Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception, or parturition.
In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).
Dicyclomine Hydrochloride Capsules, USP, 10 mg are supplied as dark blue capsules printed “West-ward 3126″ and are available in:
Bottles of 100 capsules.
Bottles of 1000 capsules.
Dicyclomine Hydrochloride Tablets, USP 20 mg are supplied as Blue, Round Tablets; Embossed “WW27″ and are available in:
Bottles of 100 tablets.
Bottles of 1000 tablets.
Unit Dose Boxes of 100 tablets.
Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations (8.4)] .
Advise lactating women that dicyclomine hydrochloride should not be used while human milk feeding their infants [see Use in Specific Populations (8.3, 8.4)] .
In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride may produce drowsiness or blurred vision. The patients should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine hydrochloride. [see Warnings and Precautions (5.3)].
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724 USA
Revised September 2011
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTIONDRUG: Dicyclomine
GENERIC: Dicyclomine Hydrochloride
SCORE: No score
SIZE: 7 mm
|DICYCLOMINE dicyclomine hydrochloride tablet|
|Labeler — REMEDYREPACK INC. (829572556)|
Revised: 03/2013 REMEDYREPACK INC.
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