Bosentan (Oral Route)

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Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor.

It is very important that you understand the requirements of the Tracleer® access program, and become familiar with the Tracleer® educational materials and Patient Medication Guide. Direct any questions to your doctor or pharmacist before starting bosentan therapy.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For pulmonary arterial hypertension:
    • Adults—At first, 62.5 milligrams (mg) two times a day (morning and evening) for 4 weeks. Your doctor may increase your dose up to 125 mg two times a day. If you are also taking this medicine with ritonavir for at least 10 days, starting dose is 62.5 mg once a day or every other day as directed by your doctor.
    • Children above 12 years of age and weighing less than 40 kilograms (kg) (88 pounds)—62.5 mg two times a day.
    • Children below 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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