NIFEDIPINE tablet film coated extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)

थमां उपलब्ध:

St Marys Medical Park Pharmacy

INN (इंटरनेशनल नाम):

NIFEDIPINE

रचना:

NIFEDIPINE 30 mg

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

NIFEDIPINE - NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
ST MARYS MEDICAL PARK PHARMACY
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NIFEDIPINE
EXTENDED-RELEASE TABLETS, USP
_FOR ORAL USE_
RX ONLY
DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents
known as the calcium channel
blockers. Nifedipine is 3, 5-pyridinedicarboxylic acid, 1,
4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-,
dimethyl ester, C
H N O and has the structural formula:
Nifedipine is a yellow crystalline substance, practically insoluble in
water but soluble in ethanol. It has
a molecular weight of 346.33. Nifedipine Extended-release Tablet is
formulated as a once-a-day
extended-release tablet for oral administration designed to deliver
30, 60, or 90 mg of nifedipine.
Inert ingredients in the formulations are: black iron oxide; cellulose
acetate; colloidal silicon dioxide;
hypromellose; lactose monohydrate; magnesium stearate;
microcrystalline cellulose; polyethylene
glycol; polyethylene oxide; polysorbate; povidone; propylene glycol;
red ferric oxide; sodium
chloride; titanium dioxide; triacetin.
SYSTEM COMPONENTS AND PERFORMANCE
Nifedipine Extended-release Tablet is similar in appearance to a
conventional tablet. It consists,
however, of a semipermeable membrane surrounding an osmotically active
drug core. As water from
the gastrointestinal tract enters the tablet, pressure increases in
the core of the tablet, releasing drug
through the precision laser-drilled tablet orifice in the one side of
the tablet.
Nifedipine Extended-release Tablet is designed to provide nifedipine
at an approximately constant rate
over 24 hours. This controlled rate of drug delivery into the
gastrointestinal lumen is independent of pH
or gastrointestinal motility.
Nifedipine Extended-release Tablet depends for its action on the
existence of an osmotic gradient
between the contents of the tablet core and fluid in the GI tract.
Drug delivery is essentially constant as
long as the osmotic gradient remains constant, and then gradually
falls to zero. Upon swallowing, the
biologic