Verapamil

Verapamil
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Verapamil is a Calcium Channel Blocker that is FDA approved for the {{{indicationType}}} of essential hypertension (tablet and capsule), rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation (injection). Common adverse reactions include Edema, Hypotension, Constipation, Dizziness, Headache, Pharyngitis, Sinusitis, Influenza-like symptoms.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Essential Hypertension

• Dosing information (tablet)

• The dose of verapamil HCl extended-release should be individualized by titration and the drug should be administered with food.
• Initiate dosage: 180 mg in the morning.

• Lower initial dosage: 120 mg PO qd may be warranted in patients who may have an increased response to verapamil (e.g., the elderly or small people etc.).
• Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. ::* The antihypertensive effects of verapamil HCl extended-release are evident within the first week of therapy.
• If adequate response is not obtained with 180 mg' of verapamil HCl extended-release, the dose may be titrated upward in the following manner:

• 240 mg each morning,
• 180 mg each morning plus 180 mg each evening; or 240 mg each morning plus 120 mg each evening,
• 240 mg every twelve hours.
• When switching from immediate release verapamil to extended-release verapamil, the total daily dose in milligrams may remain the same.

• Dosing information (capsule)

• Administer Verapamil Hydrochloride Extended-release Capsules (PM) once daily at bedtime.
• Usual dosage: 200 mg PO qd at bedtime

• In rare instances, initial doses of 100 mg PO qd may be warranted in patients who have an increased response to verapamil [e.g. patients with impaired renal function, impaired hepatic function, elderly, low-weight patients, etc. (see Use in Specific Populations (8.5, 8.6, 8.7))].
• Base upward titration on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of Verapamil Hydrochloride Extended-release Capsules (PM) are evident within the first week of therapy.

• If an adequate response is not obtained with 200 mg of Verapamil Hydrochloride Extended-release Capsules (PM), the dose may be titrated upward in the following manner:

• a) 300 mg each evening
• b) 400 mg each evening (2 × 200 mg)
• When Verapamil Hydrochloride Extended-release Capsules (PM) is administered at bedtime, office evaluation of blood pressure during morning and early afternoon hours is essentially a measure of peak effect. The usual evaluation of trough effect, which sometimes might be needed to evaluate the appropriateness of any given dose of Verapamil Hydrochloride Extended-release Capsules (PM), would be just prior to bedtime.

• THE CONTENTS OF THE Verapamil Hydrochloride Extended-release Capsules (PM) CAPSULE SHOULD NOT BE CRUSHED OR CHEWED. Verapamil Hydrochloride Extended-release Capsules (PM) ARE TO BE SWALLOWED WHOLE OR THE ENTIRE CONTENTS OF THE CAPSULE SPRINKLED ONTO APPLESAUCE.

• Sprinkling the Capsule Contents on Food

• Verapamil Hydrochloride Extended-release Capsules (PM) capsules may also be administered by carefully opening the capsule and sprinkling the pellets onto one tablespoonful of applesauce. Swallow the applesauce immediately without chewing and follow with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and it should be soft enough to be swallowed without chewing. Use any pellet/applesauce mixture immediately and do not store for future use. Absorption of the pellets sprinkled onto other foods has not been tested. This method of administration may be beneficial for patients who have difficulty swallowing whole capsules. Subdividing the contents of a Verapamil Hydrochloride Extended-release Capsules (PM) capsule is not recommended.

paroxysmal supraventricular tachycardias

• Indication (injection only)

• Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.

atrial flutter or atrial fibrillation

• Indication (injection only)

• 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 (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).

• In controlled studies in the United States, 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 faster ventricular rate respond with a decrease in ventricular 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. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.

• Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole − see CONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient’s response is gained, use in an office setting may be acceptable.

• Cardioversion has been used safely and effectively after verapamil hydrochloride injection.

• Dosing information (injection)

• Initial dosage: 5 to 10 mg (0.075 to 0.15 mg/kg body weight) given as an intravenous bolus over at least 2 minutes.
• Repeat dosage: 10 mg (0.15 mg/kg body weight) 30 minutes after the first dose if the initial response is not adequate. An optimal interval for subsequent I.V. doses has not been determined, and should be individualized for each patient.
• Older patients − The dose should be administered over at least 3 minutes to minimize the risk of untoward drug effects.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Myocardial Infarction

• Developed by: American College of Cardiology Foundation (ACCF) and American Heart Association (AHA)

• Class of Recommendation: Class I

• Level of Evidence: Not applicable

• Dosing Information

• Not applicable

Non–Guideline-Supported Use

Arteriosclerotic vascular disease

• Dosing Information

• 120 mg PO tid 2261941
• 240 mg PO bid 9581724

Amaurosis fugax

• Dosing information

• 120 mg/day 8326973, 1952830

Cluster headache

• Dosing information

• 120 to 1200 mg/day 2708046
• 120 mg bid 2234557
• 120 mg/day 8026943
• 120 mg tid 10746617

Muscle Cramp

• Dosing information

• 120 mg PO at bedtime 3046538
• 60 mg tid 6112398
• 80 mg tid 6112398
• 240 mg/day 2202231

Electroconvulsive therapy

• Dosing information

• 0.1 mg/kg12145060

Hypertrophic cardiomyopathy

• Dosing information

• 320-480 mg/day7196813
• 240-360 mg/day10677401

Keloid scar

• Dosing information

• Intralesional injection 0.5 to 2 mL 8863976

Kidney disease

• Dosing information

• 180 mg/day 12421112

Prophylaxis of Migraine

• Dosing information

• 80 mg qid 6355533

Peyronie's disease

• Dosing information

• 5 mg 10604323

Pulmonary hypertension

• Dosing information

• 17.5 mg over 25 minutes 3970793
• 5 mg IV 6837978

Spasm of cerebral arteries

• Dosing information

• 20 mg 18312091

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Dosing information

• Initial dose:

• 0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual single dose range: 0.75 to 2 mg) should be administered as an intravenous bolus over at least 2 minutes under continuous ECG monitoring.
• 1 to 15 years: 0.1 to 0.3 mg/kg body weight (usual single dose range: 2 to 5 mg) should be administered as an intravenous bolus over at least 2 minutes. Do not exceed 5 mg.

• Repeat dose:

• 0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual single dose range: 0.75 to 2 mg) 30 minutes after the first dose if the initial response is not adequate (under continuous ECG monitoring). An optimal interval for subsequent I.V. doses has not been determined, and should be individualized for each patient.
• 1 to 15 years: 0.1 to 0.3 mg/kg body weight (usual single dose range: 2 to 5 mg) 30 minutes after the first dose if the initial response is not adequate. Do not exceed 10 mg as a single dose. An optimal interval for subsequent I.V. doses has not been determined, and should be individualized for each patient.

• 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. Verapamil is physically compatible and chemically stable for at least 24 hours at 25°C protected from light in most common large volume parenteral solutions. Admixing verapamil hydrochloride injection with albumin, amphotericin B, hydralazine hydrochloride and trimethoprim with sulfamethoxazole should be avoided. Verapamil hydrochloride injection will precipitate in any solution with a pH above 6.0.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Verapamil sandbox in pediatric patients.

Non–Guideline-Supported Use

Cluster Headache

• Dosing information

• 4.3 to 5.5 mg/kg/day 8014035

Hypertrophic cardiomyopathy

• Dosing information

• 3-6 mg/kg/day 9731645
• 4 mg/kg/day 10694584

Contraindications

There is limited information regarding Verapamil Contraindications in the drug label.

Warnings

There is limited information regarding Verapamil Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Verapamil Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Verapamil Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Verapamil Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Verapamil in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Verapamil in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Verapamil during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Verapamil in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Verapamil in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Verapamil in geriatric settings.

Gender

There is no FDA guidance on the use of Verapamil with respect to specific gender populations.

Race

There is no FDA guidance on the use of Verapamil with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Verapamil in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Verapamil in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Verapamil in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Verapamil in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Verapamil Administration in the drug label.

Monitoring

There is limited information regarding Verapamil Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Verapamil and IV administrations.

Overdosage

There is limited information regarding Verapamil overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Verapamil Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Verapamil Mechanism of Action in the drug label.

Structure

There is limited information regarding Verapamil Structure in the drug label.

Pharmacodynamics

There is limited information regarding Verapamil Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Verapamil Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Verapamil Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Verapamil Clinical Studies in the drug label.

How Supplied

There is limited information regarding Verapamil How Supplied in the drug label.

Storage

There is limited information regarding Verapamil Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Verapamil Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Verapamil sandbox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Verapamil Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Verapamil Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.