Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (labetalol - UNII:R5H8897N95)
Alvogen Inc.
labetalol hydrochloride
labetalol hydrochloride 100 mg
ORAL
PRESCRIPTION DRUG
Labetalol Hydrochloride Tablets are indicated in the management of hypertension. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. Labetalol Hydrochloride Tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see WARNINGS). Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
Labetalol Hydrochloride Tablets, 100 mg, light orange, round, scored, film-coated tablets debossed on one side with “CL 37” and “100”, bottles of 100 (NDC 47781-552-01) and bottles of 500 (NDC 47781-552-05). Labetalol Hydrochloride Tablets, 200 mg, white, round, scored, film-coated tablets debossed on one side with “CL 38” and “200”, bottles of 100 (NDC 47781-553-01) and bottles of 500 (NDC 47781-553-05). Labetalol Hydrochloride Tablets, 300 mg, mid-orange, round, scored, film-coated tablets debossed on one side with “CL 39” and “300”, bottles of 100 (NDC 47781-554-01). Labetalol Hydrochloride Tablets should be stored between 2° and 30°C (36° and 86°F).
New Drug Application
LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED ALVOGEN INC. ---------- LABETALOL HYDROCHLORIDE TABLETS DESCRIPTION Labetalol Hydrochloride Tablets are adrenergic receptor blocking agents that have both selective alpha -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1- hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure: Labetalol HCl has the empirical formula C H N O ∙HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R´ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets contain 100 mg, 200 mg, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100-mg and 300-mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide. CLINICAL PHARMACOLOGY Labetalol HCl combines both selective, competitive, alpha -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following oral and intravenous (IV) administration, respectively. Beta -agonist activity has been demonstrated in animals with minimal beta -agonist (ISA) activity detected. In animals, at doses greater than those required for alpha- or beta-adrenergic blockade, a membrane stabilizing effect has been demonstrated. PHARMACODYNAMICS The capacity of labetalol HCl to block alpha receptors in man has been demonstrated by 1 19 24 2 3 1 2 1 attenuation of the pressor effect of phenylephrine and b Les hele dokumentet