Actonel (Risedronate Sodium) – Comprehensive Product Description

Actonel (risedronate sodium) is a prescription bisphosphonate medication used to treat and prevent osteoporosis in postmenopausal women, as well as to manage bone loss due to corticosteroid use or Paget’s disease. It works by slowing down bone resorption, increasing bone density, and reducing the risk of fractures.

Actonel
Generic Name: Risedronate Sodium
Other Common Names/Brands:

Risedronate

Risofos

Risotab

Risomax

Actonel EC (enteric-coated version)

Fosamax (related bisphosphonate)

Risedronate Sodium
Molecular Formula: C7H10NO7P2Na
Drug Class: Bisphosphonates (Bone resorption inhibitors)

Actonel works by inhibiting osteoclast-mediated bone resorption, thus slowing bone turnover and allowing osteoblasts (bone-forming cells) to rebuild stronger bone mass. It binds to hydroxyapatite crystals in bone, making it highly effective in improving bone mineral density (BMD).

Actonel is indicated for the treatment and prevention of:

Postmenopausal osteoporosis

Glucocorticoid-induced osteoporosis

Osteoporosis in men

Paget’s disease of bone

It is proven to reduce the risk of vertebral and non-vertebral fractures, including hip fractures.

Clinical Backing
VERT Study (2000): Demonstrated significant reduction in vertebral fractures in postmenopausal women within one year.

HIP Trial: Reduced the incidence of hip fractures by 60% over 3 years.

Clinical guidelines: Recommended as first-line therapy for osteoporosis by NICE and American College of Physicians (ACP).

Available Strengths at EZ Chemist
35 mg tablets (weekly)

150 mg tablets (monthly)

30 mg tablets (daily for Paget’s disease)

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Indication Dose Frequency
Postmenopausal osteoporosis 35 mg Once weekly
Paget’s disease 30 mg Daily for 60 days
Osteoporosis in men 35 mg Once weekly
Glucocorticoid-induced osteoporosis 5 mg Once daily

Take first thing in the morning with a full glass of plain water

Stay upright (do not lie down) for at least 30 minutes

Take 30 minutes before food, beverages, or other medications

Swallow whole; do not chew or crush the tablet

Prescribing Information
Prescription-only (Schedule H drug in India)

Requires monitoring of calcium and vitamin D levels

Often co-prescribed with calcium and vitamin D supplements

Safety Information
Safe and effective for long-term osteoporosis management (up to 5 years recommended use)

Ensure adequate intake of calcium and vitamin D during treatment

Avoid in patients with esophageal abnormalities or inability to sit upright

Side Effects
Common Side Effects:

Abdominal pain

Nausea

Heartburn

Headache

Diarrhea

Musculoskeletal pain

Serious Side Effects:

Esophageal ulceration or esophagitis (especially if instructions not followed)

Osteonecrosis of the jaw (ONJ) – rare, mostly in cancer patients on IV bisphosphonates

Atypical femur fractures (long-term use)

Hypocalcemia

Contraindicated in hypocalcemia, severe kidney impairment (CrCl <30 mL/min), and esophageal disorders

Avoid use if patient is unable to sit or stand upright for 30 minutes

Use with caution in patients with GERD or active upper GI disease

Stop use before dental surgery to reduce ONJ risk in high-risk patients

Long-term therapy (>5 years) should be re-evaluated periodically

Calcium, iron, magnesium, antacids: reduce absorption; avoid within 30–60 mins of dosing

NSAIDs: increase risk of GI irritation

H2 blockers/PPIs: may affect bone metabolism with long-term use

Aspirin: increased GI risk if taken together

Drug Classification
Therapeutic Class: Bone resorption inhibitor

Pharmacologic Class: Bisphosphonate

Pregnancy Category: C (not recommended unless benefit outweighs risk)

Legal Status: Prescription-only medicine (POM)

FAQs about Actonel
Q: How long does it take Actonel to work?
A: Improvements in bone density can be seen as early as 6 months, with significant fracture risk reduction by 1 year.

Q: Can I take Actonel with food?
A: No, it must be taken on an empty stomach with plain water, at least 30 minutes before eating.

Q: What if I miss a dose?
A: If weekly dose is missed, take it the next morning. If missed by more than 1 day, skip and resume next scheduled dose.

Q: How long should Actonel be taken?
A: Generally recommended for 3 to 5 years. Periodic reassessment is advised.

Q: Is it safe for long-term use?
A: Yes, though rare side effects such as femur fracture and ONJ are associated with long-term use. Regular monitoring is advised.

Q: Can men take Actonel?
A: Yes, it is approved for osteoporosis in men as well.
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