Label Changes for:

Procardia (nifedipine) Capsules

July 2013

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)  

 

July 2013

PRECAUTIONS

Drug Interactions:
  • Nifedipine is metabolized by CYP3A4. Co-administration of nifedipine with phenytoin, an inducer of CYP3A4, lowers the systemic exposure to nifedipine by approximately 70%. Avoid co-administration of nifedipine with phenytoin or any known CYP3A4 inducer or consider an alternative antihypertensive therapy.
Lactation
  • Nifedipine is transferred through breast milk. PROCARDIA XL should be used during breastfeeding only if the potential benefit justifies the potential risk.

 

September 2011

WARNINGS

Use in Essential Hypertension
  • Procardia and other immediate-release nifedipine capsules have also been used for the long-term control of essential hypertension, although Procardia capsules have not been approved for this purpose and no properly controlled studies have been conducted to define an appropriate dose or dose interval for such treatment.
  • Procardia capsules should not be used for the control of essential hypertension

ADVERSE REACTIONS

  • Acute generalized exanthematous pustulosis also has been reported

 

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