DICYCLOMINE HYDROCHLORIDE capsule 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:

Actavis Pharma, Inc.

INN (International Name):

DICYCLOMINE HYDROCHLORIDE

Composition:

DICYCLOMINE HYDROCHLORIDE 10 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 structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Dicyclomine hydrochloride is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in breastmilk. Because of the potential for serious adverse reactions in breastfed infants from dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.4)] . Safety and effectiveness in pediatric patients have not been established. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Contraindications (4)] . There are published cases reporting that the administration of dicyclomine hydrochloride syrup to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established. Clinical studies of dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride has not been studied. Dicyclomine hydrochloride drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine hydrochloride should be administered with caution in patients with renal impairment.   Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.

Product summary:

Dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP are supplied as follows: Dicyclomine hydrochloride capsules, USP  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 (NDC 0591-0794-01) and 1000 (NDC 0591-0794-10). Dicyclomine hydrochloride tablets, USP  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 (NDC 0591-0795-01) and 1000 (NDC 0591-0795-10). 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE CAPSULE
DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE TABLET
ACTAVIS PHARMA, INC.
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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
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 acute
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 sensitive to
anticholinergic drugs (such as
elderly patients and/or in p