Methylergonovine Maleate Injection and Pretomanid Tablets

• Generic Name: methylergonovine
• Dosage Forms: injection, solution
• Other Brand Names: Methergine

Methylergonovine is in a group of drugs called ergot alkaloids. It affects the smooth muscle of a woman's uterus, improving the muscle tone as well as the strength and timing of uterine contractions.

Methylergonovine is used just after a baby is born, to help deliver the placenta (also called the "afterbirth"). It is also used to help control bleeding and to improve muscle tone in the uterus after childbirth.

Methylergonovine 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.