etidronate, Didronel

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GENERIC NAME: etidronate

BRAND NAME: Didronel

DRUG CLASS AND MECHANISM: Etidronate is in a class of drugs called bisphosphonates that is used for treating osteoporosis (reduced density of bone that leads to fractures) and bone pain from diseases such as metastatic breast cancer, multiple myeloma, and Paget's disease. The bisphosphonate class includes alendronate (Fosamax), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), and tiludronate (Skelid). Bone is in a constant state of remodeling; 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 by osteoclasts. After menopause, there is an increased rate of bone loss leading to osteoporosis, and etidronate has been shown to increase bone density and decrease fractures of bones. The FDA approved etidronate in September 1977.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets: 200 and 400 mg.

STORAGE: Etidronate should be stored at room temperature, 15 C to 30 C (59 F to 86 F).

PRESCRIBED FOR: Etidronate is used for treating Paget's disease and preventing heterotopic ossification. Heterotopic ossification is a process in which bone is deposited in soft tissues and muscles, usually after hip replacement or spinal cord surgery. Non-FDA approved (off-label) uses include hypercalcemia (increased blood levels of calcium) associated with cancer, prevention of steroid induced osteoporosis, and postmenopausal osteoporosis.

DOSING: The recommended dose for treating adults with Paget's disease is 5-10 mg/kg daily for up to 6 months or 11 to 20/mg/kg daily for up to 3 months. The maximum dose is 20 mg/kg daily.

The dose for preventing heterotopic ossification after hip replacement is 20 mg/kg daily one month before and for 3 months after surgery.

For prevention of heterotopic ossification after spinal cord injury the dose is 20 mg/kg daily for 2 weeks then 10 mg/kg daily for 10 weeks.

Food (especially, calcium rich foods such as dairy products), antacids, vitamins with mineral supplements, and certain medications can interfere with the absorption of etidronate. Therefore, etidronate should be taken on an empty stomach 2 hours before or after eating or taking other medications.

DRUG INTERACTIONS: Calcium replacement products (for example, calcium chloride, calcium gluconate, and calcium carbonate [Caltrate 600, Caltrate 600 Plus D, Clatrate 600 Plus]) and antacids (for example, aluminum hydroxide) reduce the absorption and effects of etidronate.

PREGNANCY: The safety and effectiveness of etidronate has not been established in pregnant women.

NURSING MOTHERS: The safety and effectiveness of etidronate has not been established in nursing mothers.

SIDE EFFECTS: Common side effects of etidronate include headache, nausea, diarrhea, rash, hair loss, low calcium, low magnesium, low phosphate, reduced kidney function, leg cramps, and bone and joint pain. Etidronate may worsen existing stomach or intestinal ulcers and can cause esophageal ulcers. Rarely, patients may experience jaw problems (osteonecrosis of the jaw) associated with delayed healing and infection after tooth extraction. Severe skin reactions, seizures, as well as decreased red and white blood cell levels occur rarely.

Reference: FDA Prescribing Information


Medically Reviewed by a Doctor on 8/17/2012



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