Indications

This is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures. Risedronate is a prescription medicine used: To prevent and treat osteoporosis in postmenopausal women. ... Read more This is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures. Risedronate is a prescription medicine used: To prevent and treat osteoporosis in postmenopausal women. To increase bone mass in men with osteoporosis. To prevent and treat osteoporosis in men and women that is caused by treatment with steroid medicines such as prednisone. To treat Paget’s disease of bone in men and women.

Composition

Pharmacology

Your body is constantly breaking down old bone and making new bone tissue. If you have osteoporosis, your body breaks down more bone than it forms so gradually bone loss occurs and your bones become thinner and fragile. This is especially common in women after menopause (change of life). Many people with osteoporosis have no symptoms and you may not even know that you have it. However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists. Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronat inhibits osteoclasts. The osteoclasts adhere normally to the bone surface but show evidence of reduced active resorption.

Dosage & Administration

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures : The recommended dose is Risedronate Sodium 5 mg once daily or Risedronate Sodium 35 mg once weekly on the same day each week or Risedronate Sodium 150 mg once monthly. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis : The recommended dose is Risedronate Sodium 5 mg once daily. To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months): Systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent. The recommended dose is Risedronate Sodium 5 mg once daily. Treatment of osteoporosis in men at high risk of fractures : The recommended dose is Risedronate Sodium 35 mg once weekly. The tablet should be taken on the same day each week.

Contraindications

Risedronate Sodium tablet is contraindicated in patients with known hypersensitivity to Risedronate Sodium and in patients with hypocalcaemia, severe renal impairment (creatinine clearance lower than 30 ml/min), during pregnancy and lactation.

Side Effects

Serious side effects: chest pain; difficulty or pain when swallowing; pain or burning under the ribs or in the back; new or worsening heartburn; severe joint, bone, or muscle pain; or jaw pain, numbness, or swelling. Less serious side effects: mild heartburn or stomach upset; diarrhea, gas,or constipation; mild joint or back pain; headache.

Pregnancy & Lactation

Risedronate Sodium is meant for use only in postmenopausal women. Therefore, Risedronate Sodium should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor. Risedronate Sodium is meant for use only in postmenopausal women. Therefore, breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.

Precautions & Warnings

Take special care with Risedronate if you: Have low blood calcium (hypocalcemia) Cannot sit or stand up for 30 minutes Have kidneys that work poorly Have an allergy to Risedronate Sodium Before taking Risedronate talk to doctor if you: Are pregnant or may become pregnant. We do not know if Risedronate Sodium can harm your unborn child. Are breast-feeding or plan to breast-feed. We do not know if Risedronate Sodium can passthrough your milk and if it can harm your baby. Have kidney problems Risedronate Sodium may not be right for you. Risedronate sodium is not intended for use in children. During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Risedronate sodium and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Risedronate sodium.

Therapeutic Class

Bisphosphonate preparations

Storage Conditions

Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.