"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
DOSAGE AND ADMINISTRATION
The dosage of SULAR (nisoldipine) 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 (nisoldipine) 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 (nisoldipine) 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 (nisoldipine) is an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.
SULAR (nisoldipine) 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:
|10 mg||Oyster||440 on one side and FH 10 on the other side.|
|20 mg||Yellow Cream||441 on one side and FH 20 on the other side.|
|30 mg||Mustard||442 on one side and FH 30 on the other side.|
|40 mg||Burnt Orange||443 on one side and FH 40 on the other side.|
SULAR (nisoldipine) Tablets are supplied in:
|Bottles of 100|| 10 mg
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 (nisoldipine) is a trademark of Sciele™ Pharma, Inc. Manufactured for: Sciele™ Pharma, Inc. Atlanta, GA 30328. By: Bayer AG, Leverkusen, Germany. FDA Rev date: 1/2/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/25/2008
Additional Sular Information
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