nisoldipine
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 Nisoldipine extended-release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive 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 nisoldipine extended-release tablets 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.