Label Changes for:

Procardia XL (nifedipine) Tablets

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.
Other Interactions:
  • Grapefruit Juice: Co-administration of nifedipine with grapefruit juice resulted in approximately a doubling in nifedipine AUC and Cmax with no change in half-life. The increased plasma concentrations most likely result from inhibition of CYP 3A4 related first-pass metabolism. Avoid ingestion of grapefruit and grapefruit juice should be avoided while taking nifedipine.
Lactation
  • Nifedipine is transferred through breast milk. PROCARDIA XL should be used during breastfeeding only if the potential benefit justifies the potential risk.
Geriatric Use
  • Age appears to have a significant effect on the pharmacokinetics of nifedipine. The clearance is decreased resulting in a higher AUC in the elderly. These changes are not due to changes in renal function (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
     

 

September 2011

WARNINGS

Gastrointestinal Obstruction Requiring Surgery
  • include alteration in gastrointestinal...diverticulitis, diverticulosis, and inflammatory bowel disease
  • ...concomitant medications: opiates...neuromuscular blocking agents.
Gastrointestinal Ulcers
  • Cases of tablet adherence to the gastrointestinal wall with ulceration have been reported, some requiring hospitalization and intervention.

ADVERSE EXPERIENCES

  • Gastrointestinal obstruction resulting in hospitalization and surgery, including the need for bezoar removal, has occurred in association with PROCARDIA XL, even in patients with no prior history of gastrointestinal disease.
  • Cases of tablet adherence to the gastrointestinal wall with ulceration have been reported, some requiring hospitalization and intervention.
  • Acute generalized exanthematous pustulosis also has been reported.

 

October 2010

 

WARNINGS

Congestive Heart Failure
  • Patients with tight aortic stenosis may be at greater risk for such an event, as the unloading effect of nifedipine would be expected to be of less benefit, owing to the fixed impedance to flow across the aortic valve in these patients
Gastrointestinal Obstruction Requiring Surgery
  • There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of Procardia. Bezoars can occur in very rare cases and may require surgical intervention.
  • Cases of serious gastrointestinal obstruction have been identified in patients with no known gastrointestinal disease, including the need for hospitalization and surgical intervention.
  • Risk factors for gastrointestinal obstruction identified from post-marketing reports of Procardia XL (GITS tablet formulation) include alteration in gastrointestinal anatomy (severe gastrointestinal narrowing, colon cancer, small bowel obstruction, bowel resection, gastric bypass, vertical banded gastroplasty, and colostomy), hypomotility disorders (constipation, gastroesophageal reflux disease, ileus, obesity, hypothyroidism, and diabetes) and concomitant medications (H2-histamine blockers, nonsteroidal antiinflammatory drugs, laxatives, anticholinergic agents, and levothyroxine)...

PRECAUTIONS

Other
  • As with any other non-deformable material, caution should be used when administering Procardia XL in patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of Prcardia XL.

ADVERSE EXPERIENCES

  • Gastrointestinal obstruction resulting in hospitalization and surgery, including the need for bezoar removal, has occurred in association with Procardia XL, even in patients with no prior history of gastrointestinal disease.

 

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