Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1673
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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<1 Year of Age Gastroesophageal Reflux
Disease (GERD): See
PRECAUTIONS, Pediatric Patients<1 Year of
Age. The studies
described in PRECAUTIONS, Pediatric Patients<1 Year of
Age suggest the following starting doses in pediatric
patients<1 year of age: Gastroesophageal Reflux Disease
(GERD)���0.5 mg/kg/dose of famotidine oral suspension
for the treatment of GERD for up to 8 weeks once daily in
patients<3 months of age and 0.5 mg/kg/dose twice daily
in patients 3 months to<1 year of age. Patients should
also be receiving conservative measures (e.g., thickened
feedings). The use of intravenous famotidine in pediatric
patients<1 year of age with GERD has not been adequately
studied.<br/>Dosage for
Pediatric Patients 1-16 Years of Age: See
PRECAUTIONS, Pediatric Patients 1-16 Years of
Age. The studies
described in PRECAUTIONS, Pediatric Patients 1-16 Years of Age
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.<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 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 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 adult patients with severe
Zollinger-Ellison Syndrome. To prepare intravenous solutions,
aseptically dilute 2 mL of Famotidine Injection
(solution containing 10 mg/mL) with Sodium Chloride Injection
0.9% or other compatible intravenous solution (see Stability) to a total volume of either 5 mL or 10 mL
and inject over a period of not less than 2 minutes. To prepare intravenous infusion solutions,
aseptically dilute 2 mL of Famotidine Injection with
100 mL of Dextrose 5% or other compatible solution (see
Stability), and infuse over a 15-30 minute
period.<br/>Concomitant Use of
Antacids: Antacids
may be given orally concomitantly if needed.<br/>Stability: Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration whenever
solution and container permit. When added
to or diluted with most commonly used intravenous solutions,
e.g., Water for Injection, Sodium Chloride Injection 0.9%,
Dextrose Injection 5% and 10% or Lactated Ringer's
Injection, diluted Famotidine Injection is physically and
chemically stable (i.e., maintains at least 90% of initial
potency) for 7 days at room temperature���see HOW
SUPPLIED, Storage. When added
to or diluted with Sodium Bicarbonate Injection 5%, Famotidine
Injection at a concentration of 0.2 mg/mL (the recommended
concentration of famotidine intravenous infusion solutions) is
physically and chemically stable (i.e., maintains at least 90%
of initial potency) for 7 days at room temperature���see
HOW
SUPPLIED, Storage. However, a precipitate may
form at higher concentrations of Famotidine Injection (>0.2
mg/mL) in Sodium Bicarbonate Injection 5%.
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The active
ingredient in Famotidine Injection, USP is a histamine H-receptor antagonist. Famotidine is
[1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propylidene]
sulfamide. 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 concentrated solution for intravenous
injection. Each mL of the single dose solution contains 10 mg of
famotidine and the following inactive ingredients: L-aspartic acid 4 mg,
mannitol 20 mg and Water for Injection q.s. 1 mL. The multiple dose
vials of 4 mL and 20 mL also contain benzyl alcohol 0.9% added as
preservative.
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Hypersensitivity to
any component of these products. 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, USP 10 mg/mL is available in the following: Containing no
preservative 2 mL (20 mg) Single
Dose Vial packaged in 25s (NDC 10019-045-02) Containing benzyl
alcohol as preservative 4 mL (40 mg) Two
Dose Vial packaged in 25s (NDC 10019-046-04) 20 mL Multiple Dose
Vial packaged in 10s (NDC 10019-046-03)<br/>Storage: Store Famotidine Injection at
2��-8��C (36��-46��F).
If solution freezes, bring to room temperature; allow
sufficient time to solubilize all the components. Although
diluted Famotidine Injection has been shown to be physically and
chemically stable for 7 days at room temperature, there are no
data on the maintenance of sterility after dilution. Therefore,
it is recommended that if not used immediately after
preparation, diluted solutions of Famotidine Injection should be
refrigerated and used within 48 hours (see DOSAGE AND
ADMINISTRATION). Manufactured by Baxter Healthcare
Corporation Deerfield,
IL 60015 USA For Product
Inquiry 1 800 ANA DRUG (1-800-262-3784) MLT-01337/5.0
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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 and
Mutagenesis and 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 IV 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 seenin
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 human response, 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 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<1 Year Of Age: Use of
famotidine in pediatric patients<1 year of age is
supported by evidence from adequate and well-controlled studies
of famotidine in adults, and by the following studies in
pediatric patients<1 year of age. Two
pharmacokinetic studies in pediatric patients<1 year of
age (N=48) demonstrated that clearance of famotidine in patients>3 months to 1 year of age is similar to that seen in older
pediatric patients (1-15 years of age) and adults. In contrast,
pediatric patients 0-3 months of age had famotidine clearance
values that were 2- to 4-fold less than those in older pediatric
patients and adults. These studies also show that the mean
bioavailability in pediatric patients<1 year of age
after oral dosing is similar to older pediatric patients and
adults. Pharmacodynamic data in pediatric patients 0-3 months of
age suggest that the duration of acid suppression is longer
compared with older pediatric patients, consistent with the
longer famotidine half-life in pediatric patients 0-3 months of
age. (See CLINICAL
PHARMACOLOGY IN PEDIATRIC PATIENTS, Pharmacokinetics and
Pharmacodynamics.) In a
double-blinded, randomized, treatment-withdrawal study, 35
pediatric patients<1 year of age who were diagnosed as
having gastroesophageal reflux disease were treated for up to 4
weeks with famotidine oral suspension (0.5mg/kg/dose or 1
mg/kg/dose). Although an intravenous famotidine formulation was
available, no patients were treated with intravenous famotidine
in this study. Also, caregivers were instructed to provide
conservative treatment including thickened feedings. Enrolled
patients were diagnosed primarily by history of vomiting
(spitting up) and irritability (fussiness). The famotidine
dosing regimen was once daily for patients<3 months of
age and twice daily for patients���3 months of age.
After 4 weeks of treatment, patients were randomly withdrawn
from the treatment and followed an additional 4 weeks for
adverse events and symptomatology. Patients were evaluated for
vomiting (spitting up), irritability (fussiness) and global
assessments of improvement. The study patients ranged in age at
entry from 1.3 to 10.5 months (mean 5.6��2.9 months),
57% were female, 91% were white and 6% were black. Most patients
(27/35) continued into the treatment withdrawal phase of the
study. Two patients discontinued famotidine due to adverse
events. Most patients improved during the initial treatment
phase of the study. Results of the treatment withdrawal phase
were difficult to interpret because of small numbers of
patients. Of the 35 patients enrolled in the study, agitation
was observed in 5 patients on famotidine that resolved when the
medication was discontinued; agitation was not observed in
patients on placebo (see ADVERSE
REACTIONS, Pediatric Patients). These
studies suggest that a starting dose of 0.5 mg/kg/dose of
famotidine oral suspension may be of benefit for the treatment
of GERD for up to 4 weeks once daily in patients<3
months of age and twice daily in patients 3 months to<1
year of age; the safety and benefit of famotidine treatment
beyond 4 weeks have not been established. Famotidine should be
considered for the treatment of GERD only if conservative
measures (e.g., thickened feedings) are used concurrently and if
the potential benefit outweighs the risk.<br/>Pediatric Patients
1-16 Years of Age: 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 thatthe
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.<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 (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 severe
renal 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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The adverse
reactions in overdose cases are similar to the adverse reactions
encountered in normal clinical experience (see ADVERSE
REACTIONS). 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 IV dose in dogs was approximately
300 mg/kg. Signs of acute intoxication in IV 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. Convulsions, in patients with impaired renal function, have
been reported very rarely. Respiratory: bronchospasm,
interstitial pneumonia Skin: toxic epidermal
necrolysis/Stevens Johnson syndrome (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
for Oral Suspension or Famotidine Injection. In addition, transient
irritation at the injection site has been observed with Famotidine
Injection.<br/>Pediatric Patients: In a
clinical study in 35 pediatric patients<1 year of age
with GERD symptoms [e.g. vomiting (spitting up), irritability
(fussing)], agitation was observed in 5 patients on famotidine
that resolved when the medication was discontinued.
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Famotidine
Injection 4 mL and 20 mL multiple dose vials contain the preservative
benzyl alcohol. There have been reports of fatal���gasping
syndrome' in neonates (children less than one month of age)
following the administration of intravenous solutions containing the
preservative benzyl alcohol. Symptoms include a striking onset of
gasping respiration, hypotension, bradycardia, and cardiovascular
collapse. Benzyl alcohol, given its small size, presumably crosses the
placental barrier into immature fetal tissues as readily as it crosses
the blood-brain barrier. Therefore, Famotidine Injection from multiple
dose vials containing benzyl alcohol should not be used in neonates and
pregnant women.
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Famotidine
Injection, supplied as a concentrated solution for intravenous
injection, 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:
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Famotidine
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