PLENDIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PLENDIL (PLENDIL).
Dihydropyridine calcium channel blocker that inhibits calcium ion influx across cardiac and vascular smooth muscle cells, leading to vasodilation and reduced peripheral vascular resistance.
| Metabolism | Primarily hepatic via CYP3A4; undergoes extensive first-pass metabolism. |
| Excretion | Renal (approximately 70% as metabolites, <0.5% unchanged); fecal (approximately 10%) |
| Half-life | Terminal elimination half-life 2-5 hours in healthy adults; 7-12 hours in patients with hepatic impairment or advanced age |
| Protein binding | >99% bound, primarily to albumin and alpha1-acid glycoprotein |
| Volume of Distribution | 4-10 L/kg; large Vd indicates extensive tissue distribution |
| Bioavailability | Oral: 15-20% (extensive first-pass metabolism) |
| Onset of Action | Oral: 30-60 minutes |
| Duration of Action | 24 hours (due to sustained-release formulation) |
| Action Class | Calcium channel blockers- Dihydropyridines (DHP) |
Initial: 5 mg orally once daily. Maintenance: 2.5–10 mg orally once daily. Maximum: 10 mg/day.
| Dosage form | TABLET, EXTENDED RELEASE |
| Renal impairment | No adjustment required for any degree of renal impairment. |
| Liver impairment | Child-Pugh A or B: Initial dose 2.5 mg orally once daily. Child-Pugh C: Contraindicated or not recommended. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | Initial dose 2.5 mg orally once daily; titrate cautiously due to increased systemic exposure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PLENDIL (PLENDIL).
| Breastfeeding | Excreted in breast milk; M/P ratio unknown. Insufficient data to determine risk; manufacturer recommends discontinuing nursing or drug due to potential for serious adverse reactions in infant. |
| Teratogenic Risk | Pregnancy Category C. First trimester: No adequate studies in humans; animal studies show fetal toxicity at high doses. Second and third trimesters: Potential for fetal hypotension, hypoxia, and growth restriction due to maternal hypotension; avoid use if possible. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to felodipine or any component"]
| Precautions | ["Beta-blocker withdrawal: taper gradually","Peripheral edema","Hepatic impairment","Grapefruit juice increases drug levels"] |
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| Monitor maternal blood pressure, heart rate, and signs of hypotension. Fetal monitoring for growth, heart rate, and amniotic fluid volume if used in pregnancy. |
| Fertility Effects | Reversible fertility impairment in animal studies (reduced pregnancy rates). Human data limited; potential for decreased sperm motility in males. |