Label Changes for:

Verelan PM (verapamil hydrochloride) Extended-Release capsules

December 2009

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2009

Label converted to PLR format

WARNINGS and PRECAUTIONS

Hypotension (revised)
  • Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels which may result in dizziness or symptomatic hypotension. In hypertensive patients, decreases in blood pressure below normal are unusual. The incidence of hypotension observed in 4,954 patients enrolled in clinical trials of other verapamil formulations was 2.5%. In clinical studies of Verelan PM, 1.7% of the patients developed significant hypotension. Tilt table testing (60 degrees) was not able to induce orthostatic hypotension.
Patients with Hypertrophic Cardiomyopathy
  • Idiopathic Hypertrophic subaortic stenosis (IHSS) has been added to the first sentence of the first paragraph

ADVERSE REACTIONS

Clinical TriaOpen Trials/Postmarketing Experience
  • ECG Abnormal
  • Hypertension
  • Elevated liver enzymes
  • asthenia

DRUG INTERACTIONS

Clonidine
  • Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with verapamil. Monitor heart rate in patients receiving concomitant verapamil and clonidine.
Telithromycin
  • Hypotension and bradyarrhythmias have been observed in patients receiving concurrent telithromycin, an antibiotic in the ketolide class of antibiotics.
CYP3A4 Inhibitors and Inducers
  • Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent telithromycin, an antibiotic in the ketolide class of antibiotics
Antineoplastic Agents (revised)
  • Verapamil can increase doxorubicin levels. The absorption of verapamil can be reduced by the cyclophosphamide, oncovin, procarbazine, prednisone (COPP) and the vindesine, adriamycin, cisplatin (VAC) cytotoxic drug regimens. Concomitant administration of R verapamil can decrease the clearance of paclitaxel.
USE IN SPECIFIC POPULATIONS
Pregnancy 
  • Verapamil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus” has been added as the sixth sentence.
Nursing Mothers (revised)
  • Verapamil is excreted into human milk. In case studies where verapamil concentration in human milk was calculated, the nursing infant doses ranged from less than 0.01% to 0.1% of the mother’s verapamil dose. Consider possible infant exposure when verapamil is administered to a nursing woman.
Impaired Hepatic Function (revised)
  • Since verapamil is highly metabolized by the liver, consider lower dosages and closely monitor responses to the drug in patients with impaired hepatic function. Severe liver dysfunction prolongs the elimination half-life of immediate-release verapamil to about 14 to 16 hours; hence, approximately 30% of the dose given to patients with normal liver function should be administered to these patients. Monitor for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects.
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