Dicyclomine Hydrochloride (Page 4 of 4)

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

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.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

14 CLINICAL STUDIES

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).

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

17.2 Use in Infants

Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations (8.4)].

17.3 Use in Nursing Mothers

Advise lactating women that dicyclomine hydrochloride should not be used while breastfeeding their infants [see Use in Specific Populations ( 8.3, 8.4)] .

17.4 Peripheral and Central Nervous System

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)].

Manufactured For:
Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054

Rev. B 11/2020

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC: 70934-682-30

Label
(click image for full-size original)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-682(NDC:0591-0795)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
FD&C BLUE NO. 1
HYPROMELLOSE 2910 (15 MPA.S)
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
LACTOSE MONOHYDRATE
Product Characteristics
Color blue Score no score
Shape ROUND Size 7mm
Flavor Imprint Code WATSON;795
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-682-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085223 04/29/2020
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-682)

Revised: 01/2022 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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