APO-RISEDRONATE

What it is

APO-RISEDRONATE contains risedronate sodium hemipentahydrate as its active ingredient. The medicine is available in tablet strengths of 35 mg, 75 mg and 150 mg. Risedronate is a potent pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption.

Approved indications

— Treatment of osteoporosis. — Treatment of glucocorticoid-induced osteoporosis. — Preservation of bone mineral density in patients on long-term corticosteroid therapy.

Dosing overview

APO-RISEDRONATE tablets are intended for oral administration and must only be taken with plain water. Risedronate must be taken 30 minutes before the first food or drink other than water. To facilitate delivery to the stomach, risedronate should be taken while the patient is in an upright position and patients should avoid lying down for 30 minutes.

Key safety warnings

Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations. Caution should be used in patients who have a history of oesophageal disorders which delay oesophageal transit or emptying (such as stricture or achalasia), in patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet, and if risedronate is given to patients with active or recent oesophageal or upper gastrointestinal problems (including known Barrett's oesophagus). Osteonecrosis of the jaw has been reported in patients with cancer receiving treatment regimens including primarily intravenously-administered bisphosphonates and also in patients with osteoporosis receiving oral bisphosphonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (such as cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene), and while on treatment, these patients should avoid invasive dental procedures if possible. A small number of patients on long-term bisphosphonate therapy (usually longer than three years) have developed stress fractures of the proximal femoral shaft, some of which occurred in the absence of apparent trauma, and some of these patients experienced prodromal pain in the affected area weeks to months before a complete fracture occurred. During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture. Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy, with possible risk factors including steroid use and chemotherapy and/or local risk factors such as infection or trauma.

Contraindications

Known hypersensitivity to the drug or any of the ingredients in the tablets. Hypocalcaemia. Inability to stand or sit upright for at least 30 minutes.

PBS listing

Information regarding PBS listing, item numbers, restriction type and ex-manufacturer price is not available in the provided documents.

Regulatory history

APO-RISEDRONATE 35 mg tablets (blister pack and bottle) were first listed on the ARTG on 11 November 2010. APO-RISEDRONATE 75 mg and 150 mg tablets were first listed on the ARTG on 8 March 2012.