NIFEDIPINE- nifedipine tablet, film coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Tên quốc tế):

NIFEDIPINE

Thành phần:

NIFEDIPINE 30 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Nifedipine extended-release tablets are 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 tablets 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 tablets are indicated for the management of chronic

Tóm tắt sản phẩm:

Nifedipine Extended-release Tablets, USP are available containing 30 mg, 60 mg or 90 mg of nifedipine, USP. The 30 mg tablets are supplied as light pink film-coated, round, unscored tablets with M over 030 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-5541-39 blistercards of 30 tablets The 60 mg tablets are supplied as light pink film-coated, round, unscored tablets with M over 060 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-6563-39 blistercards of 30 tablets The 90mg tablets are supplied as light pink film-coated, round, unscored tablets with M over 090 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-7571-39 blistercards of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture, humidity and light. Dispense in a tight light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED MAY 2011 NFER:R2

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
NIFEDIPINE ER TABS
DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents
known as the calcium channel
blockers. Nifedipine is dimethyl
1,4-dihydro-2,6-dimethyl-4-(_o_-nitrophenyl)-3,5-pyridinedicarboxylate,
C
H N O , and has the structural formula:
Nifedipine, USP is a yellow powder, practically insoluble in water but
soluble in ethanol. It has a
molecular weight of 346.33. Nifedipine extended-release tablets, USP
are formulated as a once-a-day
controlled-release tablet for oral administration designed to deliver
30 mg, 60 mg or 90 mg of
nifedipine.
Inert ingredients in the formulations are: black iron oxide, cellulose
acetate, ferric oxide,
hydroxypropyl cellulose, hypromellose, magnesium stearate,
polyethylene glycol, polyethylene oxide,
polyvinyl alcohol, propylene glycol, red iron oxide, sodium chloride,
talc, titanium dioxide and yellow
iron oxide.
_Meets USP Dissolution Test 8._
SYSTEM COMPONENTS AND PERFORMANCE
Nifedipine extended-release tablets are similar in appearance to a
conventional tablet. It consists,
however, of a semipermeable membrane surrounding an osmotically active
drug core. The core itself is
divided into two layers: an “active” layer containing the drug,
and a “push” layer containing
pharmacologically inert (but osmotically active) components. As water
from the gastrointestinal tract
enters the tablet, pressure increases in the osmotic layer and
“pushes” against the drug layer, releasing
drug through the precision laser-drilled tablet orifice in the active
layer.
Nifedipine extended-release tablets are 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 tablets
depend for its action on the existence of
an osmotic gradient between the contents of the bi-layer core a