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tiludronate (Rx)Brand and Other Names:Skelid

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 200mg
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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

tiludronate 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%

            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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            Images

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            Formulary

            FormularyPatient Discounts

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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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