DICYCLOMINE HYDROCHLORIDE- dicyclomine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Clinical Solutions Wholesale

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 Teratogenic Effects: 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 struct

Product summary:

Dicyclomine Hydrochloride Capsules USP and Dicyclomine Hydrochloride Tablets USP are supplied as follows: Dicyclomine hydrochloride Capsules 10 mg blue capsules: Clear Dark Blue cap/Clear Dark Blue body hard gelatin capsules, imprinted with white ink WATSON over 794 on cap and 10 mg on the body, in bottles of 100 and 1000. Dicyclomine hydrochloride Tablets 20 mg tablets: Blue, round, unscored, flat-faced, beveled-edge tablets, debossed WATSON and 795 on the periphery on one side and plain on the other side, in bottles of 100 and 1000 and blister pack of 30. Store at Controlled Room Temperature 15°-30°C (59°-86°F). Dispense in a well-closed container as defined in USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE TABLET
CLINICAL SOLUTIONS WHOLESALE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICYCLOMINE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICYCLOMINE
HYDROCHLORIDE.
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
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 10 mg ( 3)
Dicyclomine hydrochloride tablets 20 mg ( 3)
CONTRAINDICATIONS
Infants less than 6 months of age ( 4)
Glaucoma ( 4)
Nursing mothers ( 4)
Obstructive uropathy ( 4)
Unstable cardiovascular status in accute hemorrhage ( 4)
Obstructive disease of the gastrointestinal tract ( 4)
Myasthenia gravis ( 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 sweating); drug should be discontinued and supportive
measures instituted ( 5.3)
Psychosis and delirium have been reported in patients sensiti