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Avodart (dutasteride)

THERAPEUTIC CLASS

Type I and II 5 alpha-reductase inhibitor (5-ARI) (2nd generation)

DEA CLASS

RX

INDICATIONS

Treatment of symptomatic BPH in men w/ an enlarged prostate, either as monotherapy or in combination w/ the α-adrenergic antagonist, tamsulosin.

ADULT DOSAGE

Benign Prostatic Hyperplasia

Monotherapy:
1 cap (0.5mg) qd

W/ Tamsulosin:
1 cap (0.5mg) qd and tamsulosin 0.4mg qd

ADMINISTRATION

Oral route

Swallow whole; do not chew or open
Take w/ or w/o food

HOW SUPPLIED

Cap: 0.5mg

CONTRAINDICATIONS

Pregnancy, women of childbearing potential, pediatric patients.

WARNINGS/PRECAUTIONS

Not approved for the prevention of prostate cancer. May decrease serum prostate specific antigen (PSA) concentration during therapy or in the presence of prostate cancer; establish a new baseline PSA at least 3 months after starting treatment and monitor PSA periodically thereafter. Any confirmed increase from the lowest PSA value while on treatment may signal presence of prostate cancer. May increase risk of high-grade prostate cancer. Prior to initiating treatment, consider other urological conditions that may cause similar symptoms; BPH and prostate cancer may coexist. Risk to male fetus; caps should not be handled by pregnant women or women who could become pregnant. Avoid donating blood until at least 6 months after last dose. Reduced total sperm count, semen volume, and sperm motility reported.

ADVERSE REACTIONS

Impotence, decreased libido, breast disorders, ejaculation disorders.

DRUG INTERACTIONS

Caution w/ potent, chronic CYP3A4 inhibitors (eg, ritonavir).

PREGNANCY AND LACTATION

Category X, not for use in nursing.

MECHANISM OF ACTION

Selective type I and II 5α-reductase inhibitor (2nd generation); inhibits conversion of testosterone to dihydrotestosterone, the androgen primarily responsible for initial development and subsequent enlargement of the prostate gland.

PHARMACOKINETICS

Absorption: Absolute bioavailability (60%); Tmax=2-3 hrs. Distribution: Vd=300-500L; plasma protein binding (99% albumin, 96.6% α-1 acid glycoprotein). Metabolism: Liver (extensive) via CYP3A4, 3A5; 4'-hydroxydutasteride, 1,2-dihydrodutasteride, 6-hydroxydutasteride (major metabolites). Elimination: Feces (5% unchanged, 40% metabolites), urine (<1% unchanged); T1/2=5 weeks.

ASSESSMENT

Assess for urological conditions that may cause similar symptoms, previous hypersensitivity to the drug, and for possible drug interactions.

MONITORING

Monitor for signs/symptoms of prostate cancer and other urological diseases. Obtain new PSA baseline at least 3 months after starting treatment and monitor PSA periodically thereafter.

PATIENT COUNSELING

Inform of the importance of periodic PSA monitoring. Advise that therapy may increase risk of high-grade prostate cancer. Counsel that drug should not be handled by women who are pregnant or who could become pregnant, due to potential fetal risks; advise to wash area immediately w/ soap and water if contact is made. Instruct not to donate blood until at least 6 months after last dose.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F).

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

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