NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Nadolol Tablets, USP are available containing 20 mg, 40 mg and 80 mg The 20 mg tablets are White to off-white, round biconvex tablets, debossed with "ING" above "178" on one side and score line on other side. They are available as follows: NDC 50742-178-01 bottles of 100 tablets NDC 50742-178-10 bottles of 1000 tablets The 40 mg tablets are White to off-white, round biconvex tablets, debossed with "ING" above "179" on one side and score line on other side. They are available as follows: NDC 50742-179-01 bottles of 100 tablets NDC 50742-179-10 bottles of 1000 tablets The 80 mg tablets are White to off-white, round biconvex tablets, debossed with "ING" above "180" below the score line on one side and plain on other side. They are available as follows: NDC 50742-180-01 bottles of 100 tablets NDC 50742-180-10 bottles of 1000 tablets Store at 20o to 25o C (68o F to 77o F) [See USP Controlled Room temperature] Protect from light. Dispense in a tight, light-resistant container. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004 Issued: 06/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
INGENUS PHARMACEUTICALS, LLC
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NADOLOL TABLETS USP, 20 MG, 40 MG AND 80 MG
DESCRIPTION
Nadolol 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.
Its structural
formula is:
Nadolol, USP is a White to off-white, practically odourless,
crystalline powder. It is freely soluble in
Alcohol and in methanol; soluble in water at pH 2; slightly soluble in
chloroform, in methylene
chloride, isopropyl alcohol, and in water (between pH 7 and pH 10);
insoluble in acetone, in benzene, in
ether, in hexane, and in trichloroethane.
Nadolol tablets, USP are available for oral administration contains 20
mg, 40 mg or 80 mg of nadolol,
USP and the following inactive ingredients: lactose monohydrate,
pregelatinized starch,
microcrystalline cellulose, hydroxypropyl cellulose and magnesium
stearate.
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 beta1 receptors located chiefly in cardiac muscle
and the beta2 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 membrane
stabilizing action. Animal and human
studies show that nadolol slows the sinus rate and