Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
BRETYLIUM TOSYLATE (UNII: 78ZP3YR353) (BRETYLIUM - UNII:RZR75EQ2KJ)
Pharmaceutics International, Inc. (Pii)
INTRAMUSCULAR
PRESCRIPTION DRUG
Bretylium Tosylate Injection, USP is indicated in the prophylaxis and therapy of ventricular fibrillation. Bretylium Tosylate Injection, USP is also indicated in the treatment of life-threatening ventricular arrhythmias, such as ventricular tachycardia that have failed to respond to adequate doses of a first-line antiarrhythmic agent, such as lidocaine. Use of Bretylium Tosylate Injection, USP should be limited to intensive care units, coronary care units or other facilities where equipment and personnel for constant monitoring of cardiac arrhythmias and blood pressure are available. Following injection of bretylium tosylate there may be a delay of 20 minutes to 2 hours in the onset of antiarrhythmic action, although it appears to act within minutes in ventricular fibrillation. The delay in effect appears to be longer after intramuscular than after intravenous injection. There are no contraindications to use in treatment of ventricular fibrillation or life-threatening refractory ventricular arrhythmias, excep
Bretylium Tosylate Injection, USP is supplied in 10 mL single-dose cyclic olefin copolymer (COC) vials. Store at 20o to 25o C (68o to 77o F); [see USP Controlled Room Temperature]. Manufactured by: Pharmaceutics International, Inc. Hunt Valley, Maryland Revision Date: November 11, 2014
Abbreviated New Drug Application
BRETYLIUM TOSYLATE- BRETYLIUM TOSYLATE INJECTION PHARMACEUTICS INTERNATIONAL, INC. (PII) ---------- BRETYLIUM TOSYLATE INJECTION, USP RX ONLY AQUEOUS SOLUTION FOR THE ACUTE MANAGEMENT OF CARDIAC ARRHYTHMIAS PLASTIC VIAL FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY DESCRIPTION Bretylium Tosylate Injection, USP is a sterile, nonpyrogenic solution for use in the management of ventricular arrhythmias. Each milliliter contains 50 mg bretylium tosylate in water for injection. The osmolarity is 0.174 mOsm/mL (approx.). May contain sodium hydroxide and hydrochloric acid for pH adjustment. pH is approximately 5.2. The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose administration. When smaller doses are required, the unused portion should be discarded. Bretylium tosylate, a bromobenzyl quaternary ammonium compound is chemically designated (o- Bromobenzyl) ethyldimethyl-ammonium p-toluenesulfonate, a white powder freely soluble in water. It has the following structural formula: The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration. Therapeutic class: Bretylium tosylate is classified as an antiarrhythmic agent. CLINICAL PHARMACOLOGY Bretylium tosylate selectively accumulates in sympathetic ganglia and their postganglionic adrenergic neurons when administered slowly or incrementally where it inhibits norepinephrine release by depressing adrenergic nerve terminal excitability. Bretylium tosylate also suppresses ventricular fibrillation and ventricular arrhythmias. The mechanisms of the antifibrillatory and antiarrhythmic actions of bretylium tosylate are not established. In efforts to define these mechanisms, the following electrophysiologic actions of bretylium t Olvassa el a teljes dokumentumot