Actonel (risedronate)

What is risedronate, and how does it work (mechanism of action)?

• Risedronate is in a class of drugs called bisphosphonates used for the treatment of Paget's disease of bone (in which the formation of bone is abnormal) and in persons with osteoporosis (in which the density and strength of bones are reduced). Other biphosphonates include the drugs alendronate (Fosamax), ibandronate (Boniva), pamidronate (Aredia), tiludronate (Skelid), and etidronate (Didronel). Bone is continually being formed and dissolved. New bone is laid down by cells called osteoblasts while old bone is removed by cells called osteoclasts. Bisphosphonates strengthen bone by inhibiting bone removal (resorption) by osteoclasts. By slowing down the rate at which bone is dissolved, risedronate increases the amount of bone. Risedronate is more potent in blocking the dissolution of bone than etidronate and alendronate.
• The FDA approved risedronate for the treatment of Paget's disease in 1998 and for the prevention and treatment of osteoporosis in 1999.

What brand names are available for risedronate?

Actonel, Actonel with Calcium, Atelvia

Is risedronate available as a generic drug?

GENERIC AVAILABLE: Yes

Do I need a prescription for risedronate?

Yes

What are the uses for risedronate?

• Risedronate is used for the treatment of Paget's disease of bone (osteitis deformans), treatment and prevention of postmenopausal osteoporosis in women, and treatment of osteoporosis in men.
• It also is used to prevent and treat osteoporosis caused by steroid medications (glucocorticoid-induced osteoporosis).

What are the side effects of risedronate?

The most common side effects of risedronate include:

• Headache
• Joint pain
• Diarrhea
• Abdominal pain
• Rash
• Indigestion
• Constipation
• High blood pressure
• Nausea

Other less common side effects include:

• Flulike syndrome
• Depression
• Chest pain
• Dizziness
• pharyngitis
• rhinitis

Possible serious side effects include:

• Diaphyseal femur
• Difficulty swallowing (dysphagia)
• Esophageal cancer
• Esophageal ulcer
• Femur fracture
• Stomach and duodenal ulcer
• Osteonecrosis

Severe irritation of the esophagus (for example, esophagitis, esophageal ulcers, esophageal erosions) can occur. This occurs more often when patients do not drink enough water with risedronate, or do not wait 30 minutes before lying down.
Rarely, patients may experience jaw problems (osteonecrosis of the jaw) associated with delayed healing and infection after tooth extraction.

What is the dosage for risedronate?

• For post menopausal osteoporosis, 5 mg of risedronate is taken once daily, 35 mg is taken weekly or 150 mg is taken monthly.
• For Osteoporosis in men is treated with 35 mg weekly.
• For Paget's disease is treated with 30 mg daily for two months, and steroid-induced osteoporosis is treated with 5 mg daily.
• Risedronate should be taken with 6 to 8 ounces of plain water.
• Because food interferes with the absorption of risedronate, it should be taken first thing in the morning before anything is eaten or liquids consumed.
• Also, no food or drink should be taken for at least 30 minutes after taking risedronate.
• To avoid pills sticking and irritating the throat or esophagus, persons should not lie down for at least 30 minutes after taking risedronate.
• Also, it should not be taken at the same time as iron supplements, vitamins with minerals, or antacids containing calcium, magnesium, or aluminum which reduce the absorption of risedronate.

Which drugs or supplements interact with risedronate?

• Food, calcium, antacids, and medications containing iron, magnesium, or aluminum reduce the absorption of risedronate, resulting in loss of effectiveness. Thus, it should be taken with plain water only. 

  Is risedronate safe to take if I'm pregnant or breastfeeding?

  
  

  • The safety and effectiveness of risedronate has not been established in pregnant women. Physicians must therefore weigh the potential benefits and unknown risks carefully.
  • The safety of risedronate for the infant has not been established in women who breastfeeding.
  
  

  What else should I know about risedronate?

  
  

  What preparations of risedronate are available?

  
  

  • Tablets: 5, 30, 35, and 150 mg.
  • Tablets (Delayed release): 35 mg

  
  

  How should I keep risedronate stored?

  Tablets should be stored at room temperature, 15 C - 30 C (59 F - 86 F).

  Summary

  
  Risedronate (Actonel, Actonel with Calcium, Atelvia) is a prescription medication used to treat postmenopausal osteoporosis, osteoporosis in men, and to prevent and treat osteoporosis caused by steroid medications. Common side effects include:
  
  • Constipation
  • Nausea
  • Joint pain
  • Headache
  • Indigestion
  • High blood pressure
  Drug interactions, dosage, warnings and precautions, and pregnancy and breastfeeding safety should be reviewed prior to taking this medication.