Bosentor 62.5 mg Film-Coated 60 Tablets

Bosentan Film-coated tablet 62.5 mg 

What Bosentan is used for:

Bosentan is indicated for the treatment of pulmonary arterial hypertension.

Do not use Bosentan:

Hypersensitivity to Bosentan or any component of the formulation; concurrent use of cyclosporine or glyburide; women who are or may become pregnant. 

Warnings and Precautions:

• 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.

Possible side effects:

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. 

Other medicines and Bosentan:

Tell your doctor or pharmacist if you are taking:

• Cytochrome P450: Coadministration of Bosentan with drugs metabolized by CYP2C9 and CYP3A can increase exposure to Bosentan and/or the coadministered drug 

• Hormonal contraceptives: Bosentan use decreases contraceptive exposure and reduces effectiveness

How to use Bosentan:

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 

How to store Bosentan:

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store at 20ºC – 25ºC. Excursions are permitted between 15°C and 30°C. These storage temperatures apply to both film-coated and dispersible tablets. 

Divided dispersible tablets should be stored under the same conditions and used within 7 days. Tablet pieces may be returned to the opened blister and stored there out of reach of children for up to 7 days.

Do not use Bosentan if you notice any deterioration or damage to the outer packaging.

Do not throw away any medicines via wastewater or household waste.