OPSUMIT

Nazione: Indonesia

Lingua: indonesiano

Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Principio attivo:

MACITENTAN

Commercializzato da:

PYRIDAM FARMA TBK - Indonesia

INN (Nome Internazionale):

MACITENTAN

Dosaggio:

10 MG

Forma farmaceutica:

TABLET SALUT SELAPUT

Confezione:

DUS, 2 BLISTER @ 15 TABLET SALUT SELAPUT

Prodotto da:

ACTELION PHARMACEUTICAL Ltd - Switzerland

Data dell'autorizzazione:

2019-05-23

Scheda tecnica

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