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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

PubMedBrazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas2026-10-15

Alpha1-adrenoceptor antagonists block the positive chronotropic effect of 6-nitrodopamine in the isolated rat right atrium.

Alves B L BL, Niederauer A J S AJS, Britto-Júnior J J, Sobanski J F JF et al.

6-Nitrodopamine (6-ND) released from isolated rat atria produces potent positive chronotropic actions. Direct negative chronotropic responses to some selective α1-adrenoceptor (AR) antagonists like prazosin have been reported. Since α1-AR antagonists inhibit 6-ND-induced smooth muscle contractions, we have hypothesized that negative chronotropism induced by α1-AR antagonists reflects 6-ND blockade. This study investigated whether selective α1-AR antagonists affect 6-ND-induced positive chronotropism in isolated rat atria. Alfuzosin at 10 nM did not affect the atrial rate, but at 100 nM, it significantly reduced the atrial rate. This effect was not observed in L-NAME (100 mM)-treated preparations or in atria from rats chronically treated with L-NAME. Alfuzosin (100 nM) significantly reduced the 6-ND-induced positive chronotropism without affecting the chronotropic responses to noradrenaline, adrenaline, or dopamine. Similar results were obtained with doxazosin (1-10 nM), tamsulosin (10-100 nM), and prazosin (1-10 nM). Isoprenaline induced concentration-dependent increases in atrial rate, which were not significantly affected by any of these α1-AR antagonists. The results demonstrated that α1-AR antagonists reduced atrial basal rate only at concentrations affecting the positive chronotropic effect of 6-ND, and this reduction was not observed when NO synthesis was blocked, indicating that the negative chronotropic effect may involve 6-ND receptor blockade.

PMID 42879640
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PubMedIndian journal of orthopaedics2026-10-14

Efficacy and Safety of Tamsulosin in the Prevention of Postoperative Urinary Retention in Hip Fractures (TamPOUR-Hip Trial): A Randomized, Double-Blind Placebo-Controlled Study.

Tripathy Sujit Kumar SK, Varghese Paulson P, Khan Shahnawaz S, Patel Ranjan Kumar RK et al.

Postoperative urinary retention (POUR) is a common problem after hip fracture surgery in the elderly patients, leading to increased morbidity, catheterization, and prolonged hospitalization. Tamsulosin, an α1-adrenergic antagonist, may reduce POUR by decreasing bladder outlet resistance. This study evaluated the efficacy and safety of perioperative tamsulosin in preventing POUR in hip fracture patients. In this prospective, randomized, double-blind, placebo-controlled trial, 120 patients undergoing hip fracture surgery under spinal anaesthesia were allocated to receive either tamsulosin (0.4 mg daily) or placebo from admission until the second postoperative day. Foley catheter was removed on postoperative day one, and POUR was defined as post-void residual urine > 200 mL at six hours of catheter removal. Primary outcome was incidence of POUR; secondary outcomes included indwelling re-catheterization rates, urinary tract infections (UTIs), and adverse events. POUR was observed in 16.7% of patients in the tamsulosin group compared with 33.3% in the placebo group. Tamsulosin significantly reduced the pre-void bladder volume (311.3 ± 174.5 mL vs. 402.9 ± 198.4 mL; p = 0.008) and post-void residual urine volume (median 20 mL vs. 53.5 mL; p < 0.001). Re-catheterization was less frequent with tamsulosin (8.3% vs. 21.7%), though not statistically significant. Multivariate logistic regression analysis identified female sex, longer surgical duration, and blood loss as independent risk factors for POUR, while tamsulosin use was not found to be preventive. Adverse events, including dizziness and postural hypotension, were mild and self-limiting. Perioperative tamsulosin was safe and improved bladder emptying, but did not significantly reduce the incidence of POUR in elderly patients undergoing hip fracture surgery. Larger multicentric studies are needed to further clarify its role in this population.

PMID 42871280
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PubMedAnalytical and bioanalytical chemistry2026-10-10

A novel substrate for CYP3A4 phenotyping: in vitro biotransformation of hubamine into butanone.

Hofer Rebecca R, Stock Valentina V, Liedl Klaus R KR, Troppmair Jakob J et al.

CYP3A4 is a major drug-metabolising enzyme responsible for the biotransformation of many commonly used pharmaceuticals. However, its interindividual variability strongly influences pharmacokinetics, and thereby efficacy and adverse drug reactions. This variability underscores the need for accessible, minimally invasive phenotyping. Exhaled volatile analysis using unlabelled substrates offers a promising approach, provided that metabolism generates specific volatile products. In this study, we report the potential use of N-(sec-butyl)-N-(3,3-diphenylpropyl)butan-2-amine (hubamine) as a novel substrate for a CYP3A4 phenotyping assay. In vitro studies using HepG2 cells demonstrated that hubamine is metabolised to N-dealkylated hubamine (a non-volatile) and butanone (a volatile). Metabolite formation was significantly higher in HepG2 cells overexpressing CYP3A4 compared with CYP2C9 and CYP2D6 overexpressing cells, indicating high CYP3A4 specificity. Hubamine demonstrated superior performance compared with the substrates tolterodine, diisopromine and gstachamine. Method optimisation identified 75 µM substrate concentration and 90 min incubation time as ideal conditions, while preserving high cell viability. Inhibition assays confirmed CYP3A4-dependent metabolism. We demonstrate that gas chromatography-ion mobility spectrometry can be used as a sensitive, selective and portable analytical technique for detecting butanone, highlighting its suitability as a compact analytical platform for volatile metabolite analysis in complex headspace samples and its potential for decentralised analytical applications.

PMID 42855504
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PubMedJournal of pediatric urology2026-09-30

Efficacy and safety of medical expulsive therapy (MET) after extracorporeal shockwaves lithotripsy (SWL) in pediatric patients.

Hassan Ahmed Bakr Eldesouky ABE, Sheir Khaled Zaki KZ, Elshal Ahmed Mohamed AM, Bazeed Mahmoud Anees MA et al.

To evaluate the impact of tamsulosin as a post-SWL adjunctive treatment for pediatric urolithiasis. A randomized controlled trial (RCT) was carried out for children with renal stones amenable for SWL. Eligible children were randomized into 2 groups. Group 1 received tamsulosin (0.01 mg/kg once daily) for 2 weeks after each SWL session while group 2 served as a control. Stone clearance was defined as no residual fragments by low-dose non-contrast computed tomography (NCCT) at one and three months after last session. A total of 106 patients were included (53 in each group). Pre-SWL patients and stone criteria were comparable between both groups. Stone clearance was achieved in 43 patients (81.1%) in group 1 and 36 patients (67.9%) in group 2 (P = 0.119). Time to stone clearance was comparable for both groups (P = 0.110). Post-SWL complications were encountered in one patient (1.9%) in group 1 and three patients (5.7%) in group 2 (P = 0.308). Tamsulosin minor adverse effects were observed in 18.9%, but no patients discontinue treatment. Tamsulosin treatment following SWL for renal stones in children showed trends for increasing SFR and decreasing complications in comparison with control group. However, statistically significant differences were not achieved.

PMID 42816303
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PubMedCureus2026-09-27

Prescription Trends in the Management of Lower Urinary Tract Symptoms in Men: An Online Survey of Indian Urologists.

Patwardhan Prakash P, Palkar Santosh S, Sharma Rahul R, Kamble Sanjay S et al.

Background Lower urinary tract symptoms (LUTS), highly prevalent among aging men, adversely affect the quality of life. Pharmacological management has evolved with multiple drug classes, but real-world prescribing patterns in India have not been adequately studied. Thus, we evaluated prescription trends among Indian urologists for the management of male LUTS, assessed symptom patterns, evaluated factors influencing choice of fixed-dose combination (FDC), with special focus on silodosin-mirabegron FDC, and identified adverse events (AEs) and adherence. Methods This cross-sectional, questionnaire-based survey was performed over three months (January 2, 2026, to April 5, 2026) and included 110 Indian urologists actively managing male patients with LUTS. A 27-item structured questionnaire captured demographic characteristics, clinical practice patterns, and prescribing preferences for LUTS pharmacotherapy, including monotherapies, combination therapies, and FDCs, along with AEs and adherence. Results Of 135 urologists invited, 110 (81.48%) completed the survey. LUTS mainly involved a combination of storage, voiding, and post-micturition symptoms (n = 59, 53.6%). As a class, α1-blockers were the most frequently prescribed monotherapy (n = 109, 99.1% frequent/very frequent use), with silodosin (n = 98, 89.1%) and tamsulosin (n = 84, 76.4%) being most preferred. Use of dutasteride (n = 108, 98.2%) exceeded finasteride (n = 13, 11.8%). In patients with benign prostatic hyperplasia (BPH) with overactive bladder, silodosin-mirabegron was the most favored FDC (n = 97, 88.2%). FDCs of α1-blockers with muscarinic receptor antagonists and β-3 adrenergic agonists were preferred due to their proven efficacies (n = 83, 75.5% and n = 87, 79.1%, respectively) and lower incidences of AEs (n = 69, 62.7% and n = 80, 72.7%). Common AEs included dry mouth (n = 73, 66.4%), anejaculation (n = 69, 62.7%), and headache (n = 67, 60.9%). Moderate adherence (25%-75%) was reported by 95 (86.4%) urologists. Conclusion Adherence to pharmacotherapy, as assessed by participating urologists, was moderate, with urologists preferring silodosin as first-line therapy and silodosin-mirabegron FDC for mixed LUTS.

PMID 42799232
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PubMedJournal of clinical medicine2026-09-26

Effect of Tamsulosin on Nocturnal Blood Pressure Load and Dipping Status: A Prospective Ambulatory Blood Pressure Monitoring Study.

Yesildal Cumhur C, Yilmaz Anil A, Hayit Huseyin H, Keskin Nurgul N et al.

Background: Alpha-1 adrenergic receptor antagonists are widely used in the management of benign prostatic hyperplasia (BPH) . Their effects on blood pressure (BP) patterns remain incompletely characterized. This study aimed to prospectively evaluate the impact of tamsulosin on ambulatory blood pressure monitoring (ABPM) parameters, with particular focus on nocturnal BP load and dipping status. Methods: A total of 83 male patients aged 40-90 years who were initiated on tamsulosin for BPH-related lower urinary tract symptoms (LUTS) were prospectively enrolled; 58 patients with complete, technically adequate paired recordings were included in the final analysis. Participants underwent 24 h ABPM before treatment and at 1 month. Dipping status was defined as a nocturnal BP reduction ≥10%. Pre-post treatment ABPM parameters were compared using paired statistical analyses, and changes in dipping status were evaluated using McNemar's test. Results: Mean 24 h, daytime, and nighttime systolic and diastolic blood pressure (DBP) values did not change significantly after treatment (p > 0.05). However, nocturnal systolic and DBP load decreased significantly following tamsulosin initiation (p = 0.035 and p = 0.005, respectively), along with a reduction in minimum DBP (p < 0.001). Changes in dipping status were heterogeneous: 25% of baseline non-dippers converted to a dipper pattern, whereas 36.4% of initial dippers became non-dippers, with no statistically significant overall shift (p = 0.81). Conclusions: At one month, tamsulosin was not associated with significant changes in mean ambulatory BP. Reductions in nocturnal BP load were observed, but the incremental clinical significance of BP load beyond mean ambulatory BP indices is uncertain. The marked decrease in minimum DBP warrants cautious interpretation as a potential safety signal. These findings should be considered exploratory and require confirmation in controlled studies incorporating earlier and longer follow-up.

PMID 42795885
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