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

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

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.

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

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: Avoid ethanol (may cause gastric mucosal irritation).

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

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.

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

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)

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).

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

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.

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]

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