Concise Prescribing Info
Pulmonary artery hypertension (PAH) (WHO Group I) in patients w/ NYHA Class II, III, or IV symptoms to improve exercise capacity & decrease the rate of clinical deterioration.
Dosage/Direction for Use
Adult & adolescents >12 yr Pulmonary artery HTN Weighing ≥40 yr Initially 62.5 mg bid for 4 wk, increase to 125 mg bid as maintenance dose, <40 kg Initial & maintenance: 62.5 mg bid. Consider a reduction in dose to 62.5 mg bid for 3-7 days when discontinuing treatment.
May be taken with or without food: Avoid grapefuit & grapefruit juice.
Hypersensitivity. Concomitant use w/ cyclosporine or glyburide. Pregnancy.
Special Precautions
Monitor transaminases at baseline then mthly thereafter; Hb prior to treatment, after 1 & 3 mth & every 3 mth thereafter. Discontinue treatment if patients develops elevated transaminases in combination w/ symptoms of hepatic injury or elevated bilirubin (≥2 x ULN). Avoid use in patients w/ baseline serum transaminases >3 x ULN at baseline or moderate to severe hepatic impairment. Peripheral edema may occur. Patients w/ underlying heart failure. May cause hepatotoxicity & birth defects. Reduced hematocrit/Hb w/in the 1st wk of therapy w/ subsequent stabilization levels. Reliable contraception should be used during therapy & 1 mth after discontinuation of therapy. May decrease sperm counts in men during treatment. Lactation.
Adverse Reactions
Chest pain, edema, flushing, hypotension, palpitations, syncope; headache; fluid retention; pruritus, anemia, decreased Hb, hepatic insufficiency, arthralgia; resp tract infection, sinusitis.
Drug Interactions
May increase levels/effects of clarithromycin, ifosfamide. Increased level/effects w/ atazanavir, boceprevir, clarithromycin, cobicistat, cyclosporine, strong & moderate CYP2C9 inhibitors; darunavir; eltrombopag, fosamprenavir, gemfibrozil, glyburide, indinavir; lopinavir, nelfinavir; phosphodiesterase 5 inhibitors; rifampin; ritonavir; saquinavir; telaprevir; teriflunomide; tipranavir. Levels/effects may be decreased by glyburide, rifampin. May decrease levels/effects of antihepaciviral combination drugs, asunaprevir, atazanavir, axitinib, bedaquiline, boceprevir, bosutinib, clarithromycin, clozapine, cobimetinib, contraceptives, cyclosporine, CYP3A4 substrates, daclatasvir, darunavir, dasabuvir, daflazacort, elbasvir, estriol, (topical & systemic), fentanyl, flibanserin, fosamprenavir, glyburide, grazoprevir, guanfacine, hydrocodone, ibrutinib, ifosfamide, indinavir, lopinavir, lurasidone, mirodenafil, nelfinavir, nimodipine, nisoldipine, olaparib, palbociclib, phosphodiesterase-5 inhibitors, ranozaline, rolapitant, saquinavir, saxagliptin, simeprevir, simvastatin, sonidegib, telaprevir, tipranavir, ulipristal, velpatasvir, venetoclax, vit K antagonist, zolpidem.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX01 - bosentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Silkay FC tab 125 mg
6 × 10's
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