Verapamil
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Questions & Answers
Side Effects & Adverse Reactions
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).
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.
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.
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.
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 HCl and institution of appropriate therapy depending upon the clinical situation.
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 has a serious disease with a high mortality rate. Most adverse effects responded well to dose reduction and only rarely did verapamil 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 management of essential hypertension.
History
There is currently no drug history available for this drug.
Other Information
Verapamil hydrochloride extended-release tablet USP is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release tablet USP is available for oral administration as brown colored oval, biconvex, film-coated tablets containing 120 mg verapamil hydrochloride USP and as brown colored oval, biconvex, film-coated tablets containing 180 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:
C27H38N2O4·HCl
M.W. 491.06
Benzeneacetronitrile, 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 tablet USP contains 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
Verapamil hydrochloride extended-release tablets USP, 120 mg and 180 mg meet USP Drug Release Test 1.
Sources
Verapamil Manufacturers
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Pd-rx Pharmaceuticals, Inc.
![Verapamil Tablet, Extended Release [Pd-rx Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Verapamil | Pd-rx Pharmaceuticals, Inc.
Essential HypertensionThe dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of sustained-release verapamil HCl, verapamil hydrochloride extended-release tablet, given in the morning. Lower, initial doses of 120 mg a day 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 hydrochloride extended-release tablets are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, 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 hydrochloride tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.
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Unit Dose Services
Verapamil | Unit Dose Services
Essential Hypertension
The dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of verapamil hydrochloride extended-release tablets, given in the morning. Lower, initial doses of 120 mg a day 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 hydrochloride extended-release tablets are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner:
a) 240 mg each morning,
b) 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening
c) 240 mg every twelve hours.
When switching from immediate release verapamil hydrochloride tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.
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American Health Packaging
Verapamil | Prasco Laboratories
There is currently no dosage information available for this product. We apologize for any inconvenience.
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St Marys Medical Park Pharmacy
Verapamil | St Marys Medical Park Pharmacy
Essential Hypertension
The dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of verapamil hydrochloride extended-release tablets, given in the morning. Lower, initial doses of 120 mg a day 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 hydrochloride extended-release tablets are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner:
a) 240 mg each morning,
b) 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening
c) 240 mg every twelve hours.
When switching from immediate release verapamil hydrochloride tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.
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Apotex Corp.
Verapamil | Apotex Corp.
Essential Hypertension
The dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of verapamil hydrochloride extended-release tablets, given in the morning. Lower, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., the elderly or small people). 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 hydrochloride extended-release tablets are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner:
a) 240 mg each morning,
b) 180 mg each morning plus
180 mg each evening, or
240 mg each morning plus
120 mg each evening,
c) 240 mg every twelve hours.
When switching from immediate release verapamil hydrochloride tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.
-
St Marys Medical Park Pharmacy
Verapamil | St Marys Medical Park Pharmacy
Essential Hypertension
The dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of verapamil hydrochloride extended-release tablets, given in the morning. Lower, initial doses of 120 mg a day 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 hydrochloride extended-release tablets are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner:
a) 240 mg each morning,
b) 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening
c) 240 mg every twelve hours.
When switching from immediate release verapamil hydrochloride tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.
![Verapamil (Verapamil Hydrochloride) Tablet, Film Coated, Extended Release [Unit Dose Services]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ae2fa326-fff1-4d82-a6ec-7886afae46b0&name=50436-6915.jpg)
![Verapamil (Verapamil Hydrochloride) Tablet, Film Coated, Extended Release [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6016af90-6311-4f35-bfc3-ce49c105ba4f&name=hydroxychloroquine-sulfate-usp-1.jpg)
![Verapamil (Verapamil Hydrochloride) Tablet, Film Coated, Extended Release [St Marys Medical Park Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2776b194-6ccf-469a-8865-2c843d712b68&name=VerapamilERLabel.jpg)
![Verapamil (Verapamil Hydrochloride) Tablet, Film Coated, Extended Release [Apotex Corp.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Verapamil (Verapamil Hydrochloride) Tablet, Film Coated, Extended Release [St Marys Medical Park Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=74c5b1d1-93d3-4afe-9255-e9977dfa5bdd&name=Verapamil120mg.jpg)
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