nisoldipine

FDA Drug Profile — Sular

Drug Details

Generic Name
nisoldipine
Brand Names
Sular
Application Number
NDA020356
Sponsor
Covis Pharma US, Inc
NDC Codes
3
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
NISOLDIPINE

Indications and Usage

INDICATIONS AND USAGE SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.

Warnings

WARNINGS Increased angina and/or myocardial infarction in patients with coronary artery disease: Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration and/or severity of angina, or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been established. In controlled studies of SULAR in patients with angina this was seen about 1.5% of the time in patients given nisoldipine, compared with 0.9% in patients given placebo.