Therapeutic Indications Of Tracleer tablets Bosentan is indicated for the treatment of pulmonary arterial hypertension. Method Of Administration Of Tracleer tablets Administer Bosentan orally following the dosing recommendations in Table 1. Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the increased risk of hepatotoxicity. Table 1: Dosing Recommendations Initial 4 weeks Maintenance (after 4 weeks) Patients >12 years of age and >40 kg 62.5 mg twice daily 125 mg twice daily Patients >12 years of age and <40 kg 62.5 mg twice daily 62.5 mg twice daily Patients ≤12 years of age ≥4-8 kg 16 mg twice daily 16 mg twice daily ˃8-16 kg 32 mg twice daily 32 mg twice daily ˃16-24 kg 48 mg twice daily 48 mg twice daily ˃24-40 kg 64 mg twice daily 64 mg twice daily Undesirable Side Effects Of Tracleer tablets Like all medicines, Bosentan b can cause side effects, although not everybody gets them. Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body. Warnings & Special Precautions While Taking Tracleer tablets • Fluid retention/peripheral edema • Hematologic effects: Dose-related decreases in hematocrit/hemoglobin may be observed • Hepatotoxicity: [US Boxed Warning]: Bosentan is associated with transaminase elevations (ALT or AST ≥3 times ULN), and in a small number of cases may occur with elevations in bilirubin. Monitor transaminases at baseline then monthly thereafter. Adjust dosage if elevations in liver enzymes occur without symptoms of hepatic injury or elevated bilirubin. In the postmarketing surveillance (with close monitoring), there have been rare cases of unexplained hepatic cirrhosis after prolonged therapy (>12 months) in patients with multiple comorbidities and drug therapies. There have also been cases of hepatic failure. Treatment should be stopped in patients who develop elevated transaminases either in combination with symptoms of hepatic injury (unusual fatigue, jaundice, nausea, vomiting, abdominal pain, and/or fever) or elevated bilirubin (≥2 times ULN); safety of reintroduction is unknown. Avoid use in patients with baseline serum transaminases >3 times ULN at baseline (monitoring for hepatotoxicity may be more difficult) or moderate to severe hepatic impairment • Hypersensitivity: Hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), anaphylaxis, rash and angioedema have been observed • Pulmonary veno-occlusive disease: If signs of pulmonary edema occur, consider possibility of pulmonary veno-occlusive disease; may require discontinuation of bosentan. Storage Conditions Of Tracleer tablets Store below 25°c Don’t refrigerate Keep this medicine out of the sight and reach of children. Store in the original package to protect from moisture. Do not use this medicine after the expiry date which is stated on the box/blisters/label. The expiry date refers to the last day of the month.