NIFEDIPINE tablet, film coated, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

PD-Rx Pharmaceuticals, Inc.

INN (International Nazwa):

NIFEDIPINE

Skład:

NIFEDIPINE 30 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina), nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely, since severe hypotension can occur from the combined effects of the drugs (see WARNINGS). Nifedipine Extended-release Tablet is indicated for the treatment of hypertension, to lower blood pressure.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.  These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Nifedipine Extended-release tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nifedipine Extended-release Tablet may be used alone or in combination with other antihypertensive agents. Known hypersensitivity reaction to nifedipine.

Podsumowanie produktu:

Nifedipine Extended-release Tablets 30 mg are round, biconvex, pink coated tablets imprinted with "KU 260" in black ink. They are supplied as follows: Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Protect from moisture, humidity, and light. For Medical Information Contact:  Medical Affairs Department Phone: [phone]

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
PD-RX PHARMACEUTICALS, INC.
----------
NIFEDIPINE
EXTENDED-RELEASE TABLETS, USP
NIFEDIPINE EXTENDED-RELEASE TABLETS, USP
_ FOR ORAL USE_
_RX ONLY_
CIA70797L
Rev. 05/2023
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 346.3. 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
17
18
2
6,
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
gastrointestinal tract. Drug
delivery is essentially constant as long as the osmotic gradi