Nifedipine ER (GITS)

PROCARDIA XL

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What it isNifedipine GITS extended-release (PROCARDIA XL, 1989) blocks L-type calcium channels; hypertension and stable or vasospastic angina.

Why this oneThe once-daily osmotic tablet avoids the rapid peaks, reflex tachycardia and pressure swings of immediate-release nifedipine.

What limits itPeripheral edema often ends treatment; headache, flushing, and reflex tachycardia reflect vasodilation.

FDA-approved for

hypertension (1989)
chronic stable / vasospastic angina (1989)

FDA label

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FDA dosing	Population	Start	Target	Max
Hypertension	Adults	30 mg QD	30–60 mg QD	90 mg/day (titration above 90 mg not recommended)

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

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

NO BOXED WARNINGS

Principal riskReflex tachycardia and peripheral edema