ENABLEX- darifenacin tablet, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

DARIFENACIN (UNII: APG9819VLM) (DARIFENACIN - UNII:APG9819VLM)

थमां उपलब्ध:

Physicians Total Care, Inc.

INN (इंटरनेशनल नाम):

DARIFENACIN

रचना:

DARIFENACIN 7.5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

ENABLEX®   (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ENABLEX®   (darifenacin)  extended-release tablets  are contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.

उत्पाद समीक्षा:

ENABLEX® 7.5 mg extended-release tablets are round, shallow, convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse. Bottle of 30       NDC 54868-5704-0 ENABLEX® 15 mg extended-release tablets are round, shallow, convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse. Bottle of 30       NDC 54868-5363-0 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light. Keep this and all drugs out of the reach of children. REV: January 2010                                                                   T2010-04

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

ENABLEX - DARIFENACIN TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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ENABLEX
(DARIFENACIN)
EXTENDED-RELEASE TABLETS
RX ONLY
PRESCRIBING INFORMATION
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 C
H N O .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.
CLINICAL PHARMACOLOGY
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 M receptor than for the other known muscarinic
receptors (9- and 12-fold greater
affinity for M compared to M and M , respectively, and 59-fold greater
affinity for M compared to
both M and M ). M 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 M
receptors in these organs.
PHARMACODYNAMICS
In three cystometric studies performed in patients with involuntary
detrusor contractions, increased
bladder capacity was demonstr