Actonel

Actonel (risedronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). Risedronate alters the cycle of bone formation and breakdown in the body. Actonel slows bone loss while increasing bone mass, which may prevent bone fractures. Actonel is used to treat or prevent osteoporosis. Actonel is also used to treat Paget’s disease of bone.

Product dosage: 35mg
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Synonyms Acido risedronico Acidum risedronicum Acrel Actokit Benet Bifodron Bondapen Bonmate Bonna Ductonar Esat Maxidronato Motivus Norifaz Norsed Optinate Ostenel Osteonate od Oxidren Rentop Ribastamin Ridron Rised Risedon Risedronato Risedronatum Risedronic acid Risendros Risofos Sedron Seralis

Actonel (risedronate sodium) is a bisphosphonate medication specifically formulated to treat and prevent osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. It works by inhibiting osteoclast-mediated bone resorption, thereby reducing the risk of fractures. This product card provides comprehensive, evidence-based information for healthcare professionals to ensure optimal therapeutic outcomes.

Features

• Active ingredient: Risedronate sodium
• Available in 5 mg, 35 mg, and 150 mg tablet strengths
• Delayed-release formulation to enhance gastrointestinal tolerance
• Once-daily or once-weekly dosing regimens for patient convenience
• FDA-approved for treatment and prevention of postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, and Paget’s disease of bone

Benefits

• Significantly reduces the risk of vertebral and non-vertebral fractures
• Increases bone mineral density at the lumbar spine and hip
• Demonstrates rapid onset of action with sustained efficacy over long-term use
• Well-tolerated profile with a lower incidence of upper gastrointestinal adverse events compared to other bisphosphonates
• Flexible dosing options improve adherence and patient satisfaction

Common use

Actonel is primarily prescribed for the management of osteoporosis in postmenopausal women to reduce the incidence of fractures. It is also indicated for the treatment of osteoporosis in men, as well as for the prevention and treatment of glucocorticoid-induced osteoporosis in patients initiating or continuing systemic corticosteroid therapy. Additionally, it is used in the treatment of Paget’s disease of bone to normalize bone turnover.

Dosage and direction

For the treatment of postmenopausal osteoporosis, the recommended dosage is 5 mg orally once daily or 35 mg once weekly. For the prevention of postmenopausal osteoporosis, 5 mg once daily or 35 mg once weekly is advised. For glucocorticoid-induced osteoporosis, the dose is 5 mg once daily. For Paget’s disease, the regimen is 30 mg orally once daily for 2 months. Tablets must be taken on an empty stomach with a full glass of plain water (not mineral water) at least 30 minutes before the first food, beverage, or other medication of the day. Patients should remain upright for at least 30 minutes after ingestion to facilitate esophageal transit and minimize irritation.

Precautions

Patients should be evaluated for hypocalcemia prior to initiation, and any deficiencies must be corrected. Caution is advised in patients with active upper gastrointestinal problems, such as dysphagia, esophageal disease, gastritis, duodenitis, or ulcers. Dental health should be assessed before starting therapy due to the risk of osteonecrosis of the jaw. Atypical femoral fractures have been reported with long-term use; patients presenting with thigh or groin pain should be evaluated. Renal function should be monitored, as Actonel is not recommended for patients with severe renal impairment (CrCl <30 mL/min).

Contraindications

Actonel is contraindicated in patients with abnormalities of the esophagus that delay emptying, such as stricture or achalasia. It should not be used in individuals unable to stand or sit upright for at least 30 minutes. Hypocalcemia is a contraindication, and the drug must not be administered to patients with known hypersensitivity to risedronate sodium or any component of the formulation.

Possible side effect

Common adverse reactions include arthralgia, back pain, abdominal pain, dyspepsia, nausea, diarrhea, and headache. Less frequently, patients may experience esophagitis, esophageal ulceration, gastritis, or musculoskeletal pain. Rare but serious side effects include osteonecrosis of the jaw, atypical femoral fractures, severe bone, joint, or muscle pain, and ocular inflammation such as uveitis or scleritis. Hypocalcemia may occur, particularly in patients with predisposing conditions.

Drug interaction

Calcium supplements, antacids, and other products containing divalent cations (e.g., magnesium, iron, aluminum) can interfere with the absorption of Actonel and should be taken at a different time of day. Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal irritation. Use with caution in patients taking aminoglycosides, loop diuretics, or other drugs that may lower serum calcium levels.

Missed dose

If a once-daily dose is missed, the patient should skip that dose and resume the next morning. For once-weekly dosing, if a dose is missed, the patient should take one tablet on the morning after remembering and then resume the original weekly schedule. Patients should not take two tablets on the same day.

Overdose

Symptoms of overdose may include hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events such as upset stomach, heartburn, esophagitis, gastritis, or ulcer. Treatment should consist of supportive measures, including milk or antacids to bind risedronate. Patients should remain upright to avoid esophageal irritation. Dialysis is not beneficial due to high protein binding.

Storage

Store at room temperature, 20°C to 25°C (68°F to 77°F), in a tightly closed container. Protect from light and moisture. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging.

Disclaimer

This information is intended for healthcare professionals and should not replace clinical judgment. Always consider the individual patient’s condition, contraindications, and potential interactions. Consult the full prescribing information for comprehensive details.

Reviews

Clinical trials and post-marketing surveillance demonstrate Actonel’s efficacy in fracture risk reduction and bone density improvement, with a favorable safety profile. Healthcare providers report high patient satisfaction due to flexible dosing and tolerability. Long-term studies confirm sustained benefits with appropriate monitoring.