Etidronate Disodium
Loading...Etidronate Disodium Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Etidronate disodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when etidronate disodium is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue etidronate disodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6 to 8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION). In patients who cannot comply with dosing instructions due to mental disability, therapy with etidronate disodium should be used under appropriate supervision.
There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.
In Paget’s patients the response to therapy may be of slow onset and continue for months after etidronate disodium therapy is discontinued. Dosage should not be increased prematurely. A 90-day drug-free interval should be provided between courses of therapy.
No specific warnings.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Etidronate disodium tablets, USP are 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. Etidronate disodium tablets are not approved for the treatment of osteoporosis.
Etidronate disodium tablets are indicated for the treatment of symptomatic Paget’s disease of bone. Etidronate disodium therapy usually arrests or significantly impedes the disease process as evidenced by:
- •
- Symptomatic relief, including decreased pain and/or increased mobility (experienced by 3 out of 5 patients).
- •
- Reductions in serum alkaline phosphatase and urinary hydroxyproline levels (30% or more in 4 out of 5 patients).
- •
- Histomorphometry showing reduced numbers of osteoclasts and osteoblasts, and more lamellar bone formation.
- •
- Bone scans showing reduced radionuclide uptake at pagetic lesions.
In addition, reductions in pagetically elevated cardiac output and skin temperature have been observed in some patients.
In many patients, the disease process will be suppressed for a period of at least one year following cessation of therapy. The upper limit of this period has not been determined.
The effects of the etidronate disodium treatment in patients with asymptomatic Paget’s disease have not been studied. However, etidronate disodium treatment of such patients may be warranted if extensive involvement threatens irreversible neurologic damage, major joints, or major weight-bearing bones.
Etidronate disodium tablets are indicated in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury.
Etidronate disodium tablets reduce the incidence of clinically important heterotopic bone by about two-thirds. Among those patients who form heterotopic bone, etidronate disodium tablets retard the progression of immature lesions and reduces the severity by at least half. Follow-up data (at least 9 months post-therapy) suggests these benefits persist.
In total hip replacement patients, etidronate disodium tablets do not promote loosening of the prosthesis or impede trochanteric reattachment.
In spinal cord injury patients, etidronate disodium tablets do not inhibit fracture healing or stabilization of the spine.
History
There is currently no drug history available for this drug.
Other Information
Etidronate disodium tablets, USP contain either 200 mg or 400 mg of etidronate disodium, the disodium salt of (1-hydroxyethylidene) diphosphonic acid, for oral administration. This compound, also known as EHDP, regulates bone metabolism. Etidronate disodium, USP is a white powder, highly soluble in water, with a molecular weight of 250 and the following structural formula:
Inactive ingredients: Each tablet contains magnesium stearate, microcrystalline cellulose, pregelatinized starch and starch (corn).
Sources
Etidronate Disodium Manufacturers
-
Mylan Pharmaceuticals Inc.
![Etidronate Disodium Tablet [Mylan Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Etidronate Disodium | Mylan Pharmaceuticals Inc.
Etidronate disodium tablets should be taken as a single, oral dose. As with other bisphosphonates, it is recommended that etidronate disodium tablets 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 2 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 Regimens5 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.
Retreatment GuidelinesRetreatment should be initiated only after 1) an etidronate disodium-free period of at least 90 days and 2) there is biochemical, symptomatic or other evidence of active disease process. It is advisable to monitor patients every 3 to 6 months although some patients may go drug free for extended periods. Retreatment regimens are the same as for initial treatment. For most patients the original dose will be adequate for retreatment. If not, consideration should be given to increasing the dose within the recommended guidelines.
Heterotopic OssificationThe 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). Etidronate disodium therapy should begin as soon as medically feasible following the injury, preferably prior to evidence of heterotopic ossification.Retreatment has not been studied.
-
Carilion Materials Management
Etidronate Disodium | Carilion Materials Management
Etidronate disodium tablets should be taken as a single, oral dose. As with other bisphosphonates, it is recommended that etidronate disodium tablets 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 2 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 Regimens5 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.
Retreatment GuidelinesRetreatment should be initiated only after 1) an etidronate disodium-free period of at least 90 days and 2) there is biochemical, symptomatic or other evidence of active disease process. It is advisable to monitor patients every 3 to 6 months although some patients may go drug free for extended periods. Retreatment regimens are the same as for initial treatment. For most patients the original dose will be adequate for retreatment. If not, consideration should be given to increasing the dose within the recommended guidelines.
Heterotopic OssificationThe 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). Etidronate disodium therapy should begin as soon as medically feasible following the injury, preferably prior to evidence of heterotopic ossification.Retreatment has not been studied.
![Etidronate Disodium Tablet [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dcbd076e-3989-4cae-9466-54a0e9118128&name=68151-1521.jpg)
Login To Your Free Account