Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2303
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Famotidine (Injection, Solution)
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In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to
take oral medication, Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.<br/>Dosage for Pediatric Patients: See PRECAUTIONS,
Pediatric Use The studies described in PRECAUTIONS, Pediatric Use suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg
intravenously (injected over a period of not less than two minutes or as a 15 minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, 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 gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated
gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.<br/>Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency: In adult patients with moderate (creatinine clearance<50 mL/min) or severe (creatinine clearance<10 mLmin)
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 Famotidine Injection 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.<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 intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a
higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some patients with severe Zollinger-Ellison Syndrome. Famotidine Injection, supplied in Galaxy containers (PL 2501 Plastic), is a 50 mL iso-osmotic solution premixed
with 0.9% sodium chloride for administration as an infusion over a 15-30 minute period. This premixed solution is for intravenous use only using sterile equipment.
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The active ingredient in Famotidine Injection 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. Famotidine Injection is supplied as a sterile solution, for intravenous use only, in plastic single dose Galaxycontainers. Each 50 mL of the premixed, iso-osmotic intravenous injection contains 20 mg famotidine, USP, and the following inactive ingredients: L-aspartic acid 6.8 mg, sodium chloride,
USP, 450 mg and Water for Injection. The pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to 6.4. The Galaxy plastic container is fabricated from a specially designed multilayered plastic (PL 2501). Solutions are in
contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and
safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
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Hypersensitivity to any component of this product. Cross sensitivity in this class of compounds has been observed. Therefore,Famotidine Injection should not be administered to patients with a history of hypersensitivity to other H-receptor antagonists.
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FOR INTRAVENOUS USE ONLY Famotidine Injection containing 20 mg of famotidine per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle
made iso-osmotic with sodium chloride. Famotidine Injection is supplied in a carton of 12 x 50 mL single dose Galaxy plastic containers as follows:<br/>Storage: Store Famotidine Injection in Galaxy containers (PL 2501 Plastic) at room temperature (25��C/77��F). Exposure of the
premixed product to excessive heat should be avoided. Brief exposure to temperatures up to 35��C (95��F) does not adversely affect the product. Baxter Healthcare Corporation Deerfield, IL 60015 USA Baxter and Galaxy are registered trademarks of Baxter International Inc. 7-19-22-710 April 2001
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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, DOSAGE AND
ADMINISTRATION.)<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 to 2000 mg/kg/day (approximately 2500 times the
recommended human dose for active duodenal ulcer), there was no evidence of carcinogenic potential for famotidine. Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or
without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a
mutagenic effect was observed. In studies with rats given oral doses of up to 2000 mg/kg/day or intravenous doses of up to 200 mg/kg/day, fertility and
reproductive performance were not affected.<br/>Pregnancy:<br/>Pregnancy Category B: 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 I.V. 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 (250 times the usual human dose) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not
always predictive of humanresponse, this drug should be used during pregnancy only if clearly needed.<br/>Nursing Mothers: Studies performed in lactating rats have shown that famotidine is secreted into breast milk. Transient growth depression was
observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk. Because of the
potential for serious adverse reactions in nursing infants from famotidine, a decisionshould be made whether to discontinue nursing or discontinue the drug, taking into account the
importance of the drug to the mother.<br/>Pediatric Use: Use of famotidine in pediatric patients 1-16 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 to that 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. Similarly, in pediatric patients 1-15 years of age, intravenous doses of 0.5 mg/kg were associated with a mean AUC similar to that seen in adults
treated intravenously 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 that the starting dose for pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not
less than two minutes or as a 15 minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, 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 gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated
gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.<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 patients cannot be ruled out. No dosage adjustment is required based on age . 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 severe renal impairment is necessary (see PRECAUTIONS, Patients with Moderate or Severe Renal Insufficiency andDOSAGE 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. The intravenous LDof famotidine for mice and rats ranged from 254-563 mg/kg and the minimum lethal single I.V. dose
in dogs was approximately 300 mg/kg. Signs of acute intoxication in I.V. treated dogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension,
tachycardia and collapse. The oral LDof famotidine in male and female rats and mice was greater than 3000 mg/kg and the minimum lethal acute oral dose in dogs exceeded 2000
mg/kg. Famotidine did not produce overt effects at high oral doses in mice, rats, cats and dogs, but induced significant anorexia and growth depression in rabbits starting with 200
mg/kg/day orally.
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Famotidine
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Famotidine (Injection, Solution)
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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 reactions reported for famotidine tablets may also occur with Famotidine Injection. In addition, transient irritation
at the injection site has been observed with famotidine injection.
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Famotidine Injection is supplied as a premixed solution in Galaxy plastic containers (PL 2501 Plastic), and is intended
for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the
oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: 1. Short term treatment of active duodenal ulcer. Most 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 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). Famotidine Injection is indicated for short term treatment of
patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical
Studies). Famotidine Injection 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) .
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Famotidine
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