etidronate

Generic Name: etidronate (e ti DROE nate)
Brand names: Didronel, Didronel I.V.

What is etidronate?

Etidronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body.

Etidronate is used to treat Paget's disease, and to treat conditions of irregular bone growth due to hip fracture or spinal cord injury.

Etidronate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about etidronate?

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

Especially 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).

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 pre-existing dental problems.

What should I discuss with my healthcare provider before taking etidronate?

Do not take etidronate if you have a condition called osteomalacia (softening of the bones).

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. 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. It is not known whether etidronate is harmful to an unborn baby. Before taking this medication, 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.

How should I take etidronate?

Take etidronate exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not crush, chew, or suck the pill. Swallow it whole. Take each etidronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an etidronate tablet. For at least the first 2 hours after taking etidronate, 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 etidronate regularly to get the most benefit.

Paget's disease is usually treated for 30 to 60 days with etidronate. After you stop taking etidronate, you must stay off the medication for at least 90 days before starting etidronate therapy again.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Etidronate 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.

Store etidronate at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms 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.

What should I avoid while taking etidronate?

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).

Etidronate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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.

Less serious side effects may include:

• mild diarrhea;

• headache, confusion;

• nausea; 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. You may report side effects to FDA at 1-800-FDA-1088.

Etidronate Dosing Information

Usual Adult Dose for Hypercalcemia of Malignancy:

Intravenous: 7.5 mg/kg (ideal body weight) intravenously by slow infusion over at least 2 hours once a day for 3 days (round dose to nearest 25 mg). Some patients have been treated for up to 7 days. To prolong the reduction in serum calcium, oral etidronate may be started on the day following the last intravenous dose. If significant hypercalcemia recurs, a second intravenous course for 3 days may be instituted. A minimum of 7 days should elapse between doses.

-or-

Oral: 20 mg/kg (ideal body weight) orally once a day, 2 hours before or after meals for 30 days (round dose to nearest 200 mg). Therapy should be continued for 30 days. If the patient remains normocalcemic, treatment may be extended up to 90 days.

Food, milk products, vitamins, minerals, and antacids should not be administered within two hours of a dose of etidronate.

-or-

30 mg/kg (ideal body weight, rounded to nearest 50 mg) by continuous intravenous infusion over 24 hours may be administered. This dosage appears to safe and effective and may be more convenient than standard therapy. However, this dosage of etidronate is not approved for the treatment of hypercalcemia of malignancy.

Usual Adult Dose for Paget's Disease:

5 to 10 mg/kg (ideal body weight) orally once a day, 2 hours before or after meals for up to 6 months (round dose to nearest 200 mg). Therapy at this dosage range should not exceed 6 months.

-or-

10 to 20 mg/kg (ideal body weight) orally (round dose to nearest 200 mg) once a day for up to 3 months if the patient has failed to respond to lower doses or requires suppression of rapid bone turnover.

Food, milk products, vitamins, minerals, and antacids should not be administered within two hours of a dose of etidronate.

Usual Adult Dose for Osteoporosis:

400 mg orally once a day, 2 hours before or after meals for 14 days. Therapy is cyclical. Etidronate should be administered for the first 14 days of every 12 week cycle. Food, milk products, vitamins, minerals, and antacids should not be administered within two hours of a dose of etidronate.

Usual Adult Dose for Heterotopic Ossification -- Spinal Cord Injury:

20 mg/kg (ideal body weight) orally once a day, 2 hours before or after meals for 2 weeks (round dose to nearest 200 mg). This should be followed by 10 mg/kg/day (ideal body weight) orally for an additional 10 weeks (round dose to nearest 200 mg). Food, milk products, vitamins, minerals, and antacids should not be administered within two hours of a dose of etidronate.

Usual Adult Dose for Heterotopic Ossification -- Total Hip Arthroplasty:

20 mg/kg (ideal body weight) orally once a day, 2 hours before or after meals (round dose to nearest 200 mg) beginning 1 month prior to surgery and continuing for 3 months after surgery. Food, milk products, vitamins, minerals, and antacids should not be administered within two hours of a dose of etidronate.

Usual Pediatric Dose for Heterotopic Ossification -- Spinal Cord Injury:

> 1 year:

20 mg/kg (ideal body weight) orally once a day, 2 hours before or after meals for 2 weeks (round dose to nearest 200 mg). This should be followed by 10 mg/kg/day (ideal body weight) orally for an additional 10 weeks (round dose to nearest 200 mg). Food, milk products, vitamins, minerals, and antacids should not be administered within two hours of a dose of etidronate.

What other drugs will affect etidronate?

Before taking etidronate, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin).

This list is not complete and there may be other drugs that can interact with 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.

Where can I get more information?

• Your pharmacist can provide more information about etidronate.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 04/01/2009 11:26:11 AM.