Monograph Details
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Urogenital System
> Benign prostatic hyperplasia/urinary retention
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AVODART |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Type I and II 5α-reductase inhibitor. |
| Generic Name |
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Dutasteride 0.5mg; caps. |
| Indications |
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BPH, as monotherapy to improve symptoms and reduce risks of acute urinary retention and need for prostate surgery; or in combination with tamsulosin. |
| Children |
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Not applicable. |
| Adults |
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Swallow whole. Monotherapy: 0.5mg once daily. Combination therapy: 0.5mg once daily with tamsulosin 0.4mg once daily. |
| Contraindications |
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Not for use in children or women. Pregnant women and those of childbearing potential should avoid handling capsules. |
| Precautions |
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Hepatic dysfunction. Monitor prostate specific antigen (PSA) values (establish new baseline PSA after 3–6 months of treatment); double PSA levels to compare with normal values. Exclude prostate cancer. Monitor for prostate cancer, obstructive uropathy. Avoid donating blood until at least six months after last dose. |
| Interactions |
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May be potentiated by CYP3A4/5 inhibitors (eg, ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, ciprofloxacin); caution. |
| Adverse Reactions |
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Impotence, decreased libido, ejaculation disorder, gynecomastia, dizziness (with tamsulosin). |
| How Supplied |
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Caps—30, 90 |
| Additional Resources |
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• Related Prescribing Note |
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