Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1143
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PEPCID (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, PEPCID Injection Premixed or PEPCID Injection
may be administered until oral therapy can be instituted. The recommended dosage for PEPCID Injection Premixed and
PEPCID 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 1-16 years of age 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 PEPCID 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 PEPCID Injection
Premixed or PEPCID 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 PEPCID 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 PEPCID 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.<br/>PEPCID Injection Premixed: PEPCID Injection Premixed, supplied in Galaxycontainers (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.<br/>Directions for Use of Galaxy Containers: Check the container for minute leaks prior to use
by squeezing the bag firmly. If leaks are found, discard solution
as sterility may be impaired. Do not add supplementary medication.
Do not use unless solution is clear and seal is intact. CAUTION: Do not use plastic containers in series connections.
Such use could result in air embolism due to residual air being drawn
from the primary container before administration of the fluid from
the secondary container is complete. Preparation
for administration: To prepare PEPCID intravenous
solutions, aseptically dilute 2 mL of PEPCID Injection
(solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection
or other compatible intravenous solution to a total volume of either 5 mL or 10 mL and inject
over a period of not less than 2 minutes. To prepare PEPCID intravenous infusion solutions, aseptically dilute 2 mL of PEPCID Injection with 100 mL
of 5% dextrose or other compatible solution , and infuse over a 15-30 minute period.<br/>Concomitant Use of Antacids: Antacids may be given 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.<br/>PEPCID Injection Premixed: PEPCID Injection Premixed, as supplied premixed in
0.9% sodium chloride in Galaxy containers (PL 2501
Plastic), is stable through the labeled expiration date when stored
under the recommended conditions.<br/>PEPCID Injection: When added to or diluted with most commonly used
intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride
Injection, 5% and 10% Dextrose Injection, or Lactated Ringer's Injection,
diluted PEPCID 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%, PEPCID Injection at a concentration of 0.2 mg/mL
(the recommended concentration of PEPCID 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 PEPCID Injection
(>0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.
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Hypersensitivity to any component of these products.
Cross sensitivity in this class of compounds has been observed. Therefore,
PEPCID should not be administered to patients with a history of hypersensitivity
to other H-receptor antagonists.
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General: Symptomatic response to therapy with PEPCID 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 .<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 PEPCID. 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 PEPCID. 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 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 PEPCID, 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 PEPCID in pediatric patients<1 year
of age is supported by evidence from adequate and well-controlled
studies of PEPCID 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. In a double-blind,
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
(0.5 mg/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 famotidinedosing 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 PEPCID in pediatric patients 1-16 years of
age is supported by evidence from adequate and well-controlled studies
of PEPCID 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.<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
. 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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PEPCID (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 PEPCID
Tablets were compared to placebo, the incidence of adverse experiences
in the group which received PEPCID 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 PEPCID 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 PEPCID 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 PEPCID Tablets may also occur
with PEPCID for Oral Suspension, PEPCID Injection Premixed or PEPCID
Injection. In addition, transient irritation at the injection site
has been observed with PEPCID 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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PEPCID Injection Premixed, supplied as a premixed
solution in plastic containers (PL 2501 Plastic), and PEPCID
Injection, supplied as a concentrated solution for intravenous injection,
are intended for intravenous use only. PEPCID Injection Premixed and
PEPCID Injection are 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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PEPCID
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