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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

PubMedGalen medical journal2026-07-25

Effect of Tamsulosin on Osteopontin Gene Expression in Preventing Ethylene Glycol-Induced Kidney Stone in Male Wistar Rats : Short title: Effect of Tamsulosin on Osteopontin Gene Expression.

Parvizrad Ramin R, Ghorbani Marghamlki Elahe E, Nikfar Somayeh S, Khalili Dermani Sara S

Tamsulosin, an α1-adrenergic receptor antagonist, has been proposed as a potential therapeutic agent against urolithiasis-induced renal damage. However, limited in vivo evidence exists regarding its renoprotective mechanisms. Forty male Wistar rats were randomly allocated into four groups (n=10/group): positive control, negative control (ethylene glycol-induced urolithiasis), prevention (tamsulosin administered simultaneously with ethylene glycol), and treatment (tamsulosin administered after model induction). Biochemical parameters including serum creatinine, urea, uric acid, calcium, and phosphorus were measured using rat-validated commercial kits (Pars Azmun, Iran). Normal ranges were defined based on published reference values. Gene expression was analyzed by qPCR using the 2^-ΔΔCt method. Study design and reporting followed the ARRIVE checklist. At day 30, the prevention group exhibited significantly lower serum creatinine (0.60 ± 0.08 mg/dL) compared to the negative control (0.98 ± 0.12 mg/dL, P0.01). Although urea levels were slightly higher in the prevention group (4.0 ± 0.7 mg/dL) versus the negative control (3.22 ± 0.6 mg/dL), the calculated BUN/creatinine ratio was significantly improved (46.7 vs. 33.0, P0.05). No significant changes were observed in serum calcium or phosphorus. Gene expression analysis showed upregulation of protective markers in the prevention group. In vivo findings on the beneficial effects of tamsulosin on the renal profile in ethylene glycol-induced urolithiasis illustrate its protective effects on the renal system through improvement of creatinine clearance and BUN/creatinine balance. This underscores its probable use as a protective therapeutic agent against renal injury of crystallization origin.

PMID 42499366
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PubMedClinical pharmacology in drug development2026-07-20

Pharmacokinetics and Bioequivalence of Tamsulosin Hydrochloride Extended-Release Capsules in Healthy Chinese Volunteers: A Randomized, Open-Label, Crossover Study Under Fasting and Fed Conditions.

Du Lijie L, Wang Xiaolu X, Zhang Yi Y, Yang Jiamin J et al.

Tamsulosin hydrochloride is a long-acting, highly selective α1A receptor antagonist, primarily used to treat benign prostatic hyperplasia. It effectively alleviates lower urinary tract symptoms, including dysuria, nocturia, and urgency caused by prostate enlargement. This study aimed to evaluate the pharmacokinetics and bioequivalence of two tamsulosin extended-release capsules in Chinese volunteers under both fasting and fed conditions. A single-center, randomized, open-label, two-formulation, single-dose, two-period, two-way crossover design was used. A total of 64 healthy volunteers were enrolled, with 28 in the fasting group and 36 in the fed group. In the fasting group, each subject received a single dose of either the test or reference formulation in a randomized crossover design. In the fed group, volunteers consumed a high-fat meal 1 h before dosing. Blood samples were collected for up to 72 h post-dose, and plasma tamsulosin concentrations were measured using liquid chromatography-tandem mass spectrometry. The geometric mean ratios and 90% confidence intervals for key exposure metrics for both formulations under fasting and fed conditions were within the 0.8000-1.2500 bioequivalence range. Both formulations demonstrated bioequivalence under both conditions, and no severe adverse events were observed.

PMID 42474264
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PubMedEuropean journal of pediatrics2026-07-20

Second- and third-line treatment options for refractory monosymptomatic enuresis in children: a scoping review.

Selvi Ismail I, Marco Beatriz Banuelos BB, Dönmez M İrfan Mİ, Baydilli Numan N et al.

Around one-third of patients with monosymptomatic nocturnal enuresis (MNE) do not respond to conventional first-line treatments. Although international guidelines outline second- and third-line treatment options, these recommendations may not fully address the needs of every case encountered in daily practice. Therefore, the question of which treatment strategy should be used for refractory cases remains unanswered. We conducted a scoping review (PROSPERO CRD420251171197) following PRISMA Extension for Scoping Reviews (PRISMA-ScR), searching the PubMed, Embase, Ovid MEDLINE, Scopus, Web of Science, Google Scholar, CINAHL and the Cochrane Library databases to identify all published reports of treatment for refractory MNE in paediatric patients up to March 2026. Eligible studies included randomized controlled trials and prospective or retrospective observational cohort studies written in English. The primary outcome was the number of wet nights (classified as complete, partial or no response according to the ICCS criteria). Secondary outcomes included a comparison of the efficacy of second- and third-line treatment options if enough data could be found. The Cochrane RoB 2 tool was used to assess the risk of bias in randomized clinical trials, and the Methodological Index for Non-Randomized Studies (MINORS) was used for non-randomized cohort studies. Following screening and eligibility assessment, 17 out of 2578 articles met the PICO inclusion criteria. The included studies enrolled a total of 1348 children and adolescents with mean ages ranging from approximately 8 to 17 years. Many of the second- or third-line treatments described in the literature were excluded due to incorrect methodology, study design or patient population. The results showed that, following first-line treatment, a combination of biofeedback, electrical nerve stimulations, anticholinergics (e.g. oxybutynin, tolterodine, solifenacin), β3-adrenoceptor agonists (e.g. vibegron), tricyclic antidepressants (e.g. imipramine) and selective serotonin reuptake inhibitor (e.g. fluoxetine) improved both partial response (PR) and complete response (CR) at varying rates across highly heterogeneous interventions and study populations. However, the evidence does not strongly support a treatment algorithm. Furthermore, reports on electro-acupuncture, furosemide, onabotulinumtoxin A injections or the herbal medicine 'shokenchuto' were considered unreliable for pure refractory MNE, despite improvements in PR and CR occurring at different rates. Conclusion: The question of which treatment strategy should be used for refractory cases remains unanswered due to a lack of sufficiently unbiased, prospective, randomized, controlled studies involving long-term follow-up. Some second- and third-line treatment options may improve PR and CR rates, despite the limited available evidence to support a treatment algorithm. However, further research is needed to confirm these benefits.

PMID 42472999
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PubMedMedicine2026-07-18

A case report of primary prostate intravascular large B-cell lymphoma.

Yuan Fengju F, Liu Qian Q, Ding Wuwu W, Nie Jia J et al.

Primary intravascular large B-cell lymphoma (IVLBCL) is a rare and aggressive extranodal lymphoma that rarely affects the prostate. Its nonspecific clinical and laboratory features often lead to misdiagnosis as benign prostatic hyperplasia (BPH) or prostatitis, delaying appropriate treatment. We report a case of primary prostatic IVLBCL initially misdiagnosed as BPH, highlighting the diagnostic challenges and the importance of comprehensive pathological evaluation. A 75-year-old male presented with a 1-year history of a weakened urinary stream, dribbling, increased nocturia, and urinary urgency. Symptoms transiently improved with self-medication of the α1-blocker tamsulosin but later recurred. Histopathological examination revealed clusters of atypical tumor cells within the prostatic vasculature. Immunohistochemistry showed positivity for leukocyte common antigen, Vimentin, CD20, and CD79a, with a Ki-67 index > 90%. A final diagnosis of primary intravascular large B-cell lymphoma of the prostate was established. Following diagnosis, the patient and his family declined any antitumor therapy (including chemotherapy) and opted for best supportive care and were discharged against medical advice. The patient died 5 months after diagnosis without receiving any subsequent antitumor therapy. Prostatic IVLBCL is a diagnostic mimic of BPH and requires a high index of suspicion. Immunohistochemistry and molecular studies are essential for accurate diagnosis. Early recognition and appropriate chemotherapy can improve outcomes in this rare malignancy.

PMID 42470066
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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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