Drug information on Bosentas FC (62.5 mg) (Bosentan) from Cipla Limited

Medical Condition(s) for which Bosentas FC (62.5 mg) may be prescribed

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•  Most Common: Respiratory tract infection, nausea, stomach pain, loss of appetite, chest pain, fainting, low blood pressure, palpitation and anemia.

•  Central Nervous System : Headache, dizziness and tiredness.

•  Gastrointestinal: Diarrhea.

•  Genitourinary : Reduced sperm count.

•  Miscellaneous: Liver failure, rash, jaundice and joint pain.

Initial: The recommended dose is 62.5 mg twice daily for 4 weeks. Maintenance dose is 125 mg twice daily.

It comes as a tablet to take by mouth, with or without food.

Contraindicated in pregnant women, co-administration with cyclosporine A and glyburide may increase the risk of liver damage; hypersensitivity.

• Caution should be exercised in patients with history of heart disease, liver disease and anemia.

• It may cause dizziness or drowsiness, do not drive a car or operate machinery while taking this medication.

• During the treatment monitor the level of hemoglobin regularly.

• Avoid pregnancy while taking this medication by using proper birth control methods.

• ♦Patient may develop oligohidrosis(absence of sweating) or high body temperature. If it is so consult with your healthcare provider.

Avoid alcoholic beverages.

Store it at room temperature (20ºC – 25ºC), and in an airtight container.

♦ Safety Labeling Changes Approved By FDA