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finasteride (Rx)Brand and Other Names:Propecia, Proscar

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 1mg
  • 5mg
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Benign Prostatic Hyperplasia

Proscar: 5 mg PO qDay; assess response after 12 weeks to 6 months

Androgenic Alopecia (Men Only)

Propecia: 1 mg PO qDay for at least 3 months

Female Hirsutism (Off-label)

5 mg PO qDay

Dosing Modifications

Renal impairment: Dose adjustment not necessary

Hepatic impairment: Caution in liver dysfunction; monitor

Not indicated

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Interactions

Interaction Checker

finasteride 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%

            Erectile dysfunction (1.3-8.1%)

            Decrease libido (1.8-6.4%)

            Breast enlargement (0.5-1.8%)

            Ejaculation disorder (0.8-1.2%)

            <1%

            Breast tenderness (0.4-0.7%)

            Rash (0.5%)

            Postmarketing Reports

            Neoplasms: Male breast cancer

            Breast disorders: Breast tenderness and enlargement

            Nervous system/psychiatric: Depression

            Hypersensitivity reactions: Rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face)

            Reproductive system: Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain

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            Warnings

            Contraindications

            Hypersensitivity

            Women of childbearing potential

            Cautions

            Use with caution with obstructive uropathy; carefully monitor patients with large residual urinary volume or severely diminished urinary flow

            Use caution in liver disease

            May cause decreased serum PSA in presence of prostate cancer; increases in PSA levels from nadir while on finasteride may signal the presence of prostate cancer and should be carefully evaluated (even if PSA value within normal range)

            Pregnant and potentially pregnant women should not handle crushed or broken tablets or semen of male partner; may have negative impact in fetal development

            Rare reports of male breast cancer observed with use; any breast tenderness, enlargement, pain, lumps, nipple discharge or any other type of breast changes should be reported immediately to healthcare provider

            5-ARIs and prostate cancer risk

            • June 9, 2011: Recent data from 2 large, randomized, controlled trials observed a reduction in overall incidence of prostate cancer but 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 (BPH)
            • A minimum of 6 months may be necessary to assess response in BPH
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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 & type 2 isoforms of 5-alpha-reductase; suppresses serum dihydrotestosterone levels by inhibiting the conversion of testosterone to dihydrotestosterone

            Absorption

            Bioavailability: 65%

            Onset: 6 months (BPH); >3 months (hair loss)

            Peak plasma time: 2-6 hours

            Distribution

            Protein bound: 90%

            Vd: 76 L

            Metabolism

            Hepatic CYP3A4

            Metabolites: t-butyl side chain monohydroxylate, monocarboxylic acid metabolite (active)

            Elimination

            Half-life: 6 hours

            Excretion: Feces (57%); urine (39%)

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            Formulary

            FormularyPatient Discounts

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            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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