Composition
Tab: Aprocitentan 12.5 mg
Indications & Dosage
Treatment of hypertension in combination with other antihypertensive drug: Adult: 12.5 mg once daily. Children: Not recommended.
Contraindications
Hepatic impairment, unstable or severe cardiac disease, renal failure, pregnancy, hypersensitivity to the drug.
Precautions
Severe pulmonary arterial hypertension, elderly, raised liver enzymes; monitor prior to and at monthly intervals during therapy. Advise patients to report any signs suggestive of liver damage. Monitor haemoglobin prior to and at monthly intervals during therapy for first 4 months and quarterly thereafter. Monitor for signs of fluid retention. Women of childbearing potential should use non-hormonal contraception during treatment; perform monthly pregnancy test where appropriate. Avoid abrupt withdrawal; withdraw treatment gradually.
Interactions
Methotrexate, Tizanidine, CYP3A4 inhibitors or CYP3A4 inducers, CYP2C9 inhibitors
Pregnancy
Contraindicated in pregnancy.
Lactation
Not recommended.
Side Effects
Anaemia, embryo-fetal toxicity, hepatotoxicity, oedema, fluid retention, hemoglobin decrease, sperm count decrease, liver impairment, heart disease, renal impairment, hypotension. Rare: Liver cirrhosis, liver failure