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Details with Side Effects
DOSAGE AND ADMINISTRATION
The recommended starting dose of Enablex is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy.
Enablex should be taken once daily with water. Enablex may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.
For patients with moderate hepatic impairment (Child-Pugh B) or when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of Enablex should not exceed 7.5 mg. Enablex is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, Use in Specific Populations and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
Enablex extended-release tablets 7.5 mg are round, shallow, bi-convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse.
Enablex extended-release tablets 15 mg are round, shallow, bi-convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse.
Storage And Handling
Enablex®,7.5 mg are round, shallow, bi-convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse.
Bottle of 30..............................NDC 0430-0170-15
Bottle of 90..............................NDC 0430-0170-23
Enablex®, 15 mg are round, shallow, bi-convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse.
Bottle of 30..............................NDC 0430-0171-15
Bottle of 90..............................NDC 0430-0171-23
Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F) [see USP Controlled Room Temperature]. Protect from light.
Keep this and all drugs out of the reach of children.
Manufactured by: Novartis Pharma Stein AG, Stein, Switzerland for Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866 1-800-521-8813
Last reviewed on RxList: 3/22/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Enablex Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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