"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 must be adjusted to each patient's needs. Therapy usually should be initiated with 17 mg orally once daily, then increased by 8.5 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 17 to 34 mg once daily. Blood pressure response increases over the 8.5 - 34 mg daily dose range but adverse event rates also increase. Doses beyond 34 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 8.5 mg daily is recommended in these patient groups. SULAR tablets should be administered orally once daily. SULAR should be taken on an empty stomach (1 hour before or 2 hours after a meal). 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 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:
|8.5 mg||Oyster||SCI 500|
|17 mg||Yellow Cream||SCI 501|
|34 mg||Burnt Orange||SCI 503|
SULAR Tablets are supplied in bottles of 100:
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.
Manufactured for: Shionogi Inc., Florham Park, NJ 07932. Manufactured By: Aenova France SAS, 38291 Saint- Quentin-Fallavier, France, Made in France. Revised: Mar 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/19/2016
Additional Sular Information
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