DICYCLOMINE HYDROCHLORIDE tablet DICYCLOMINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

INN (International Name):

DICYCLOMINE HYDROCHLORIDE

Composition:

DICYCLOMINE HYDROCHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - unstable cardiovascular status in acute hemorrhage - myasthenia gravis [see Warnings and Precautions (5.4)] - glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)] - obstructive uropathy [see Warnings and Precautions (5.8)] - obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5)] - severe ulcerative colitis [see Warnings and Precautions (5.7)] - reflux esophagitis Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to w

Product summary:

Dicyclomine Hydrochloride Capsules USP, 10 mg 10 mg blue capsules with a white powder fill, imprinted logo LANNETT on the cap and 0586 on the body, supplied in bottles of 100, 500, and 1000 capsules. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. Bottles of 100 capsules: NDC 0527-0586-01 Bottles of 500 capsules: NDC 0527-0586-05 Bottles of 1000 capsules: NDC 0527-0586-10 Dicyclomine Hydrochloride Tablets USP, 20 mg 20 mg blue, round, flat-faced, beveled edge tablets, debossed LAN over 1282, supplied in bottles of 100, 500 and 1000 tablets. To prevent fading, avoid exposure to direct sunlight. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. Bottles of 100 tablets: NDC 0527-1282-01 Bottles of 500 tablets: NDC 0527-1282-05 Bottles of 1000 tablets: NDC 0527-1282-10

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE TABLET
DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE CAPSULE
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICYCLOMINE HYDROCHLOLRIDE
CAPSULES AND DICYCLOMINE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR DICYCLOMINE HYDROCHLOLRIDE CAPSULES AND DICYCLOMINE
HYDROCHLORIDE
TABLETS.
DICYCLOMINE HYDROCHLOLRIDE 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
Dicyclomine hydrochloride is an antispasmodic and anticholinergic
(antimuscarinic) agent indicated for the treatment of
functional bowel/irritable bowel syndrome (1)
DOSAGE AND ADMINISTRATION
Dosage for dicyclomine hydrochloride 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):
Starting dose: 20 mg four times a day. After a week treatment with the
starting dose, the dose may be escalated to 40
mg four times a day, unless side effects limit dosage escalation
Discontinue dicyclomine hydrochloride if efficacy not achieved or side
effects require doses less than 80 mg per day
after two weeks of treatment
DOSAGE FORMS AND STRENGTHS
Dicyclomine Hydrochloride Capsules USP, 10 mg (3)
Dicyclomine Hydrochloride Tablets USP, 20 mg (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
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
decreased