Silkay 125

Silkay 125





Concise Prescribing Info
Bosentan monohydrate
Pulmonary arterial HTN (PAH) in patients of WHO functional class II-IV.
Dosage/Direction for Use
Initially 62.5 mg bd for 4 wk, may be increased to maintenance: 125 mg bd.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ cyclosporine A. Baseline AST &/or ALT values >3 x ULN. Moderate to severe hepatic impairment (Child-Pugh class B or C). Women of childbearing potential not using effective contraception. Pregnancy.
Special Precautions
Pulmonary veno-occlusive disease; PAH w/ concomitant left ventricular failure or associated w/ HIV infection; pulmonary HTN secondary to COPD. Monitor AST & ALT levels prior to & mthly thereafter. Check Hb conc prior to treatment, every mth for 1st 4 mth & quarterly thereafter. Avoid abrupt discontinuation. Not recommended w/ glibenclamide, fluconazole, rifampicin. Avoid co-administration of CYP3A4 & CYP2C9 inhibitors. May affect ability to drive or operate machinery. Avoid use in patients w/ moderate or severe hepatic impairment. Mild hepatic impairment. May affect male fertility. Women of childbearing potential should use effective contraception during & for 1 mth after last dose. Not to be used during pregnancy. Not recommended during lactation. Childn 12-18 yr. Elderly ≥65 yr.
Adverse Reactions
Headache; abnormal LFT; edema, fluid retention. Anemia, decreased Hb; hypersensitivity reactions; syncope; palpitations; flushing, hypotension; nasal congestion; GERD, diarrhea; erythema.
Drug Interactions
Increased plasma conc w/ fluconazole, ketoconazole, itraconazole, ritonavir, voriconazole. Decreased blood conc of cyclosporine A. Decreased plasma conc of tacrolimus, sirolimus, glibenclamide, warfarin, simvastatin. Reduced effect w/ rifampicin. Reduced systemic exposure w/ carbamazepine, phenobarb, phenytoin, St. John's wort. Increased initial trough plasma conc w/ lopinavir + ritonavir. Hepatotoxicity w/ nevirapine. Decreased AUC of norethisterone, ethinylestradiol, sildenafil. Reduced systemic exposure of tadalafil. 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.
Silkay 125 FC tab 125 mg
1 × 10's
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