AVODART® (dutasteride)

Abridged Prescribing Information

(Please refer to the full Summary of Product Characteristics before prescribing.)

Avodart Soft Capsules (dutasteride 0.5mg)

Uses Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.

Dosage and administration Adults (including elderly): One capsule (0.5mg) taken orally once a day. Capsules should be swallowed whole and may be taken with or without food. Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly.

Contra-indications Use in women, children and adolescents. Known hypersensitivity to dutasteride, other 5-alpha reductase inhibitiors, or any component of the preparation. Patients with severe hepatic impairment.

Special Warnings and Precautions Evaluations for prostate cancer, including DRE, must be performed on patients with BPH prior to initiating Avodart therapy and periodically thereafter. Women, children and adolescents must avoid contact with leaking capsules.  If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.  Use dutasteride with caution in patients with mild to moderate hepatic impairment. Avodart decreases levels of serum prostate-specific antigen (PSA) by approximately 50% after 6 months in patients with BPH, even in the presence of prostate cancer.  Therefore in patients treated with Avodart for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.  The ratio of free to total PSA remains constant even under the influence of Avodart. No adjustment to its value appears necessary when using free to total PSA ratio.

Interactions In vitro studies indicate that dutasteride is mainly eliminated via metabolism by CYP3A4 and CYP3A5. Long-term combination of dutasteride with potent inhibitors of CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of dutasteride. Dutasteride has no effect on the pharmacokinetics of warfarin, digoxin, tamsulosin or terazosin.

Pregnancy and lactation Avodart is contraindicated in women. Small amounts of dutasteride have been found in semen of subjects receiving dutasteride 0.5mg. As with all 5 alpha reductase inhibitors, a condom is recommended for use in patients when their partner is or may potentially become pregnant to avoid exposure to semen.

Side effects The following adverse reactions were reported with a higher incidence than the placebo groups during clinical trials. Impotence altered (decreased) libido, ejaculation disorders, gynaecomastia (including breast enlargement and/or breast tenderness).

Presentation and Basic NHS cost Avodart soft capsules 0.5mg: £24.81 per 30 capsule pack

Product licence number19494/0006

Product licence holder GlaxoSmithKline UK Ltd, Stockley Park West, Middlesex, UB11 1BT

Prescribing Information Approved December 2004

ADT/EBN/05/17364/1