SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

The dosage of SULAR must be adjusted to each patient's needs. Therapy usually should be initiated with 20 mg orally once daily, then increased by 10 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 20 to 40 mg once daily. Blood pressure response increases over the 10 - 60 mg daily dose range but adverse event rates also increase. Doses beyond 60 mg once daily are not recommended. SULAR has been used safely with diuretics, ACE inhibitors, and beta-blocking agents. Patients over age 65, or patients with impaired liver function are expected to develop higher plasma concentrations of nisoldipine. Their blood pressure should be monitored closely during any dosage adjustment. A starting dose not exceeding 10 mg daily is recommended in these patient groups. SULAR tablets should be administered orally once daily. Administration with a high fat meal can lead to excessive peak drug concentration and should be avoided. Grapefruit products should be avoided before and after dosing. SULAR is an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.

SULAR extended release tablets are supplied as 10 mg, 20 mg, 30 mg, and 40 mg round film coated tablets. The different strengths can be identified as follows:

SULAR Tablets are supplied in:

Protect from light and moisture. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

SULAR is a trademark of Sciele™ Pharma, Inc. Manufactured for: Sciele™ Pharma, Inc. Atlanta, GA 30328. By: Bayer AG, Leverkusen, Germany. FDA Rev date: 1/2/2008

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