Opsumit

Opsumit

macitentan

Manufacturer:

Johnson & Johnson

Distributor:

Zuellig
Concise Prescribing Info
Contents
Macitentan
Indications/Uses
Long-term treatment of pulmonary arterial HTN (PAH) in adult patients of WHO Functional Class (FC) II to III, as monotherapy or in combination.
Dosage/Direction for Use
Administration
May be taken with or without food: Take at about the same time every day. Swallow whole.
Contraindications
Hypersensitivity to macitentan. Baseline values of AST &/or ALT >3 x ULN. Severe hepatic impairment (w/ or w/o cirrhosis). Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Patients w/ WHO class I functional pulmonary arterial HTN; not recommended in patients w/ moderate hepatic impairment. Obtain liver enzyme tests prior to initiation. Monitor mthly of ALT & AST & for signs of hepatic injury. Severe anaemia; measure Hb conc prior to initiation of treatment & repeat tests during treatment. Patients w/ veno-occlussive disease. Concomitant use w/ strong CYP3A4 inducers (eg, rifampicin, St. John's wort, carbamazepine & phenyotin) & strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole clarithromycin, telithromycin, nefazodone, ritonavir & saquinavir). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; hypersensitive to soya. May have a minor influence on the ability to drive & use machines. Elderly >75 yr.
Adverse Reactions
Nasopharyngitis, bronchitis, anaemia, headache, oedema, fluid retention. Pharyngitis, flu, UTI, hypotension, nasal congestion.
Drug Interactions
Increased exposure w/ strong CYP3A4 inhibitor eg, ketoconazole. Reduced efficacy w/ strong CYP3A4 inducers eg, rifampicin.
ATC Classification
C02KX04 - macitentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Opsumit FC tab 10 mg
Packing/Price
30's
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