Nifedipine ER (GITS)

FDA label

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Titration Titrate over a 7 to 14 day period

Renal Undefined (not studied in nifedipine ER; use caution as absorption may be modified by renal disease)

Hepatic Reduced clearance/increased exposure in cirrhosis — careful monitoring and dose reduction may be necessary; consider initiating at the lowest dose

Three 30 mg tablets are not interchangeable with one 90 mg tablet (higher Cmax)

Instructions

• Administer orally once daily on an empty stomach
• Swallow tablets whole; do not bite, chew, divide, or crush
• Avoid grapefruit juice (stop at least 3 days before initiating)
• If discontinuing, decrease dosage gradually under supervision

Available strengths

• ER tab 30, 60, 90 mg
• cap 10, 20 mg

Contraindications

• Concomitant administration with strong P450 (CYP3A) inducers, such as rifampin, since efficacy of nifedipine could be significantly reduced
• Cardiogenic shock

Cautions

• Excessive hypotension, especially during initial titration or with concomitant beta-blockers
• Increased angina and/or myocardial infarction on starting or with dose increases (severe obstructive CAD)
• Beta-blocker withdrawal — taper beta-blocker before starting
• Congestive heart failure, especially with tight aortic stenosis
• Dose-dependent peripheral edema

Adverse reactions

• Peripheral edema
• Headache
• Flushing/heat sensation
• Dizziness
• Fatigue/asthenia
• Nausea
• Constipation

Pregnancy Pregnancy Category C; animal studies show embryotoxic, teratogenic, and fetotoxic effects; no adequate well-controlled human studies; monitor BP, especially with IV magnesium sulfate

Lactation Nifedipine is excreted in human milk; nursing mothers advised not to breastfeed while taking the drug