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warnings
WARNINGS VERAPAMIL HYDROCHLORIDE SHOULD BE GIVEN AS A SLOW INTRAVENOUS INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME ( see Dosage And Administration ). Hypotension: Verapamil hydrochloride injection often produces a decrease in blood pressure below baseline levels that is usually transient and asymptomatic but may result in dizziness. Systolic pressure less than 90 mm Hg and/or diastolic pressure less than 60 mm Hg was seen in 5% to 10% of patients in controlled U.S. trials in supraventricular tachycardia and in about 10% of the patients with atrial flutter/fibrillation. The incidence of symptomatic hypotension observed in studies conducted in the U.S. was approximately 1.5%. Three of the five symptomatic patients required intravenous pharmacologic treatment (norepinephrine bitartrate, metaraminol bitartrate, or 10% calcium gluconate). All recovered without sequelae. Extreme Bradycardia/Asystole: Verapamil hydrochloride affects the AV and SA nodes and rarely may produce second- or third-degree AV block, bradycardia, and, in extreme cases, asystole. This is more likely to occur in patients with a sick sinus syndrome (SA nodal disease), which is more common in older patients. Bradycardia associated with sick sinus syndrome was reported in 0.3% of the patients treated in controlled double-blind trials in the U.S. The total incidence of bradycardia (ventricular rate less than 60 beats/min) was 1.2% in these studies. Asystole in patients other than those with sick sinus syndrome is usually of short duration (few seconds or less), with spontaneous return to AV nodal or normal sinus rhythm. If this does not occur promptly, appropriate treatment should be initiated immediately. (See Adverse Reactions and Suggested Treatment of Acute Cardiovascular Adverse Reactions .) Heart Failure: When heart failure is not severe or rate related, it should be controlled with digitalis glycosides and diuretics, as appropriate, before verapamil is used. In patients with moderately severe to severe cardiac dysfunction (pulmonary wedge pressure above 20 mm Hg, ejection fraction less than 30%), acute worsening of heart failure may be seen. Concomitant Antiarrhythmic Therapy: Digitalis: Verapamil hydrochloride injection has been used concomitantly with digitalis preparations without the occurrence of serious adverse effects. However, since both drugs slow AV conduction, patient...
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adverse reactions
ADVERSE REACTIONS The following reactions were reported with verapamil hydrochloride injection used in controlled U.S. clinical trials involving 324 patients: Cardiovascular: Symptomatic hypotension (1.5%); bradycardia (1.2%); severe tachycardia (1.0%). The worldwide experience in open clinical trials in more than 7,900 patients was similar. Central Nervous System Effects: Dizziness (1.2%); headache (1.2%). Occasional cases of seizures during verapamil injection have been reported. Gastrointestinal: Nausea (0.9%); abdominal discomfort (0.6%). In rare cases of hypersensitive patients, broncho/laryngeal spasm accompanied by itch and urticaria has been reported. The following reactions have been reported at low frequency: emotional depression, rotary nystagmus, sleepiness, vertigo, muscle fatigue, diaphoresis, and respiratory failure. Suggested Treatment of Acute Cardiovascular Adverse Reactions* The frequency of these adverse reactions was quite low, and experience with their treatment has been limited. Adverse Reaction Proven Effective Treatment Supportive Treatment 1. Symptomatic hypotension requiring treatment Calcium chloride I.V. Norepinephrine bitartrate I.V. Metaraminol bitartrate I.V. Isoproterenol HCl I.V. Dopamine I.V. Intravenous fluids Trendelenburg position 2. Bradycardia, AV block, Asystole Isoproterenol HCl I.V. Calcium chloride I.V. Cardiac pacing Norepinephrine bitartrate I.V. Atropine I.V. Intravenous fluids (slow drip) 3. Rapid ventricular rate (due to antegrade conduction in flutter/fibrillation with W-P-W or L-G-L syndromes) DC-cardioversion (high energy may be required) Procainamide I.V. Lidocaine I.V. Intravenous fluids (slow drip) *Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. “To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ”
adverse reactions table
Adverse Reaction Proven Effective TreatmentSupportive Treatment 1. Symptomatic hypotension requiring treatment Calcium chloride I.V. Norepinephrine bitartrate I.V. Metaraminol bitartrate I.V. Isoproterenol HCl I.V. Dopamine I.V. Intravenous fluids Trendelenburg position 2. Bradycardia, AV block, AsystoleIsoproterenol HCl I.V. Calcium chloride I.V. Cardiac pacing Norepinephrine bitartrate I.V. Atropine I.V. Intravenous fluids (slow drip) 3. Rapid ventricular rate (due to antegrade conduction in flutter/fibrillation with W-P-W or L-G-L syndromes)DC-cardioversion (high energy may be required) Procainamide I.V. Lidocaine I.V.Intravenous fluids (slow drip)