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tamsulosin + tolterodine (Roliflo OD)

✓ Approved

Ranbaxy Laboratories Limited · ADRA1A · Small Molecule

What is tamsulosin + tolterodine?

tamsulosin + tolterodine is a small molecule developed by Ranbaxy Laboratories Limited. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesRoliflo OD
CompanyRanbaxy Laboratories Limited
Drug ClassSmall Molecule
Molecular TargetADRA1A, CHRM1, CHRM2, CHRM3, CHRM4
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Ranbaxy Laboratories Limited

Mechanism of Action

Molecular Targets

tamsulosin + tolterodine acts on 5 molecular targets:

ADRA1Aadrenoceptor alpha 1A (ADRA1L1, ADRA1C)
CHRM1cholinergic receptor muscarinic 1 (M1, HM1)
CHRM2cholinergic receptor muscarinic 2 (HM2)
CHRM3cholinergic receptor muscarinic 3 (EGBRS, m3AChR)
CHRM4cholinergic receptor muscarinic 4 (HM4, M4R)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

tamsulosin + tolterodine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Renal and urinary disordersHypertonic bladder✓ Approved

Related Research Articles

PubMedInternational journal of clinical and experimental pathology2026-07-17

Tamsulosin versus placebo for medical expulsive therapy in ureteral calculi: a systematic review and meta-analysis of randomized controlled trials.

Yang Jinxin J, Yang Jin J, Zhang Hanchao H, Hu Haifeng H et al.

Ureteral calculi are a common cause of emergency department visits worldwide. Although small stones often pass spontaneously, medical expulsive therapy is frequently used to facilitate stone clearance and reduce the need for surgical intervention. Tamsulosin, an α1-adrenergic receptor antagonist, is commonly prescribed for this purpose, but its efficacy compared with placebo remains uncertain. We conducted a systematic review and meta-analysis of randomized controlled trials comparing tamsulosin with placebo in patients with ureteral calculi. A comprehensive search of PubMed, Embase, and the Cochrane Central Register of Controlled Trials was performed from database inception through April 2025. The primary outcome was the stone expulsion rate, and secondary outcomes included time to expulsion and the incidence of adverse events. Pooled estimates were calculated as risk ratios or mean differences with 95 percent confidence intervals, using a random-effects model. A total of 42 randomized controlled trials involving 7,117 patients met the inclusion criteria. Compared with placebo, tamsulosin significantly increased the stone expulsion rate (risk ratio 1.42, 95 percent confidence interval 1.29 to 1.56, P < 0.001) and shortened the time to expulsion by an average of 3.04 days (95 percent confidence interval 2.28 to 3.81 days, P < 0.00001). The overall incidence of adverse events did not differ significantly between groups, although subgroup analysis indicated a lower risk of moderate to severe complications with tamsulosin (risk ratio 0.35, 95 percent confidence interval 0.22 to 0.98, P < 0.0001). Substantial heterogeneity was observed across outcomes. In conclusion, tamsulosin improves stone expulsion and reduces clearance time without increasing overall adverse events. However, given the considerable heterogeneity among studies, these findings should be interpreted with caution. Further high-quality, large-scale trials are needed to confirm the benefits of tamsulosin and to identify patient subgroups most likely to benefit from therapy.

PMID 42466212
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PubMedUrology2026-07-16

Endoscopic Outlet Surgery versus Medical Therapy for Benign Prostatic Hyperplasia: Impact on Incident Mood Disorders.

Bhambhvani Hriday P HP, Tzeng Michael M, Lee Richard K RK

To compare incidence of new-onset depression, anxiety, suicidal ideation, and bipolar disorder among men with BPH treated with endoscopic outlet surgery versus medical management. Using the TriNetX Research Network, we conducted a retrospective cohort study with two parallel 1:1 propensity score-matched (PSM) analyses comparing endoscopic outlet surgery (TURP, GreenLight PVP, laser enucleation of the prostate, or Aquablation) to (1) third-generation alpha-blocker monotherapy and (2) combination alpha-blocker/5α-reductase inhibitor therapy. After exclusion and matching on demographics, comorbidities, and healthcare utilization, 10,048 matched pairs were included. Surgery was associated with significantly lower rates of depression at 1 year (RR 0.68, 95% CI 0.55-0.84), 3 years (RR 0.76, 95% CI 0.66-0.87), and 5 years (RR 0.81, 95% CI 0.72-0.92) compared to alpha-blocker monotherapy; anxiety was similarly reduced at 1 year (RR 0.74, 95% CI 0.61-0.90), 3 years (RR 0.79, 95% CI 0.69-0.90), and 5 years (RR 0.79, 95% CI 0.71-0.89). Compared to combination therapy, surgery demonstrated greater protective effects for depression (5-year RR 0.70, 95% CI 0.62-0.79) and anxiety (5-year RR 0.77, 95% CI 0.69-0.86). No differences were observed for suicidal ideation or bipolar disorder. In sensitivity analyses restricted to those with ≥3 prescriptions of tamsulosin monotherapy or ≥3 prescriptions each of tamsulosin and finasteride, the protective effects of surgery were further strengthened for both depression and anxiety across all time points (all p<0.0001). Endoscopic outlet surgery is associated with significantly lower risk of incident depression and anxiety compared to both medical management strategies over five years of follow-up.

PMID 42456781
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PubMedUrologiia (Moscow, Russia : 1999)2026-07-08

[A systematic review of the efficacy of tamsulosin as part of combination therapy in adult patients with chronic bacterial/abacterial prostatitis and chronic pelvic pain syndrome].

Kasimova A R R, Kolbin A S S, Spivak L G G

Prostatitis is an inflammatory disease of the prostate gland that can present with lower abdominal pain, urinary incontinence, and sexual dysfunction. The diagnosis of prostatitis encompasses two main conditions: acute bacterial prostatitis (ABP) and chronic bacterial prostatitis (CBP). Urinary dysfunction is a key factor in the pathogenesis of chronic prostatitis. Overactive contraction of the urinary sphincter can cause bladder outlet obstruction and residual urine, which can lead to urinary reflux into the prostate. Alpha-1-adrenergic receptor antagonists (alpha blockers) are a class of drugs that inhibit smooth muscle contraction in the prostate and bladder neck. Tamsulosin is the first selective 1-adrenergic receptor antagonist, primarily the 1A and 1D subtypes, which are found in the smooth muscle of the prostate, bladder neck, and prostatic urethra. Blockade of these receptors reduces smooth muscle tone in these structures, which, in turn, improves urine flow from the bladder. We carried out a systematic review of the literature to evaluate the efficacy of tamsulosin in the treatment of acute and chronic bacterial and abacterial prostatitis, as well as chronic pelvic pain syndrome (CPPS). A search for clinical trials was carried out in the PubMed database, the clinical trials registry clinicaltrials.gov, and the Russian electronic library elibrary.ru by two independent researchers using keywords describing treatments that potentially included tamsulosin. The search yielded information on 21 publications, 20 of which were included in the systematic review. Five studies were non-comparative, meaning they analyzed only patients receiving tamsulosin in addition to background therapy. The remaining studies had different comparison groups and could include active strategies such as antibacterial, analgesic, anti-inflammatory, herbal (urological) medications, and others. Treatment duration ranged from 4 to 52 weeks. The prescribed dose of tamsulosin was 0.4 mg orally once daily. Most studies used the NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) scores to evaluate outcomes. The average age of the participants ranged from 28.9 to 59.1 years. The quality of the included studies was highly variable. Of the 20 studies included in this review, 19 examined the use of tamsulosin in patients with CP/CPPS. Positive treatment outcomes were observed in all studies using tamsulosin. Increases in maximum urinary flow rate, significant symptom regression, as measured by standardized scales, and improvements in quality of life were observed. The greatest differences in symptom regression were observed early in treatment, up to 45 days. This is likely due to the fact that urinary dysfunction, pain, and decreased quality of life become more prominent early in the disease course. The safety of the treatment was assessed in 15 of the 20 studies. No standardized scales were used to assess safety. The safety of tamsulosin was assessed based on the reporting of adverse reactions. The development of serious adverse reactions (defined in Roszdravnadzor Order No. 1071 of February 15, 2017) was reported in two studies, but it was not possible to reliably link them to tamsulosin use. CONCLUSION: The results of this systematic review confirm that tamsulosin is an effective drug for inclusion in combination treatment regimens for various forms of prostatitis, including CBP, chronic abacterial prostatitis, and CPPS. Its use significantly reduces symptoms such as pain and dysuria, which in turn improves patients' quality of life.

PMID 42417338
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PubMedUrologiia (Moscow, Russia : 1999)2026-07-08

[A patient with acute urinary retention in the emergency department. Defining management strategy].

Kopanova V V V, Neimark A I I, Nozdrachev N A A, Davydov A V V et al.

To evaluate the efficiency and safety of the rectal formulation of an 1A-adrenoblocker in combination with prostatic peptides (Prostatex Plus) in restoring urination in patients with first-onset acute urinary retention (AUR) associated with benign prostatic hyperplasia (BPH). A multicenter study of Prostatex Plus was carried out as a product with both symptomatic and pathogenetic mechanisms of action. Considering the importance of improving adherence in older comorbid patients, ease of use, and minimizing adverse effects, the choice of combining two active substances in a single suppository is evident. The study included 74 patients with first-onset AUR associated with BPH. All patients presented to the emergency department of an emergency hospital. After receiving urgent care, which included single bladder drainage via urethral catheterization, patients were discharged for outpatient follow-up. The main group included 44 patients who received Prostatex Plus, one suppository in the emergency department and then for 20 days at night into an emptied rectum. The comparison group included 30 patients who received an 1A-adrenoblocker orally (tamsulosin) in the emergency department and then daily for 20 days in the morning. Patients were assessed at baseline, and at 7 and 20 days after the initial visit. Patients aged 69 to 80 years were included (mean age 75.5+/-3.58 years). The mean duration of BPH was 2+/-4.5 years (from 1.2 to 9 years). The urine volume at AUR ranged from 300 to 980 mL, with a mean of 650+/-120 mL. The duration of urinary retention was 8+/-4.2 h (from 3 to 11 h). With Prostatex Plus, spontaneous voiding was restored in 35 (79.5%) patients, whereas with oral tamsulosin it was restored in 18 (64.2%). At subsequent visits, voiding quality assessed by uroflowmetry and the IPSS was significantly better in the Prostatex Plus group than in the comparison group.

PMID 42417348
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PubMedJAMA network open2026-07-06

Tamsulosin Deprescribing for Lower Urinary Tract Symptoms in Older Men: A Randomized Clinical Trial.

Bauer Scott R SR, Kenfield Stacey A SA, Oni-Orisan Akinyemi A, Shlipak Michael G MG et al.

Tamsulosin is the most common treatment for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). The ability of N-of-1 deprescribing trials to identify who may benefit from discontinuing chronic tamsulosin therapy is unknown. To determine if N-of-1 deprescribing trials can identify older men who are receiving minimal benefit from tamsulosin therapy for LUTS. Double-blind, placebo-controlled, multiple crossover (N-of-1) randomized clinical trial conducted at a single academic urology department between September 2021 and July 2022. After a 1-week placebo run-in, men aged 55 to 80 years who were continuous users of tamsulosin for at least 12 months to treat symptoms of BPH were randomly assigned to 2 blocks of 2-week treatment periods alternating tamsulosin and placebo, separated by 1-week washout periods. Data were analyzed from November 2022 to October 2024. Tamsulosin, dosed at either 0.4 mg or 0.8 mg, vs matching placebo. The efficacy outcome was daily American Urological Association Symptom Index (AUASI) with an adapted recall period of 24 hours. Effect size was categorized based on the upper bound of the individual 95% CI for the tamsulosin-placebo difference in daily AUASI: minimal or no (≥0), moderate (>-6.0 to <0), or strong (≤-6.0) effect. Adverse drug events were assessed daily as a secondary outcome. Demographics, clinical characteristics, and attitudes toward deprescribing were assessed at baseline. Among the 31 participants enrolled, the mean (SD) age was 68.8 (5.7) years. Of 30 participants who attempted the full N-of-1 protocol, 11 (36.7%) had minimal or no tamsulosin effect, 11 (36.7%) had moderate effect, 4 (13.3%) had strong effect, and 4 (13.3%) did not tolerate the 1-week placebo run-in due to worsening symptoms. Based on a mean (SD) of 54 (3) daily LUTS assessments per participant, individual-level estimated mean difference in daily AUASI between tamsulosin and placebo ranged from -10.9 (95% CI, -12.6 to -9.1) to 2.1 (95% CI, 0.4 to 3.9). The group-level mean difference in daily AUASI was -2.96 (95% CI, -4.37 to -1.54). In this randomized N-of-1 clinical trial of tamsulosin deprescribing, treatment response was heterogeneous. The findings suggest that 1 in 3 older men who had minimal symptomatic benefit from tamsulosin may be high-priority candidates for deprescribing. ClinicalTrials.gov Identifier: NCT05415748.

PMID 42406401
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PubMedBMC chemistry2026-07-02

A QbD-based method for the simultaneous determination of tadalafil, terazosin, and tamsulosin using organic-solvent free mixed-micellar HPLC: a sustainable green approach.

Alrashdi Yahya Bin Abdullah YBA, Magdy Galal G, Osman Mohamed M MM, Alamir Samy G SG et al.

The recent updates to benign prostatic hyperplasia treatment from American (2023) and European (2024) guideline recommend the use of alpha-1 blockers in conjunction with phosphodiesterase-5 inhibitors. A new green mixed micellar liquid chromatographic method was established to concurrently analyze alpha-1 blockers, terazosin/tamsulosin, and tadalafil, a major phosphodiesterase-5 inhibitor. Quality by Design was integrated to enhance essential chromatographic variables and resulted in elevated desirability functions. A comprehensive design space was established, guaranteeing the method's reliability. The separation was carried out on a reversed-phase C18 column (150 × 4.6 mm, 5 µm) using organic-solvent-free mobile phase consisting of a mixture of Brij-35 (20 mM), sodium dodecyl sulfate (150 mM), and sodium dihydrogen phosphate buffer (10 mM) adjusted to pH 4.84 and flow rate of 1 mL/min. Ultraviolet detection was performed at 285 nm for tadalafil and 214 nm for terazosin and tamsulosin. The linearity range observed for all drugs under investigation was (5-100 µg/mL). The limits of detection were 0.27, 0.29, and 0.32 µg/mL, and the limits of quantification were 0.81, 0.88, and 0.97 µg/mL for terazosin, tadalafil, and tamsulosin, respectively. Validation in accordance with International Council for Harmonisation guidelines was successfully implemented. The approach was effectively utilized to identify analytes in the formulated tablets and pharmaceutical products. The ecological impact of the method was evaluated using the complex green analytical procedure index and Analytical GREEnness metrics, demonstrating the advantages of the proposed procedure over previously reported methods.

PMID 42387558
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