Zuellig Pharma
Concise Prescribing Info
Pulmonary arterial HTN (PAH) in patients of WHO functional class II-IV.
Dosage/Direction for Use
Initially 62.5 mg bd for 4 wk. Maintenance: 125 mg bd.
May be taken with or without food: Swallow whole, do not divide/chew/crush.
Hypersensitivity. Concomitant use of cyclosporin A. Moderate to severe hepatic impairment (Child-Pugh class B or C). Baseline values of liver aminotransferase (AST &/or ALT >3 x ULN). Women of childbearing potential not using reliable methods of contraception. Pregnancy.
Special Precautions
Liver function, measure liver aminotransferase prior to treatment initiation & subsequently at mthly intervals. Hb conc, check Hb conc prior to treatment initiation, every 1 mth during 1st 4 mth & quarterly thereafter. Pulmonary veno-occlusive disease, PAH w/ concomitant left ventricular failure, monitor signs signs for fluid retention. PAH associated w/ HIV infection. Pulmonary HTN secondary to COPD. May affect ability to drive or operate machinery. May affect fertility. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Not recommended during lactation. Paed. Elderly.
Adverse Reactions
Anaemia, decreased Hb, hypersensitivity reactions, headache, syncope, palpitations, flushing, hypotension, nasal congestion, GERD, diarrhoea, abnormal LFT, erythema, oedema, fluid retention.
Drug Interactions
Increased plasma conc w/ potent CYP3A4 inhibitor (eg, ketoconazole, itraconazole, ritonavir) & CYP2C9 inhibitor (eg, voriconazole). Decreased blood conc of cyclosporine A. Reduced/decreased plasma conc of tacrolimus, sirolimus. glibenclamide, warfarin, simvastatin. Decreased plasma conc w/ potent CYP2C9 & CYP3A4 inducers eg, rifampicin. Reduced systemic exposure w/ other CYP3A4 inducers eg, carbamazepine, phenobarb, phenytoin, St. John's wort. Reduced clearance w/ lopinavir + ritonavir, other ritonavir-boosted PIs. Additive toxicity w/ nevirapine. Decreased AUC of norethisterone, ethinyl estradiol, sildenafil. Reduced tadalafil systemic exposure. Decreased AUC, Cmax & Cmin of digoxin.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX01 - bosentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Tracleer FC tab 125 mg
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