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Etidronate Disodium
Overview
What is Etidronate Disodium?
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).
What does Etidronate Disodium look like?
What are the available doses of Etidronate Disodium?
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What should I talk to my health care provider before I take Etidronate Disodium?
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How should I use Etidronate Disodium?
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 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:
What interacts with Etidronate Disodium?
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What are the warnings of Etidronate Disodium?
General
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 ). 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.
Paget’s Disease
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.
Heterotopic Ossification
No specific warnings.
What are the precautions of Etidronate Disodium?
General
Patients should maintain an adequate nutritional status, particularly an adequate intake of calcium and vitamin D.
Therapy has been withheld from some patients with enterocolitis since diarrhea may be experienced, particularly at higher doses.
Etidronate disodium is not metabolized and is excreted intact via the kidney. Hyperphosphatemia may occur at doses of 10 to 20 mg/kg/day, apparently as a result of drug-related increases in tubular reabsorption of phosphate. Serum phosphate levels generally return to normal 2 to 4 weeks post therapy. There is no experience to specifically guide treatment in patients with impaired renal function. Etidronate disodium dosage should be reduced when reductions in glomerular filtration rates are present. Patients with renal impairment should be closely monitored. In approximately 10% of patients in clinical trials of etidronate disodium I.V. infusion, for hypercalcemia of malignancy, occasional, mild-to-moderate abnormalities in renal function (increases of > 0.5 mg/dL serum creatinine) were observed during or immediately after treatment.
Etidronate disodium suppresses bone turnover, and may retard mineralization of osteoid laid down during the bone accretion process. These effects are dose and time dependent. Osteoid, which may accumulate noticeably at doses of 10 to 20 mg/kg/day, mineralizes normally post therapy. In patients with fractures, especially of long bones, it may be advisable to delay or interrupt treatment until callus is evident.
Osteonecrosis of the Jaw (ONJ)
ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including etidronate sodium. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.
For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.
Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.
Musculoskeletal Pain
In post-marketing experience, there have been infrequent reports of severe and occasionally incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates (see ). The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping medication. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
In Paget’s patients, treatment regimens exceeding the recommended (see ) daily maximum dose of 20 mg/kg or continuous administration of medication for periods greater than 6 months may be associated with osteomalacia and an increased risk of fracture.
Long bones predominantly affected by lytic lesions, particularly in those patients unresponsive to etidronate disodium therapy, may be especially prone to fracture.
Patients with predominantly lytic lesions should be monitored radiographically and biochemically to permit termination of etidronate disodium in those patients unresponsive to treatment.
Drug Interactions
There have been isolated reports of patients experiencing increases in their prothrombin times when etidronate was added to warfarin therapy. The majority of these reports concerned variable elevations in prothrombin times without clinically significant sequelae. Although the relevance of these reports and any mechanism of coagulation alterations is unclear, patients on warfarin should have their prothrombin time monitored.
Carcinogenesis
Long-term studies in rats have indicated that etidronate disodium is not carcinogenic.
Pregnancy
In teratology and developmental toxicity studies conducted in rats and rabbits treated with dosages of up to 100 mg/kg (5 to 20 times the clinical dose), no adverse or teratogenic effects have been observed in the offspring. Etidronate disodium has been shown to cause skeletal abnormalities in rats when given at oral dose levels of 300 mg/kg (15 to 60 times the human dose). Other effects on the offspring (including decreased live births) are at dosages that cause significant toxicity in the parent generation and are 25 to 200 times the human dose. The skeletal effects are thought to be the result of the pharmacological effects of the drug on bone.
Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over periods of weeks to years. The amount of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous vs. oral) on this risk has not been studied.
There are no adequate and well controlled studies in pregnant women. Etidronate disodium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when etidronate disodium is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Pediatric patients have been treated with etidronate disodium, at doses recommended for adults, to prevent heterotopic ossifications or soft tissue calcifications. A rachitic syndrome has been reported infrequently at doses of 10 mg/kg/day and more for prolonged periods approaching or exceeding a year. The epiphyseal radiologic changes associated with retarded mineralization of new osteoid and cartilage, and occasional symptoms reported, have been reversible when medication is discontinued.
Geriatric Use
Clinical studies of etidronate disodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. As stated in PRECAUTIONS, etidronate disodium dosage should be reduced when reductions in glomerular filtration rates are present. In addition, patients with renal impairment should be closely monitored.
What are the side effects of Etidronate Disodium?
The incidence of gastrointestinal complaints (diarrhea, nausea) is the same for etidronate disodium at 5 mg/kg/day as for placebo, about 1 patient in 15. At 10 to 20 mg/kg/day the incidence may increase to 2 or 3 in 10. These complaints are often alleviated by dividing the total daily dose.
Paget’s Disease
In Paget’s patients, increased or recurrent bone pain at pagetic sites, and/or the onset of pain at previously asymptomatic sites has been reported. At 5 mg/kg/day about 1 patient in 10 (vs. 1 in 15 in the placebo group) report these phenomena. At higher doses the incidence rises to about 2 in 10. When therapy continues, pain resolves in some patients but persists in others.
Heterotopic Ossification
No specific adverse reactions.
Worldwide Post-Marketing Experience
The worldwide post-marketing experience for etidronate disodium reflects its use in the following approved indications: Paget’s disease, heterotopic ossification, and hypercalcemia of malignancy. It also reflects the use of etidronate disodium for osteoporosis where approved in countries outside the US. Other adverse events that have been reported and were thought to be possibly related to etidronate disodium include the following: alopecia; arthropathies, including arthralgia and arthritis; bone fracture; esophagitis; glossitis; hypersensitivity reactions, including angioedema, follicular eruption, macular rash, maculopapular rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria; osteomalacia; neuropsychiatric events, including amnesia, confusion, depression, and hallucination; and paresthesias.
In patients receiving etidronate disodium, there have been rare reports of agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge. In addition, there have been rare reports of exacerbation of asthma. Exacerbation of existing peptic ulcer disease including perforation has been reported rarely.
In osteoporosis clinical trials, headache, gastritis, leg cramps, and arthralgia occurred at a significantly greater incidence in patients who received etidronate as compared with those who received placebo.
What should I look out for while using Etidronate Disodium?
What might happen if I take too much Etidronate Disodium?
Clinical experience with acute etidronate disodium overdosage is extremely limited. Decreases in serum calcium following substantial overdosage may be expected in some patients. Signs and symptoms of hypocalcemia also may occur in some of these patients. Some patients may develop vomiting. In one event, an 18 year old female who ingested an estimated single dose of 4000 mg to 6000 mg (67 to 100 mg/kg) of etidronate disodium was reported to be mildly hypocalcemic (7.52 mg/dL) and experienced paresthesia of the fingers. Hypocalcemia resolved 6 hours after lavage and treatment with intravenous calcium gluconate. A 92 year old female who accidentally received 1600 mg of etidronate disodium per day for 3.5 days experienced marked diarrhea and required treatment for electrolyte imbalance. Orally administered etidronate disodium may cause hematologic abnormalities in some patients (see ).
Etidronate disodium suppresses bone turnover and may retard mineralization of osteoid laid down during the bone accretion process. These effects are dose and time dependent. Osteoid which may accumulate noticeably at doses of 10 to 20 mg/kg/day of chronic, continuous dosing mineralizes normally post therapy.
Prolonged continuous treatment (chronic overdosage) has been reported to cause nephrotic syndrome and fracture.
Gastric lavage may remove unabsorbed drug. Standard procedures for treating hypocalcemia, including the administration of Ca intravenously, would be expected to restore physiologic amounts of ionized calcium and relieve signs and symptoms of hypocalcemia. Such treatment has been effective.
How should I store and handle Etidronate Disodium?
Voriconazole Tablets should be stored at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of etidronate disodium, USP.The 200 mg tablets are white, rectangular-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3286-91bottles of 60The 400 mg tablets are white, capsule-shaped tablets with on one side and on the other side. They are available as follows:NDC 0378-3288-91bottles of 60Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F or 40°C) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: 15 Garnet StreetCarole Park QLD 4300 AustraliaALP:ETDN:R8 Revised: 3/2017
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Paget’s disease of bone (osteitis deformans) is an idiopathic, progressive disease characterized by abnormal and accelerated bone metabolism in one or more bones. Signs and symptoms may include bone pain and/or deformity, neurologic disorders, elevated cardiac output and other vascular disorders, and increased serum alkaline phosphatase and/or urinary hydroxyproline levels. Bone fractures are common in patients with Paget’s disease.
Etidronate disodium slows accelerated bone turnover (resorption and accretion) in pagetic lesions and, to a lesser extent, in normal bone. This has been demonstrated histologically, scintigraphically, biochemically, and through calcium kinetic and balance studies. Reduced bone turnover is often accompanied by symptomatic improvement, including reduced bone pain. Also, the incidence of pagetic fractures may be reduced and elevated cardiac output and other vascular disorders may be improved by etidronate disodium therapy.
Non-Clinical Toxicology
There have been isolated reports of patients experiencing increases in their prothrombin times when etidronate was added to warfarin therapy. The majority of these reports concerned variable elevations in prothrombin times without clinically significant sequelae. Although the relevance of these reports and any mechanism of coagulation alterations is unclear, patients on warfarin should have their prothrombin time monitored.Patients should maintain an adequate nutritional status, particularly an adequate intake of calcium and vitamin D.
Therapy has been withheld from some patients with enterocolitis since diarrhea may be experienced, particularly at higher doses.
Etidronate disodium is not metabolized and is excreted intact via the kidney. Hyperphosphatemia may occur at doses of 10 to 20 mg/kg/day, apparently as a result of drug-related increases in tubular reabsorption of phosphate. Serum phosphate levels generally return to normal 2 to 4 weeks post therapy. There is no experience to specifically guide treatment in patients with impaired renal function. Etidronate disodium dosage should be reduced when reductions in glomerular filtration rates are present. Patients with renal impairment should be closely monitored. In approximately 10% of patients in clinical trials of etidronate disodium I.V. infusion, for hypercalcemia of malignancy, occasional, mild-to-moderate abnormalities in renal function (increases of > 0.5 mg/dL serum creatinine) were observed during or immediately after treatment.
Etidronate disodium suppresses bone turnover, and may retard mineralization of osteoid laid down during the bone accretion process. These effects are dose and time dependent. Osteoid, which may accumulate noticeably at doses of 10 to 20 mg/kg/day, mineralizes normally post therapy. In patients with fractures, especially of long bones, it may be advisable to delay or interrupt treatment until callus is evident.
The incidence of gastrointestinal complaints (diarrhea, nausea) is the same for etidronate disodium at 5 mg/kg/day as for placebo, about 1 patient in 15. At 10 to 20 mg/kg/day the incidence may increase to 2 or 3 in 10. These complaints are often alleviated by dividing the total daily dose.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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