Avodart Generic Name & Formulations
Legal Class
Rx
General Description
Dutasteride 0.5mg; caps.
Pharmacological Class
Type I and II 5 alpha-reductase inhibitor.
How Supplied
Caps—30, 90
Manufacturer
Generic Availability
YES
Avodart Indications
Indications
BPH, as monotherapy to improve symptoms and reduce risks of acute urinary retention and need for prostate surgery; or in combination with tamsulosin. Limitation of use: not approved for preventing prostate cancer.
Avodart Dosage and Administration
Adult
Swallow whole. Monotherapy: 0.5mg once daily. Combination therapy: 0.5mg once daily with tamsulosin 0.4mg once daily.
Children
Not indicated.
Avodart Contraindications
Contraindications
Pregnant women.
Avodart Boxed Warnings
Not Applicable
Avodart Warnings/Precautions
Warnings/Precautions
Not for use in women. Increased risk of high-grade prostate cancer. Monitor prostate specific antigen (PSA) values (establish new baseline PSA after at least 3months of treatment); double PSA levels to compare with normal values. Rule out prostate cancer and other urological disorders prior to treatment. Hepatic dysfunction. Advise pregnant women to avoid handling caps; may cause potential risk to male fetus. Men should avoid donating blood until at least 6months after last dose.
Avodart Pharmacokinetics
See Literature
Avodart Interactions
Interactions
May be potentiated by CYP3A4/5 inhibitors (eg, ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, ciprofloxacin); caution.
Avodart Adverse Reactions
Adverse Reactions
Impotence, decreased libido, ejaculation disorder, gynecomastia, dizziness (with tamsulosin).
Avodart Clinical Trials
See Literature
Avodart Note
Not Applicable
Avodart Patient Counseling
See Literature