Dosing & Uses
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
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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)
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.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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