Plazomicin Pregnancy and Breastfeeding Warnings

Brand names: Zemdri

Medically reviewed by Drugs.com. Last updated on Feb 16, 2024.

Plazomicin Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Other aminoglycosides have caused fetal harm when used during pregnancy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have failed to reveal evidence of reduced survival, impaired fertility, or fetal harm, at doses that produced significant maternal toxicity. Visceral or skeletal malformations were not observed when animal models were given subcutaneous doses ranging from 0.8 to 2.5-fold the human AUC at the clinical dose of 15 mg/kg/day during organogenesis. There are reports of total irreversible, bilateral congenital deafness in children whose mothers used streptomycin during pregnancy. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Plazomicin Breastfeeding Warnings

Safety has not been established; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment: The effects in the nursing infant are unknown.

The effects on milk production are unknown. Approximately 2% to 4% of maternal plasma concentrations were detected in maternal milk; the AUC in nursing pups was approximately 0.04% of maternal systemic exposure (via lactational exposure).

See references

Further information

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