VERAPAMIL HYDROCHLORIDE 240 mg/1
verapamil hydrochloride · TABLET, EXTENDED RELEASE · Cadila Pharmaceuticals Limited
VERAPAMIL HYDROCHLORIDE is a tablet, extended release containing verapamil hydrochloride at 240 mg/1, taken oral. Manufactured by Cadila Pharmaceuticals Limited.
Key Facts
- Brand Name
- VERAPAMIL HYDROCHLORIDE
- Generic Name
- verapamil hydrochloride
- NDC Code (Product)
71209-048- Manufacturer
- Cadila Pharmaceuticals Limited
- Strength
- 240 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206173
- Marketing Start
- 05/27/2017
Recall History
Zydus Pharmaceuticals (USA) Inc
Cross contamination with other products.
Zydus Pharmaceuticals (USA) Inc
Cross contamination with other products.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Apotex Inc.
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Amerisource Health Services LLC
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Glenmark Pharmaceuticals Inc., USA
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Amerisource Health Services LLC
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Verapamil Hydrochloride Tablets are indicated for the treatment of the following: Angina 1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) Arrhythmias 1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS; Accessory bypass tract ) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential hypertension: Verapamil is 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 p…
Dosage & Administration
DOSAGE AND ADMINISTRATION The dose of verapamil must be individualized by titration. The usefulness and safety of dosages exceeding 480 mg/day have not been established; therefore, this daily dosage should not be exceeded. Since the half-life of verapamil increases during chronic dosing, maximum response may be delayed. Angina: Clinical trials show that the usual dose is 80 mg to 120 mg three times a day. However, 40 mg three times a day may be warranted in patients who may have an increased response to verapamil (e.g., decreased hepatic function, elderly, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately eight hours after dosing. Dosage may be increased at daily (e.g., patients with unstable angina) or weekly intervals until optimum clinical response is obtained. Arrhythmias: The dosage in digitalized patients with chronic atrial fibrillation (see PRECAUTIONS ) ranges from 240 to 320 mg/day in divided (three times a day or four times a day) doses. The dosage for prophylaxis of PSVT (non-digitalized patients) ranges from 240 to 480 mg/day in divided (three times a day or four times a day) doses. In general, maximum effects for any gi…
Warnings
WARNINGS 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 pr…
Contraindications
CONTRAINDICATIONS Verapamil Hydrochloride Tablets are contraindicated in: 1. Severe left ventricular dysfunction (see WARNINGS ) 2. Hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) 4. Second-or-third-degree AV block (except in patients with a functioning artificial ventricular pacemaker) 5. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS ) 6. Patients with known hypersensitivity to verapamil hydrochloride.
Drug Interactions
Drug interactions Cytochrome inducers/inhibitors: In vitro metabolic studies indicate that verapamil is metabolized by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9, and CYP2C18. Clinically significant interactions have been reported with inhibitors of CYP3A4 (e.g., erythromycin, ritonavir) causing elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g., rifampin) have caused a lowering of plasma levels of verapamil. HMG-CoA reductase inhibitors: The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with verapamil has been associated with reports of myopathy/rhabdomyolysis. Coadministration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs. Aspirin: In a few reported cases, co-administration of verapamil with aspirin has led to increased bleeding times greater than obser…
Adverse Reactions
ADVERSE REACTIONS Serious adverse reactions are uncommon when verapamil hydrochloride therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil. The following reactions to orally administered verapamil occurred at rates greater than 1% or occurred at lower rates but appeared clearly drug-related in clinical trials in 4,954 patients: Constipation 7.3% Dyspnea 1.4% Dizziness 3.3% Bradycardia (HR<50/min) 1.4% Nausea 2.7% AV block total (1°, 2°, 3°) 1.2 % 1.2% Hypotension 2.5% 2° and 3° 0.8% Headache 2.2% Rash 1.2% Edema 1.9% Flushing 0.6% CHF,Pulmonary edema 1.8% Fatigue 1.7% Elevated liver enzymes (see WARNINGS ) In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50 at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients. The followin…
Frequently Asked Questions
What is VERAPAMIL HYDROCHLORIDE used for?
VERAPAMIL HYDROCHLORIDE contains verapamil hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is VERAPAMIL HYDROCHLORIDE a controlled substance?
VERAPAMIL HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for VERAPAMIL HYDROCHLORIDE?
The generic name for VERAPAMIL HYDROCHLORIDE is verapamil hydrochloride. There are 10 other brand versions of verapamil hydrochloride.
What is the NDC code for VERAPAMIL HYDROCHLORIDE 240 mg/1?
The NDC (National Drug Code) for VERAPAMIL HYDROCHLORIDE 240 mg/1 is 71209-048, listed by Cadila Pharmaceuticals Limited.
Other VERAPAMIL HYDROCHLORIDE Dosages
Other Verapamil Brands
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- verapamil hydrochloride180 mg/151655-959
- VERELAN PM100 mg/162175-570
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- Verapamil Hydrochloride120 mg/10378-6320
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)