Tracleer

Tracleer

bosentan

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Bosentan
Indications/Uses
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.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant cyclosporin A, glibenclamide. Moderate to severe hepatic impairment. Pregnancy.
Special Precautions
Pulmonary veno-occlusive disease, PAH w/ concomitant left ventricular failure; preexisting anaemia &/or hypotension. CHD, HIV infection, testicular function (fertility). Monitor AST & ALT levels prior to & mthly thereafter. Check Hb levels after 1st & 3rd mth of initiation & every 3 mth thereafter. Co-administration of epoprostenol. May affect ability to drive or operate machinery. Preexisting moderate to severe hepatic impairment. Pregnancy & lactation. Paed. Elderly.
Adverse Reactions
Hypersensitivity eg, dermatitis, pruritus, rash.
Drug Interactions
Ketoconazole, cyclosporine A, glibenclamide, rifampicin, lopinavir + ritonavir, other ritonavir-boosted PIs & other antiretroviral agents; itraconazole, ritonavir & other CYP3A4 inhibitors; voriconazole & other CYP2C9 inhibitors; other hepatotoxic drugs, fluconazole, digoxin, phenytoin, tolbutamide, tacrolimus, sirolimus, simvastatin, hormonal contraceptives.
ATC Classification
C02KX01 - bosentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Tracleer FC tab 125 mg
Packing/Price
60's
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