Bentyl
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
BENTYL® (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
History
There is currently no drug history available for this drug.
Other Information
BENTYL is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms:
- BENTYL capsules for oral use contain 10 mg dicyclomine hydrochloride USP. BENTYL 10 mg capsules also contain inactive ingredients: calcium sulfate, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, pregelatinized corn starch, and titanium dioxide.
- BENTYL tablets for oral use contain 20 mg dicyclomine hydrochloride USP. BENTYL 20 mg tablets also contain inactive ingredients: acacia, dibasic calcium phosphate, corn starch, FD&C Blue No. 1, lactose, magnesium stearate, pregelatinized corn starch, and sucrose.
- BENTYL injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as an ampoule containing 20 mg/2 mL (10 mg/mL). Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride.
BENTYL (dicyclomine hydrochloride) is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2•HCl and the following structural formula:
Molecular weight: 345.95
Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.
Sources
Bentyl Manufacturers
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Aptalis Pharma Us, Inc.
![Bentyl (Dicyclomine Hydrochloride) Capsule Bentyl (Dicyclomine Hydrochloride) Tablet Bentyl (Dicyclomine Hydrochloride) Injection, Solution [Aptalis Pharma Us, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bentyl | Aptalis Pharma Us, Inc.
Dosage must be adjusted to individual patients needs.
2.1 Oral Dosage and Administration in AdultsThe 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.
2.2 Intramuscular Dosage and Administration in Adults
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.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.
2.3 Preparation for Intramuscular AdministrationParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Aspirate the syringe before injecting to avoid intravascular injection, since thrombosis may occur if the drug is inadvertently injected intravascularly.
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