Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED VERAPAMIL HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1442-1 VERAPAMIL HCI INJECTION, USP 5mg/2mL (2.5mg/mL) 2mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms All forms are individually packaged. Store at 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature.] HOW SUPPLIED; PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING RFID Label SERIALIZED LABELING; PRINCIPAL DISPLAY PANEL - VIAL LABELING VIAL LABELING
- HOW SUPPLIED VERAPAMIL HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1442-1 VERAPAMIL HCI INJECTION, USP 5mg/2mL (2.5mg/mL) 2mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms All forms are individually packaged. Store at 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature.] HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING RFID Label SERIALIZED LABELING
- PRINCIPAL DISPLAY PANEL - VIAL LABELING VIAL LABELING
Overview
Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor available as a sterile solution for intravenous injection in 5-mg (2 ml) and 10-mg (4 ml) vials. Each form contains Verapamil HCl 2.5 mg/ml and sodium chloride 8.5 mg/ml in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is between 4.1 and 6.0. The structural formula of verapamil HCl is given below: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs. STRUCTURE
Indications & Usage
INDICATIONS & USAGE Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: • Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil administration. • Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). In controlled studies in the U.S., about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous Verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a fast ventricular rate respond with a decrease in heart rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after Verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. The effect of a single injection lasts for 30–60 minutes when conversion to sinus rhythm does not occur. Because a small fraction (<1.0%) of patients treated with Verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation with an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole—see Contraindications and Warnings), the initial use of intravenous Verapamil hydrochloride should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including DC-cardioversion capability (see Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient’s response is gained, an office setting may be acceptable. Cardioversion has been used safely and effectively after intravenous Verapamil.
Dosage & Administration
DOSAGE & ADMINISTRATION For intravenous use only. VERAPAMIL SHOULD BE GIVEN AS A SLOW INTRAVENOUS INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME UNDER CONTINUOUS ECG AND BLOOD PRESSURE MONITORING. The recommended intravenous doses of Verapamil are as follows: Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and vial seal is intact. Unused amount of solution should be discarded immediately following withdrawal of any portion of contents. For stability reasons this product is not recommended for dilution with Sodium Lactate Injection USP in polyvinyl chloride bags. Admixing intravenous Verapamil with albumin, amphotericin B, hydralazine HCl, and trimethoprim with sulfamethoxazole should be avoided. Verapamil will precipitate in any solution with a pH above 6.0. DOSAGE AND ADMINISTRATION
Warnings & Precautions
WARNINGS VERAPAMIL SHOULD BE GIVEN AS A SLOW INTRAVENOUS INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME. (See Dosage and Administration.) Hypotension: Intravenous Verapamil 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%-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 pharmacologic treatment (norepinephrine bitartrate IV, metaraminol bitartrate IV, or 10% calcium gluconate IV). All recovered without sequelae. Extreme bradycardia/asystole: Verapamil 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 including suggested treatment of 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: Intravenous Verapamil has been used concomitantly with digitalis preparations without the occurrence of serious adverse effects. However, since both drugs slow AV conduction, patients should be monitored for AV block or excessive bradycardia. Procainamide: Intravenous Verapamil has been administered to a small number of patients receiving oral procainamide without the occurrence of serious adverse effects. Quinidine: Intravenous Verapamil has been administered to a small number of patients receiving oral quinidine without the occurrence of serious adverse effects. However a few cases of hypotension have been reported in patients taking oral quinidine who received intravenous Verapamil. Caution should therefore be used when employing this combination of drugs. Beta-adrenergic blocking drugs: Intravenous Verapamil has been administered to patients receiving oral beta blockers without the development of serious adverse effects. However, since both drugs may depress myocardial contractility or AV conduction, the possibility of detrimental interactions should be considered. The concomitant administration of intravenous beta blockers and intravenous Verapamil has resulted in serious adverse reactions (see Contraindications), especially in patients with severe cardiomyopathy, congestive heart failure, or recent myocardial infarction. Disopyramide: Until data on possible interactions between Verapamil and disopyramide are obtained, disopyramide should not be administered within 48 hours before or 24 hours after Verapamil administration. Heart block: Verapamil prolongs AV conduction time. While high-degree AV block has not been observed in controlled clinical trials in the U.S., a low percentage (less than 0.5%) has been reported in the world literature. Development of second- or third-degree AV block or unifascicular, bifascicular, or trifascicular bundle branch block requires reduction in subsequent doses or discontinuation of Verapamil and institution of appropriate therapy, if needed. (See Adverse Reactions and Concomitant antiarrhythmic therapy.) Hepatic and renal failure: Significant hepatic and renal failure should not increase the effects of a single intravenous dose of Verapamil but may prolong its duration. Repeated injections of intravenous Verapamil in such patients may lead to accumulation and an excessive pharmacologic effect of the drug. There is no experience to guide use of multiple doses in such patients, and this generally should be avoided. If repeated injections are essential, blood pressure and PR interval should be closely monitored and smaller repeat doses should be utilized. Data on the clearance of Verapamil by dialysis are not yet available. Premature ventricular contractions: During conversion to normal sinus rhythm or marked reduction in ventricular rate, a few benign complexes of unusual appearance (sometimes resembling premature ventricular contractions) may be seen after treatment with Verapamil. Similar complexes are seen during spontaneous conversion of supraventricular tachycardia and after DC-cardioversion or other pharmacologic therapy. These complexes appear to have no clinical significance. Duchenne’s muscular dystrophy: Intravenous Verapamil can precipitate respiratory muscle failure in these patients and should, therefore, be used with caution. Increased intracranial pressure: Intravenous Verapamil has been seen to increase intracranial pressure in patients with supratentorial tumors at the time of anesthesia induction. Caution should be taken and appropriate monitoring performed.
Contraindications
Verapamil hydrochloride injection is contraindicated in: 1. Severe hypotension or cardiogenic shock 2. Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker) 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) 4. Severe congestive heart failure (unless secondary to a supraventricular tachycardia amenable to Verapamil therapy) 5. Patients receiving intravenous beta-adrenergic blocking drugs (e.g., propranolol). Intravenous Verapamil and intravenous beta-adrenergic blocking drugs should not be administered in close proximity to each other (within a few hours), since both may have a depressant effect on myocardial contractility and AV conduction. 6. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). These patients are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if Verapamil is administered. 7. Ventricular tachycardia. Administration of intravenous Verapamil to patients with wide-complex ventricular tachycardia (QRS≥ 0.12 sec) can result in marked hemodynamic deterioration and ventricular fibrillation. Proper pretherapy diagnosis and differentiation from wide-complex supraventricular tachycardia is imperative in the emergency room setting. 8. Known hypersensitivity to Verapamil hydrochloride
Adverse Reactions
The following reactions were reported with intravenous Verapamil use 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%). Although rare, cases of seizures during verapamil injection has been reported. Gastrointestinal: Nausea (0.9%); abdominal discomfort (0.6%). In rare cases of hypersensitivity, broncho/laryngeal spasm accompanied by itch and urticaria has been reported. The following reactions were reported in a few patients: emotional depression, rotary nystagmus, sleepiness, vertigo, muscle fatigue, or diaphoresis. Suggested Treatment of Acute Cardiovascular Adverse Reactions* The frequency of these adverse reactions was quite low, and experience with their treatment has been limited. *Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. ADVERSE REACTIONS
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