DICYCLOMINE HYDROCHLORIDE- dicyclomine hydrochloride tablet DICYCLOMINE HYDROCHLORIDE- dicyclomine hydrochloride capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DICYCLOMINE HYDROCHLORIDE (UNII: CQ903KQA31) (DICYCLOMINE - UNII:4KV4X8IF6V)

Tersedia dari:

Bryant Ranch Prepack

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)] , nursing mothers [see Use in Specific Populations (8.3)] and in patients with: Adequate and well-controlled studies have not been conducted with dicyclomine in pregnant women at the recommended doses of 80 mg/day to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug shoul

Ringkasan produk:

Product: 71335-0160 NDC: 71335-0160-1 30 TABLET in a BOTTLE NDC: 71335-0160-2 40 TABLET in a BOTTLE NDC: 71335-0160-3 60 TABLET in a BOTTLE NDC: 71335-0160-4 90 TABLET in a BOTTLE NDC: 71335-0160-5 20 TABLET in a BOTTLE NDC: 71335-0160-6 21 TABLET in a BOTTLE NDC: 71335-0160-7 120 TABLET in a BOTTLE NDC: 71335-0160-8 100 TABLET in a BOTTLE Product: 71335-0588 NDC: 71335-0588-1 30 CAPSULE in a BOTTLE NDC: 71335-0588-2 90 CAPSULE in a BOTTLE NDC: 71335-0588-3 40 CAPSULE in a BOTTLE NDC: 71335-0588-4 60 CAPSULE in a BOTTLE NDC: 71335-0588-5 20 CAPSULE in a BOTTLE NDC: 71335-0588-6 100 CAPSULE in a BOTTLE NDC: 71335-0588-7 180 CAPSULE in a BOTTLE NDC: 71335-0588-8 120 CAPSULE in a BOTTLE

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE TABLET
DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICYCLOMINE HYDROCHLORIDE
CAPSULES AND DICYCLOMINE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR DICYCLOMINE HYDROCHLORIDE CAPSULES AND DICYCLOMINE
HYDROCHLORIDE
TABLETS.
DICYCLOMINE HYDROCHLORIDE CAPSULES, FOR ORAL USE
DICYCLOMINE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1950
RECENT MAJOR CHANGES
Warnings and Precautions: Peripheral and Central Nervous System (5.3)
07/2012
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
Dosage for dicyclomine must be adjusted to individual patient needs
(2).
If a dose is missed, patients should continue the normal dosing
schedule (2).
ORAL IN ADULTS (2.1):
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Dicyclomine is an antispasmodic and anticholinergic (antimuscarinic)
agent indicated for the treatment of functional
bowel/irritable bowel syndrome (1)
Starting dose: 20 mg 4 times a day. After a week treatment with the
starting dose, the dose may be escalated to 40
mg 4 times a day, unless side effects limit dosage escalation
Discontinue dicyclomine if efficacy not achieved or side effects
require doses less than 80 mg per day after 2 weeks
of treatment
Dicyclomine hydrochloride capsules 10 mg (3)
Dicyclomine hydrochloride tablets 20 mg (3)
Infants less than 6 months of age (4)
Nursing mothers (4)
Unstable cardiovascular status in acute hemorrhage (4)
Myasthenia gravis (4)
Glaucoma (4)
Obstructive uropathy (4)
Obstructive disease of the gastrointestinal tract (4)
Severe ulcerative colitis (4)
Reflux esophagitis (4)
Cardiovascular conditions: worsening of conditions (5.2)
Peripheral and central nervous system: heat prostration can occur with
drug use (fever and heat stroke due to
d