Complete SPL Sections#
Description
Description section
FLUXID™ (famotidine orally disintegrating tablets) is a histamine 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: 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 orally disintegrating tablet contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: citric acid, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, natural and artificial cherry flavor, sodium bicarbonate, sucralose and sucrose.
CLINICAL PHARMACOLOGY IN ADULTS
Clinical Pharmacology section
CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS
Clinical Pharmacology section
INDICATIONS AND USAGE
Indications section
FLUXID™ is indicated in: 1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. 2. 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. 3. Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. 4. Short term treatment of gastroesophageal reflux disease (GERD) . FLUXID™ is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). FLUXID™ is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). 5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ).
CONTRAINDICATIONS
Contraindications section
Hypersensitivity to any component of this product. Cross sensitivity in this class of compounds has been observed. Therefore, FLUXID™ should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists.
PRECAUTIONS
Precautions Section
ADVERSE REACTIONS
Adverse Reactions section
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 injection 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 experience profile seen with FLUXID™ was similar to that seen with famotidine tablets.
OVERDOSAGE
Overdosage section
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. Single oral doses of up to 3000 mg/kg in rats and mice and 2000 mg/kg in dogs were not lethal.
DOSAGE AND ADMINISTRATION
Dosage and Administration section
HOW SUPPLIED
How Supplied section
FLUXID™ (famotidine orally disintegrating tablets) 20 mg are white, round, biconvex, cherry-flavored and engraved “SP371” on one side and “20” on the other side. They are supplied as follows: Bottles of 30 (unit-of-use)NDC 0091-3371-32 Bottles of 100NDC 0091-3371-01 FLUXID™ (famotidine orally disintegrating tablets) 40 mg are white, round, biconvex, cherry-flavored and engraved “SP372”on one side and “40” on the other side. They are supplied as follows: Bottles of 30 (unit-of-use)NDC 0091-3372-32 Bottles of 100NDC 0091-3372-01 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF. Manufactured for: Schwarz Pharma Milwaukee, WI 53201, USA By: CIMA LABS INC.® Eden Prairie, MN 55344, USA FLUXID™ uses CIMA® U.S. Patent Nos. 6,024,981 and 6,221,392.
