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 for the treatment and prevention of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. It is also indicated for the treatment of Paget’s disease of bone. By directly targeting osteoclast-mediated bone resorption, Actonel effectively increases bone mineral density (BMD) and significantly reduces the incidence of vertebral and nonvertebral fractures. This prescription therapy represents a cornerstone in the long-term management of skeletal disorders characterized by accelerated bone loss, offering a well-tolerated and efficacious option for patients under appropriate medical supervision.

Features

• Active pharmaceutical ingredient: Risedronate sodium.
• Available in oral tablet formulations (5 mg, 35 mg, 75 mg, 150 mg).
• Belongs to the nitrogen-containing bisphosphonate drug class.
• Specifically inhibits osteoclast-mediated bone resorption.
• Delayed-release formulation available (Atelvia) for alternative dosing.
• Requires specific administration instructions to ensure optimal bioavailability.

Benefits

• Significant Fracture Risk Reduction: Demonstrated efficacy in reducing the risk of new vertebral fractures by up to 65-70% over three years and nonvertebral fractures by up to 39% in patients with established osteoporosis.
• Increased Bone Mineral Density: Promotes a consistent and statistically significant increase in BMD at the lumbar spine and hip, as measured by dual-energy X-ray absorptiometry (DEXA) scans.
• Rapid and Sustained Action: Provides rapid suppression of bone turnover markers, with effects sustained over long-term treatment, helping to restore bone microarchitecture.
• Proven Tolerability Profile: Exhibits a favorable gastrointestinal tolerability profile compared to some other bisphosphonates when administered correctly.
• Convenient Dosing Schedules: Offers multiple dosing regimens, including a once-daily 5 mg tablet, a once-weekly 35 mg tablet, a twice-monthly 75 mg tablet (taken on two consecutive days per month), and a once-monthly 150 mg tablet, enhancing patient adherence.
• Treatment of Paget’s Disease: Effective in inducing remission and normalizing bone turnover in Paget’s disease of bone, alleviating associated pain and complications.

Common use

Actonel is primarily prescribed for the treatment and prevention of osteoporosis in postmenopausal women. It is used to treat osteoporosis in men to increase bone mass. A separate indication includes the treatment of Paget’s disease of bone, a condition characterized by disorganized bone remodeling leading to enlarged and misshapen bones. Its use is predicated on a confirmed diagnosis via bone density testing (T-score ≤ -2.5 for treatment, or ≤ -1.0 with risk factors for prevention) or biochemical markers indicative of Paget’s disease. Treatment decisions should always be made by a healthcare professional following a comprehensive assessment of the patient’s fracture risk, medical history, and underlying conditions.

Dosage and direction

For Osteoporosis in Postmenopausal Women:

• Treatment: 5 mg tablet taken orally once daily, or 35 mg tablet taken once weekly, or 75 mg tablet taken on two consecutive days each month, or 150 mg tablet taken once monthly.
• Prevention: 5 mg tablet taken orally once daily, or 35 mg tablet taken once weekly.

For Osteoporosis in Men: 35 mg tablet taken once weekly.

For Paget’s Disease of Bone: 30 mg tablet taken orally once daily for 2 months. Retreatment may be considered.

Administration Instructions (CRITICAL):

• Take Actonel immediately upon rising for the day, at least 30 minutes before the first food, beverage (other than plain water), or other medication of the day.
• Swallow the tablet whole with a full glass (6-8 oz) of plain water only. Do not use mineral water, coffee, tea, juice, or milk.
• Remain in an upright position (sitting or standing) for at least 30 minutes after swallowing the tablet. Do not lie down.
• Do not chew or suck the tablet.

Precautions

• Upper Gastrointestinal Irritation: Actonel may cause local irritation of the upper gastrointestinal mucosa. Use with caution in patients with active upper GI problems (e.g., dysphagia, esophagitis, gastritis, duodenitis, ulcers).
• Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating therapy. Ensure adequate intake of calcium and vitamin D.
• Renal Impairment: Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min).
• Osteonecrosis of the Jaw (ONJ): Although rare, ONJ has been reported, typically associated with tooth extraction and/or local infection with delayed healing. A routine oral examination should be performed prior to treatment.
• Atypical Femoral Fractures: Low-energy, low-trauma fractures of the femoral shaft have been reported. Patients should report any thigh or groin pain.
• Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported.

Contraindications

• Hypersensitivity to risedronate sodium or any component of the formulation.
• Abnormalities of the esophagus which delay esophageal emptying (e.g., stricture, achalasia).
• Inability to stand or sit upright for at least 30 minutes.
• Hypocalcemia.

Possible side effect

Common side effects may include:

• Musculoskeletal pain (arthralgia, back pain, myalgia)
• Gastrointestinal disorders (dyspepsia, nausea, abdominal pain, diarrhea, constipation)
• Headache

Less common but serious side effects require immediate medical attention:

• Signs of upper GI irritation: severe heartburn, pain on swallowing, difficulty swallowing, chest pain, new or worsening heartburn
• Symptoms of hypocalcemia: muscle cramps, spasms, numbness or tingling sensation (especially around the mouth, fingers, and toes)
• Severe bone, joint, or muscle pain
• Jaw pain, swelling, numbness, loose teeth, or poor healing after dental work
• Unusual thigh or groin pain (potential sign of femoral fracture)
• Eye pain and inflammation (uveitis, scleritis)

Drug interaction

• Calcium Supplements, Antacids, and Multivitamins: Significantly impair absorption. Administer at a different time of day (at least 30 minutes after Actonel or much later in the day).
• NSAIDs (e.g., ibuprofen, naproxen): Concurrent use may increase the risk of gastrointestinal irritation.
• Aspirin: Use with caution due to increased potential for GI adverse effects.
• Proton Pump Inhibitors (PPIs): May decrease the bioavailability of risedronate, potentially reducing efficacy.

Missed dose

• If a once-daily dose is missed: Do not take it later in the day. Skip the missed dose and resume your regular schedule the next morning. Do not take two tablets on the same day.
• If a once-weekly dose is missed: Take one tablet on the morning after you remember, then return to your original weekly schedule on the chosen day. Do not take two tablets in the same week.
• If a once-monthly dose is missed: If the next month’s scheduled dose is more than 7 days away, take one tablet in the morning following the day it is remembered. Then return to the original monthly schedule. Do not take two tablets within the same week.

Overdose

Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events (such as upset stomach, heartburn, esophagitis, gastritis, or ulcer) may occur. There is no specific antidote. Milk or antacids should NOT be given as they will bind with the drug. The patient should remain fully upright. Treatment should consist of supportive measures, including monitoring of serum calcium and phosphate levels.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Keep in the original container with the desiccant canister to protect from moisture.
• Keep out of reach of children.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

“After my DEXA scan confirmed osteoporosis, my endocrinologist prescribed weekly Actonel. Two years into treatment, my follow-up scan showed a significant 8% increase in spine BMD. The dosing routine is straightforward as long as you are disciplined in the morning.” – M.S., 68

“Managing Paget’s disease was challenging due to persistent bone pain. A 2-month course of Actonel normalized my alkaline phosphatase levels and provided remarkable pain relief. The mandatory 30-minute upright wait is a minor inconvenience for the benefit received.” – R.K., 55

“I switched to Actonel from another bisphosphonate due to GI discomfort. I’ve found it to be much gentler on my stomach when taken correctly with a full glass of water first thing in the morning. My annual bone density has remained stable.” – A.L., 71