Pulmonary Arterial Hypertension (WHO group1).
Oral; 10mg once daily.
Paediatric: Safety and efficacy in pediatric patients have not been established. Pregnancy: contraindicated, Female patients of reproductive potential must have a negative pregnancy test prior to starting treatment, monthly during treatment, and one month after discontinuation of treatment. Lactation: it is not known whether it is excreted into the human breast milk, advise women not to breastfeed during treatment Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Anemia, Nasopharyngitis/pharyngitis, Bronchitis, Headache, Influenza, Urinary tract infection, hypersensitivity reactions (angioedema, pruritus and rash), nasal congestion, Elevations of liver aminotransferases (ALT, AST), edema/fluid retention, decrease in hemoglobin, decrease sperm count.
Strong CYP3A4 Inducers like rifampicin, Strong CYP3A4 Inhibitors like ketoconazole.