DETROL LA- tolterodine tartrate_capsule, extended release

Animal Data
No anomalies or malformations were observed after oral administration of tolterodine to pregnant mice during organogenesis at approximately 9-12 times the clinical exposure to the pharmacologically active components of DETROL LA (based on the AUC of tolterodine and its 5-HMT metabolite at a dose of 20 mg/kg/day). At 14-18 times the clinical exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine was embryo-lethal, caused reduced fetal weight, and increased the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra‑abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification). Pregnant rabbits administered tolterodine subcutaneously at about 0.3-2.5 times the clinical exposure (dose of 0.8 mg/kg/day) did not show any embryotoxicity or teratogenicity.
Animal Data
The use of radiolabeled tolterodine in pregnant mice produced milk: plasma ratios that ranged between 0.0 and 0.7.
CLINICAL PHARMACOLOGY
Tolterodine acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors. Both urinary bladder contraction and salivation are mediated via cholinergic muscarinic receptors. After oral administration, tolterodine is metabolized in the liver, resulting in the formation of 5-hydroxymethyl tolterodine (5-HMT), the major pharmacologically active metabolite. 5-HMT, which exhibits an antimuscarinic activity similar to that of tolterodine, contributes significantly to the therapeutic effect. Both tolterodine and 5-HMT exhibit a high specificity for muscarinic receptors, since both show negligible activity or affinity for other neurotransmitter receptors and other potential cellular targets, such as calcium channels. Tolterodine has a pronounced effect on bladder function. Effects on urodynamic parameters before and 1 and 5 hours after a single 6. 4 mg dose of tolterodine immediate release were determined in healthy volunteers. The main effects of tolterodine at 1 and 5 hours were an increase in residual urine, reflecting an incomplete emptying of the bladder, and a decrease in detrusor pressure. These findings are consistent with an antimuscarinic action on the lower urinary tract. The effect of 2 mg BID and 4 mg BID of DETROL immediate release (tolterodine IR) tablets on the QT interval was evaluated in a 4-way crossover, double-blind, placebo- and active-controlled (moxifloxacin 400 mg QD) study in healthy male (N=25) and female (N=23) volunteers aged 18en dash55 years. Study subjects [approximately equal representation of CYP2D6 extensive metabolizers (EMs) and poor metabolizers (PMs)] completed sequential 4-day periods of dosing with moxifloxacin 400 mg QD, tolterodine 2 mg BID, tolterodine 4 mg BID, and placebo. The 4 mg BID dose of tolterodine IR (two times the highest recommended dose) was chosen because this dose results in tolterodine exposure similar to that observed upon coadministration of tolterodine 2 mg BID with potent CYP3A4 inhibitors in patients who are CYP2D6 poor metabolizers [see Drug Interactions (7. 2) max Table 2 summarizes the mean change from baseline to steady state in corrected QT interval (QT c c c Table 2. Mean (CI) change in QT c max Drug/Dose N QT c F (msec) QT c F (msec) (machine) QT c P (msec) (manual) QT c P (msec) (machine) Tolterodine 2 mg BID At T max 48 5. 81) Tolterodine 4 mg BID 48 11. 15) Moxifloxacin At T max 45 19. 26 The effect on QT interval with 4 days of moxifloxacin dosing in this QT trial may be greater than typically observed in QT trials of other drugs. 24) The reason for the difference between machine and manual read of QT interval is unclear. The QT effect of tolterodine immediate release tablets appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4 mg/day. The effect of tolterodine 8 mg/day was not as large as that observed after four days of therapeutic dosing with the active control moxifloxacin. However, the confidence intervals overlapped. Tolterodine’s effect on QT interval was found to correlate with plasma concentration of tolterodine. There appeared to be a greater QT c This study was not designed to make direct statistical comparisons between drugs or dose levels. There has been no association of Torsade de Pointes in the international post-marketing experience with DETROL or DETROL LA [see Warnings and Precautions (5. 7) ] In a study with 14 max max min There is no effect of food on the pharmacokinetics of tolterodine extended release. Tolterodine is highly bound to plasma proteins, primarily alpha 1 Tolterodine is extensively metabolized by the liver following oral dosing. The primary metabolic route involves the oxidation of the 5-methyl group and is mediated by the cytochrome P450 2D6 (CYP2D6) and leads to the formation of a pharmacologically active metabolite, 5-HMT. Further metabolism leads to formation of the 5-carboxylic acid and N A subset of individuals (approximately 7% of Caucasians and approximately 2% of African Americans) are poor metabolizers for CYP2D6, the enzyme responsible for the formation of 5-HMT from tolterodine. The identified pathway of metabolism for these individuals (“poor metabolizers”) is dealkylation via cytochrome P450 3A4 (CYP3A4) to N Following administration of a 5 mg oral dose of 14 A summary of mean (+/- standard deviation) pharmacokinetic parameters of tolterodine extended release and 5-HMT in extensive (EM) and poor (PM) metabolizers is provided in Table 3. These data were obtained following single and multiple doses of tolterodine extended release administered daily to 17 healthy male volunteers (13 EM, 4 PM). Summary of Mean (+/-SD) Pharmacokinetic Parameters of Tolterodine Extended Release and its Active Metabolite (5-Hydroxymethyl Tolterodine) in Healthy Volunteers C max max max C avg 1/2 Tolterodine 5-Hydroxymethyl Tolterodine t max Data presented as median (range). (h) C max C avg (µg/L) t ½ (h) t max (h) C max (µg/L) C avg (µg/L) t ½ (h) Single dose 4 mg Parameter dose-normalized from 8 to 4 mg for the single-dose data. EM 4 (2en dash6) 1. 2) 4 (3en dash6) 1. 9) Multiple dose 4 mg EM PM 4 (2en dash6) 4 (3en dash6) 3. 9) 19 (16) 1. 8) 13 (11) 6. 5) 18 (16) 4 (2en dash6) = not applicable. 0) Fluoxetine is a selective serotonin reuptake inhibitor and a potent inhibitor of CYP2D6 activity. In a study to assess the effect of fluoxetine on the pharmacokinetics of tolterodine immediate release and its metabolites, it was observed that fluoxetine significantly inhibited the metabolism of tolterodine immediate release in extensive metabolizers, resulting in a 4. 8-fold increase in tolterodine AUC. There was a 52% decrease in C max The effect of a 200 mg daily dose of ketoconazole on the pharmacokinetics of tolterodine immediate release was studied in 8 healthy volunteers, all of whom were CYP2D6 poor metabolizers. In the presence of ketoconazole, the mean C max For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, miconazole, clarithromycin, ritonavir, the recommended dose of DETROL LA is 2 mg daily [see Dosage and Administration (2. 3) ] In healthy volunteers, coadministration of tolterodine immediate release 4 mg (2 mg bid) for 7 days and a single dose of warfarin 25 mg on day 4 had no effect on prothrombin time, Factor VII suppression, or on the pharmacokinetics of warfarin. Tolterodine immediate release 4 mg (2 mg bid) had no effect on the pharmacokinetics of an oral contraceptive (ethinyl estradiol 30 µg/levonorgestrel 150 µg) as evidenced by the monitoring of ethinyl estradiol and levonorgestrel over a 2-month period in healthy female volunteers. Coadministration of tolterodine immediate release up to 8 mg (4 mg bid) for up to 12 weeks with diuretic agents, such as indapamide, hydrochlorothiazide, triamterene, bendroflumethiazide, chlorothiazide, methylchlorothiazide, or furosemide, did not cause any adverse electrocardiographic (ECG) effects. Tolterodine immediate release does not cause clinically significant interactions with other drugs metabolized by the major drug-metabolizing CYP enzymes. In vivo In vitro i.

DETROL LA Capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14) DETROL LA is an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

1 o 2. 2 The recommended dose of DETROL LA Capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for DETROL LA 2 mg [see Clinical Studies (14) ] For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10-30 mL/min), the recommended dose of DETROL LA is 2 mg once daily. DETROL LA is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr<10 mL/min have not been studied and use of DETROL LA in this population is not recommended [see Warnings and Precautions (5. 6) Use in Specific Populations (8. 7) For patients who are taking drugs that are potent inhibitors of CYP3A4 [e. , ketoconazole, clarithromycin, ritonavir], the recommended dose of DETROL LA is 2 mg once daily [see Drug Interactions (7.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (incidence >=4% and >placebo) were dry mouth, headache, constipation, and abdominal pain. 1 To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www. gov/medwatch. The efficacy and safety of DETROL LA Capsules was evaluated in 1073 patients (537 assigned to DETROL LA; 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months. These included a total of 1012 patients (505 randomized to DETROL LA 4 mg once daily and 507 randomized to placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. Adverse events were reported in 52% (n=263) of patients receiving DETROL LA and in 49% (n=247) of patients receiving placebo. The most common adverse events reported by patients receiving DETROL LA were dry mouth, headache, constipation, and abdominal pain. Dry mouth was the most frequently reported adverse event for patients treated with DETROL LA, occurring in 23. 4% of patients treated with DETROL LA and 7. 7% of placebo-treated patients. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic agents. A serious adverse event was reported by 1. 4% (n=7) of patients receiving DETROL LA and by 3. 6% (n=18) of patients receiving placebo. Table 1 lists the adverse events, regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than or equal to 1% of patients treated with DETROL LA 4 mg once daily. Incidence in nearest integer. Body System Adverse Event % DETROL LA n=505 % Placebo n=507 Autonomic Nervous dry mouth 23 8 General headache 6 5 fatigue 2 1 Central/Peripheral dizziness 2 1 Gastrointestinal constipation 6 4 abdominal pain 4 2 dyspepsia 3 1 Vision xerophthalmia 3 2 vision abnormal 1 0 Psychiatric somnolence 3 2 anxiety 1 0 Respiratory sinusitis 2 1 Urinary dysuria 1 0 The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Similar percentages of patients treated with DETROL LA or placebo discontinued treatment due to adverse events. Dry mouth was the most common adverse event leading to treatment discontinuation among patients receiving DETROL LA [n=12 (2. placebo n=6 (1. The following events have been reported in association with tolterodine use in worldwide post-marketing experience: General: Cardiovascular: Gastrointestinal: Central/Peripheral Nervous: Reports of aggravation of symptoms of dementia (e. , confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia. Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably determined.

DETROL LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL LA is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like DETROL LA, are metabolized to 5-hydroxymethyl tolterodine [see Warnings and Precautions (5. 4) DETROL LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL LA is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like DETROL LA, are metabolized to 5-hydroxymethyl tolterodine.

Renal Impairment: 8. 6 Hepatic Impairment: 8. 7 There are no available data with DETROL LA use in pregnant women to inform drug-associated risks. In animal reproduction studies, oral administration of tolterodine and its 5-HMT metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20 mg/kg/day; however, higher doses produced adverse developmental outcomes (see Data In the U. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. No anomalies or malformations were observed after oral administration of tolterodine to pregnant mice during organogenesis at approximately 9-12 times the clinical exposure to the pharmacologically active components of DETROL LA (based on the AUC of tolterodine and its 5-HMT metabolite at a dose of 20 mg/kg/day). At 14-18 times the clinical exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine was embryo-lethal, caused reduced fetal weight, and increased the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra‑abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification). Pregnant rabbits administered tolterodine subcutaneously at about 0. 5 times the clinical exposure (dose of 0. 8 mg/kg/day) did not show any embryotoxicity or teratogenicity. There is no information on the presence of tolterodine or its 5-HMT metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. Based on limited data, tolterodine is excreted into the milk in mice in low amounts (see Data The use of radiolabeled tolterodine in pregnant mice produced milk: plasma ratios that ranged between 0. The effectiveness of DETROL LA has not been established in pediatric patients. Efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710 pediatric patients (486 on DETROL LA, 224 on placebo) aged 5en dash10 years with urinary frequency and urge incontinence. The percentage of patients with urinary tract infections was higher in patients treated with DETROL LA (6. 6%) compared to patients who received placebo (4. Aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2. 9% of children treated with DETROL LA compared to 0. 9% of children treated with placebo. No overall differences in safety were observed between the older and younger patients treated with tolterodine. In multiple-dose studies in which tolterodine immediate release 4 mg (2 mg bid) was administered, serum concentrations of tolterodine and of 5-HMT were similar in healthy elderly volunteers (aged 64 through 80 years) and healthy young volunteers (aged less than 40 years). In another clinical study, elderly volunteers (aged 71 through 81 years) were given tolterodine immediate release 2 or 4 mg (1 or 2 mg bid). Mean serum concentrations of tolterodine and 5-HMT in these elderly volunteers were approximately 20% and 50% higher, respectively, than concentrations reported in young healthy volunteers. However, no overall differences were observed in safety between older and younger patients on tolterodine in the Phase 3, 12-week, controlled clinical studies; therefore, no tolterodine dosage adjustment for elderly patients is recommended. Renal impairment can significantly alter the disposition of tolterodine immediate release and its metabolites. In a study conducted in patients with creatinine clearance between 10 and 30 mL/min, tolterodine and 5-HMT levels were approximately 2en dash3 fold higher in patients with renal impairment than in healthy volunteers. Exposure levels of other metabolites of tolterodine (e. , tolterodine acid, N N N [see Dosage and Administration (2. 2 Warnings and Precautions (5. 6) Liver impairment can significantly alter the disposition of tolterodine immediate release. In a study of tolterodine immediate release conducted in cirrhotic patients (Child-Pugh Class A and B), the elimination half-life of tolterodine immediate release was longer in cirrhotic patients (mean, 7. 8 hours) than in healthy, young, and elderly volunteers (mean, 2 to 4 hours). The clearance of orally administered tolterodine immediate release was substantially lower in cirrhotic patients (1. 7 L/h/kg) than in the healthy volunteers (5. The recommended dose for patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) is DETROL LA 2 mg once daily. DETROL LA is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) [see Dosage and Administration (2. 2) Warnings and Precautions (5.

6 Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly inhibited the metabolism of tolterodine immediate release in CYP2D6 extensive metabolizers, resulting in a 4. 8-fold increase in tolterodine AUC. There was a 52% decrease in C max [see Clinical Pharmacology (12. 1) [see Clinical Pharmacology (12. 3) Ketoconazole (200 mg daily), a potent CYP3A4 inhibitor, increased the mean C max For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, clarithromycin, or ritonavir, the recommended dose of DETROL LA is 2 mg once daily [see Dosage and Administration (2. 2) and Clinical Pharmacology (12. 3) No clinically relevant interactions have been observed when tolterodine was co-administered with warfarin, with a combined oral contraceptive drug containing ethinyl estradiol and levonorgestrel, or with diuretics [see Clinical Pharmacology (12. In vivo [see Clinical Pharmacology (12. Interactions between tolterodine and laboratory tests have not been studied. The concomitant use of DETROL LA with other anticholinergic (antimuscarinic) agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, somnolence, and other anticholinergic pharmacological effects.

OVERDOSAGE
Overdosage with DETROL LA Capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the recommended human dose. In clinical trials of normal volunteers and patients, QT interval prolongation was observed with tolterodine immediate release at doses up to 8 mg (4 mg bid) and higher doses were not evaluated [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.2) ] A 27-month-old child who ingested 5 to 7 tolterodine immediate release 2 mg tablets was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered.
NONCLINICAL TOXICOLOGY
Carcinogenicity studies with tolterodine were conducted in mice and rats. At the maximum tolerated dose in mice (30 mg/kg/day), female rats (20 mg/kg/day), and male rats (30 mg/kg/day), exposure margins were approximately 6-9 times, 7 times, and 11 times the clinical exposure to the pharmacologically active components of DETROL LA (based on AUC of tolterodine and its 5-HMT metabolite). At these exposure margins, no increase in tumors was found in either mice or rats. No mutagenic or genotoxic effects of tolterodine were detected in a battery of in vitro Salmonella typhimurium Escherichia coli, in vivo In female mice treated for 2 weeks before mating and during gestation with 20 mg/kg/day (about 9-12 times the clinical exposure via AUC), neither effects on reproductive performance or fertility were seen. In male mice, a dose of 30 mg/kg/day did not induce any adverse effects on fertility.
CLINICAL STUDIES
DETROL LA Capsules 2 mg were evaluated in 29 patients in a Phase 2 dose-effect study. DETROL LA 4 mg was evaluated for the treatment of overactive bladder with symptoms of urge urinary incontinence and frequency in a randomized, placebo-controlled, multicenter, double-blind, Phase 3, 12-week study. A total of 507 patients received DETROL LA 4 mg once daily in the morning and 508 received placebo. The majority of patients were Caucasian (95%) and female (81%), with a mean age of 61 years (range, 20 to 93 years). In the study, 642 patients (42%) were 65 to 93 years of age. The study included patients known to be responsive to tolterodine immediate release and other anticholinergic medications, however, 47% of patients never received prior pharmacotherapy for overactive bladder. At study entry, 97% of patients had at least 5 urge incontinence episodes per week and 91% of patients had 8 or more micturitions per day. The primary efficacy assessment was change in mean number of incontinence episodes per week at week 12 from baseline. Secondary efficacy measures included change in mean number of micturitions per day and mean volume voided per micturition at week 12 from baseline. Patients treated with DETROL LA experienced a statistically significant decrease in number of urinary incontinence per week from baseline to last assessment (week 12) compared with placebo as well as a decrease in the average daily urinary frequency and an increase in the average urine volume per void. Mean change from baseline in weekly incontinence episodes, urinary frequency, and volume voided between placebo and DETROL LA are summarized in Table 4. Table 4. 95% Confidence Intervals (CI) for the Difference between DETROL LA (4 mg daily) and Placebo for Mean Change at Week 12 from Baseline Intent-to-treat analysis. SD = Standard Deviation. DETROL LA (n=507) Placebo (n=508) 1 to 2 patients missing in placebo group for each efficacy parameter. Treatment Difference, vs. (95% Cl) Number of incontinence Mean Baseline Mean Change from Baseline 22.1 en dash11.8 (SD 17.8) 23.3 en dash6.9 (SD 15.4) -4.8 The difference between DETROL LA and placebo was statistically significant. (en dash6.9, en dash2.8) Number of micturitions/day Mean Baseline Mean Change from Baseline 10.9 en dash1.8 (SD 3.4) 11.3 en dash1.2 (SD 2.9) -0.6 (en dash1.0, en dash0.2) Volume voided per micturition Mean Baseline Mean Change from Baseline 141 34 (SD 51) 136 14 (SD 41) 20 (14, 26)
PATIENT INFORMATION
DETROL registered DE-trol el-ay) Read the Patient Information that comes with DETROL LA before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment. Only your doctor can determine if treatment with DETROL LA is right for you. What is DETROL LA? DETROL LA is a prescription medicine for adults overactive bladder DETROL LA did not help the symptoms of overactive bladder when studied in children. What is overactive bladder? Overactive bladder happens when you cannot control your bladder muscle. When the muscle contracts too often or cannot be controlled, you get symptoms of overactive bladder, which are leakage of urine (urge urinary incontinence), needing to urinate right away (urgency), and needing to urinate often (frequency). Who should not take DETROL LA? Do not take DETROL LA if: registered What should I tell my doctor before starting DETROL LA? Before starting DETROL LA, tell your doctor about all of your medical conditions, including if you: Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Other drugs can affect how your body handles DETROL LA. Your doctor may use a lower dose of DETROL LA if you are taking: registered registered registered registered registered registered registered registered registered Know the medicines you take. Keep a list of them with you to show your doctor or pharmacist each time you get a new medicine. How should I take DETROL LA? What are possible side effects of DETROL LA? DETROL LA may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat, or tongue. If you experience these symptoms, you should stop taking DETROL LA and get emergency medical help right away. The most common side effects with DETROL LA are: Medicines like DETROL LA can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how DETROL LA affects you. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. These are not all the side effects with DETROL LA. For a complete list, ask your doctor or pharmacist. How do I store DETROL LA? Keep DETROL LA and all medicines out of the reach of children. General Information about DETROL LA Medicines are sometimes prescribed for conditions that are not in the patient information leaflet. Only use DETROL LA the way your doctor tells you. Do not share it with other people even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about DETROL LA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DETROL LA that is written for health professionals. You can also call Viatris at 1-877-446-3679 (1-877-4-INFO-RX). What are the ingredients in DETROL LA? Active ingredients: tolterodine tartrate Inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. 2 mg capsule also contains yellow iron oxide. Capsules have pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone. Distributed by: Viatris Specialty LLC copyright 2023 Viatris Inc. DETROL is a registered trademark of Viatris Specialty LLC, a Viatris Company. The brands listed are trademarks of their respective owners. UPJ:PL:DTRLLAC:R1 Revised: 3/2023

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DETROL LA- tolterodine tartrate_capsule, extended release Product manual source documgent