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etidronate (Rx)Brand and Other Names:Didronel

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
  • 400mg
more...

Paget's 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

etidronate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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