OPSYNVI

This brand name is authorized in United States

Active ingredients

The drug OPSYNVI contains a combination of these active pharmaceutical ingredients (APIs):

1 Macitentan
UNII Z9K9Y9WMVL - MACITENTAN

Macitentan is an orally active potent endothelin receptor antagonist, active on both ETA and ETB receptors. Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.

Read about Macitentan
2 Tadalafil
UNII 742SXX0ICT - TADALAFIL

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the absence of sexual stimulation.

Read about Tadalafil

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
OPSYNVI Film-coated tablet FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
C02KX54 C Cardiovascular system → C02 Antihypertensives → C02K Other antihypertensives → C02KX Antihypertensives for pulmonary arterial hypertension
Discover more medicines within C02KX54

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: US FDA, National Drug Code Identifier(s): 66215-812, 66215-814

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