Tamsulosin

ATC code

G04CA02

Therapeutic class

Drug for benign prostatic hypertrophy · Alpha-adrenergic receptor antagonist

Forms

extended-release oral tablet

Brand names

Omnic Ocas (ES) · Flomax (US) · Josir (FR) · Mecir (FR)

Overall confidence

medium

Regulatory sources consulted

Treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Facilitation of distal ureteral stone expulsion. · off-label

Major warning · Orthostatic hypotension: May cause a reduction in blood pressure which, rarely, can result in syncope. Patients should be cautioned to sit or lie down at the first signs. — AEMPS CIMA
Major warning · Intraoperative Floppy Iris Syndrome (IFIS): Has been observed during cataract and glaucoma surgery in patients on or previously treated with tamsulosin. Discontinuation of treatment 1-2 weeks prior to surgery may be helpful, but the benefit has not been established. — AEMPS CIMA

HighKetoconazoleJ02AB02
Mechanism: Strong inhibition of CYP3A4, increasing tamsulosin Cmax and AUC by a factor of 2.2 and 2.8, respectively.
Recommendation: Caution should be exercised when tamsulosin is co-administered with strong inhibitors of CYP3A4. In CYP2D6 poor metabolizers, this combination should be avoided.
AEMPS CIMA FT 66678
ModerateParoxetineN06AB05
Mechanism: Strong inhibition of CYP2D6, increasing tamsulosin Cmax and AUC by a factor of 1.3 and 1.6, respectively.
Recommendation: No dose adjustment is required, but caution and monitoring are recommended, especially when initiating the combination.
AEMPS CIMA FT 66678

dizziness · ejaculation disorders · retrograde ejaculation · ejaculation failure

syncope · angioedema · priapism · Stevens-Johnson syndrome

FDA category: Not Applicable

Tamsulosin is not indicated for use in women.