NADOLOL tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V)

Sẵn có từ:

Lupin Pharmaceuticals, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Nadolol Tablets are indicated for the long-term management of patients with angina pectoris. Nadolol Tablets are 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol Tablets. 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 Educati

Tóm tắt sản phẩm:

Nadolol Tablets USP are available as tablets containing nadolol 20 mg, 40 mg, or 80 mg. Nadolol Tablets USP containing 20 mg of nadolol, are blue coloured round scored tablets debossed with "L" and "U" on either side of scoreline on one side and "N15" on the other side They are supplied as follows: NDC 68180-761-06                Bottle of 30s NDC 68180-761-01                Bottle of 100s NDC 68180-761-03                Bottle of 1000s Nadolol Tablets USP containing 40 mg of nadolol, are blue coloured round scored tablets debossed with "L" and "U" on either side of scoreline on one side and "N16" on the other side. They are supplied as follows: NDC 68180-762-06                Bottle of 30s NDC 68180-762-01                Bottle of 100s NDC 68180-762-03                Bottle of 1000s Nadolol Tablets USP containing 80 mg of nadolol, are blue coloured round biconvex scored tablets debossed with "L" and "U" on either side of scoreline on one side and "N17" on the other side. They are supplied as follows: NDC 68180-763-06                Bottle of 30s NDC 68180-763-01                Bottle of 100s NDC 68180-763-03                Bottle of 1000s All tablets are scored (bisect bar) and easy to break.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

NADOLOL- NADOLOL TABLET
LUPIN PHARMACEUTICALS, INC.
----------
NADOLOL TABLETS
20 MG, 40 MG AND 80 MG
RX ONLY
PRODUCT OVERVIEW:
NADOLOL TABLETS
RX ONLY
DESCRIPTION
Nadolol Tablet USP is a synthetic nonselective beta-adrenergic
receptor blocking agent designated
chemically as
1-(_tert_-butylamino)-3-[(5,6,7,8-tetrahydro-_cis_-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol.
Structural formula:
Nadolol is a white to off-white crystalline powder. It is freely
soluble in ethanol, soluble in
hydrochloric acid, slightly soluble in water and in chloroform, and
very slightly soluble in sodium
hydroxide.
Nadolol Tablet USP is available for oral administration as 20 mg, 40
mg, and 80 mg tablets.
Inactive ingredients: citric acid anhydrous, colloidal silicon
dioxide, corn starch, FD&C Blue No. 2-
aluminium lake, magnesium stearate, microcrystalline cellulose,
povidone, talc.
CLINICAL PHARMACOLOGY
Nadolol is a nonselective beta-adrenergic receptor blocking agent.
Clinical pharmacology studies have
demonstrated beta-blocking activity by showing (1) reduction in heart
rate and cardiac output at rest and
on exercise, (2) reduction of systolic and diastolic blood pressure at
rest and on exercise, (3) inhibition
of isoproterenol-induced tachycardia, and (4) reduction of reflex
orthostatic tachycardia.
Nadolol specifically competes with beta-adrenergic receptor agonists
for available beta receptor sites;
it inhibits both the beta receptors located chiefly in cardiac muscle
and the beta receptors located
chiefly in the bronchial and vascular musculature, inhibiting the
chronotropic, inotropic, and vasodilator
responses to beta-adrenergic stimulation proportionately.
Nadolol has no intrinsic sympathomimetic activity and, unlike some
other beta-adrenergic blocking
agents, nadolol has little direct myocardial depressant activity and
does not have an anesthetic-like
1
2
membrane- stabilizing action. Animal and human studies show that
Nadolol slows the sinus rate and
depresses AV conduction. In dogs, only minimal amounts of nadolol were
detect