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FLUXID (Tablet, Orally Disintegrating)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2958

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FLUXID (Tablet, Orally Disintegrating)
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Instructions for Use/Handling FLUXID���Tablets: Just prior to administration, remove the tablet from the bottle with dry hands. Immediately place the FLUXID���Tablet on top of the tongue, wait until it dissolves, then swallow with saliva. The tablet typically disintegrates in less than 2 minutes. Administration with liquid is not necessary.<br/>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 (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).<br/>Dosage for Pediatric Patients 6-16 years of age: See PRECAUTIONS, Pediatric Patients 6-16 years of age. The studies described in PRECAUTIONS, Pediatric Patients 6-16 years of age suggest the following starting doses in pediatric patients 6-16 years of age: Gastroesophageal Reflux Disease with or without esophagitis including erosions andulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. Tablet should not be broken. While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease, 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 inpediatric patients 1-16 years of age have employed doses up to 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 q 6 h. 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 q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.<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 FLUXID���may be reduced to half the dose or the dosing interval may be prolonged to 36-48 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.
dailymed-instance:descripti...
FLUXID���(famotidine orally disintegrating tablets) is a histamine H-receptor antagonist. Famotidine is N���-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The empirical 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 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.
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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-receptor antagonists.
dailymed-instance:supply
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: 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.
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General: Symptomatic response to therapy with famotidine does not preclude the presence of gastric malignancy.<br/>Patients with Moderate or Severe Renal Insufficiency: Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, longer intervals between doses or lower doses may need to be used in patients with moderate (creatinine clearance<50 mL/min) or severe (creatinine clearance<10 mL/min) renal insufficiency to adjust for the longer elimination half-life of famotidine (see CLINICAL PHARMACOLOGY IN ADULTS and DOSAGE AND ADMINISTRATION).<br/>Information for patients: Patients should be instructed not to remove FLUXID���Tablets from the bottle until just prior to dosing. With dry hands, the tablet should be removed from the bottle and immediately placed on the tongue to dissolve and be swallowed with the saliva. The tablet typically disintegrates in less than 2 minutes.<br/>Drug interactions: No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.<br/>Carcinogenesis, mutagenesis, impairment of fertility: In a 106 week study in rats and a 92 week study in mice given oral doses of up to2000 mg/kg/day (approximately 405 times in rats, and 203 times in mice, the recommended maximum human dose based on body surface area), there was no evidence of carcinogenic potential for famotidine. Famotidine was negative in the Ames test, the mouse micronucleus test and the mouse chromosomal aberration test. In studies with rats given oral doses of up to 2000 mg/kg/day (approximately 405 times the recommended maximum human dose based on body surface area), fertility and reproductive performance were not affected.<br/>Pregnancy. Teratogenic Effects: Pregnancy Category B: Reproductive studies have been performed at oral doses of up to 2000 mg/kg/day in rat (approximately 405 times the recommended maximum human dose based on body surface area) and 500 mg/kg/day in rabbit (approximately 203 times the recommended maximum human dose based on body surface area), and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine. 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.<br/>Nursing mothers: Famotidine is detectable in human milk. Transient growth depression was observed in young rats suckling from mothers treated with famotidine. Because of the potential for serious adverse reactions in nursing infants from famotidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.<br/>Pediatric Patients 6-16 years of age: Use of famotidine in pediatric patients 6-16 years of age is supported by evidence from adequate and well-controlled studies of famotidine in adults, and by the following studies in pediatric patients: In published studies in small numbers of pediatric patients 1-15 years of age, clearance of famotidine was similar tothat seen in adults. In pediatric patients 11-15 years of age, oral doses of 0.5 mg/kg were associated with a mean area under the curve (AUC) similar to that seen in adults treated orally with 40 mg. Limited published studies also suggest that the relationship between serum concentration and acid suppression is similar in pediatric patients 1-15 years of age as compared with adults. These studies suggest a starting dose for pediatric patients 6 - 16 years of age as follows: Gastroesophageal Reflux Disease with or without esophagitis including erosions andulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease, 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 have employed doses up to 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.<br/>Geriatric use: Of the 4,966 subjects in clinical studies who were treated with famotidine, 488 subjects (9.8%) were 65 and older, and 88 subjects (1.7%) were greater than 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is required based on age (see CLINICAL PHARMACOLOGY IN ADULTS, Pharmacokinetics). This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Dosage adjustment in the case of moderate or severerenal impairment is necessary (see PRECAUTIONS, Patients with Moderate or Severe Renal Insufficiency and DOSAGE AND ADMINISTRATION, Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency).
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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.
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famotidine
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FLUXID (Tablet, Orally Disintegrating)
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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.
dailymed-instance:indicatio...
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).
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FLUXID