Dutasteride + Tamsulosin Brand Name in India
In India, the combination of Dutasteride 0.5 mg and Tamsulosin 0.4 mg is marketed under the brand name Avodart Plus. This fixed-dose combination (FDC) is based on the CombAT trial formulation that demonstrated superior efficacy compared to either medication alone for treating benign prostatic hyperplasia (BPH) 1.
Evidence Supporting the Combination
The combination of dutasteride and tamsulosin provides several clinical advantages:
Superior symptom improvement: The CombAT trial showed that the combination therapy significantly improved lower urinary tract symptoms (LUTS) compared to either dutasteride or tamsulosin monotherapy 1, 2.
Reduced disease progression: After 4 years of therapy, the combination significantly reduced the risk of acute urinary retention (AUR) by 68% and BPH-related surgery by 71% compared to tamsulosin alone 1, 2.
Comprehensive symptom control: The combination addresses both storage and voiding symptoms more effectively than either medication alone 3.
Mechanism of Action
This combination works through complementary mechanisms:
Tamsulosin: An α1-adrenoceptor antagonist that relaxes prostatic smooth muscles, providing rapid symptom relief 4.
Dutasteride: A 5α-reductase inhibitor that reduces prostate size over time by inhibiting the conversion of testosterone to dihydrotestosterone 4.
Clinical Considerations
When prescribing this combination:
Intended for long-term use: The combination therapy should be used only when intended for long-term treatment, as the full benefits of dutasteride may take 6-12 months to develop 1.
PSA monitoring: Dutasteride typically reduces PSA levels by approximately 50% within 6-12 months of initiating therapy. This effect must be considered when interpreting PSA results for prostate cancer screening 1.
Side effect profile: Common side effects include sexual dysfunction (reduced libido, erectile dysfunction, ejaculatory disorders), dizziness, and rhinitis 5. The combination has a higher rate of adverse events than either monotherapy alone 1.
Special precautions: Tamsulosin is associated with intraoperative floppy iris syndrome during cataract surgery, so ophthalmologists should be informed before such procedures 5.
Bioequivalence
The fixed-dose combination formulation has been shown to be bioequivalent to the coadministration of the individual components in pharmacokinetic studies 6, making it a convenient option for patients requiring both medications.
The combination of dutasteride and tamsulosin in a single capsule improves patient adherence while providing comprehensive management of BPH symptoms through both immediate relief (tamsulosin) and long-term prostate size reduction (dutasteride).