Bosentas 62.5 Tablet
Bosentan
62.5mg
Cipla Ltd.
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| Retail Price | 121.68 NPR |
Available as:
Indications
Bosentas 62.5 Tablet is used for:
Pulmonary Arterial Hypertension (PAH)
Adult Dose
Oral
Pulmonary hypertension
Adult: >12 yr <40 kg: Initial and maintenance dose is 62.5 mg bid; >40 kg: Initially, 62.5 mg bid for 4 wk, then increased to a maintenance dose of 125 mg bid.
Elderly: No dosage adjustment needed.
Hepatic impairment: Mild: No dosage adjustment needed. Moderate and severe: Contraindicated.
Child Dose
Renal Dose
Renal impairment: No dosage adjustment needed in renal impairment or dialysis patients.
Administration
Bosentan should be administered in the morning and evening with or without food.
Contra Indications
Patients with WHO Class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these benefits are sufficient to offset the risk of hepatotoxicity in WHO Class II patients, which may preclude future use as their disease progresses.
Precautions
Hepatotoxicity and teratogenicity. Elevations of AST or ALT associated with Bosentan are dose-dependent, occur both early and late in treatment, usually progress slowly, are typically asymptomatic, and usually have been reversible after treatment interruption or cessation. Aminotransferase elevations also may reverse spontaneously while continuing treatment with Tracleer.
Liver aminotransferase levels must be measured prior to initiation of treatment and then monthly and therapy adjusted accordingly .Discontinue Bosentan if liver aminotransferase elevations are accompanied by clinical symptoms of hepatotoxicity (such as nausea, vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin > 2
Lactation: Not known if excreted in breast milk; not recommended
Pregnancy-Lactation
Interactions
Increased bosentan levels w/ CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, diltiazem), CYP2C9 inhibitors (e.g. amiodarone, fluconazole), tacrolimus. Rifampicin initially increases but subsequently decreases bosentan concentration. May decrease plasma levels of warfarin, statins (e.g. simvastatin, lovastatin), hormonal contraceptives, sildenafil, tadalafil.
Potentially Fatal: Increased risk of hepatotoxicity may occur w/ glibenclamide. Ciclosporin markedly increases bosentan concentration.
Adverse Effects
Side effects of Bosentan :
>10%
Hgb decreased; >1 g/dL (57%),Inhibition of spermatogenesis (25%),Headache (16-22%),Nasopharyngitis (11%),Transaminses increased (12%),Respiratory tract infection (22%),Increased transaminases (12%)
1-10%
Edema, lower limb (5-8%),Flushing (7-9%),Hypotension (7%),Hepatic abnormalities (4%),Palpitations (4%),Anemia (3%),Dyspepsia (4%),Edema, general (4%),Fatigue (2%),Pruritus (4%)
<1%
Hyperbilirubinemia,Vasculitis,Jaundice,Leukopenia,Thrombocytopenia,Leukocytoplastic
Mechanism of Action
Competitive antagonist of endothelin-1; blocks endothelin receptors on vascular endothelium and smooth muscle resulting in inhibition of vasoconstriction
Note
Bosentas 62.5 62.5mg Tablet manufactured by Cipla Ltd.. Its generic name is Bosentan. Bosentas 62.5 is availble in Nepal.
Farmaco Nepal drug index information on Bosentas 62.5 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.