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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
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ENABLEX® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
History
There is currently no drug history available for this drug.
Other Information
ENABLEX® (darifenacin) is an extended-release tablet which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.
Chemically, darifenacin hydrobromide is (S)-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is C28H30N2O2.HBr.
The structural formula is
Darifenacin hydrobromide is a white to almost white, crystalline powder, with a molecular weight of 507.5.
ENABLEX is a once a day extended release tablet and contains the following inactive ingredients: dibasic calcium phosphate, hypromellose (hydroxypropyl methylcellulose), magnesium stearate, polyethylene glycol, talc, titanium dioxide. The 15-mg tablet also contains iron oxide red and iron oxide yellow.
Sources
Enablex Manufacturers
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Physicians Total Care, Inc.
![Enablex (Darifenacin) Tablet, Extended Release [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Enablex | Physicians Total Care, Inc.
The recommended starting dose of ENABLEX® (darifenacin) extended-release tablets 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 extended-release tablets should be taken once daily with liquid. They may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.
For patients with moderate hepatic impairment or when coadministered with potent CYP3A4 inhibitors (e.g., 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 (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Enablex | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
The recommended starting dose of ENABLEX® (darifenacin) extended-release tablets 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 extended-release tablets should be taken once daily with liquid. They may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.
For patients with moderate hepatic impairment or when coadministered with potent CYP3A4 inhibitors (e.g., 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 (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Warner Chilcott (Us), Llc
Enablex | Warner Chilcott (us), Llc
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 & Precautions (5.6), Drug Interactions (7.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
![Enablex (Darifenacin) Tablet, Extended Release [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cec47488-ebad-4a3a-904c-e916b432e2cf&name=Enablex15mgNovartis.jpg)
![Enablex (Darifenacin) Tablet, Extended Release [Warner Chilcott (Us), Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a712f252-16d9-47df-b2bf-6794228f3a88&name=fac466ed-35fc-4279-bb47-ba5b4cbda2fb-07.jpg)
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