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Actonel (risedronate sodium)

Indications

• Actonel is used to treat and prevent osteoporosis in postmenopausal women by increasing bone density.
• It is prescribed to treat osteoporosis in men to reduce the risk of fractures.
• Actonel helps treat and prevent glucocorticoid-induced osteoporosis in individuals taking corticosteroid medications.
• It is used to treat Paget’s disease of bone, a condition that causes abnormal bone destruction and regrowth.

Dosage and Administration

• Take Actonel exactly as prescribed by your doctor, typically once daily, once weekly, or once monthly, depending on your specific condition.
• Take Actonel first thing in the morning, at least 30 minutes before eating, drinking, or taking any other medications.
• Swallow the tablet whole with a full glass of plain water (6-8 ounces) while sitting or standing upright.
• Remain upright for at least 30 minutes after taking Actonel to prevent irritation to your esophagus.
• Ensure you get adequate calcium and vitamin D intake while taking Actonel, as directed by your doctor.
• Do not lie down for at least 30 minutes after taking Actonel, as this can increase the risk of esophageal irritation.
• Avoid taking Actonel with mineral water, coffee, tea, juice, or any other beverage besides plain water, as they can reduce its effectiveness.
• Do not crush, chew, or suck on the tablet, as this can cause mouth or throat irritation.
• Avoid taking Actonel at bedtime or before rising for the day.
• Do not take more than the prescribed dose, as this can increase the risk of severe side effects.

Mechanism of Action

Actonel works by inhibiting osteoclast-mediated bone resorption. Osteoclasts are cells responsible for breaking down bone tissue. By inhibiting these cells, Actonel helps maintain or increase bone density, making bones stronger and less likely to fracture. This is particularly beneficial for individuals with osteoporosis or Paget’s disease.

Contraindications

• Do not take Actonel if you have esophageal abnormalities that delay esophageal emptying, such as stricture or achalasia.
• Avoid Actonel if you are unable to sit or stand upright for at least 30 minutes.
• Do not use Actonel if you have hypocalcemia (low blood calcium levels).
• Avoid taking Actonel if you have severe kidney disease or impaired kidney function.
• Do not take Actonel if you are allergic to risedronate sodium or any of its ingredients.

Side Effects

Common Side Effects

• Stomach pain
• Heartburn
• Diarrhea
• Joint pain
• Headache

Serious Side Effects

• Esophageal ulcers or erosion
• Severe bone, joint, or muscle pain
• Jaw problems (osteonecrosis)
• Unusual thigh bone fractures
• Allergic reactions, including rash, itching, swelling, and difficulty breathing

Precautions

• Inform your doctor about all other medications you are taking, including over-the-counter drugs and supplements.
• Report any severe or persistent stomach or esophageal pain to your doctor immediately.
• Have regular dental check-ups and maintain good oral hygiene while taking Actonel.
• Discuss the risks and benefits of Actonel with your doctor if you have a history of gastrointestinal problems or esophageal disorders.
• Ensure you get adequate calcium and vitamin D intake, as Actonel alone is not enough to treat osteoporosis.
• Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding, as Actonel is not recommended for use in these conditions.

Storage Instructions

• Store Actonel at room temperature, between 20°C to 25°C (68°F to 77°F).
• Keep the tablets in a dry place and in their original container, tightly closed.
• Store Actonel out of reach of children and pets.
• Do not store Actonel in extreme heat or cold.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf