dutasteride (Rx)

Brand and Other Names:Avodart
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 0.5mg
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Benign Prostatic Hyperplasia

0.5 mg PO qDay

Dosing Modifications

Renal impairment: Dose adjustment not necessary

Hepatic impairment: Dose adjustment not necessary

Safety and efficacy not established

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Interactions

Interaction Checker

and dutasteride

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Adverse reactions decrease with duration of treatment, except for gynecomastia

            1-10%

            Impotence

            Decreased libido

            Ejaculation disorder

            Breast disorders

            <1%

            Dizziness

            Frequency Not Defined

            Cardiac failure

            Prostate cancer (high grade)

            Postmarketing Reports

            Immune system disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema

            Neoplasms: Male breast cancer

            Psychiatric disorders: Depressed mood

            Reproductive system and breast disorders: Testicular pain and testicular swelling

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            Warnings

            Contraindications

            Hypersensitivity

            Women

            Children

            Cautions

            Prior to initiating treatment, rule out other urologic conditions

            Pregnant women should avoid handling capsules due to risk of absorption through skin

            Obstructive uropathy, liver disease

            Patient should not donate blood until 6 months after last dose of dutasteride

            Dutasteride lowers serum PSA 40-50%; establish new baseline PSA after 3-6 months of treatment

            Monitor for cardiac changes or cardiac failure

            5-ARIs and prostate cancer risk

            • June 9, 2011: Recent data from 2 large, randomized, controlled trials observed an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer) in trial participants taking 5-alpha reductase inhibitors (5-ARIs)
            • The 2 trials are the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial
            • The revised prescribing information recommends that prior to initiating therapy with 5-ARIs, appropriate evaluation should be performed to rule out other urologic conditions, including prostate cancer, that might mimic benign prostatic hyperplasia
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            Pregnancy & Lactation

            Pregnancy category: X

            Lactation: Excretion in milk unknown/contraindicated

            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

            Selective inhibitor of type 1 and type 2 isoforms of 5-alpha-reductase; suppresses serum dihydrotestosterone levels by inhibiting the conversion of testosterone to dihydrotestosterone

            Absorption

            Bioavailability: 60%

            Onset: 1-2 weeks

            Peak plasma time: 2-3 hours

            Distribution

            Protein bound: 99%

            Vd: 300-500 L

            Metabolism

            Hepatic P450 enzyme CYP3A4 & CYP3A5

            Metabolites, major: 4'-hydroxydutasteride, 6-hydroxydutasteride (as active as parent), 1,2'-dihydrodutasteride

            Elimination

            Half-life: 5 weeks (at steady state)

            Excretion: Feces (40%), urine (<1%)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • 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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