tiludronate (Discontinued)

Brand and Other Names:Skelid
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 200mg

Paget's Disease

400 mg PO qDay for 3 months

Renal Impairment

ClCr< 30 mL/min: Not recommended

Not removed by dialysis

Administration

Take with 6-8 oz plain water

2 hours before or after food

Other Indications & Uses

Off-label: Osteoporosis

Safety & efficacy not established

Paget's disease

400 mg PO qDay for 3 months

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Interactions

Interaction Checker

and tiludronate

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (15)

                • aluminum hydroxide

                  aluminum hydroxide decreases levels of tiludronate 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 tiludronate 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 tiludronate 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 tiludronate 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 tiludronate 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 tiludronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

                • deferasirox

                  deferasirox, tiludronate. 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 tiludronate 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 tiludronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Avoid administering polyvalent cations 2 hr before or after tiludronate.

                • sodium bicarbonate

                  sodium bicarbonate decreases levels of tiludronate 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 tiludronate 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 tiludronate 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 tiludronate 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.

                • trimagnesium citrate anhydrous

                  trimagnesium citrate anhydrous decreases levels of tiludronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                • voclosporin

                  voclosporin, tiludronate. 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 (6)

                • aspirin

                  aspirin decreases levels of tiludronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

                • aspirin rectal

                  aspirin rectal decreases levels of tiludronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

                • aspirin/citric acid/sodium bicarbonate

                  aspirin/citric acid/sodium bicarbonate decreases levels of tiludronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

                • foscarnet

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

                • indomethacin

                  indomethacin increases levels of tiludronate by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

                • teriparatide

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

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                Adverse Effects

                1-10%

                Dizziness (4%)

                Edema (2.7%)

                Insomnia

                Flushing

                Hypertension

                Chest pain

                Frequency Not Defined

                Back pain

                Musculoskeletal pain

                Diarrhea

                Dyspepsia

                Flushing

                Headache

                Nausea

                Rhinitis

                Sinusitis

                URI

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                Warnings

                Contraindications

                Hypersensitivity

                Inability to stand or sit upright for at least 30 minutes

                Abnormalities of the esophagus which delay emptying such as stricture or achalasia

                Hypocalcemia

                Cautions

                Risk of esophageal adverse effects, including esophagitis, esophageal ulceration/erosion, or esophageal bleeding with strictures or perforation

                Following therapy, allow 3 months interval to assess response

                Not recommended in severe renal failure (CrCl <30 mL/min)

                Take with plain water only-NOT coffee, juice or mineral water; sit or stand upright for at least 30 minutes after administration

                Risk of osteonecrosis of jaw

                Food reduces bioavailability

                Risk of severe bone, joint &/or muscle pain

                Avoid concurrent multivalent cation-containing medicines or food

                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: not known if crosses in to breast milk, use 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

                Bisphosphanate that inhibits bone resorption via actions on osteoclast activity, leading to an indirect increase in bone formation

                Pharmacokinetics

                Half-Life: 50 (single dosing) -150 hr (repeated dosing)

                Onset: 2 days -1 month

                Peak Effect: 3 month

                Duration: 3-6 months after completion (multiple doses)

                Peak plasma time: 2 hr

                Bioavailability: 6%; food reduces bioavailability by up to 90%

                Protein bound: 90%

                Metabolism: None

                Excretion: Urine

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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.