Dosage of Pretomanid

1. Important Administration Instructions

Pretomanid tablets must be administered only as part of the recommended dosage regimen, in combination with bedaquiline and linezolid.

Administer the combination regimen of pretomanid tablets, bedaquiline, and linezolid by directly observed therapy.

Pretomanid tablets must be taken with food together with bedaquiline and linezolid.

Emphasize to patients the need to complete the full course of treatment.

If the healthcare provider interrupts the combination regimen of pretomanid tablets, bedaquiline, and linezolid for safety reasons, missed doses may be made up at the end of treatment; missed linezolid doses that were missed solely because of linezolid adverse reactions should not be made up.

If necessary, the duration of the combination regimen of pretomanid tablets, bedaquiline, and linezolid may be extended beyond 26 weeks.

2. Recommended Dosage

Pretomanid tablets must be taken with food together with bedaquiline and linezolid.

Administer pretomanid tablets 200 mg orally (one 200 mg tablet) once daily with food for 26 weeks.

Swallow pretomanid tablets whole with water.

For adult patients who have difficulty swallowing, use one of the following two methods:

A) Crush and suspend pretomanid tablets

- Crush and suspend a pretomanid tablet in one teaspoonful (approximately 5 mL) of room-temperature drinking water in a drinking cup, and mix well by vigorous stirring.

- Immediately administer the contents of the cup orally.

- To ensure no tablet residue remains in the cup, rinse the cup with an additional teaspoonful (approximately 5 mL) of water and immediately administer the contents of the cup orally.

- Do not store the mixture for later use.

B) Soak then crush pretomanid tablets

- Soak a pretomanid tablet in one teaspoonful (approximately 5 mL) of room-temperature drinking water in a drinking cup for 4 to 5 minutes, then crush any remaining solid. Mix the contents of the cup well by vigorous stirring.

- Immediately administer the contents of the cup orally.

- To ensure no tablet residue remains in the cup, rinse the cup with an additional teaspoonful (approximately 5 mL) of water and immediately administer the contents of the cup orally.

- Do not store the mixture for later use.