Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function
Absorption and Distribution
In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.
Elimination The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.
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 tablets, USP are supplied as follows:
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 30 (NDC 70934-682-30) .
Store at 20° — 25°C (68° — 77°F). [See USP controlled room temperature.]
Keep out of the reach of children.
Dispense in a well-closed container as defined in USP/NF.
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 breastfeeding 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 patient 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)].
Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054
Rev. B 11/2020
|DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride tablet|
|Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)|
|Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)|
|Denton Pharma, Inc. DBA Northwind Pharmaceuticals||080355546||repack (70934-682)|
Revised: 01/2022 Denton Pharma, Inc. DBA Northwind Pharmaceuticals
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