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Didronel

Active Ingredient: Etidronate

Didronel is used to treat Paget's disease, and to treat conditions of irregular bone growth due to hip fracture or spinal cord injury. It alters the cycle of bone formation and breakdown in the body.

Didronel as known as: Acide étidronique, Acido etidronico, Acidum etidronicum, Anfozan, Co etidrocal, Co etidronate, Didronat, Didronate, Difosfen, Diphos, Dronate-os, Etidrate, Etidron, Etidronat jenapharm, Etidronate disodium, Etiplus, Feminoflex, Maxibral, Oflocin, Osfo, Ostedron, Osteodidronel, Osteodrug, Osteoton, Osteum, Ostogene, Ostopor, Somaflex, Sviroxit, Tilferan

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INDICATIONS

Didronel (etidronate disodium) 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. Didronel is not approved for the treatment of osteoporosis.

INSTRUCTIONS

Take Didronel exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not crush, chew, or suck the pill. Swallow it whole. Take each Didronel tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an Didronel tablet. For at least the first 2 hours after taking Didronel, do not eat or drink anything other than plain water, and do not take any other medicines including vitamins or mineral supplements.

It is important to take Didronel regularly to get the most benefit.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Didronel. You may need to stop using the medicine for a short time.

After you stop taking Didronel, you must stay off the medication for at least 90 days before starting Didronel therapy again.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Didronel is only part of a complete program of treatment that may also include taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

If you missed a dose - take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Didronel (etidronate disodium) should be taken as a single, oral dose. As with other bisphosphonates, it is recommended that Didronel (etidronate disodium) should be swallowed with a full glass of water (6 to 8 oz). Patients should not lie down after taking the medication. 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.

STORAGE

Store at 25°C (77°F); excursions permitted to 15-30°C, sealed container, avoid moisture.

 

Do not take Didronel if you have a condition called osteomalacia (softening of the bones), or a problem with the movement of muscles in your esophagus.

If you have any of these other conditions, you may need a dose adjustment or special tests:

diarrhea;
a bone fracture;
trouble swallowing;
a stomach or esophageal ulcer or disease; or
kidney disease.

Some people using medicines similar to Didronel 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.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether Didronel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether etidronate passes into breast milk or if it could harm a nursing baby. Do not use Didronel without telling your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction to Didronel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Didronel and call your doctor at once if you have any of these serious side effects:

  • painful or difficult swallowing;
  • severe heartburn, burning pain in your upper stomach, or coughing up blood;
  • severe joint, bone, or muscle pain;
  • jaw pain, numbness, or swelling;
  • severe diarrhea;
  • bone fracture;
  • or a red, blistering, peeling skin rash.

Less serious side Didronel effects may include:

  • mild diarrhea;
  • headache, confusion;
  • muscle cramps, joint pain; or
  • numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

 

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