Drug: Bretylium

BRETYLIUM (bretylium tosylate injection ) TOSYLATE INJECTION For Intravenous or Intramuscular Use Bretylium (bretylium tosylate injection ) tosylate injection is an antifibrillatory and antiarrhythmic agent; intended for intravenous or intramuscular use. It has a molecular formular: C18H24BrNO3S. Bretylium (bretylium tosylate injection ) tosylate is a white, crystalline powder with an extremely bitter taste. It is freely soluble in water and alcohol. Each mL of sterile, nonpyrogenic solution contains 50mg bretylium (bretylium tosylate injection ) tosylate in Water for Injection, USP. The pH is adjusted, when necessary, with dilute hydrochloric acid and/or sodium hydroxide. Bretylium (bretylium tosylate injection ) tosylate injection contains no preservative.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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Hypotension and postural hypotension have been the most frequently reported adverse reactions (See WARNINGS section). Nausea and vomiting occurred in about three percent of patients, primarily when bretylium (bretylium tosylate injection ) tosylate was administered rapidly by the intravenous route (See PRECAUTIONS section). Vertigo, dizziness, light-headedness and syncope, which sometimes accompanied postural hypotension, were reported in about 7 patients in 1000. Bradycardia, increased frequency of premature ventricular contractions, transitory hypertension, initial increase in arrhythmias (See WARNINGS section), precipitation of anginal attacks, and sensation of substernal pressure have also been reported in a small number of patients, i.e., approximately 1-2 patients in 1000. 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 in about 1 patient in 1000. Hyperthermia has also been reported (see WARNINGS). The relationship of bretylium (bretylium tosylate injection ) tosylate administration to these reactions has not been clearly established. Read the Bretylium (bretylium tosylate injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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BRETYLIUM (bretylium tosylate injection ) TOSYLATE INJECTION is to be used clinically only for treatment of life-threatening ventricular arrhythmias under constant electrocardiographic monitoring. The clinical use of BRETYLIUM (bretylium tosylate injection ) TOSYLATE INJECTION is for short-term use only. Patients should either be kept supine during the course of bretylium (bretylium tosylate injection ) therapy or be closely observed for postural hypotension. The optimal dose schedule for parenteral administration of the drug has not been determined. There is comparatively little experience with dosages greater than 40mg/kg/day, although such doses have been used without apparent adverse effects. The following schedules are suggested: A. For immediately Life-threatening Ventricular Arrhythmias such as Ventricular Fibrillation or Hemodynamically Unstable Ventricular Tachycardia: Administer undiluted BRETYLIUM (bretylium tosylate injection ) TOSYLATE INJECTION at a dosage of 5mg/kg of body weight by rapid intravenous injection. Other usual cardiopulmonary resuscitative procedures, including electrical cardioversion, should be employed prior to and following the injection in accordance with good medical practice. If ventricular fibrillation persists, the dosage may be increased to 10mg/kg and repeated as necessary. For continuous suppression, dilute Bretylium (bretylium tosylate injection ) Tosylate Injection with Dextrose Injection, USP or Sodium Chloride Injection, USP using the table below and administer the diluted solution as a constant infusion of 1 to 2mg Bretylium (bretylium tosylate injection ) Tosylate Injection per minute, (see Table below). When administering Bretylium (bretylium tosylate injection ) Tosylate Injection (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control device. An alternative maintenance schedule is to infuse the diluted solution at a dosage of 5 to 10mg Bretylium (bretylium tosylate injection ) Tosylate per kg body weight, over a period greater than 8 minutes, every 6 hours. More rapid infusion may cause nausea and vomiting, and in patients older than 65 years, may increase the risk of developing orthostatic hypotension. B. Other ventricular arrhythmias: 1) Intravenous Use: Bretylium (bretylium tosylate injection ) tosylate injection must be diluted as described above before intravenous use. Administer the diluted solution at a dosage of 5 to 10mg bretylium (bretylium tosylate injection ) tosylate per kg of body weight by intravenous infusion over a period greater than 8 minutes. More rapid infusion may cause nausea and vomiting, and in patients older than 65 years, may increase the risk of developing orthostatic hypotension. Subsequent doses may be given at 1 to 2 hour intervals if the arrhythmia persists. For maintenance therapy, the same dosage may be administered every 6 hours, or a constant infusion of 1 to 2mg bretylium (bretylium tosylate injection ) tosylate per minute may be given, (See following table). Suggested Bretylium (bretylium tosylate injection ) Tosylate Injection Admixture Dilution and Administration rates for Continuous Infusion Maintenance Therapy Arranged in Descending Order of Concentration.
PREPARATION /ADMINISTRATION Amount of Bretylium (bretylium tosylate injection ) Tosylate Injection Volume of IV Fluid* Final Volume Final Conc. (mg/ mL) Dose mg/ min Microdrops per mm. mL/ hour FOR FLUID RESTRICTED PATIENTS:   1.0 7 7 500mg (10mL) 50mL 60mL 8.3 1.5 2.0 11 14 11 14 2g (40mL) 1g (20mL) 500mL 250mL 540mL 270mL 3.7 3.7 1.0 1.5 16 24 16 24   2.0 32 32 1g (20mL) 500mg (10mL) 500mL 250mL 520mL 260mL 1 .9 1 .9 1.0 1.5 2.0 32 47 63 32 47 63
    *lV fluid may be either Dextrose Injection, USP or Sodium Chloride Injection, USP. This table does not consider the overfill volume present in the IV fluids.
2) For Intramuscular Injection: DO NOT DILUTE BRETYLIUM (bretylium tosylate injection ) TOSYLATE INJECTION PRIOR TO INTRAMUSCULAR INJECTION. Inject 5 to 10mg bretylium (bretylium tosylate injection ) tosylate per kg of body weight. Subsequent doses may be given at 1 to 2 hour intervals if the arrhythmia persists. Thereafter, maintain the same dosage every 6 to 8 hours. Intramuscular injection should not be made directly into or near a major nerve, and the site of injection should be varied on repeated injection. Not more than 5mL should be injected intramuscularly in one site. (See PRECAUTONS) As soon as possible, and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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Digitalis toxicity may be aggravated by the initial release of norepinephrine caused by Bretylium (bretylium tosylate injection ) Tosylate Injection. The pressor effects of catecholamines such as dopamine or norepinephrine are enhanced by Bretylium (bretylium tosylate injection ) Tosylate. When catecholamines are administered, dilute solutions should be used and blood pressure should be monitored closely. (See WARNINGS) Although there is little published information on concomitant administration of lidocaine and Bretylium (bretylium tosylate injection ) Tosylate, these drugs are often administered concurrently without any evidence of interactions resulting in adverse effects or diminished efficacy.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Bretylium (bretylium tosylate injection ) Tosylate is indicated in the prophylaxis and therapy of ventricular fibrillation. Bretylium (bretylium tosylate injection ) tosylate 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 (bretylium tosylate injection ) TOSYLATE INJECTION 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 (bretylium tosylate injection ) TOSYLATE INJECTION 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.

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There are no contraindications to use in treatment of ventricular fibrillation or life-threatening refractory ventricular arrhythmias.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In the presence of life-threatening arrhythmias, underdosing with bretylium (bretylium tosylate injection ) probably presents a greater risk to the patient than potential overdosage. However, one case of accidental overdose has been reported in which a rapidly injected intravenous bolus of 30 mg/kg was given instead of an intended 10 mg/kg dose during an episode of ventricular tachycardia. Marked hypertension resulted, followed by protracted refractory hypotension. The patient expired 18 hours later in asystole, complicated by renal failure and aspiration pneumonitis. Bretylium (bretylium tosylate injection ) serum levels were 8000 ng/mL. The exaggerated hemodynamic response was attributed to the rapid injection of a very large dose while some effective circulation was still present. Neither the total dose nor the serum levels observed in this patient are in themselves associated with toxicity. Total doses of 30 mg/kg are not unusual and do not cause toxicity when given incrementally during cardiopulmonary resuscitation procedures. Similarly, patients maintained on chronic Bretylium (bretylium tosylate injection ) Tosylate Injection therapy have had documented serum levels of 12,000 ng/mL. These levels were achieved after sequential dosage increases over time with no apparent ill effects. If Bretylium (bretylium tosylate injection ) Tosylate Injection is overdosed and symptoms of toxicity develop, administration of nitroprusside or another short acting intravenous antihypertensive agent should be considered for the treatment of the hypertensive response. Long acting drugs that might potentiate the subsequent hypotensive effects of Bretylium (bretylium tosylate injection ) Tosylate Injection should not be used. Hypotension should be treated with appropriate fluid therapy and pressor agents such as dopamine or norepinephrine. Dialysis is probably not useful in the treatment of Bretylium (bretylium tosylate injection ) Tosylate Injection overdose.

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  • Bretylium (bretylium tosylate injection ) Tosylate Injection, 50mg/mL
  • 0517-8810-01 10mL Single Dose Vial Packaged individually
Store at controlled room temperature 15°-30°C(59°-86°F). CAUTION: Federal (USA) law prohibits dispensing without prescription.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Dilution for Intravenous use: One vial of BRETYLIUM (bretylium tosylate injection ) TOSYLATE INJECTION should be diluted with a minimum of 50 mL of Dextrose Injection 5%, USP, or Sodium Chloride Injection, USP, prior to intravenous use. Rapid intravenous administration may cause severe nausea and vomiting. Therefore, the diluted solution should be infused over a period greater than 8 minutes. In treating existing ventricular fibrillation bretylium (bretylium tosylate injection ) tosylate should be given as rapidly as possible and may be given without dilution. Use various sites for intramuscular injection: When injected intramuscularly, not more than 5mL should be given in a site, and injection sites should be varied since repeated intramuscular injection into the same site may cause atrophy and necrosis of muscle tissue, fibrosis, vascular degeneration and inflammatory changes. Reduce dosage in impaired renal function: Since bretylium (bretylium tosylate injection ) is excreted principally via the kidney, the dosage interval should be increased in patients with impaired renal function. See CLINICAL PHARMACOLOGY section for information of the effect of reduced renal function on half-life. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on potential for carcinogenicity, mutagenicity or impairment of fertility in animals or humans. Studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy Category C: Animal reproduction studies have not been conducted with bretylium (bretylium tosylate injection ) tosylate. It is also not known whether bretylium (bretylium tosylate injection ) tosylate can cause harm when administered to a pregnant woman or can affect reproduction capacity. Bretylium (bretylium tosylate injection ) tosylate should be given to pregnant women only if clearly needed. Pediatric Use The safety and effectiveness of Bretylium (bretylium tosylate injection ) Tosylate have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use. Geriatric Use Clinical studies of bretylium (bretylium tosylate injection ) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy. Intravenous infusion, especially if administered at a rate beyond that recommended in the DOSAGE AND ADMNISTRATION section, may produce an increased risk of orthostatic hypotension in the elderly. See WARNINGS) This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function, See CLINICAL PHARMACOLOGY.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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