NIFEDIPINE ER- nifedipine tablet, film coated, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

AvPAK

INN (আন্তর্জাতিক নাম):

Nifedipine

রচনা:

Nifedipine 30 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers. Nifedipine Extended-release Tablet is indicated for the management of chronic st

পণ্য সারাংশ:

Nifedipine Extended-release Tablets 30 mg are round, biconvex, pink coated tablets imprinted with “KU 260” in black ink. They are supplied as: NDC 50268-597-15 (10 tablets per card, 5 cards per carton) Nifedipine Extended-release Tablets 60 mg are round, biconvex, pink coated tablets imprinted with “KU 261” in black ink. They are supplied as: NDC 50268-598-15 (10 tablets per card, 5 cards per carton) Nifedipine Extended-release Tablets 90 mg are round, biconvex, pink coated tablets imprinted with “KU 262” in black ink. They are supplied as: NDC 50268-599-15 (10 tablets per card, 5 cards per carton) Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispensed in Unit Dose Package. For Institutional Use Only. Protect from moisture, humidity and light. For Medical Information Contact: Drug Safety at 1-855-361-3993

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

NIFEDIPINE ER- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
AVPAK
----------
NIFEDIPINE EXTENDED-RELEASE TABLETS, USP
RX ONLY
_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
17
18
2
6
gradient between the contents of the tablet core and fluid in the
gastrointestinal tract.
Drug delivery is essentially constant as long as the osmotic gradient
remains constant,
and th