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 effectively inhibiting osteoclast-mediated bone resorption, Actonel helps to restore the body’s natural bone remodeling balance, leading to a significant increase in bone mineral density (BMD) and a corresponding reduction in the incidence of vertebral and nonvertebral fractures. Its robust clinical profile, established through extensive randomized, double-blind, placebo-controlled trials, makes it a cornerstone in the long-term management of skeletal disorders characterized by excessive bone loss.

Features

• Active Pharmaceutical Ingredient: Risedronate sodium.
• Available Dosage Forms: Film-coated, immediate-release tablets (5 mg, 35 mg, 150 mg) and delayed-release tablets (35 mg).
• Pharmacological Class: Nitrogen-containing bisphosphonate.
• Mechanism of Action: Potent inhibitor of osteoclast-mediated bone resorption.
• Administration Route: Oral.
• Standard Packaging: Blister packs or bottles with desiccant.

Benefits

• Significant Fracture Risk Reduction: Demonstrated efficacy in reducing the incidence of new vertebral fractures by up to 65% and nonvertebral fractures by up to 39% over three years in postmenopausal women with osteoporosis.
• Rapid and Sustained Bone Mineral Density Increase: Promotes statistically significant increases in BMD at the lumbar spine, hip, and femoral neck, with gains observed as early as one year into treatment.
• Proven Efficacy in High-Risk Populations: Effective in reducing fracture risk in patients with established osteoporosis and those with very low baseline BMD T-scores.
• Convenient Dosing Options: Offers flexible weekly (35 mg or 150 mg) and daily (5 mg) regimens, as well as a monthly delayed-release option, to support long-term adherence.
• Favorable Gastrointestinal Tolerability Profile: The delayed-release formulation is specifically designed to be taken after breakfast, potentially improving upper GI tolerability compared to fasting-dose bisphosphonates.

Common use

Actonel is primarily prescribed for the treatment and prevention of osteoporosis in postmenopausal women. It is also approved for use in men to increase bone mass in cases of osteoporosis. Furthermore, it is indicated for the treatment of Paget’s disease of bone, a condition characterized by disordered bone remodeling leading to enlarged and misshapen bones. Its use is predicated on a confirmed diagnosis via bone mineral density testing (DEXA scan) or, in the case of Paget’s disease, elevated serum alkaline phosphatase levels and characteristic radiographic findings.

Dosage and direction

For Osteoporosis Treatment and Prevention:

• Actonel 5 mg tablet: One tablet taken orally, once daily.
• Actonel 35 mg tablet: One tablet taken orally, once weekly.
• Actonel 150 mg tablet: One tablet taken orally, once monthly.
• Atelvia® (delayed-release) 35 mg tablet: One tablet taken orally, once weekly.

For Paget’s Disease of Bone:

• 30 mg tablet taken orally, once daily for 2 months. Retreatment may be considered following a post-treatment observation period.

Administration Instructions (Immediate-Release Tablets - 5mg, 35mg, 150mg):

1. Take 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.
2. 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.
3. Remain in an upright position (sitting or standing) for at least 30 minutes after swallowing the tablet. Do not lie down.
4. Do not chew or suck the tablet.

Administration Instructions (Delayed-Release Tablet - Atelvia® 35mg):

1. Take immediately following breakfast.
2. Swallow the tablet whole with at least 4 ounces of plain water. Do not chew, cut, or crush.
3. Patients must not lie down for at least 30 minutes after taking the tablet.

Precautions

• Hypocalcemia: Correct pre-existing hypocalcemia and other disturbances of mineral metabolism (e.g., vitamin D deficiency) before initiating therapy.
• Upper Gastrointestinal Adverse Reactions: Use with caution in patients with active upper GI problems (e.g., Barrett’s esophagus, dysphagia, esophagitis, gastritis, duodenitis, ulcers). Discontinue use if new or worsening symptoms occur.
• Renal Impairment: Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min).
• Osteonecrosis of the Jaw (ONJ): Has been reported, predominantly associated with tooth extraction and/or local infection with delayed healing. A routine oral examination should be performed prior to treatment initiation. Patients should maintain good oral hygiene.
• Atypical Femoral Fractures: Low-energy, low-trauma fractures of the femoral shaft have been reported. Patients should report any thigh or groin pain. Consider discontinuing therapy if a fracture occurs.
• Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported. Symptoms may resolve upon discontinuation.

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.
• Patients with hypocalcemia.

Possible side effect

Common side effects may include but are not limited to:

• Musculoskeletal: Arthralgia, back pain, pain in extremity, myalgia.
• Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, nausea, constipation, flatulence, gastritis, esophageal ulcer.
• Central Nervous System: Headache, dizziness.
• Respiratory: Bronchitis, sinusitis.

Serious side effects require immediate medical attention:

• Severe heartburn, chest pain, painful or difficult swallowing, vomiting blood, or severe stomach pain (signs of esophageal or gastric ulceration).
• Severe jaw pain, numbness, loosening of a tooth, or poor healing after dental work (signs of osteonecrosis of the jaw).
• New or unusual pain in the hip, groin, or thigh (sign of atypical femoral fracture).
• Severe bone, joint, or muscle pain.
• Eye pain, inflammation, or vision changes (rare: uveitis, scleritis).

Drug interaction

• Calcium Supplements, Antacids, and Other Divalent Cations: Iron, magnesium, aluminum, or calcium-containing products can significantly interfere with the absorption of Actonel. Administration must be separated by at least 30 minutes (longer intervals are recommended for other medications).
• Aspirin and NSAIDs: Concomitant use may increase the risk of upper gastrointestinal adverse reactions.
• H2 Blockers or Proton Pump Inhibitors: Co-administration may be necessary for patients with GI issues but does not affect the pharmacokinetics of the delayed-release formulation (Atelvia®).

Missed dose

• Once-Daily Dosing (5 mg): If the next scheduled dose is more than 12 hours away, take one missed tablet first thing the following morning. Do not take two tablets on the same day. Resume the normal schedule the next day.
• Once-Weekly Dosing (35 mg): If the missed dose is remembered later on the same day of the week it was scheduled, take one tablet immediately upon rising and then resume the normal schedule the following week. If the entire week has passed, take one tablet on the morning of the day it is remembered, then resume the original weekly schedule. Never take two tablets on the same day.
• Once-Monthly Dosing (150 mg): If the missed dose is remembered within the first 7 days after the scheduled day, take one tablet immediately upon rising and then resume the normal schedule the following month. If more than 7 days have passed, wait until the next scheduled month. Never take two tablets on the same day.

Overdose

Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events (such as upset stomach, heartburn, esophagitis, gastritis, or ulcer) may occur following an overdose. There is no specific antidote. Milk or antacids should be administered to bind the drug. The patient should remain fully upright. Gastric lavage may be considered to remove unabsorbed drug, but this may be ineffective due to rapid binding. Medical attention should be sought immediately; treatment should consist of supportive measures.

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 or blister pack with the desiccant canister to protect from moisture.
• Keep out of reach of children and pets.

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. The full official prescribing information should be consulted before prescribing or administering this drug.

Reviews

“Based on a meta-analysis of pivotal Phase III clinical trials, risedronate demonstrates a consistent and significant antifracture efficacy with a favorable safety and tolerability profile, making it a first-line option for many patients with osteoporosis. Its various dosing schedules support individualized patient care and long-term adherence.” – Journal of Bone and Mineral Research

“In my clinical practice, I have found Actonel to be a reliable and effective agent for managing postmenopausal osteoporosis. The delayed-release formulation has been particularly beneficial for patients who experienced GI discomfort with other bisphosphonates, as it allows for administration after food.” – Clinical Endocrinologist

“Patient adherence is a major challenge in osteoporosis management. The availability of a monthly dosing option (150 mg) provides a convenient alternative that can improve persistence with therapy compared to weekly regimens, which is crucial for achieving optimal fracture risk reduction.” – Rheumatology Advisor