Indicated for the treatment of hypertension, to lower blood pressure. Felodipine extended-release tablets may be administered with other antihypertensive agents.

Felodipine, like other calcium antagonists, may occasionally precipitate significant hypotension and, rarely, syncope. It may lead to reflex tachycardia which in susceptible individuals may precipitate angina pectoris.

Although acute hemodynamic studies in a small number of patients with NYHA Class II or III heart failure treated with felodipine have not demonstrated negative inotropic effects, safety in patients with heart failure has not been established. Caution, therefore, should be exercised when using felodipine extended-release in patients with heart failure or compromised ventricular function, particularly in combination with a beta-blocker.

Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release; therefore, a starting dose of 2.5 mg once a day is recommended.

Peripheral edema, generally mild and not associated with generalized fluid retention, was the most common adverse event in the clinical trials.

Co-administration of CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin, grapefruit juice, cimetidine) with felodipine may lead to several-fold increases in the plasma levels of felodipine.

Co-administration of another extended-release formulation of felodipine with itraconazole resulted in approximately 8-fold increase in the AUC, more than 6-fold increase in the C max, and 2-fold prolongation in the half-life of felodipine.

Co-administration of felodipine with erythromycin resulted in approximately 2.5-fold increase in the AUC and C max, and about 2-fold prolongation in the half-life of felodipine.

Co-administration of felodipine with grapefruit juice resulted in more than 2-fold increase in the AUC and C max, but no prolongation in the half-life of felodipine.

Co-administration of felodipine with cimetidine (a nonspecific CYP-450 inhibitor) resulted in an increase of approximately 50% in the AUC and the C max, of felodipine.

In a pharmacokinetic study, maximum plasma concentrations of felodipine were considerably lower in epileptic patients on long-term anticonvulsant therapy (e.g. phenytoin, carbamazepine, or phenobarbital) than in healthy volunteers.

Felodipine may increase the blood concentration of tacrolimus.

There are no adequate and well-controlled studies in pregnant women. Animal studies: digital anomalies and increased frequency of fetal and early postnatal deaths.

If felodipine is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus, possible digital anomalies of the infant, and the potential effects of felodipine on labor and delivery and on the mammary glands of pregnant females.

It is not known whether this drug is secreted in human milk and because of the potential for serious adverse reactions from felodipine in the infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Dosage greater than 10 mg per day for patients under age 65. GoToSource

• Use in patients under the age of 18. GoToSource

• Congestive heart failure. GoToSource

• Angina. GoToSource 

• Raynaud’s syndrome. GoToSource 

• Cognitive impairment. GoToSource

Increased risk of bleeding when used with oral anticoagulants. GoToSource 

New-onset and exacerbation of psoriasis. GoToSource 

Edema (swelling). GoToSource 

Tachycardia (fast heart rate). GoToSource

No major injury lawsuits reported.