ADALAT CC
Clinical safety rating
cautionComprehensive clinical and safety monograph for ADALAT CC (ADALAT CC).
Nifedipine, a dihydropyridine calcium channel blocker, inhibits calcium ion influx across cardiac and smooth muscle cell membranes, leading to vasodilation and decreased myocardial contractility.
| Metabolism | Hepatic metabolism via CYP3A4; nifedipine is converted to inactive metabolites. |
| Excretion | Renal: 70-80% as metabolites, fecal: 15-20% as metabolites, biliary: minimal (<5% unchanged). |
| Half-life | Terminal elimination half-life: 7-10 hours; clinical context: sustained-release formulation provides therapeutic concentrations over 24 hours with once-daily dosing, but half-life does not directly reflect drug effect duration due to slow absorption. |
| Protein binding | 92-98% bound primarily to albumin. |
| Volume of Distribution | 1.2-1.6 L/kg; clinical meaning: indicates extensive tissue distribution, with higher concentrations in organs such as liver and kidney, and lower in brain due to P-glycoprotein efflux. |
| Bioavailability | 65-90% after oral administration; absolute bioavailability of nifedipine in ADALAT CC: approximately 65% due to first-pass metabolism in liver and gut wall. |
| Onset of Action | After oral administration of ADALAT CC (extended-release): 30-60 minutes for antihypertensive effect, measured by blood pressure reduction. |
| Duration of Action | ADALAT CC (extended-release) provides therapeutic effect over 24 hours with once-daily dosing; clinical context: blood pressure reduction is sustained throughout the dosing interval due to extended-release formulation, though peak effect occurs at 6 hours. |
| Molecular Weight | 346.34 |
30 mg orally once daily; may titrate to 60 mg or 90 mg once daily based on response and tolerability.
| Dosage form | TABLET, EXTENDED RELEASE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. For severe renal impairment (CrCl <30 mL/min), start at 30 mg once daily and titrate cautiously. |
| Liver impairment | For mild to moderate hepatic impairment (Child-Pugh A or B), reduce initial dose to 30 mg once daily; for severe impairment (Child-Pugh C), contraindicated or use with extreme caution. |
| Pediatric use | Safety and efficacy not established; use is not recommended in pediatric patients. |
| Geriatric use | Initiate at 30 mg once daily; titrate slowly due to increased risk of hypotension and higher drug exposure. Monitor closely. |
| 1st trimester | Adverse effects on embryofetal development in animals; may cause reduced uteroplacental blood flow and fetal hypoxia. Use only if benefit outweighs risk. |
| 2nd trimester | May cause decreased uterine blood flow and fetal hypoxia; avoid use for management of preterm labor. Use only if benefit outweighs risk. |
| 3rd trimester | May inhibit labor; maternal hypotension may reduce placental perfusion. Use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for ADALAT CC (ADALAT CC).
| Placental transfer | Crosses placenta; detected in cord blood. |
| Breastfeeding | Excreted into breast milk; limited data suggest low levels. Monitor infant for hypotension. Use caution. |
| Lactation Rating | L3 |
| Teratogenic Risk | Adalat CC (nifedipine) is an extended-release formulation of nifedipine, a dihydropyridine calcium channel blocker. In animal studies, nifedipine has been associated with embryotoxicity, fetotoxicity, and teratogenicity (e.g., digital anomalies, cleft palate) at doses several times the maximum recommended human dose. In humans, data are limited but there is no clear evidence of a significant increase in major congenital malformations. First trimester exposure is not strongly associated with major defects; however, some studies suggest a possible small increase in oral clefts. Second and third trimester use may cause maternal hypotension and subsequent fetal distress (e.g., reduced uteroplacental perfusion). Use near term may theoretically inhibit labor, but nifedipine is used as a tocolytic for preterm labor. Overall, the risk is considered low; however, fetal monitoring is recommended if used in pregnancy. FDA Pregnancy Category C (prior to 2015 categorization). |
| Fetal Monitoring | Monitor maternal blood pressure and heart rate regularly, especially after dose initiation or adjustment. In pregnancy, assess fetal heart rate and uterine activity during treatment for preterm labor or hypertension. Monitor for signs of maternal hypotension, which may cause fetal distress. In preeclampsia, monitor maternal liver function, renal function, platelet count, and fetal growth via ultrasound. If used as a tocolytic, monitor for pulmonary edema and maternal fluid status. Fetal nonstress testing or biophysical profile may be indicated. |
| Fertility Effects | In animal studies, nifedipine has not been reported to impair fertility. In humans, no significant adverse effects on fertility have been documented. There is some evidence that calcium channel blockers may affect sperm motility and function in vitro, but clinical relevance is uncertain. Overall, no known major impact on male or female fertility. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to nifedipine or any componentConcurrent use with strong CYP3A4 inducers (e.g., rifampin)Cardiogenic shockUnstable anginaAortic stenosis (severe)Pregnancy (especially during preterm labor)
| Precautions | Beta-blocker withdrawal: taper if discontinuing; exacerbation of angina, Heart failure: use caution in patients with severe left ventricular dysfunction, Hepatic impairment: reduce dose, Peripheral edema: may occur; differentiate from worsening heart failure, Monitor blood pressure during initiation and titration |
| Food/Dietary | Avoid grapefruit and grapefruit juice as they inhibit CYP3A4 metabolism, raising nifedipine levels and risk of toxicity. High-fat meals may increase absorption; take consistently with respect to meals. Avoid alcohol as it may exacerbate hypotension. |
| Clinical Pearls | Adalat CC (nifedipine extended-release) is a dihydropyridine calcium channel blocker used primarily for hypertension. Avoid in patients with unstable angina or within 4 weeks of myocardial infarction due to reflex tachycardia risk. May cause peripheral edema, especially in higher doses; consider adding an ACE inhibitor if edema is problematic. CYP3A4 inhibitors (e.g., grapefruit juice, macrolides, azole antifungals) significantly increase nifedipine levels; avoid coadministration. Tablet shell may appear intact in stool; this is normal. |
| Patient Advice | Swallow the tablet whole; do not crush or chew. · Do not consume grapefruit or grapefruit juice while taking this medication. · May cause dizziness or lightheadedness; avoid driving if affected. · Notify your doctor if you experience rapid heartbeat, swelling in the ankles or feet, or prolonged erections. · Take exactly as prescribed; do not skip doses or stop abruptly without consulting your doctor. |
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