Morphine Sulfate Injection, Concentrate and Pretomanid Tablets

• Generic Name: morphine
• Dosage Forms: injection, solution, concentrate
• Other Brand Names: Arymo ER, Kadian, MorphaBond ER, MS Contin, Avinza, Duramorph PF, Infumorph, Mitigo, RMS, Roxanol

Morphine is an opioid medication. An opioid is sometimes called a narcotic.

Morphine is used to treat moderate to severe pain. Short-acting formulations are taken as needed for pain.

The extended-release form of morphine is for around-the-clock treatment of pain. This form of morphine is not for use on an as-needed basis for pain.

• 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.