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risedronate, Actonel

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GENERIC NAME: risedronate

BRAND NAME: Actonel

DRUG CLASS AND MECHANISM: Risedronate is in a class of drugs called bisphosphonates which also includes the drugs alendronate (Fosamax) and etidronate (Didronel). It is used for the treatment of Paget's disease of bone (a disease in which the formation of bone is abnormal) and in persons with osteoporosis (in which the density and strength of bones are reduced). Bone is continually being formed and dissolved. By slowing down the rate at which bone is dissolved, risedronate increases the amount of bone. Risedronate has a chemically unique component as compared with the other bisphosphonates which is believed to reduce the likelihood of gastro-intestinal side effects. Risedronate is more potent in blocking the dissolution of bone than etidronate and alendronate. The FDA approved risedronate for treatment of Paget's disease in 1998 and for the prevention and treatment of osteoporosis in 1999.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Tablets of 5, 30, and 35 mg.

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

PRESCRIBED FOR: Risedronate is used for the treatment of Paget's disease of bone (osteitis deformans) and to treat or prevent osteoporosis. It is also used to prevent and treat osteoporosis that is caused by cortisone-related medications (glucocorticoid-induced osteoporosis).

DOSING: For osteoporosis, 5 mg of risedronate is taken once daily or 35 mg is taken weekly with 6 to 8 ounces of plain water. For Paget's disease, initial treatment is 30 mg daily for two months. Because food interferes with the absorption of risedronate, it should be taken first thing in the morning before anything is eaten or drunk. Also, no food or drink should be taken for at least 30 minutes afterwards. To avoid pills sticking and irritating the throat or esophagus, persons should not lie down for at least 30 minutes after taking risedronate. It should also not be taken at the same time as iron supplements, vitamins with minerals, or antacids containing calcium, magnesium, or aluminum.

DRUG INTERACTIONS: Food, calcium and other minerals reduces the absorption of risedronate, resulting in loss of effectiveness. Thus, it should be taken with plain water only.

PREGNANCY: The safety and effectiveness of risedronate has not been established in pregnant women. Physicians must therefore weigh the potential benefits and unknown risks carefully.

NURSING MOTHERS: The safety and effectiveness of risedronate has not been established in women who are nursing.

SIDE EFFECTS: Risedronate generally is well-tolerated. The most common side effects are headache (1 in 5 persons), joint pain (1 in 3), diarrhea (1 in 5), abdominal pain (1 in 9), rash (1 in 9), and nausea (1 in 10). A related drug, alendronate, can irritate the esophagus and cause heartburn in patients when it sticks in the esophagus.

Reference: FDA Prescribing Information

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