Label Changes for:

Adalat (nifedipine) extended release tablets

March 2010

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

PRECAUTIONS

Use in Cirrhotic Patients
  • Use in Cirrhotic patients: Clearance of nifedipine is reduced and systemic exposure increased in patients with cirrhosis. It is unknown how systemic exposure may be altered in patients with moderate to severe liver impairment. Careful monitoring and dose reduction may be necessary; consider initiating therapy with the lowest dose available.
Drug Interactions
  • CYP 3A inhibitors: CYP 3A inhibitors such as ketoconazole fluconazole, itraconazole clarithromycin, erythromycin, grapefruit, nefazodone, saquinar, indinavir, nelfinavir, and ritonavir may result in increased exposure to nifedipine when co-administered. Careful monitoring and dose adjustment may be necessary; consider initiating nifedipine at the lowest dose available if given concomitantly with these medications.
  • Strong CYP3A Inducers, such as rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St. John’s Wort
  • Antitubercular Drugs: Strong CYP 3A inducers, such as rifampin, rifapentin, and rifabutin reduce the bioavailability of nifedipine which will reduce the efficacy of nifedipine. Alternative antihypertensive therapy should be considered in patients taking these medications in combination with strong CYP 3A inducers, such as rifampin.
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