"The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
BENTYL® (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
DOSAGE AND ADMINISTRATION
Dosage must be adjusted to individual patient needs.
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.
Intramuscular Dosage and Administration in Adults
BENTYL Intramuscular Injection must be administered via intramuscular route only. Do not administer by any other route.
The recommended intramuscular dose is 10mg to 20 mg four times a day [see CLINICAL PHARMACOLOGY]. 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.
Preparation for Intramuscular Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage Forms And Strengths
- BENTYL 10 mg Capsules: blue, imprinted BENTYL 10
- BENTYL 20 mg Tablets: compressed, light blue, round, debossed BENTYL 20
- BENTYL Injection 20mg/2ml (10mg/ml)
Storage And Handling
10 mg blue Capsules, imprinted BENTYL 10, supplied in bottles of 100. Store at room temperature, preferably below 86°F (30°C).
NDC number: 58914-012-10.
20 mg compressed, light blue, round tablets, debossed BENTYL 20, supplied in bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).
20 mg/2 mL (10 mg/mL) Injection supplied in boxes of five 20 mg/2 mL ampules (10 mg/mL). Store at room temperature, preferably below 86°F (30°C). Protect from freezing.
Manufactured for: Aptalis Pharma US, Inc. 100 Somerset Corporate Boulevard, Bridgewater, NJ 08807 USA. www.aptalispharma.com. Revised: 01/2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/1/2013
Additional Bentyl Information
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