Osteorise

Osteorise Use In Pregnancy & Lactation

risedronic acid

Manufacturer:

CCL Pharma

Distributor:

Manawhari
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category C: Survival of neonates was decreased in rats treated during gestation with oral doses >/=16 mg/kg/day (approximately 5.2 times the 30-mg/day human dose based on surface area, mg/m2).
Similar to other bisphosphonates, treatment during mating and gestation with doses as low as 3.2 mg/kg/day (approximately 1 time the 30-mg/day dose based on surface area, mg/m2) has resulted in periparturient hypocalcemia and mortality in pregnant rats allowed to deliver.
There are no adequate and well-controlled studies of Risedronate Sodium (Osteorise) in pregnant women. Risedronate Sodium (Osteorise) should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Nursing Mothers: Risedronate was detected in feeding pups exposed to lactating rats for a 24-hour period post-dosing, indicating a small degree of lacteal transfer. It is not known whether risedronate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bisphosphonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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