists

Itraconazole: Histamine H2 antagonists may decrease the absorption of itraconazole; monitor

Ketoconazole: Histamine H2 antagonists may decrease the absorption of ketoconazole; monitor

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may cause gastric mucosal irritation).

Food: Famotidine bioavailability may be increased if taken with food.

Stability

Oral:

Powder for oral suspension: Prior to mixing, dry powder should be stored at room temperature of 25°C (77°F). Reconstituted oral suspension is stable for 30-days at room temperature. Do not freeze

Tablet: Store at 20°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F); protect from moisture

Orally-disintegrating tablet: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F); protect from moisture

I.V.:

Solution for injection: Prior to use, store at 2°C to 8°C (36°F to 46°F). If solution freezes, allow to solubilize at room temperature.

I.V. push: Dilute famotidine with NS (or another compatible solution) to a total of 5-10 mL (some centers also administer undiluted). Following reconstitution, solutions for I.V. push should be used immediately, or may be stored in refrigerator and used within 48 hours.

Infusion: Dilute with D5W 100 mL or another compatible solution. Following reconstitution, solutions for infusion are stable for 7 days at room temperature.

Solution for injection, premixed bags: Store at room temperature of 25°C (77°F). Avoid excessive heat.

Compatibility

Stable in D5W, D10W, LR, fat emulsion 10%, NS, sodium bicarbonate 5%; variable stability (consult detailed reference) in TPN

Y-site administration: Compatible: Acyclovir, allopurinol, amifostine, aminophylline, ampicillin, ampicillin/sulbactam, amsacrine, atropine, aztreonam, bretylium, calcium gluconate, cefazolin, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftizoxime, ceftriaxone, cefuroxime, chlorpromazine, cisatracurium, cisplatin, cladribine, cyclophosphamide, cytarabine, dexamethasone sodium phosphate, dextran 40, digoxin, diphenhydramine, dobutamine, docetaxel, dopamine, doxorubicin, doxorubicin liposome, droperidol, enalaprilat, epinephrine, erythromycin lactobionate, esmolol, etoposide, filgrastim, fluconazole, fludarabine, folic acid, gatifloxacin, gemcitabine, gentamicin, granisetron, haloperidol, heparin, hydrocortisone, hydrocortisone sodium succinate, hydromorphone, hydroxyzine, imipenem/cilastatin, inamrinone, insulin (regular), isoproterenol, labetalol, lidocaine, linezolid, lorazepam, magnesium sulfate, melphalan, meperidine, methotrexate, methylprednisolone sodium succinate, metoclopramide, midazolam, morphine, nafcillin, nitroglycerin, norepinephrine, ondansetron, oxacillin, paclitaxel, perphenazine, phenylephrine, phenytoin, phytonadione, piperacillin, potassium chloride, potassium phosphates, procainamide, propofol, remifentanil, sargramostim, sodium bicarbonate, sodium nitroprusside, teniposide, theophylline, thiamine, thiotepa, ticarcillin, ticarcillin/clavulanate potassium, tirofiban, verapamil, vinorelbine. Incompatible: Alatrofloxacin, amphotericin B cholesteryl sulfate complex, cefepime, piperacillin/tazobactam. Variable (consult detailed reference): Furosemide, TPN

Compatibility when admixed: Compatible: Cefazolin, flumazenil, vancomycin

Mechanism of Action

Competitive inhibition of histamine at H2 receptors of the gastric parietal cells, which inhibits gastric acid secretion

Pharmacodynamics/Kinetics

Onset of action: GI: Oral: Within 1-3 hour

Duration: 10-12 hours

Protein binding: 15% to 20%

Bioavailability: Oral: 40% to 50%

Half-life elimination:

Injection, oral suspension, tablet: 2.5-3.5 hours; prolonged with renal impairment; Oliguria: 20 hours

Orally-disintegrating tablet: 2.5-5 hours

Time to peak, serum: Oral: ~1-3 hours

Excretion: Urine (as unchanged drug)

Dosage

Children: Treatment duration and dose should be individualized

Peptic ulcer: 1-16 years:

Oral: 0.5 mg/kg/day at bedtime or divided twice daily (maximum dose: 40 mg/day); doses of up to 1 mg/kg/day have been used in clinical studies

I.V.: 0.25 mg/kg every 12 hours (maximum dose: 40 mg/day); doses of up to 0.5 mg/kg have been used in clinical studies

GERD: Oral:

<3 months: 0.5 mg/kg once daily

3-12 months: 0.5 mg/kg twice daily

1-16 years: 1 mg/kg/day divided twice daily (maximum dose: 40 mg twice daily); doses of up to 2 mg/kg/day have been used in clinical studies

Children 12 years and Adults: Heartburn, indigestion, sour stomach: OTC labeling: Oral: 10-20 mg every 12 hours; dose may be taken 15-60 minutes before eating foods known to cause heartburn

Adults:

Duodenal ulcer: Oral: Acute therapy: 40 mg/day at bedtime for 4-8 weeks; maintenance therapy: 20 mg/day at bedtime

Helicobacter pylori eradication (unlabeled use): 40 mg once daily; requires combination therapy with antibiotics

Gastric ulcer: Oral: Acute therapy: 40 mg/day at bedtime

Hypersecretory conditions: Oral: Initial: 20 mg every 6 hours, may increase in increments up to 160 mg every 6 hours

GERD: Oral: 20 mg twice daily for 6 weeks

Esophagitis and accompanying symptoms due to GERD: Oral: 20 mg or 40 mg twice daily for up to 12 weeks

Patients unable to take oral medication: I.V.: 20 mg every 12 hours

Dosing adjustment in renal impairment: Clcr<50 mL/minute: Manufacturer recommendation: Administer 50% of dose or increase the dosing interval to every 36-48 hours (to limit potential CNS adverse effects).

Administration

Oral:

Suspension: Shake vigorously before use. May be taken with or without food.

Tablet: May be taken with or without food.

Orally-disintegrating tablet: Place tablet on tongue with dry hands; tablet dissolves rapidly in saliva. May be taken with or without liquid or food; do not break tablet

I.V.:

I.V. push: Inject over at least 2 minutes

Solution for infusion: Administer over 15-30 minutes

Dietary Considerations

Phenylalanine content: Pepcid® AC chewable: Each 10 mg tablet contains phenylalanine 1.4 mg

Patient Education

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy without consulting prescriber. Take as directed; do not alter dose or frequency or discontinue without consulting prescriber. May cause some drowsiness or dizziness (use caution when driving or engaging in tasks that require alertness until response to drug is known); constipation (increased exercise, fluids, fruit, or fiber may help); or diarrhea (buttermilk, boiled milk, or yogurt may help). Report acute headache, unresolved constipation or diarrhea, palpitations, black tarry stools, abdominal pain, rash, worsening of condition being treated, or recurrence of symptoms after therapy is completed.

Orally-disintegrating tablet: Do not break tablet.

Oral suspension: Shake well before use.

OTC: Do not use for more than 14 days unless recommended by prescriber.

Breast-feeding precaution: Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause dizziness or drowsiness; may rarely cause insomnia

Mental Health: Effects on Psychiatric Treatment

May cause agranulocytosis; use caution with clozapine and carbamazepine

Dosage Forms

[DSC] = Discontinued product

Gelcap (Pepcid® AC): 10 mg

Infusion [premixed in NS] (Pepcid®): 20 mg (50 mL)

Injection, solution: 10 mg/mL (4 mL, 20 mL, 50 mL) [contains benzyl alcohol]

Pepcid®: 10 mg/mL (4 mL [DSC], 20 mL)

Injection, solution [preservative free] (Pepcid®): 10 mg/mL (2 mL)

Powder for oral suspension (Pepcid®): 40 mg/5 mL (50 mL) [contains sodium benzoate; cherry-banana-mint flavor]

Tablet: 10 mg [OTC], 20 mg, 40 mg

Pepcid®: 20 mg, 40 mg [film coated]

Pepcid® AC: 10 mg, 20 mg

Tablet, chewable (Pepcid® AC): 10 mg [contains phenylalanine 1.4 mg/tablet; mint flavor]

Tablet, orally-disintegrating (Fluxid™): 20 mg, 40 mg [cherry flavor]

References

Ahmad S, "Famotidine and Cardiac Arrhythmia," DICP , 1991, 25(3):315.

Broussard CN and Richter JE, "Treating Gastro-oesophageal Reflux Disease During Pregnancy and Lactation: What Are the Safest Therapy Options," Drug Saf , 1998, 19(4):325-37.

Fennerty MD and Higbee M, "Drug Therapy of Gastrointestinal Disease," Geriatric Pharmacology , Bressler R and Katz MD, eds, New York, NY: McGraw-Hill, 1993, 585-608.

Fish DN, "Safety and Cost of Rapid I.V. Injection of Famotidine in Critically Ill Patients," Am J Health Syst Pharm , 1995, 52(17):1889-94.

Gottlieb S, Decktor DL, Eckert JM, et al, "Efficacy and Tolerability of Famotidine in Preventing Heartburn and Related Symptoms of Upper Gastrointestinal Discomfort," Am J Therapeut , 1995, 2:314-9.

Inotsume N, Mishimura M, Nakano M, et al, "Removal of Famotidine by Haemodialysis in Elderly Anuric Patients," Eur J Clin Pharmacol , 1990, 38(3):313-4.

James LP and Kearns GL, "Pharmacokinetics and Pharmacodynamics of Famotidine in Paediatric Patients," Clin Pharmacokinet , 1996, 31(2):103-10.

Lipsy RJ and Freeman CD, "Hemodynamic Effects of Intravenous Famotidine in Critically Ill Patients," Pharmacotherapy ,1995, 15(1):48-51.

Simon TJ, Berlin RG, Gardner AH, et al, "Self-Directed Treatment of Intermittent Heartburn: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Evaluation of Antacid and Low Doses of an H2-Receptor Antagonist (Famotidine)," Am J Therapeut , 1995, 2:304-13.

Treem WR, Davis PM, and Hyams JS, "Suppression of Gastric Acid Secretion by Intravenous Administration of Famotidine in Children," J Pediatr , 1991, 118(5):812-6.

International Brand Names

Agufam® (TH); Amfamox® (AU); Apo-Famo® (PL); Apo-Famotidine® (CA, CZ, HU, NZ, SG); Apogastine® (IL); Asid® (BR); Blocacid® (IN, RU, SG); Brolin® (ES); Confobos® (ES); Corocyd® (ID); Cronol® (ES); Digervin® (ES); Dipsin® (PT); Dispromil® (ES); Duovel® (TR); Durater® (DO, GT, HN, MX, PA, SV); Eradix® (AT); Eviantrina® (ES); Faberdin® (ID); Facid® (ID); Fadine® (TH); Fadul® (DE); Fagastin® (PL); Fagastril® (ES); Famec® (TR); Famidyna® (PL); Famo 1A Pharma® (DE); Famo AbZ® (DE); Famobeta® (DE); Famocid® (ID, RU, TH); Famoc® (SG, TH); Famodar® (LB, RO); Famodil® (IT); Famodin® (BD, RO, TR); Famodine® (BD, BR, EG, KW, LB, SY); Famodyl® (DO); Famogal® (CO); Famogast® (PL, RO, TR); Famo® (IL, TR); Famoj® (BD); Famokey® (ES); Famonerton® (DE); Famonox® (TH); Famopril® (SG); Famopsin® (CY, TH); Famosan® (CZ, HR, RO, RU, YU); Famose® (BR); Famoser® (TR); Famoset® (BR); Famosia® (TH); Famos® (ID); Famosin® (AT); Famotab® (TH); Famotack® (BD); Famotak® (RO); Famotal® (NO); Famotec® (EC); Famotep® (TR); Famotidina Bayvit® (ES); Famotidina Cinfa® (ES); Famotidina® (CL, RO); Famotidina Edigen® (ES); Famotidina Esteve® (ES); Famotidina Geminis® (ES); Famotidina Genfar® (EC); Famotidina Harkley® (ES); Famotidina L.CH.® (CL); Famotidina Lisan® (CR); Famotidina Mabo® (ES); Famotidina Merck® (PT); Famotidina MK® (CR, DO, GT, HN, PA, SV); Famotidina Raffo® (AR); Famotidina Ratiopharm® (ES); Famotidin Atid® (DE); Famotidin AZU® (DE); Famotidin Biochemie® (DE); Famotidin® (CZ, NO, RO, RU, YU); Famotidine-Akri® (RU); Famotidine® (GB, PL); Famotidine Indo Farma® (ID); Famotidine-Teva® (IL); Famotidin findusFit® (DE); Famotidin Genericon® (AT); Famotidin Heumann® (DE); Famotidin Interpharm® (AT); Famotidin Klast® (DE); Famotidin Milinda® (DE); Famotidin Ratiopharm® (AT); Famotidin-ratiopharm® (DE); Famotidin Sandoz® (DE); Famotidin Stada® (AT, DE); famotidin von ct® (DE); Famotin® (BD, CR, DO, EC, GT, PA, SG, TH); Famotsan® (TR); Famoxal® (MX); Famox® (BR, NZ, SG); Famtac® (IN); Famtol® (DE); Famulcer® (ES); Famultran® (BG); Fanosin® (ES); Fanox® (ES); Farmotex® (MX); Fasidine® (TH); Fatidin® (PT); Fibonel® (CL); Fluktan® (ID); Fudone® (IN, RU, ZA); Gasfamin® (ID); Gaster® (ID, JP); Gasterol® (TR); Gastifam® (TR); Gastridin® (IT); Gastrion® (ES); Gastrium® (CL); Gastrodomina® (EG, ES); Gastrofam® (TR); Gastro® (IL); Gastropen® (ES); Gastropep® (DO); Gastrosidin® (RO, TR); Gen-Famotidine (CA); Gestofam® (ID); Geziletas® (AR); Ingastri® (ES); Interfam® (ID); Invigan® (ES); It-Famochem® (EC); Kemofam® (ID); Lasa® (PT); Lecedil® (RU, YU); Mecofam® (ID); Mensoma® (PT); Motiax® (IT); Motidine® (SG, TH); Motidin® (HU); Motipep® (ID); Muclox® (ES); Neotab® (TR); Nevofam® (TR); Nor-Famotina® (DO, GT, HN, SV); Nos® (ES); Notidin® (TR); Novatac® (BD); Novo-Famotidine (CA, PL); Novo Famotidine (RO); Nu-Famotidine (CA); Nulcefam® (ID); Nulceran® (PT); Nulcerin® (ES); Panalba® (RO); Pepcid® AC (CA); Pepcidac® (FR); Pepcid® (AU, CA, DE, ES, FI, GB, IE, NL, NO, SE); Pepcidina® (PT); Pepcidin® (DK, FI, NL, NO, SE); Pepcidine® (AR, AT, AU, BE, FR, HK, LU, MX, NZ, TH); Pepcid® I.V. (CA); Pepcine® (TH); Pepdenal® (TH); Pepdif® (TR); Pepdine® (EG, FR); Pepdul® (DE); Pepfamin® (TH); Peptan® (SE); Peptifam® (JO); Peptigal® (HU); Peptoci® (TH); Peptril® (DO); Pepzan® (NZ, TH); Percidine® (SG); Pharmotidine® (TH); Pompaton® (ID); Purifam® (ID); Quamatel® (CZ, HU, PL, RO, RU); Quamatel Mini® (HU); ratio-Famotidine (CA); Regastin® (ID); Renapepsa® (ID); Rhoxal-famotidine (CA); Riva-Famotidine (CA); Rogasti® (IL); Rubacina® (ES); Servipep® (BD, HU); Sigafam® (MX); Tairal® (ES); Tameran® (ES); Tamin® (ES); Tipodex® (ES); Tismafam® (ID); Ulcatif® (ID); Ulcelac® (AR); Ulceran-40® (CZ); Ulceran® (BG, CZ, HK, JO, RO, RU, SG, TH, UA); Ulcerid® (ID); Ulcetrax® (ES); Ulcofam® (TH); Ulcusan® (AT); Ulfadin® (CO); Ulfagel® (EC); Ulfamet® (TH); Ulfam® (ID); Ulfamid® (CZ, HR, PL, RO, RU, SI); Ulgarine® (ES); Ulmo® (ID); Vagostal® (ES); Yamadin® (BD)

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