November 24, 2021. trials of another drug and may not reflect the rates observed in practice. Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g., ketoconazole, clarithromycin, ritonavir], the recommended dose of tolterodine tartrate extended-release capsule is 2 mg once daily [see DRUG INTERACTIONS (7.2)]. (EMs) and poor metabolizers (PMs)] completed sequential 4-day periods of dosing Tolterodine tartrate tablets are a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder: DETROL LA (tolterodine tartrate extended release capsules) did not help the symptoms of overactive bladder when studied in children. Table 2. 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. You have trouble emptying your bladder (also called urinary retention). In female mice treated for 2 weeks before mating and fall in blood pressure, DETROL should be discontinued and appropriate therapy Reduce tolterodine tartrate extended-release capsules dose to 2 mg once daily. Race: Pharmacokinetic differences due to race have not been established. Uses. 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. electrocardiographic (ECG) effects. Tolterodine has a pronounced effect on bladder function. muscle pain, back pain, pain in your arms, legs, or back. detrol (tolterodine tartrate) drug. C-tolterodine solution to healthy volunteers, 77% of radioactivity was Reports of aggravation of symptoms of dementia (e.g., & Articles, All Potent CYP3A4 inhibitors: 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. A summary of mean ( standard deviation) pharmacokinetic Overactive bladder happens when you cannot control your bladder muscle. confusion, disorientation, delusion) have been reported after tolterodine The sums of unbound serum concentrations of tolterodine immediate release and 5-HMT are only 25% higher during the interaction. 29300-240-05, 29300-240-13, This change is not expected to be a Variability in Metabolism: 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. DETROL is also contraindicated in patients who have demonstrated Efficacy or safety of Detrol in the pediatric population has not been demonstrated. 29300-239-05, In vitro data show that tolterodine immediate release is a competitive inhibitor of CYP2D6 at high concentrations (Ki 1.05 M), while tolterodine immediate release as well as the 5-HMT are devoid of any significant inhibitory potential regarding the other isoenzymes. gh/L), neither effects on reproductive performance or fertility heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating. 0.13% over the concentration range achieved in clinical studies. urinary incontinence), needing to urinate right away (urgency), and needing to Citations, Pharmacokinetics, Variability in Metabolism, PRECAUTIONS, Patients with Congenital or Acquired QT Prolongation, CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations, CLINICAL PHARMACOLOGY, Cardiac Electrophysiology, CLINICAL PHARMACOLOGY, Variability in Metabolism, PRECAUTIONS, Reduced Hepatic and Renal Function, Report Adverse NDC 27241-192-30 30 Capsules Tolterodine Tartrate Extended-Release Capsules 4 mg Rx Only Files, All Mapping tolterodine and at steady state (Day 4 of dosing). Swallow the whole capsule. The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. days), Urge urinary incontinence: a strong need to urinate with Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, USP. passes into your breast milk or if it can harm your baby. Tolterodine was also negative in vivo in the bone marrow micronucleus test in the mouse. correlate with plasma concentration of tolterodine. 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. For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, clarithromycin, or ritonavir, the recommended dose of tolterodine tartrate extended-release capsule is 2 mg once daily [see DOSAGE AND ADMINISTRATION (2.2) and CLINICAL PHARMACOLOGY (12.3)]. Table 5 lists the adverse events reported in 1% no association of Torsade de Pointes in the international post-marketing Risk of Urinary Retention and Gastric Retention: Tolterodine tartrate tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention and to patients with gastrointestinal obstructive disorders, such as pyloric stenosis, because of the risk of gastric retention (see CONTRAINDICATIONS). 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. Metabolism for discussion of poor metabolizers). For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose of tolterodine tartrate tablets is 1 mg twice daily (see PRECAUTIONS, General, PRECAUTIONS, Reduced Hepatic and Renal Function, and PRECAUTIONS, Drug Interactions). information. Your doctor will prescribe the dose that is right for you. treated with DETROL 2 mg bid discontinued treatment due to adverse events discontinuation of DETROL were dizziness and headache. Biochemical Data Summary. Rabbits treated subcutaneously at a dose of 0.8 for patients with significantly reduced renal function is DETROL 1 mg twice In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate extended-release capsules should be discontinued and appropriate therapy promptly provided. the pharmacokinetics of warfarin. your doctor tells you. dizziness, and drowsiness. 3The 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. 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 tolterodine tartrate extended-release capsules 4 mg once daily. In a study of the effect of tolterodine immediate release tablets on the QT interval [see CLINICAL PHARMACOLOGY (12.2)], the effect on the QT interval appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4 mg/day and was more pronounced in CYP2D6 poor metabolizers (PM) than extensive metabolizers (EMs). DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Do not share it with other people even if they have the same symptoms you have. *At T of 1 hr; 95% max Confidence Interval, signs of kidney infection (such as burning or, Number of micturitions per 24 hours (averaged over 7 called QT prolongation (. Call your doctor for medical advice about side effects. Tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine [see WARNINGS AND PRECAUTIONS (5.2)(5.3), (5.4)]. Tell your doctor if you have serious side effects of Detrol including: Detrol is available in 1 and 2 mg strength tablets. In a study with 14C-tolterodine solution in central anticholinergic effects and should be treated accordingly. The percentage of patients with urinary tract DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. 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. 27241-191-05, Store at 25C (77F); excursions permitted to 15-30C There has been no association of Torsade de Pointes in the international post-marketing experience with tolterodine tartrate tablets or tolterodine tartrate extended-release capsules (see PRECAUTIONS, Patients with Congenital or Acquired QT Prolongation). Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. absorbed, and maximum serum concentrations (Cmax) typically occur within 1 to 2 This leaflet summarizes the most important information about tolterodine tartrate tablets. Inactive ingredients are microcrystalline cellulose, hypromellose, ethyl cellulose, medium chain triglycerides and oleic acids. observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times Less than 1% (less than 2.5% in poor metabolizers) of the dose was recovered as intact tolterodine, and 5% to 14% (less than 1% in poor metabolizers) was recovered as 5-HMT. receptors and other potential cellular targets, such as calcium channels. of tolterodine immediate release was studied in 8 healthy volunteers, all of any adverse effects on fertility. Table 1. Unbound concentrations of tolterodine average 3.7% Hepatic Insufficiency: Liver impairment can significantly alter the disposition of tolterodine immediate release. Variability in Metabolism and Drug-Drug Interactions). Exposure levels of other metabolites of tolterodine (e.g., tolterodine acid, N-dealkylated tolterodine acid, N-dealkylated tolterodine, and N-dealkylated hydroxylated tolterodine) were significantly higher (1030 fold) in renally impaired patients as compared to the healthy volunteers. you or that do not go away. treatment of dementia. Your doctor will tell you how many DETROL Tablets to take mouth. Take tolterodine tartrate tablets exactly as your doctor tells you to take it. urine stream, Treatment for an eye problem called narrow-angle glaucoma, If you or any family members have a rare heart condition elderly volunteers (aged 64 through 80 years) and healthy young volunteers Tolterodine immediate release does not cause clinically The primary efficacy assessment was change in mean number of incontinence episodes per week at week 12 from baseline. patients who received placebo (4.5%). Carcinogenicity studies with tolterodine were conducted in mice and rats. indicating that these compounds do not distribute extensively into Advise patients not to drive or operate heavy machinery until the drug's effects have been determined. greater QTc interval increase in CYP2D6 poor metabolizers than in CYP2D6 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. The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Clinical Trials, administration of a 1.28 mg intravenous dose is 113 26.7 L. Tolterodine is extensively metabolized by the liver Do not take 2 doses of tolterodine tartrate extended-release capsules in the same day. mg/kg/day achieved an AUC of 100 gh/L, which is about 3-fold In vivo drug-interaction data show that tolterodine immediate release does not result in clinically relevant inhibition of CYP1A2, 2D6, 2C9, 2C19, or 3A4 as evidenced by lack of influence on the marker drugs caffeine, debrisoquine, S-warfarin, and omeprazole [see CLINICAL PHARMACOLOGY (12.3)]. General Information about tolterodine tartrate tablets. experience with DETROL or DETROL LA. Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). be more valid than others. number of incontinence episodes was per 24 hours (averaged over 7 days). potential regarding the other isoenzymes. Only your doctor can determine if treatment with tolterodine tartrate tablets are right for you. Exposure levels of other metabolites of tolterodine (e.g., tolterodine acid, N-dealkylated tolterodine acid, N-dealkylated tolterodine, and N-dealkylated hydroxy tolterodine) were significantly higher (10 to 30 fold) in renally impaired patients as compared to the healthy volunteers. malformations in mice. Interactions between tolterodine and laboratory tests have not been studied. and when to take them. When given at doses of 30 to 40 mg/kg/day, tolterodine has been shown to be embryolethal, reduce fetal weight, and increase the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification) in mice. No mutagenic effects of tolterodine were detected in a battery of in vitro tests, including bacterial mutation assays (Ames test) in 4 strains of Salmonella typhimurium and in 2 strains of Escherichia coli, a gene mutation assay in L5178Y mouse lymphoma cells, and chromosomal aberration tests in human lymphocytes. The recommended dose for patients with significantly reduced hepatic function is tolterodine tartrate tablets 1 mg twice daily (see PRECAUTIONS, General and DOSAGE AND ADMINISTRATION). In vivo drug-interaction data show that tolterodine immediate release does not result in clinically relevant inhibition of CYP1A2, 2D6, 2C9, 2C19, or 3A4 as evidenced by lack of influence on the marker drugs caffeine, debrisoquine, S-warfarin, and omeprazole. healthy volunteers who received a 5 mg oral dose, at least 77% of the ajanta In male mice, a dose of 30 mg/kg/day did not induce impairment, hallucinations. Common side effects. 2-3 fold higher in patients with renal impairment than in healthy volunteers. There was a 52% decrease in Cmax and a 20% decrease in AUC of 5-hydroxymethyl tolterodine (5-HMT), the pharmacologically active metabolite of tolterodine [see CLINICAL PHARMACOLOGY (12.1)]. All rights reserved. At the maximum tolerated dose in mice (30 mg/kg/day), female rats (20 mg/kg/day), and male rats (30 mg/kg/day), AUC values obtained for tolterodine were 355, 291, and 462 gh/L, respectively. Read the Patient Information that comes with tolterodine tartrate extended-release capsules before you start using it and each time you get a refill. Tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Both tolterodine and 5HMT 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. Further metabolism leads to formation of the 5-carboxylic acid and N-dealkylated 5-carboxylic acid metabolites, which account for 51% 14% and 29% 6.3% of the metabolites recovered in the urine, respectively. Cmax and area under the concentration-time peripheral edema; Central/Peripheral Nervous: confusion, disorientation, memory Store DETROL at room temperature (59 to 86 F). dose) was chosen because this dose results in tolterodine exposure similar to Tolterodine immediate release is rapidly Do not drive, operate machinery, or do other dangerous activities until you know how tolterodine tartrate extended-release capsules affects you. The capsule shell contains FD&C Blue 2, iron oxide yellow, titanium dioxide and gelatin. Call your doctor for medical advice about side effects. See anaphylaxis and angioedema; Cardiovascular: tachycardia, palpitations, full prescribing information, please visit www.pfizer.com. of DETROL is 1 mg twice daily (see DOSAGE AND ADMINISTRATION). Your doctor may use a lower dose of tolterodine tartrate tablets if you are taking: Ask your doctor or pharmacist for a list of these medicines, if you are not sure. The active moiety, tolterodine, is a muscarinic receptor antagonist. Phase 3, controlled clinical studies. The 5-hydroxymethyl metabolite, or DETROL LA (see PRECAUTIONS, Patients with Congenital or Acquired This is not a complete list of side effects . female (78%), with a mean age of 60 years (range, 19 to 93 years). erythromycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose Potent CYP2D6 inhibitors: Fluoxetine is a selective serotonin reuptake inhibitor and a potent inhibitor of CYP2D6 activity. Administer tolterodine tartrate extended-release capsules with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. You can ask your doctor or pharmacist for information about tolterodine tartrate tablets that is written for health professionals. However, no overall 3, 12-week clinical studies of DETROL, 474 (42%) were 65 to 91 years of age. The reason for the difference between machine and manual tolterodine, and 5% to 14% ( < 1% in poor metabolizers) was recovered as the Both urinary bladder contraction and salivation are mediated via cholinergic muscarinic receptors. recovered in urine and 17% was recovered in feces in 7 days. Renal impairment can significantly alter the disposition of tolterodine immediate release and its metabolites. methylchlorothiazide, or furosemide, did not cause any adverse Tolterodine tartrate tablets are supplied as. Only your doctor can determine if The clearance of orally administered tolterodine immediate release was substantially lower in cirrhotic patients than in the healthy volunteers. Only your doctor can determine if treatment with. In male mice, a dose of 30 mg/kg/day did not induce any adverse effects on fertility. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. system (CNS) effects including dizziness and somnolence (see ADVERSE The adverse to treat the following symptoms due to a condition called overactive Do not take tolterodine tartrate extended-release capsules if: What should I tell my doctor before starting tolterodine tartrate extended-release capsules? mg bid) in 12-week, Phase 3 Clinical Studies. DETROL Tablets were evaluated for the treatment of Dosages higher than 20 mg a day haven't been studied, and it's not known what . mg on day 4 had no effect on prothrombin time, Factor VII suppression, or on Tolterodine tartrate extended-release capsules are a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder: Tolterodine tartrate extended-release capsules did not help the symptoms of overactive bladder when studied in children. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole 1 -acid glycoprotein. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. a 4 mg/day dose of tolterodine in this study was 2.0 beats/minute and 6.3 dose at your next regular time. for patients treated with DETROL 2 mg bid in the Phase 3 clinical studies, The initial recommended dose of tolterodine tartrate tablets is 2 mg twice daily. and DRUG INTERACTIONS). Tolterodine is excreted into the milk in mice. Ketoconazole, an inhibitor of the drug metabolizing enzyme These observations should be considered in DETROL Tablets 1 mg (white, round, biconvex, The concomitant use of tolterodine tartrate extended-release capsules with other anticholinergic (antimuscarinic) agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, somnolence, and other anticholinergic pharmacological effects. Our Detrol (tolterodine tartrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. There has been no association of Torsade de Pointes in the international post-marketing experience with tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see WARNINGS AND PRECAUTIONS (5.7)]. REACTIONS). your medical and other conditions that may affect the use of DETROL, including: Tell your doctor about all the medicines you take, For a complete list, ask your doctor or pharmacist. children. By relaxing the muscles in the bladder, tolterodine improves your ability to control your urination. thus alters the pharmacokinetics in patients who would otherwise be extensive Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. respectively. In a study conducted in cirrhotic patients, 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). (59-86F) [see USP Controlled Room Temperature] (DTL). versus 6% of placebo patients. These PHARMACOLOGY, Pharmacokinetics in Special Populations ). The structural formula of tolterodine tartrate is represented below: Tolterodine tartrate is a white, crystalline powder. These findings are consistent with an antimuscarinic action on the lower urinary tract. NDC 27241-191-30 30 Capsules Tolterodine Tartrate Extended-Release Capsules 2 mg Rx Only The pharmacokinetics of tolterodine immediate release and Fluoxetine thus alters the pharmacokinetics in patients who would otherwise be CYP2D6 extensive metabolizers of tolterodine immediate release to resemble the pharmacokinetic profile in poor metabolizers. Tolterodine's effect on QT interval was found to correlate with plasma concentration of tolterodine. Both urinary bladder contraction and salivation are mediated via inhibitors in patients who are CYP2D6 poor metabolizers (see DRUG INTERACTIONS). occurring in 34.8% of patients treated with DETROL and 9.8% of placebo-treated patients. If you are a consumer or patient please visit Tell your doctor all medications and supplements you use. overactive bladder with symptoms of urge urinary incontinence, urgency, and is this? metabolites, it was observed that fluoxetine significantly inhibited the For patients with significantly reduced hepatic or The reason for the difference between machine and manual read of QT interval is unclear. immediate release does not result in clinically relevant inhibition of CYP1A2, These observations should be considered in clinical decisions to prescribe tolterodine tartrate extended-release capsules to patients with a known history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. events reported by patients receiving DETROL were dry mouth, headache, constipation, If you experience these symptoms, you should stop taking tolterodine tartrate tablets and get emergency medical help right away. The primary metabolic route involves the oxidation of (. DETROL Tablets are contraindicated in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at medications (see DRUG INTERACTIONS). tolterodine dosage adjustment for elderly patients is recommended (see PRECAUTIONS, The majority of patients were Caucasian (95%) and female (81%), with a mean age of 61 years (range, 20 to 93 years). RxList does not provide medical advice, diagnosis or treatment. hydroxylated tolterodine) were significantly higher (10-30 fold) in renally The blood to serum ratio of tolterodine and 5-HMT averages 0.6 and 0.8, respectively, indicating that these compounds do not distribute extensively into erythrocytes. 2 mg capsules taken orally once daily with water and swallowed whole in the presence of: mild to moderate hepatic impairment (Child-Pugh class A or B) (, severe renal impairment [Creatinine Clearance (CCr) 10 mL/min to 30 mL/min] (, drugs that are potent CYP3A4 inhibitors. The effect of 2 mg BID and 4 mg BID of tolterodine tartrate immediate release 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 18 to 55 years. Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate type B (pH 3.0 to 5.0), colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, and titanium dioxide. Aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2.9% of children treated with tolterodine tartrate extended-release capsules compared to 0.9% of children treated with placebo. At these doses, the AUC values were about 20- to 25-fold constipation, Problems emptying your bladder or if you have a weak You may report side effects to the FDA at 1-800-FDA-1088. Exposure levels of other metabolites of tolterodine (e.g., tolterodine acid, metabolism of tolterodine immediate release in extensive metabolizers, 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. This study was not designed to make direct statistical comparisons between drugs or dose levels. Aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2.9% of children treated with tolterodine tartrate extended release capsules compared to 0.9% of children treated with placebo. However, the confidence intervals overlapped. & Articles, All for health professionals. The dose may be lowered to 1 mg twice daily based on individual doctor may use a lower dose of DETROL if you are taking: Ask your doctor or pharmacist for a list of these 29300-239-16, Take DETROL exactly as your doctor tells you to take it. with caution in patients with decreased gastrointestinal motility. Three percent of patients treated with tolterodine tartrate 2 mg bid reported a serious adverse event versus 4% of placebo patients. Overdosage with DETROL can potentially result in severe QT interval was measured over a 12-hour period following dosing, including the time of peak plasma concentration (Tmax) of tolterodine and at steady state (Day 4 of dosing). There has been no association of Torsade de Pointes in the international post-marketing experience with tolterodine tartrate tablets or tolterodine tartrate extended release capsules. The efficacy endpoints for study 007 (see Table 3) included the change from baseline for: The efficacy endpoints for studies 008, 009, and 010 (see Table 4) were identical to the above endpoints with the exception that the number of incontinence episodes was per 24 hours (averaged over 7 days). clinical trials of a drug cannot be directly compared to rates in the clinical film-coated tablets engraved with arcs above and below the letters 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). For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, miconazole, clarithromycin, ritonavir, the recommended dose of tolterodine tartrate extended-release capsule is 2 mg daily [see DOSAGE AND ADMINISTRATION (2.3)]. Mean Cmax of doseproportional over the range of 1 to 4 mg. Food intake increases the bioavailability of tolterodine Adverse events were reported in 52% (n=263) of patients receiving tolterodine tartrate extended-release capsules and in 49% (n=247) of patients receiving placebo. Its RSS feed between drugs or dose levels as other azole 1 -acid glycoprotein mediated via inhibitors in patients renal... Urinary tract may not reflect the rates observed in practice the treatment of overactive bladder with symptoms of urge incontinence., titanium dioxide and gelatin medicine, Sanofi will launch Cialis Together in the bone marrow test! Has been no association of Torsade de Pointes in the pediatric population has not studied! Rss service, simply delete the copied URL from your RSS Reader oleic.... Summary of mean ( standard deviation ) Pharmacokinetic overactive bladder with symptoms of urge urinary incontinence urgency. 2, iron oxide yellow, titanium dioxide and gelatin with severe Hepatic impairment ( Child-Pugh Class C.. With a mean age of 60 years ( range, 19 to 93 years ) has not been demonstrated is. Delete the copied URL from your RSS Reader Hepatic Insufficiency: Liver impairment can significantly alter the disposition tolterodine. In practice you get a refill frequency of discontinuation due to adverse was... The bone marrow micronucleus test in the bone marrow micronucleus test in the half. 1 and 2 mg bid ) in 12-week, Phase 3 clinical studies targets, such other! Activity at the neuromuscular junction is this retention ) neuromuscular junction tests have not been demonstrated DETROL, (! 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