Verapamil Hydrochloride

Verapamil Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

Heart Failure:

Verapamil has a negative inotropic effect, which in most patients is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary edema. Verapamil should be avoided in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30%) or moderate to severe symptoms of cardiac failure and in patients with any degree of ventricular dysfunction if they are receiving a beta-adrenergic blocker (see PRECAUTIONS, Drug Interactions). Patients with milder ventricular dysfunction should, if possible, be controlled with optimum doses of digitalis and/or diuretics before verapamil treatment (Note interactions with digoxin under PRECAUTIONS).

Hypotension:

Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels which may result in dizziness or symptomatic hypotension. The incidence of hypotension observed in 4,954 patients enrolled in clinical trials was 2.5%. In hypertensive patients, decreases in blood pressure below normal are unusual. Tilt-table testing (60 degrees) was not able to induce orthostatic hypotension.

Elevated liver enzymes:

Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported. Such elevations have sometimes been transient and may disappear even in the face of continued verapamil treatment. Several cases of hepatocellular injury related to verapamil have been proven by rechallenge; half of these had clinical symptoms (malaise, fever, and/or right upper quadrant pain) in addition to elevations of SGOT, SGPT and alkaline phosphatase. Periodic monitoring of liver function in patients receiving verapamil is therefore prudent.

Accessory bypass tract (Wolff-Parkinson-White or Lown-Ganong-Levine):

Some patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, producing a very rapid ventricular response or ventricular fibrillation after receiving intravenous verapamil (or digitalis). Although a risk of this occurring with oral verapamil has not been established, such patients receiving oral verapamil may be at risk and its use in these patients is contraindicated (see CONTRAINDICATIONS).

Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral verapamil hydrochloride.

Atrioventricular block:

The effect of verapamil on AV conduction and the SA node may cause asymptomatic first-degree AV block and transient bradycardia, sometimes accompanied by nodal escape rhythms. PR-interval prolongation is correlated with verapamil plasma concentrations, especially during the early titration phases of therapy. Higher degrees of AV block, however, were infrequently (0.8%) observed. Marked first-degree block or progressive development to second-or third-degree AV block requires a reduction in dosage or, in rare instances, discontinuation of verapamil hydrochloride and institution of appropriate therapy, depending upon the clinical situation.

Patients with hypertrophic cardiomyopathy (IHSS):

In 120 patients with hypertrophic cardiomyopathy (most of them refractory or intolerant to propranolol) who received therapy with verapamil at doses up to 720 mg/day, a variety of serious adverse effects were seen. Three patients died in pulmonary edema; all had severe left ventricular outflow obstruction and a past history of left ventricular dysfunction. Eight other patients had pulmonary edema and/or severe hypotension; abnormally high (greater than 20 mmHg) pulmonary wedge pressure and a marked left ventricular outflow obstruction were present in most of these patients. Concomitant administration of quinidine (see PRECAUTIONS, Drug Interactions) preceded the severe hypotension in 3 of the 8 patients (2 of whom developed pulmonary edema). Sinus bradycardia occurred in 11% of the patients, second-degree AV block in 4% and sinus arrest in 2%. It must be appreciated that this group of patients had a serious disease with a high mortality rate. Most adverse effects responded well to dose reduction, and only rarely did verapamil use have to be discontinued.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Verapamil hydrochloride extended-release tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

History

There is currently no drug history available for this drug.

Other Information

Verapamil hydrochloride extended-release tablets USP are calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release tablets USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg verapamil hydrochloride USP, as brown colored, oval, biconvex, film-coated tablets containing 180 mg verapamil hydrochloride USP, and as brown colored, oval, biconvex, film-coated tablets containing 240 mg verapamil hydrochloride USP. The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half.

The structural formula of verapamil HCl USP is given below:

Structure of Verapamil Hydrochloride

C27H38N2O4·HCl..........M.W. 491.06

Benzeneacetonitrile, α[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4- dimethoxy-α-(1-methylethyl) hydrochloride

Verapamil HCl USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl USP is not chemically related to other cardioactive drugs.

In addition to verapamil HCl USP, the verapamil hydrochloride extended-release tablets USP contain the following ingredients: colloidal silicon dioxide, sodium alginate, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. The following are the color additives per tablet strength:

Strength (mg)

Color Additive(s)

120

Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black

180

Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black

240

Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black

Verapamil hydrochloride extended-release tablets USP, 120 mg, 180 mg and 240 mg meet USP Dissolution Test 1.

Verapamil Hydrochloride Manufacturers


  • Blenheim Pharmacal, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Verapamil Hydrochloride Tablet, Film Coated [Blenheim Pharmacal, Inc.]
  • A-s Medication Solutions Llc
    Verapamil Hydrochloride Tablet [A-s Medication Solutions Llc]
  • Golden State Medical Supply, Inc
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Golden State Medical Supply, Inc]
  • State Of Florida Doh Central Pharmacy
    Verapamil Hydrochloride Tablet, Extended Release [State Of Florida Doh Central Pharmacy]
  • Cardinal Health
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Cardinal Health]
  • State Of Florida Doh Central Pharmacy
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [State Of Florida Doh Central Pharmacy]
  • Blenheim Pharmacal, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Blenheim Pharmacal, Inc.]
  • State Of Florida Doh Central Pharmacy
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [State Of Florida Doh Central Pharmacy]
  • Rebel Distributors Corp
    Verapamil Hydrochloride Tablet [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Rebel Distributors Corp]
  • Bryant Ranch Prepack
    Verapamil Hydrochloride Tablet, Film Coated [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Capsule, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Verapamil Hydrochloride Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet [Remedyrepack Inc. ]
  • Mylan Institutional Inc.
    Verapamil Hydrochloride Capsule, Extended Release [Mylan Institutional Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Preferred Pharmaceuticals, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]
  • General Injectables & Vaccines, Inc
    Verapamil Hydrochloride Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Verapamil Hydrochloride Injection, Solution [General Injectables & Vaccines, Inc]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Verapamil Hydrochloride Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Watson Laboratories, Inc.
    Verapamil Hydrochloride Capsule, Delayed Release Pellets [Watson Laboratories, Inc.]
  • Physicians Total Care, Inc.
    Verapamil Hydrochloride Tablet, Film Coated [Physicians Total Care, Inc.]
  • Physicians Total Care, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Physicians Total Care, Inc.]
  • Physicians Total Care, Inc.
    Verapamil Hydrochloride Capsule, Extended Release [Physicians Total Care, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Verapamil Hydrochloride Capsule, Delayed Release Pellets [Preferred Pharmaceuticals, Inc.]
  • Mylan Institutional Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Mylan Institutional Inc.]
  • Cardinal Health
    Verapamil Hydrochloride Tablet, Film Coated [Cardinal Health]
  • Glenmark Generics Inc.,usa
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Glenmark Generics Inc.,usa]
  • Physicians Total Care, Inc.
    Verapamil Hydrochloride Capsule, Delayed Release Pellets [Physicians Total Care, Inc.]
  • Bryant Ranch Prepack
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet [Remedyrepack Inc. ]
  • Bryant Ranch Prepack
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Verapamil Hydrochloride Capsule, Delayed Release Pellets [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Remedyrepack Inc. ]
  • Mylan Pharmaceuticals Inc.
    Verapamil Hydrochloride Capsule, Extended Release [Mylan Pharmaceuticals Inc.]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Remedyrepack Inc. ]
  • St Marys Medical Park Pharmacy
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [St Marys Medical Park Pharmacy]
  • Lake Erie Medical Dba Quality Care Products Llc
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Remedyrepack Inc. ]
  • Cardinal Health
    Verapamil Hydrochloride Injection, Solution [Cardinal Health]
  • Cardinal Health
    Verapamil Hydrochloride Injection, Solution [Cardinal Health]
  • A-s Medication Solutions Llc
    Verapamil Hydrochloride Tablet, Film Coated [A-s Medication Solutions Llc]
  • Cardinal Health
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Cardinal Health]
  • Cardinal Health
    Verapamil Hydrochloride Injection, Solution [Cardinal Health]
  • Pd-rx Pharmaceuticals, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Mylan Pharmaceuticals Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Mylan Pharmaceuticals Inc.]
  • Preferred Pharmaceuticals, Inc.
    Verapamil Hydrochloride Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]
  • Major Pharmaceuticals
    Verapamil Hydrochloride Tablet, Film Coated [Major Pharmaceuticals]
  • Unit Dose Services
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Unit Dose Services]
  • Unit Dose Services
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Unit Dose Services]
  • Pd-rx Pharmaceuticals, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Remedyrepack Inc. ]
  • Mylan Pharmaceuticals Inc.
    Verapamil Hydrochloride Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Heritage Pharmaceuticals Inc.
    Verapamil Hydrochloride Tablet [Heritage Pharmaceuticals Inc.]
  • Heritage Pharmaceuticals Inc.
    Verapamil Hydrochloride Tablet [Heritage Pharmaceuticals Inc.]
  • Aphena Pharma Solutions – Tennessee, Llc
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Aphena Pharma Solutions – Tennessee, Llc]
  • Teva Pharmaceuticals Usa Inc
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Teva Pharmaceuticals Usa Inc]
  • Kremers Urban Pharmaceuticals Inc.
    Verapamil Hydrochloride Capsule, Extended Release [Kremers Urban Pharmaceuticals Inc.]
  • Northwind Pharmaceuticals
    Verapamil Hydrochloride (Verapamil Hydrochloride) Tablet, Extended Release [Northwind Pharmaceuticals]
  • Watson Laboratories, Inc.
    Verapamil Hydrochloride Tablet, Film Coated [Watson Laboratories, Inc.]
  • Hospira, Inc.
    Verapamil Hydrochloride Injection, Solution [Hospira, Inc.]
  • Caraco Pharmaceutical Laboratories, Ltd.
    Verapamil Hydrochloride Tablet, Extended Release Verapamil Hydrochloride (Verapamil Hydrochloride ) Tablet, Extended Release [Caraco Pharmaceutical Laboratories, Ltd.]
  • Carilion Materials Management
    Verapamil Hydrochloride Tablet, Film Coated [Carilion Materials Management]
  • Remedyrepack Inc.
    Verapamil Hydrochloride Tablet [Remedyrepack Inc. ]
  • Ivax Pharmaceuticals, Inc.
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Ivax Pharmaceuticals, Inc.]
  • Clinical Solutions Wholesale
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Clinical Solutions Wholesale]
  • Clinical Solutions Wholesale
    Verapamil Hydrochloride Tablet, Film Coated [Clinical Solutions Wholesale]
  • State Of Florida Doh Central Pharmacy
    Verapamil Hydrochloride Tablet, Film Coated, Extended Release [State Of Florida Doh Central Pharmacy]

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