tamsulosin (Hanmi Tams / tamsulosin, Hanmi / HIP 1402)

The silent signal is tadalafil counterbalancing tamsulosin induced ejaculatory dysfunction.

Zhang Tao T, Yu Maobin M

Tamsulosin versus tamsulosin plus tolterodine for the treatment of distal ureteral stones.

Mohseni-Rad Hamed H, Imani Geshlaghchayi Houshyar H, Iranpour Sohrab S

This study aimed to compare the efficacy of tamsulosin monotherapy versus tamsulosin combined with tolterodine for facilitating the expulsion of distal ureteral stones. A prospective, randomized controlled trial was conducted between 2022 and 2023 at the Urology Clinic of Imam Reza Hospital, Ardabil. A total of 120 patients diagnosed with distal ureteral stones (4-10 mm in size) were randomized into two groups: Group A received 0.4 mg tamsulosin daily, and Group B received 0.4 mg tamsulosin daily plus 2 mg tolterodine twice daily. Treatment duration was up to 4 weeks. Primary outcomes included stone expulsion rate and expulsion time. Secondary outcomes comprised pain control (visual analog scale, VAS), analgesic requirement, and incidence of side effects. The two groups were comparable at baseline in terms of demographic and stone characteristics. The stone expulsion rate was significantly higher in Group B (tamsulosin + tolterodine) at 83.3% (50/60) compared to Group A (tamsulosin alone) at 66.7% (40/60) (p = 0.03). The mean stone expulsion time was also significantly shorter in Group B (10.5 ± 3.2 days) compared to Group A (14.8 ± 4.1 days) (p < 0.001). Patients in Group B reported lower mean pain scores (VAS) and required less rescue analgesia. The incidence of adverse effects was comparable between the groups, with dry mouth being slightly more common in Group B. The combination of tamsulosin and tolterodine demonstrated superior efficacy in terms of stone expulsion rate and reduced expulsion time for distal ureteral stones compared to tamsulosin monotherapy. This combination therapy may offer a more effective medical expulsive therapy option for patients with distal ureteral calculi.

Lurasidone-Associated Urinary Retention in a Patient With Bipolar Affective Disorder: A Case Report.

Ridge Andrew A, Williams Kyle K, Seidel Bastian B

Atypical antipsychotics, including lurasidone, are increasingly prescribed due to their perceived lower risk of side effects. We present the case of a 65-year-old woman with longstanding BPAD who developed symptoms of urinary retention (UR), confirmed on bladder ultrasound, soon after beginning lurasidone monotherapy for bipolar affective disorder (BPAD) management. Despite dose reduction and addition of tamsulosin, symptoms of UR persisted and only resolved with cessation of lurasidone. The causal relationship between lurasidone and UR was assessed using the Naranjo Adverse Drug Reaction (ADR) Probability Scale, yielding a score of 8, indicating a highly 'probable' ADR. A literature review revealed only two prior reports of lurasidone-associated UR, highlighting the rarity of this presentation. This case underscores the need for clinicians to remain vigilant for UR in patients prescribed lurasidone, or other atypical antipsychotics, despite their generally favourable side effect profile. Early recognition and management are critical to prevent complications and ensure appropriate ongoing treatment of BPAD.

Bioequivalence, Food-Effect Assessment and Exploratory IVIVC of Two Extended-Release Tamsulosin 0.4 mg Formulations in Healthy Mexican Subjects.

Hernández Piña Omar Emmanuel OE, Martínez Muñoz Alberto A, Guido Ávila Erika Gabriela EG, Escobedo-Moratilla Abraham A et al.

Background/Objectives: Tamsulosin extended-release (ER) formulations minimize peak-related vasodilatory adverse events in benign prostatic hyperplasia (BPH) treatment. This study assessed the pharmacokinetics and bioequivalence of a generic tamsulosin 0.4 mg ER formulation against the innovator under fasting and fed conditions. Methods: Two randomized, open-label, four-period crossover, single-dose trials were conducted in healthy Mexican males. Subjects received treatment following a 10 h fast or a high-fat meal, with a 7-day washout. Plasma tamsulosin was quantified over 72 h via LC-MS/MS. An exploratory in vitro-in vivo correlation (IVIVC) analysis was also performed. Results: Analyses included 32 (fasting) and 58 (fed) subjects. In both states, 90% confidence intervals for Cmax, AUC0-t, and AUC0-∞ geometric mean ratios fell entirely within the 80.00-125.00% bioequivalence limits. The formulations showed comparable dissolution (f2 = 92.47), with numerical deconvolution proving most predictive in exploratory IVIVC. Notably, the pharmacokinetic profile of the test formulation was consistent with maintained controlled drug release under both dietary conditions and showed no pharmacokinetic evidence of food-induced dose dumping. Both formulations were well-tolerated; all adverse events were mild, with no clinically significant orthostatic hypotension observed. Conclusions: The generic tamsulosin 0.4 mg ER formulation is bioequivalent to the reference product in both fasting and fed states. Its structural robustness prevents dose dumping, ensuring a favorable hemodynamic safety profile. Comparable dissolution and IVIVC findings further support their reliability in vivo performance and therapeutic interchangeability. ClinicalTrials.gov identifiers: NCT07698288 and NCT07698275.