NADOLOL AND BENDROFLUMETHIAZIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V), BENDROFLUMETHIAZIDE (UNII: 5Q52X6ICJI) (BENDROFLUMETHIAZIDE - UNII:5Q52X6ICJI)

Dostupno od:

Impax Generics

INN (International ime):

NADOLOL

Sastav:

NADOLOL 40 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Nadolol and bendroflumethiazide 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 classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol and bendroflumethiazide 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 Education Program's Joint National Committee on Pr

Proizvod sažetak:

Nadolol and bendroflumethiazide tablets, 40 mg/5 mg, contain 40 mg nadolol combined with 5 mg bendroflumethiazide, and are white to off-white, round, bi-convex tablets debossed with "G" bisect "531" on one side and plain on the other. Nadolol and bendroflumethiazide tablets, 80 mg/5 mg, contain 80 mg nadolol combined with 5 mg bendroflumethiazide, and are white to off-white, round, bi-convex tablets debossed with "G" bisect "532" on one side and plain on the other. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NADOLOL AND BENDROFLUMETHIAZIDE- NADOLOL AND BENDROFLUMETHIAZIDE
TABLET
IMPAX GENERICS
----------
NADOLOL AND
BENDROFLUMETHIAZIDE
TABLETS, USP,
40 MG/5 MG AND 80 MG/5 MG
RX ONLY
DESCRIPTION
Nadolol and bendroflumethiazide tablets for oral administration
combine two antihypertensive agents:
nadolol, a nonselective beta-adrenergic blocking agent, and
bendroflumethiazide, a thiazide diuretic-
antihypertensive.
Each tablet contains 40 mg or 80 mg nadolol combined with 5 mg
bendroflumethiazide. Inactive
ingredients: croscarmellose sodium, hypromellose (type 2910), lactose
monohydrate, magnesium
stearate, mannitol, microcrystalline cellulose, pregelatinized starch
and talc.
NADOLOL
Nadolol is a 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 is designated chemically as
1-(_tert_-butylamino)-3-{(5,6,7,8-tetrahydro-_cis_-6,7-dihydroxy-1-
naphthyl)oxy}-2-propanol. Structural formula:
BENDROFLUMETHIAZIDE
Bendroflumethiazide is a white crystalline powder. It is soluble in
alcohol and in sodium hydroxide, and
insoluble in hydrochloric acid, water, and chloroform.
Bendroflumethiazide is designated chemically as
3-benzyl-3,4-dihydro-6-(trifluoromethyl)-2_H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide. Structural formula:
CLINICAL PHARMACOLOGY
NADOLOL
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 vas