DICYCLOMINE HYDROCHLORIDE capsule DICYCLOMINE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

DICYCLOMINE HYDROCHLORIDE

Sammensetning:

DICYCLOMINE HYDROCHLORIDE 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Dicyclomine Hydrochloride Capsules, USP are available containing 10 mg of dicyclomine hydrochloride, USP. The 10 mg capsules are a hard-shell gelatin capsule with a light turquoise blue opaque cap and light turquoise blue opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 1610 in black ink on both the cap and the body. They are available as follows: NDC 0378-1610-01 bottles of 100 capsules NDC 0378-1610-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dicyclomine Hydrochloride Tablets, USP are available containing 20 mg of dicyclomine hydrochloride, USP. The 20 mg tablets are blue, round, unscored tablets debossed with M over D6 on one side of the tablet and blank on the other side. They are available as follows. NDC 0378-1620-01 bottles of 100 tablets NDC 0378-1620-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] To prevent fading, avoid exposure to direct sunlight. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE CAPSULE
DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE TABLET
MYLAN PHARMACEUTICALS INC.
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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 du