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Etidronate

Generic Name: Etidronate
Brand name: Didronel

Indications

Didronel is indicated for the treatment of symptomatic Paget's disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury.

Dosage and Administration

Didronel is available for oral administration as 200 mg, 400 mg tablets.
Normal dosage:
Didronel should be taken as a single, oral dose. However, should gastrointestinal discomfort occur, the dose may be divided. To maximize absorption, patients should avoid taking the following items within two hours of dosing:
--Food, especially food high in calcium, such as milk or milk products.
--Vitamins with mineral supplements or antacids which are high in metals such as calcium, iron, magnesium, or aluminum.
Paget's Disease: Initial Treatment Regimens: 5 to 10 mg/kg/day, not to exceed 6 months, or 11 to 20 mg/kg/day, not to exceed 3 months.
The recommended initial dose is 5 mg/kg/day for a period not to exceed 6 months. Doses above 10 mg/kg/day should be reserved for when 1) lower doses are ineffective or 2) there is an overriding need to suppress rapid bone turnover (especially when irreversible neurologic damage is possible) or reduce elevated cardiac output. Doses in excess of 20 mg/kg/day are not recommended.
Heterotopic Ossification: The following treatment regimens have been shown to be effective:
--Total Hip Replacement Patients: 20 mg/kg/day for 1 month before and 3 months after surgery (4 months total).
--Spinal Cord Injured Patients: 20 mg/kg/day for 2 weeks followed by 10 mg/kg/day for 10 weeks (12 weeks total). Didronel therapy should begin as soon as medically feasible following the injury, preferably prior to evidence of heterotopic ossification.
Overdose: Symptoms of an etidronate overdose may include muscle cramps, stiffness, or twitching, breathing problems, swelling in your hands or feet, and muscle movements in your face that you cannot control.

Drug Description

Didronel contain etidronate disodium, the disodium salt of (1-hydroxyethylidene) diphosphonic acid, for oral administration. This compound, also known as EHDP, regulates bone metabolism. It is a white powder, highly soluble in water, with a molecular weight of 250 and the following structural formula:


Didronel® (etidronate disodium) Structural Formula Illustration

Side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty in breathing; swelling of your face, lips, tongue, or throat.

Stop using etidronate and call your doctor at once if you have any of these serious side effects:

  • severe joint, bone, or muscle pain;
  • jaw pain, numbness, or swelling;
  • severe diarrhea;
  • bone fracture; or
  • a red, blistering, peeling skin rash.

Other, less serious side effects may be more likely to occur. Continue to take etidronate and talk to your doctor if you experience

  • mild diarrhea;
  • headache, confusion;
  • nausea; or
  • Numbness or tingly feeling.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or is especially bothersome.
Precautions

  • Avoid drinking milk or eating dairy products within 2 hours after taking etidronate. Also avoid taking supplements that contain calcium, magnesium, iron, or aluminum (such as in multivitamins with iron, and in many types of antacids).
  • Do not take etidronate if you have a condition called osteomalacia (softening of the bones).
  • Before taking etidronate, tell your doctor if you have:
    • diarrhea;
    • a bone fracture;
    • a stomach or esophageal ulcer or disease; or
    • Kidney disease.
  • Some people using medicines similar to etidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.
  • You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.
  • FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
  • It is not known whether etidronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Drug Interactions
Before taking etidronate, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin). You may not be able to use etidronate, or you may need dosage adjustments or special tests during treatment.
There may be other drugs that can affect etidronate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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