Opsynvi Description

OPSYNVI 10 mg/20 mg film-coated tablets: OPSYNVI 10 mg macitentan/20 mg tadalafil is a pink, oblong, film-coated tablet debossed with "1020" on one side and "MT" on the other side.
Each 10 mg/20 mg film-coated tablet contains 10 mg macitentan and 20 mg tadalafil.
OPSYNVI 10 mg/40 mg film-coated tablets: OPSYNVI 10 mg macitentan/40 mg tadalafil is supplied as white to almost-white, oblong, film-coated tablets debossed with "1040" on one side and "MT" on the other side.
Each 10 mg/40 mg film-coated tablet contains 10 mg macitentan and 40 mg tadalafil.
OPSYNVI is a single tablet combination containing two oral components used to treat pulmonary arterial hypertension: macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
Macitentan: Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C₁₉H₂₀Br₂N₆O₄S and a molecular weight of 588.27. Macitentan is achiral.
Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive.
Tadalafil: Tadalafil, an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C₂₂H₁₉N₃O₄ representing a molecular weight of 389.41.
The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3- benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.
Excipients/Inactive Ingredients: Each OPSYNVI core tablet contains the following inactive ingredients: Hydroxypropyl cellulose, hydroxypropyl cellulose (low-substituted), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, sodium starch glycolate, sodium lauryl sulfate. OPSYNVI 10 mg/20 mg tablets are film-coated with a coating material containing hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, lactose monohydrate, talc, titanium dioxide, triacetin.OPSYNVI 10 mg/40 mg tablets are film-coated with a coating material containing hydroxypropyl methylcellulose, lactose monohydrate, talc, titanium dioxide, triacetin.