Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MACITENTAN
PYRIDAM FARMA TBK - Indonesia
MACITENTAN
10 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 15 TABLET SALUT SELAPUT
EXCELLA GMBH & CO. KG - Federal Republic of Germany
2020-07-27
1. NAME OF THE MEDICINAL PRODUCT Opsumit ® 10mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan. Excipients with known effect: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of lecithin (soya) (E322). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Long-term treatment of pulmonary arterial hypertension (PAH) in patients of WHO Functional Class (FC) II to III to reduce the morbidity and the risk of mortality. Macitentan is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitor or inhaled/oral prostanoids. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. POSOLOGY The recommended dose is 10 mg once daily _SPECIAL POPULATIONS _ _ELDERLY _ No dose adjustment is required in patients over the age of 65 years. There is limited clinical experience in patients over the age of 75 years. Therefore Opsumit should be used with caution in this population. _HEPATIC IMPAIRMENT _ DISETUJUI OLEH BPOM: 23/07/2021 ID: EREG10019312100029 Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment. However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment. Opsumit must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (> 3 × ULN). _RENAL IMPA Baca dokumen lengkapnya