Oxcarbazepine Suspension and Pretomanid Tablets

• Generic Name: oxcarbazepine
• Dosage Forms: oral suspension
• Other Brand Names: Oxtellar XR, Trileptal

Oxcarbazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.

Oxcarbazepine is used either alone or with other medicines to treat partial seizures.

The Trileptal brand of oxcarbazepine is used as a single medicine in adults and children who are at least 4 years old. Trileptal is used with other medicines in adults and children who are at least 2 years old.

The Oxtellar XR brand of oxcarbazepine is used with other medicines in adults and children who are at least 6 years old.

Oxcarbazepine may also be used for purposes not listed in this medication guide.

• Generic Name: pretomanid
• Dosage Forms: tablet
• Other Brand Names:

Limited Population: Pretomanid is an antimycobacterial indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.

Pretomanid is not indicated for patients with: drug-sensitive (DS) tuberculosis, latent infection due to Mycobacterium tuberculosis, extrapulmonary infection due to M. tuberculosis, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.

Safety and effectiveness of pretomanid have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.