etidronate (Rx)

Brand and Other Names:Didronel
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
  • 400mg

Paget Disease

Initial 5-10 mg/kg PO qDay not to exceed 6 months OR 11-20 mg/kg PO qDay not to exceed 3 months  

Not to exceed 20 mg/kg/day

Retreatment should be initiated ONLY after at least 90 etidronate-free days AND evidence of active disease

Heterotopic Ossification

Total hip replacement

  • 20 mg/kg PO qDay 1 month pre- and 3 months post-surgery (4 months total)  

Spinal cord injury

  • 20 mg/kg PO qDay for 2 weeks, THEN 10 mg/kg qDay for10 weeks (12 weeks total)
  • Initiate treatment as soon as possible post-injury, preferably before diagnosis of heterotopic ossification

Renal Impairment

Safety and efficacy not established; administer a lower dose

Administration

Take 2 hours before food, milk, calcium-containing products, antacids, or multivalent metal ion-containing medication

Dose can be divided if gastric discomfort occurs

Other Indications & Uses

Off-label: prevention of PTH-induced bone resorption, myositis ossificans progressiva, calcinosis universalis

Safety and efficacy not established

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Interactions

Interaction Checker

and etidronate

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (1)

            • human parathyroid hormone, recombinant

              etidronate decreases effects of human parathyroid hormone, recombinant by Other (see comment). Contraindicated. Comment: Coadministration of bisphosphonates with rhPTH leads to reduction in rhPTH's calcium sparing effect, which can interfere with the normalization of serum calcium.

            Serious - Use Alternative (0)

              Monitor Closely (14)

              • aluminum hydroxide

                aluminum hydroxide decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • calcium acetate

                calcium acetate decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium carbonate

                calcium carbonate decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium chloride

                calcium chloride decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium citrate

                calcium citrate decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium gluconate

                calcium gluconate decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • deferasirox

                deferasirox, etidronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.

              • magnesium supplement

                magnesium supplement will decrease the level or effect of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Formation of a chelate reduces absorption of the drug through intestinal tract; administer magnesium 2hr before or 2hr after the bisphosphonate derivative

              • selenium

                selenium will decrease the level or effect of etidronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Avoid administering polyvalent cations 2 hr before or after etidronate.

              • sodium bicarbonate

                sodium bicarbonate decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • sodium citrate/citric acid

                sodium citrate/citric acid decreases levels of etidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • sodium sulfate/?magnesium sulfate/potassium chloride

                sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of etidronate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sodium sulfate/potassium sulfate/magnesium sulfate

                sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of etidronate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • voclosporin

                voclosporin, etidronate. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (3)

              • entecavir

                etidronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

              • foscarnet

                foscarnet increases effects of etidronate by pharmacodynamic synergism. Minor/Significance Unknown. Risk of severe hypocalcemia.

              • teriparatide

                teriparatide, etidronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.

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              Adverse Effects

              1-10%

              Convulsion

              Fever

              Hypocalcemia

              Hypomagnesemia

              Hypophosphatemia

              Bone pain

              Abnormal renal function

              Frequency Not Defined

              Amnesia

              Confusion

              Depression

              Hallucination

              Headache

              Paresthesias

              Alopecia

              Rash

              Altered taste

              Gastritis

              Glossitis

              Hypocalcemia

              Hypersensitivity reactions

              Arthropathy

              Fracture

              Leg cramps

              Nephrotoxicity

              Renal insufficiency

              Rare

              • Esophageal cancer
              • Peptic ulcer disease exacerbation
              • Agranulocytosis
              • Asthma exacerbation

              Post-Marketing Reports

              Skin: Alopecia

              Hypersensitivity reactions, including angioedema, follicular eruption, macular rash, maculopapular rash, pruritus, epidermal necrolysis, Stevens-Johnson syndrome, and urticaria

              Neuropsychiatric: Amnesia, confusion, depression, and hallucinations

              Neurology: Paresthesias

              Musculoskeletal: Arthropathies, including arthralgia and arthritis; bone fracture; osteomalacia

              Hematology: Rare reports of agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge

              Pulmonary: Exacerbation of asthma

              Gastrointestinal: Exacerbation of existing peptic ulcer disease including perforation; esophagitis, glossitis

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              Warnings

              Contraindications

              Osteomalacia

              Hypersensitivity

              Esophagus abnormalities (eg, stricture, achalasia) that delay esophageal emptying

              Cautions

              Enterocolitis, renal impairment

              May cause local irritation of upper GI mucosa

              Potentially causes severe esophagitis, esophageal ulcers and erosions

              Ensure adequate intake of calcium, vitamin D

              Osteonecrosis of the jaw, can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors 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; risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates

              Risk of severe bone, joint and/or muscle pain

              At higher doses both resorption inhibition and bone growth inhibition increases

              Esophageal cancer risk (July 21, 2011 FDA safety communication)

              • Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
              • Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates (eg, sit up or stand after administration, take with full glass of water)
              • An ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus is currently being conducted by the FDA
              • The FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer
              • There are insufficient data to recommend endoscopic screening of asymptomatic patients
              • FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available
              • Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (eg, swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)
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              Pregnancy & Lactation

              Pregnancy Category: C

              Lactation: excretion in milk unknown; use with caution

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Bisphosphonate binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption. Decreases mineral release and collagen or matrix breakdown in bone.

              Pharmacokinetics

              Half-Life elimination: 1-6 hr (PO)

              Onset: Within 1-3 months of treatment

              Duration: Effect can persist up to 12 months without continuous treatment

              Bioavailability: 3%

              Vd: 1.37 L/kg

              Metabolism: None

              Excretion: Primarily unchanged in urine, unabsorbed drug excreted in feces

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.