Osteorise

Osteorise Special Precautions

risedronic acid

Manufacturer:

CCL Pharma

Distributor:

Manawhari
Full Prescribing Info
Special Precautions
General: Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, oesophagitis, oesophageal ulcer and gastric ulcer. In order to facilitate delivery to the stomach and minimize the possibility of gastrointestinal adverse effects, patients should take Risedronate Sodium (Osteorise) while in an upright position (standing or sitting) with a full glass of plain water and should avoid lying down for 30 minutes after taking this medication.
Use in 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.
Use in Lactation: 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.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: No overall differences in efficacy or safety were observed between these patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.
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