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Alogliptin / pioglitazone Pregnancy and Breastfeeding Warnings

Alogliptin / pioglitazone is also known as: Oseni

Alogliptin / pioglitazone Pregnancy Warnings

Alogliptin: Not teratogenic when administered to animals during organogenesis. In addition, no harm to the developing embryo or adverse effects on the growth and development of offspring was observed when given to animals at approximately 95 times the clinical exposure. Following oral administration to pregnant animals, placental transfer of was observed. Animal fertility studies showed no adverse effects on embryonic development, mating, or fertility at doses approximately 172 times the clinical dose. Pioglitazone: Animal studies have not revealed evidence of teratogenicity. Increases in embryotoxicity (postimplantation losses, delayed development, reduced fetal weights, and delayed parturition) were observed in animals. When administered to pregnant animals during late gestation and lactation, delayed postnatal development (attributed to decreased body weight) occurred. There are no controlled data in human pregnancy. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Potential benefit should outweigh the potential risk. Comments: All premenopausal women should use adequate methods of contraception.

See references

Alogliptin / pioglitazone Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown (alogliptin and pioglitazone) Excreted into animal milk: Yes (alogliptin and pioglitazone) The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Oseni (alogliptin-pioglitazone)." Takeda Pharmaceuticals America, Lincolnshire, IL.

References for breastfeeding information

  1. "Product Information. Oseni (alogliptin-pioglitazone)." Takeda Pharmaceuticals America, Lincolnshire, IL.

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