RX ITEM-Bentyl 10mg Cap 100 by Actavis Pharma

BENTYL - dicyclomine hydrochloride capsule
BENTYL - dicyclomine hydrochloride tablet
BENTYL - dicyclomine hydrochloride injection, solution
Aptalis Pharma US, Inc.
BENTYL� (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Dosage must be adjusted to individual patients needs.

2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.
If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

2.2 Intramuscular Dosage and Administration in Adults
BENTYL Intramuscular Injection must be administered via intramuscular route only. Do not administer by an other route. The recommended intramuscular dose is 10 mg to 20 mg four times a day. [see Clinical Pharmacology (12)]
The intramuscular injection is to be used only for 1 or 2 days when the patient cannot take oral medication.

Intramuscular injection is about twice as bioavailable as oral dosage forms.
4 CONTRAINDICATIONS

BENTYL 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

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Actavis Pharma

DICYCLOMINE HCL ORAL CAPS
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