Tracleer

Tracleer

bosentan

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Bosentan
Indications/Uses
Treatment of pulmonary arterial HTN (PAH) in patients w/ WHO functional class II-IV. Reduction in the number of new digital ulcers in patients w/ systemic sclerosis w/ active digital ulcer disease.
Dosage/Direction for Use
PAH & systemic sclerosis w/ active digital ulcer disease Initially 62.5 mg bd for 4 wk, then increase to the maintenance dose of 125 mg bd.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Intermediate to severe liver disorders (Child-Pugh class B or C). Raised liver aminotransferases before start of treatment to >3 times the upper normal limit. Concomitant use w/ cyclosporine A & glibenclamide. Women of child-bearing age who are not using adequate contraception. Pregnancy.
Special Precautions
Patients w/ WHO class I functional status of PAH. Treatment may only be started if the systemic systolic BP is >85 mmHg. No effect on healing of existing digital ulcers. Increases in liver aminotransferases. Measure liver aminotransferase values before the start of treatment & then mthly throughout treatment. Discontinue in case of clinical symptoms associated w/ liver damage. Decrease in Hb conc. Check Hb conc prior to initiation of treatment, at mthly intervals during the 1st 4 mth of treatment then every 3 mth. Reports of sickle cell anaemia crises in patients who already had sickle cell anaemia before start of treatment. Patients w/ pulmonary veno-occlusive disease. Monitor patients for signs of fluid retention (eg, wt increase). HIV patients being treated w/ antiretroviral drugs. Perform mthly pregnancy tests during treatment to ensure that pregnancy is detected as early as possible. Breast-feeding mothers should wean their babies. Childn & adolescent.
Adverse Reactions
Headache; abnormal liver function test; oedema, fluid retention. Anaemia, Hb decrease; hypersensitivity reactions; syncope; palpitations; flushing, hypotension; nasal congestion; GERD, diarrhoea; erythema.
Drug Interactions
Reduced plasma conc of CYP2C9, CYP3A4 or CYP2C19 substrates. Raised plasma conc w/ CYP2C9 & CYP3A4 inhibitors. Reduced AUC of norethisterone & ethinyloestradiol (OCs); sildenafil. Decreased plasma conc of cyclosporine A; tacrolimus, sirolimus; glibenclamide; warfarin; simvastatin; lopinavir + ritonavir. Increased risk of raised aminotransferase values w/ cyclosporine; glibenclamide. Increased plasma conc w/ fluconazole; cyclosporine A; tacrolimus, sirolimus; ketoconazole; lopinavir + ritonavir. Reduced plasma conc w/ glibenclamide; rifampicin. Increased AUC w/ sildenafil. Decreased systemic availability & Cmax of tadalafil.
ATC Classification
C02KX01 - bosentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Tracleer film-coated tab 125 mg
Packing/Price
60's
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