Verapamil Hci
FDA Drug Information • Also known as: Verapamil Hci
- Brand Names
- Verapamil Hci
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION 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
What Is Verapamil Hci Used For?
INDICATIONS & USAGE Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including:
Dosage and 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
Side Effects (Adverse Reactions)
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
Warnings and 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...
Contraindications
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
Overdosage
OVERDOSAGE Treatment of overdosage should be supportive and individualized. Beta-adrenergic stimulation and/or parenteral administration of calcium solutions (calcium chloride) have been effectively used in treatment of deliberate overdosage with oral Verapamil. Clinically significant hypotensive reactions or high-degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Asystole should be handled by the usual measures including isoproterenol hydrochloride, other vasopressor agents, or cardiopulmonary resuscitation (see ADVERSE REACTIONS- Suggested Treatment of Acute Cardiovascular Adverse Reactions).
How Supplied
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
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.