Rx Item-Enablex 15Mg Tab 30 By Actavis Pharma

ENABLEX � darifenacin tablet, extended release
Novartis Pharmaceuticals Corporation

DESCRIPTION

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 C28 H30 N2 O2 .HBr.

The structural formula is

ENABLEX (darifenacin) structural formula
(click image for full-size original)


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 anhyrdous, hypromellose (hydroxypropyl methylcellulose), magnesium stearate, polyethylene glycol, talc, titanium dioxide. The 15 mg tablet also contains iron oxide red and iron oxide yellow.

CLINICAL PHARMACOLOGY

Figure 1 Mean (SD) Steady State Darifenacin Plasma Concentration Time Profiles for ENABLEX� 7.5 and 15 mg in Healthy Volunteers Including Both CYP2D6 EMs and PMs*
General
Darifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of the urinary bladder smooth muscle and stimulation of salivary secretion.

In vitro studies using human recombinant muscarinic receptor subtypes show that darifenacin has greater affinity for the M3 receptor than for the other known muscarinic receptors (9- and 12-fold greater affinity for M3 compared to M1 and M5 , respectively, and 59-fold greater affinity for M3 compared to both M2 and M4 ). M3 receptors are involved in contraction of human bladder and gastrointestinal smooth muscle, saliva production, and iris sphincter function. Adverse drug effects such as dry mouth, constipation and abnormal vision may be mediated through effects on M3 receptors in these organs. Enablex Indications and Usage

ENABLEX� (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

RX ITEM-Enablex 15Mg Tab 30 By Actavis P
NDC 00430-0171-15 UPC/GTIN No.3-04300-17115-7 Mfg.Part No.17115

Enablex 15Mg Tab 30 By Actavis Pharma
BRAND: ENABLEX NDC: 00430-0171-15,430017115 UPC: 3-04300-17115-7,304300171157 Actavis Pharma

DARIFENACIN HYDROBROMIDE
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.