Bretylium (Tosylate)

Bretylium (Tosylate) is a potassium channel blocking agent. Bretylium (Tosylate) is a quaternary salt and is an adrenergic neuronal blocking agent. It was first introduced as an antihypertensive agent.Bretylium (Tosylate) is now used as an antiarrhythmic agent. It interferes with the neuronal release of catecholamines but also has direct antiarrhythmic properties.

Bretylium (Tosylate) is primarily indicated in conditions like Prophylaxis of acid aspiration in obstetrics, Ventricular arrhythmias.

Bretylium (Tosylate) is contraindicated in conditions like Cardiac arrhythmia,Myocardial infarction,Digitalis induced arrythmias.

Hypotension and postural hypotension have been the most frequently reported adverse reactions (see WARNINGS ). Nausea and vomiting occurred in about three percent of patients, primarily when bretylium tosylate was administered rapidly by the intravenous route. Vertigo, dizziness, lightheadedness and syncope, which sometimes accompanied postural hypotension, have been reported with an incidence of about 0.7%. Bradycardia, increased frequency of premature ventricular contractions, transitory hypertension, initial increase in arrhythmias (see WARNINGS ), precipitation of anginal attacks and sensation of substernal pressure have also been reported in a small number of patients with an incidence of about 0.2%. Renal dysfunction, diarrhea, abdominal pain, hiccups, erythematous macular rash, flushing, hyperthermia, confusion, paranoid psychosis, emotional lability, lethargy, generalized tenderness, anxiety, shortness of breath, diaphoresis, nasal stuffiness and mild conjunctivitis have been reported with an incidence of about 0.1%. The relationship of bretylium tosylate administration to these reactions has not been clearly established. Hyperthermia has also been reported (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Increase dose interval of bretylium in renal dysfunction. Dilute for IV use except in treating existing ventricular fibrillation where it should be given as rapidly as possible. Administer during pregnancy if clearly needed, Lactation data are not available.

Drug should not be given to Paediatrics, Pregnant Mothers, patients suffering from Kidney dysfunction, Geriatrics, and Neonates.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.

0.014 to 0.029 mg/kg.min (0.021 (0.0215)) As recommended. IV Inf — Maintenance, As Required 5 to 10 mg/kg (7.5 (7.5)) As recommended. IM — Maintenance, Every 6-8 Hours, As Required 5 to 10 mg/kg (7.5 (7.5)) As recommended. IV — Load for every 15-30 minutes for 3 doses Scraped Dose — Bretylium Tosylate Injection, USP is to be used clinically only for treatment of life-threatening ventricular arrhythmias under constant electrocardiographic monitoring. The clinical use of bretylium tosylate is for short-term use only. Patients should either be kept supine during the course of bretylium tosylate therapy or be closely observed for postural hypotension. The optimal dose schedule for parenteral administration of bretylium tosylate has not been determined. There is comparatively little experience with dosages greater than 40 mg/kg/day, although such doses have been used without apparent adverse effects. The following schedule is suggested.

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

Digitalis Glycosides: See WARNINGS and CONTRAINDICATIONS . Catecholamines: See WARNINGS . Monoamine Oxidase Inhibitors: The effects of the release of catecholamines from nerve endings produced by bretylium tosylate (see CLINICAL PHARMACOLOGY ) will be potentiated by monoamine oxidase inhibitors.

Inj Store at room temperature. Do not Freeze.