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Bosentan as Monohydrate 62.5mg

Film Coated Tablet

60 tablets in a box





Stock Code : 61d10899e8d8 Category :

Bosentan monohydrate is a dual endothelin receptor antagonist.It acts as a vasodilator by blocking the action of endothelin receptors. It’s used to decrease pulmonary arterial hypertension, improve exercise ability and prevent deterioration of the patient’s condition.

Bosentan, an oral ERAA/B, improves hemodynamics and exercise capacity in adults with PAH. clinical studies have shown bosentan is the one among ERAs that can significantly reduce in the mean number of digital ulcers in patients with systemic sclerosis.



Bosentan improved and prevented deterioration in the walking distance among patients with PAH and scleroderma.


Bosentan as Monohydrate 62.5

Therapeutic Fields​

Pulmonary artery hypertension

Pulmonary artery hypertension

Digital ulcers in systemic sclerosis

Digital ulcers in systemic sclerosis

• Raynaud phenomenon in systemic sclerosis

Raynaud phenomenon in systemic sclerosis

Bosentan as Monohydrate 62.5

Age weight initial-BD maintenance-BD
<12 years 1mg/kg/dose 2mg/kg/dose
>12 years >20-40kg 31.25mg 62.5mg
>40kg 62.5mg 125mg
adult <40kg 62.5mg 62.5mg
≥40kg 62.5mg 125mg

Kidney Impairment: No dosage adjustment necessary

Hepatic Impairment: Moderate to severe impairment and/or baseline transaminase >3 times ULN: Avoid use


Administer with or without food.


Fluid retention/peripheral edema, Significant decreases in hemoglobin, transaminase elevations, Hypersensitivity reactions, pulmonary edema occur; require further evaluation is necessary to determine cause and appropriate treatment or discontinuation of therapy


Hypersensitivity to bosentan or any component of the formulation; concurrent use of cyclosporine or glyburide; women who are or may become pregnant Pregnancy and breastfeeding: not recommended

Drug Interactions

Risk x: Cyclosporine, Glyburide, Mifepristone, CYP3A4 Inducers

Side effects

  • >10%: Edema, headache, increased serum ALT/ AST, respiratory tract infection

    1% to 10%: Chest pain, syncope, flushing, hypotension, palpitations, fluid retention, anemia, arthralgia, sinusitis

    <1%: Anaphylaxis, angioedema, DRESS syndrome, hepatic cirrhosis (prolonged therapy), hepatic failure (rare), hypersensitivity reaction, jaundice, leukopenia, nasal congestion, neutropenia, peripheral edema, severe anemia, skin rash, thrombocytopenia

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