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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| etidronate disodium oral - | 200 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
etidronate disodium oral
ETIDRONATE DISODIUM - ORAL
(eh-TIDD-row-nate dye-SO-dee-um)
COMMON BRAND NAME(S): Didronel
USES: Etidronate is used to treat a certain type of bone disease called Paget's disease. This disease weakens and deforms bones. Etidronate works by slowing bone loss, helping to keep your bones strong and less likely to break. It also helps reduce bone pain from this disease. This medication belongs to a class of drugs called bisphosphonates.Etidronate is also used to prevent or treat bone problems that may occur after hip replacement surgery or spinal cord injury.
HOW TO USE: Follow these instructions very closely to make sure you absorb as much of the drug as possible and reduce the risk of injury to your esophagus. Consult your doctor or pharmacist if you have any questions.Take this medication by mouth without food, usually once a day or as directed by your doctor. Take it on an empty stomach at least 2 hours before or 2 hours after a meal.Take etidronate with a full glass of plain water (6 to 8 ounces, 180 to 240 milliliters). Do not take it with any other beverage. After taking etidronate, stay fully upright (sitting, standing, or walking) and do not lie down for at least 30 minutes.Do not take etidronate at the same time as food or other medications because they may prevent its absorption. Take this medication 2 hours before or 2 hours after taking any products that contain aluminum, calcium, iron, magnesium, or zinc. Some examples include antacids, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), quinapril, vitamins/minerals, dairy products (such as milk, yogurt), and calcium-enriched juice.The dosage is based on your medical condition, weight, and response to treatment. If stomach upset occurs, talk to your doctor about dividing your daily dose into 2 or 3 smaller doses during the day instead of taking one daily dose all at once.For Paget's disease and bone problems after hip replacement or spinal cord injury, you will usually take this medication for 3 to 6 months. Do not take more of this medication or use it for longer than prescribed because the risk of side effects may increase.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
SIDE EFFECTS: Stomach upset or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: new or worsening bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, mental/mood changes, signs of infection (such as fever, persistent sore throat).This medication may rarely cause irritation and ulcers in your stomach or esophagus. Seek immediate medical attention if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult/painful swallowing, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking etidronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain bone disorder that causes soft/painful bones (osteomalacia).Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, inability to sit upright or stand for at least 30 minutes, difficult/painful swallowing, esophagus problems (such as esophageal stricture, achalasia), stomach/intestinal problems (such as heartburn, ulcers, colitis), low level of calcium in the blood.Some people taking etidronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking etidronate before your surgery. Ask for specific instructions about stopping or starting this medication.Caution is advised if you are pregnant or planning to become pregnant in the future. This medication may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with this medication.It is not known if this medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also the How to Use section.Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This medication may affect the results of certain lab tests (bone imaging tests). Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: muscle spasms, mental/mood changes.
NOTES: Do not share this medication with others.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.Laboratory and/or medical tests (such as X-rays, calcium and other blood mineral levels, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember, following the dose-timing instructions in the How to Use section. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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