News
Higher-Dose Amlodipine Besylate/Benazepril HCl Capsules (Lotrel) for Managing Hypertension
On April 11, the FDA approved 5-mg/40-mg and 10-mg/40-mg amlodipine besylate/benazepril HCl capsules (Lotrel, made by Novartis Pharmaceuticals Corp) for use in the management of hypertension.
The fixed-dose combination capsules were approved previously in 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg, and 10-mg/20-mg strengths.
According to a company news release, the higher-strength benazepril capsules are intended to expand dosing flexibility and offer new treatment options for patients who previously received no control and who may benefit from use of the highest available dose of the angiotensin-converting enzyme inhibitor benazepril. The new doses are expected to be available later this month.
Amlodipine/benazepril capsules are indicated for use in those whose hypertension is not adequately controlled with either drug alone; they are not intended for first-line use.
The FDA has approved bupropion extended-release tablets for the prevention of seasonal affective disorder in patients with a seasonal pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning. Combined results of 3 clinical trials showed that use of the drug was linked to an increased depression-free rate at the end of the winter season relative to placebo (84.3% vs 72.0%). Time to onset of a seasonal affective disorder episode also favored the treatment group over placebo and achieved statistical significance in 1 study.
Extended-release bupropion therapy for seasonal affective disorder should generally be initiated in the autumn prior to the onset of depressive symptoms with a single dose of 150 mg administered each morning. If tolerated, patients should be uptitrated to the target dose of 300 mg/day after 1 week. Therapy should continue through the winter season before being tapered to 150 mg/day for 2 weeks prior to discontinuation in early spring.
The FDA has approved 5-mg/40-mg and 10-mg/40-mg dosage strengths of amlodipine/benazepril capsules for the treatment of uncontrolled hypertension. The highest approved dose of the angiotensin-converting enzyme inhibitor benazepril is provided to improve dosing options and flexibility. The combination capsules are not intended for first-line use.