Osteonate ^® OD

Each tablet contain:

Risedronate sodium anhydrous ………………………………… 5 mg

Risedronate has an affinity for hydroxyapatite crystal in bone and acts as an antiresorptive agent.

At the cellular level, risedronate inhibits osteoclasts activity. The osteoclasts adhere normally to the bone surface. Osteoclast is a cell that will resorp the bone normally. With the presence of risedronate, there is evidence of reduced active resorption.

After an oral dose, absorption is relatively rapid (t max 1 hour) and occurs throughout the upper gastrointestinal tract. Risedronate is effective when administered at least 30 minutes before breakfast.

There is no evidence of systemic metabolism of risedronate.

Approximately half of the absorbed dose is excreted in urine within 24 hours. The renal clearance is not concentration dependent, and there is a linear relationship between renal clearance and creatinine clearance. Unabsorbed drug is eliminated unchanged in feces.

• Hypocalcemia

•  Known hypersensitivity to any component of the drug

• Patients which are not able to stand or sit upright for at least 30 minutes

•  Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.

• Osteonate is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 ml/min)

• Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting risedronate therapy.

• Patients should receive calcium (eg: Osfit^®) and vitamin D supplement (eg: Osteofem^®) if dietary intake is inadequate.