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DOSAGE AND ADMINISTRATION
Duodenal Ulcer
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 PEPCID at full dosage for longer than 6 to 8
weeks. A regimen of 20 mg b.i.d. is also effective.
Maintenance Therapy: The recommended oral dose is 20 mg once a day at bedtime.
Benign Gastric Ulcer Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
Gastroesophageal Reflux Disease (GERD)
The recommended oral dosage for treatment of patients with symptoms of
GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for
the treatment of 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
INDICATIONS AND USAGE
PEPCID is indicated in:
- Short term treatment of active duodenal ulcer. Most patients heal
within 4 weeks; there is rarely reason to use PEPCID 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.
- Maintenance therapy for duodenal ulcer patients at reduced dosage
after healing of an active ulcer.Controlled studies have not extended
beyond one year.
- 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.
- Short term treatment of gastroesophageal reflux disease (GERD).
PEPCID is indicated for short term treatment of patients with symptoms
of GERD.PEPCID is also indicated for the short term treatment of
esophagitis due to GERD including erosive or ulcerative disease
diagnosed by endoscopy.
- Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas).
Clinical Studies
Duodenal Ulcer
In a U.S. multicenter, double-blind study in outpatients with
endoscopically confirmed duodenal ulcer, orally administered PEPCID was
compared to placebo. As shown in Table 1, 70% of patients treated with
PEPCID 40 mg h.s. were healed by week 4.
CLINICAL PHARMACOLOGY
PEPCID is a competitive inhibitor of histamine H2-receptors. The
primary clinically important pharmacologic activity of PEPCID is
inhibition of gastric secretion. Both the acid concentration and volume
of gastric secretion are suppressed by PEPCID, while changes in pepsin
secretion are proportional to volume output.
In normal volunteers and hypersecretors, PEPCID inhibited basal and
nocturnal gastric secretion, as well as secretion stimulated by food
and pentagastrin. After oral administration, the onset of the
antisecretory effect occurred within one hour; the maximum effect was
dose-dependent, occurring within one to three hours. Duration of
inhibition of secretion by doses of 20 and 40 mg was 10 to 12 hours.
DESCRIPTION
The active ingredient in PEPCID (Famotidine) is a histamine
H2-receptor antagonist. PEPCID (Famotidine) is
N¢-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide.
The empirical formula of famotidine is C8H15N7O2S3 and its molecular
weight is 337.43.
In 3d formula looks like :
Its structural formula is:
DOSAGE AND ADMINISTRATION
The usual adult dosage of `SOMA' (carisoprodol) Tablets, USP is one 350
mg tablet, three times daily and at bedtime. Usage in patients under
age 12 is not recommended.
HOW SUPPLIED
`SOMA' (carisoprodol) Tablets, USP 350 mg: Round, convex, white
tablets, inscribed with SOMA 350, are available in bottles of 100 (NDC
0037-2001-01).
Storage: Store at controlled room temperature 20 to 25° C (68 to 77° F).
Dispense in a tight container.
OVERDOSAGE
Overdosage of Soma produces CNS depression, and in severe cases coma.
Shock, respiratory depression, seizures and death have also been
reported rarely. The following signs and symptoms may be associated
with Soma overdosage: horizontal and vertical nystagmus, blurred
vision, mydriasis, mild tachycardia and hypotension, respiratory
depression, euphoria, CNS stimulation, muscular incoordination, and/or
rigidity, confusion, headache, hallucinations, and dystonic reactions.
The effects of an overdosage of Soma and alcohol or other CNS
depressants or psychotropic agents can be additive even when one of the
drugs has been taken in the usual recommended dosage. Fatal accidental
and non-accidental overdoses have been reported alone or in combination
with alcohol or psychotropic drugs.
INDICATIONS
Carisoprodol is indicated as an adjunct to rest, physical therapy, and
other measures for the relief of discomfort associated with acute,
painful musculoskeletal conditions.
CLINICAL PHARMACOLOGY
Soma is a centrally acting
skeletal muscle relaxant that does not directly relax tense skeletal
muscles in man. The mode of action of Soma in relieving acute muscle
spasm of local origin has not been clearly identified, but may be
related to its sedative properties. In animals, Soma
has been shown to produce muscle relaxation by blocking interneuronal
activity and depressing transmission of polysynaptic neurons in the
spinal cord and in the descending reticular formation of the brain. The
onset of action is rapid and lasts four to six hours.
Soma is metabolized in the
liver and is excreted by the kidneys. One of the products of
metabolism, meprobamate, is active as an anxiolytic. The degree to
which it contributes to the efficacy of Soma is unknown. Soma is dialyzable by peritoneal and hemodialysis.
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