国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Labetalol Hydrochloride (UNII: 1GEV3BAW9J) (Labetalol - UNII:R5H8897N95)
Akorn
Labetalol Hydrochloride
Labetalol Hydrochloride 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension. Labetalol HCl Injection is 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 HCl Injection, 5 mg/mL, is supplied in: 20 mL (100 mg) (NDC 17478-420-20) multi-dose vial, box of 1 40 mL (200 mg) (NDC 17478-420-40) multi-dose vial, box of 1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PROTECT FROM LIGHT.
Abbreviated New Drug Application
LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE INJECTION, SOLUTION AKORN ---------- LABETALOL HYDROCHLORIDE INJECTION, USP RX ONLY DESCRIPTION Labetalol Hydrochloride is an adrenergic receptor blocking agent that has both selective alpha - and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate, chemically designated as 5-[1-hydroxy-2-[(1-methyl-3- phenylpropyl) amino] ethyl]salicylamide monohydrochloride, and has the following structural formula: Labetalol HCl has the molecular formula C H N O • HCl and a molecular weight of 364.87. 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 Injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.0. EACH ML CONTAINS: ACTIVE: Labetalol Hydrochloride USP, 5 mg. PRESERVATIVES: Methylparaben, 0.80 mg; Propylparaben, 0.10 mg. INACTIVES: Anhydrous Dextrose, 45 mg; Edetate Disodium 0.10 mg; Citric Acid Anhydrous and/or Sodium Hydroxide may be added to adjust pH (3.0 to 4.0), and Water for Injection. CLINICAL PHARMACOLOGY Labetalol 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 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. 1 19 24 2 3 1 2 1 PHARMACODYNAMICS The capacity of labetalol to block alpha-receptors in man has been demonstrated by attenuation of the pres 完全なドキュメントを読む