Country: United States
Language: English
Source: NLM (National Library of Medicine)
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)
Hikma Pharmaceuticals USA Inc.
PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia. 1. Supraventricular arrhythmias Intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff‑Parkinson‑White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia. 2. Ventricular tachycardias With the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. If, after consideration of the risks involved, propranolol is used, it should be given intravenously in lo
Each mL contains 1 mg of Propranolol Hydrochloride, USP in Water for Injection, USP. The pH is adjusted with anhydrous Citric Acid, USP. Supplied as: 1 mL vials in boxes of 10 (NDC 0143-9872-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing or excessive heat. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: May 2022 PIN166-WES/7
Abbreviated New Drug Application
PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE INJECTION HIKMA PHARMACEUTICALS USA INC. ---------- PROPRANOLOL HYDROCHLORIDE INJECTION, USP RX ONLY DESCRIPTION Propranolol Hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as (+)-1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is: C H NO •HCl Propranolol Hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Injection, USP is available as a sterile injectable solution for intravenous administration. Each mL contains 1 mg of Propranolol Hydrochloride, USP in Water for Injection, USP. The pH is adjusted with anhydrous Citric Acid, USP. CLINICAL PHARMACOLOGY GENERAL Propranolol is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor stimulating agents for available receptor sites. When access to beta‑receptor sites is blocked by propranolol, chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately. At doses greater than required for beta blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain. MECHANISM OF ACTION The effects of propranolol are due to selective blockade of beta-adrenergic receptors, 16 21 2 leaving alpha-adrenergic responses intact. There are two well-characterized subtypes of beta receptors (beta and beta ); propranolol interacts with both subtypes equally. Beta -adrenergic receptors are found primarily in the heart. Blockade of cardiac beta - adrenergic receptors leads to a decrease in the activity of both normal and ectopic pacemaker cells and a decrease in A-V nodal conduction velocity. All of these actions can contribute to antia Read the complete document