Classes
DEA Class; Rx
Common Brand Names; Procardia, Procardia XL, Adalat CC, Nifedical XL, Adalat, Afeditab CR, Nifediac CC
- Calcium Channel Blockers;
- Calcium Channel Blockers, Dihydropyridine
Description
Indications
Indicated for the treatment of variant angina (Prinzmetal angina) and chronic stable angina.
Contraindications
Hypersensitivity to nifedipine or other calcium-channel blockers
Cardiogenic shock
Concomitant administration with strong CYP3A4 inducers (eg, rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, St John’s wort) significantly reduces nifedipine efficacy
Immediate release preparation (sublingually or orally) for urgent or emergent hypertension
Adverse Effects
Adverse effects differ between short-acting (conventional) and extended-release formulations, with the conventional preparations having more serious adverse drug reactions in some cases
- Peripheral edema (10-30%)
- Dizziness (23-27%)
- Flushing (23-27%)
- Headache (10-23%)
- Heartburn (11%)
- Nausea (11%)
- Muscle cramps (8%)
- Mood change (7%)
- Nervousness (7%)
- Cough (6%)
- Dyspnea (6%)
- Palpitations (6%)
- Wheezing (6%)
- Hypotension, transient (5%)
- Urticaria (2%)
- Pruritus (2%)
- Constipation (<2%)
- Chest pain (<2%)
Warnings
Use with caution in (≤4 weeks) myocardial infarction (MI), congestive heart failure (CHF), advanced aortic stenosis, peripheral edema, symptomatic hypotension, unstable angina, concurrent use of beta blockers, hepatic or renal impairment, persistent progressive dermatologic reactions, exacerbation of angina (during initiation of treatment, after a dose increase, or after withdrawal of beta blocker)
Short-acting nifedipine may be less safe than other calcium-channel blockers in management of angina, hypertension, or acute MI
Use cautiously in combination with quinidine
Conventional (short-acting) form not indicated for hypertension
Use extended-release form with caution in severe GI stenosis; rare reports of GI obstructive symptoms in patients with known strictures or without history of GI obstruction in association with ingestion of long-acting nifedipine; bezoars can occur in very rare cases and may necessitate surgical intervention
Extended-release form contains lactose; thus, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine
Cirrhosis: Clearance reduced and systemic exposure increased
CYP3A inhibitors (eg, ketoconazole, fluconazole, itraconazole clarithromycin, erythromycin, grapefruit, nefazodone, saquinavir, indinavir, nelfinavir, ritonavir) may inhibit nifedipine metabolism and result in increased exposure when coadministered
Strong CYP3A inducers (eg, rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St John’s wort) may enhance nifedipine metabolism and result in decreased exposure when coadministered
Avoid use in heart failure due to lack of benefit, and/or worse outcomes with calcium channel blockers in general
Use with caution in patients with hypertrophic cardiomyopathy and outflow tract obstruction; reduction in afterload may worsen symptoms associated with this condition
Avoid use of immediate release formulation in the elderly; may cause hypotension and risk precipitating myocardial ischemia
Pregnancy and Lactation
Pregnancy category: C
Lactation: Drug is distributed into breast milk; manufacturer suggests discontinuing drug or refraining from nursing (however, American Academy of Pediatrics states that drug is safe for nursing)
Maximum Dosage
90 mg/day PO for Procardia XL or 180 mg/day PO for immediate-release capsules for angina; 90 mg/day PO for most extended-release tabs and 120 mg/day PO for Procardia XL for hypertension.
90 mg/day PO for Procardia XL or 180 mg/day PO for immediate-release capsules for angina; 90 mg/day PO for most extended-release tabs and 120 mg/day PO for Procardia XL for hypertension.
Safety and efficacy have not been established; however, up to 3 mg/kg/day PO (not to exceed 180 mg/day) for extended-release tablets has been used off-label for hypertension; 0.5 mg/kg/dose (not to exceed 10 mg/dose) has been used off-label for hypertensive urgency/emergency.
Safety and efficacy have not been established; however, up to 3 mg/kg/day PO (not to exceed 180 mg/day) for extended-release tablets has been used off-label for hypertension; 0.5 mg/kg/dose (not to exceed 10 mg/dose) has been used off-label for hypertensive urgency/emergency.
How supplied
Nifedipine
capsule
- 10mg
- 20mg
tablet, extended release
- 30mg
- 60mg
- 90mg