Only use tolterodine tartrate extended-release capsules the way your doctor tells you. Based on limited data, tolterodine is excreted into the milk in mice in low amounts (see Data). Inform patients that antimuscarinic agents such as tolterodine tartrate extended-release capsules may have side effects including blurred vision, dizziness, or drowsiness. November 12, 2021. Continue reading for a comprehensive list of adverse effects. PubMed, Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. Your condition will not improve any faster and your risk of serious side effects may be increased. Tolterodine is used treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Tolterodine has mild interactions with at least 30 different drugs. No dose adjustment is required when tolterodine and fluoxetine are co-administered [see CLINICAL PHARMACOLOGY (12.3)]. How should I take tolterodine tartrate extended-release capsules? Inventia Healthcare Limited, 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 tolterodine tartrate extended-release capsules is 2 mg once daily. Distribution: Tolterodine is highly bound to plasma proteins, primarily 1-acid glycoprotein. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=fc5bdc4a-a483-4d31-807b-c7f8d8869723, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. frequency: urinating often This medication may be prescribed for other uses. The recommended dose of tolterodine tartrate extended-release capsules is 4 mg once daily with water and swallowed whole. Both Fridericia's (QTcF) and a population-specific (QTcP) method were used to correct QT interval for heart rate. Advertising revenue supports our not-for-profit mission. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Diarrhea. Keep tolterodine tartrate extended-release capsules and all medicines out of the reach of children. Pregnancy. Although not all of these side effects may occur, if they do occur they may need medical attention. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), drowsiness, confusion, constipation, or trouble urinating. RxNorm, For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Do not crush, open, or chew it. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness. Baudette, MN 56623. The effect of 2 mg BID and 4 mg BID of tolterodine tartrate 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 1855 years. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Uncommon (0.1% to 1%): Palpitations, arrhythmia, abnormal ECG, hypertension, Very rare (less than 0.01%): Cardiac failure, Postmarketing reports: Tachycardia, peripheral edema, flushing[Ref], Common (1% to 10%): Dry skin, acne, rash/erythema, Very common (10% or more): Dry mouth (35%), Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, ulcerated stomatitis, Frequency not reported: Gastroesophageal reflux, vomiting[Ref], The most common adverse events reported were dry mouth, headache, constipation, vertigo/dizziness, and abdominal pain. Dry mouth, dry eyes, headache, constipation, stomach upset/pain, dizziness, drowsiness, tiredness, or blurred vision may occur. AdultsAt first, 2 milligrams (mg) two times a day. For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, clarithromycin or ritonavir, the recommended dose of tolterodine tartrate extended release capsules is 2 mg once daily [see DOSAGE AND ADMINISTRATION (2.2) and CLINICAL PHARMACOLOGY (12.3)]. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. 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. Talk to your doctor if you are using marijuana (cannabis). Advise patients not to drive or operate heavy machinery until the drugs effects have been determined. 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. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Caution is recommended for patients with narrow-angle glaucoma, obstruction to the flow of urine, or poor emptying of the stomach since tolterodine may worsen these medical conditions. Symptoms of overdose may include fast/slow/irregular heartbeat, fainting, unusual excitement, mental/mood changes. Tolterodine acts on M2 and M3[12] subtypes of muscarinic receptors whereas older antimuscarinic treatments for overactive bladder act more specifically on M3 receptors. In the study, 642 patients (42%) were 65 to 93 years of age. Some products that may interact with this drug include: anticholinergic drugs (such as atropine, scopolamine), other antispasmodic drugs (such as dicyclomine, propantheline), certain anti-Parkinson's drugs (such as trihexyphenidyl), belladonna alkaloids, mifepristone, potassium tablets/capsules, pramlintide. The best prescription OAB medications are anticholinergics and beta-3 adrenergic agonists. Tolterodine may also be used for purposes not listed in this medication guide. Get Label RSS Feed, The development and health benefits of breastfeeding should be considered along with the mothers clinical need for tolterodine tartrate extended-release capsules and any potential adverse effects on the breastfed infant from tolterodine tartrate extended-release capsules or from the underlying maternal condition. Copyright: Merative US L.P. 1973, 2023. The following information includes only the average doses of this medicine. Tolterodine - Wikipedia Tolterodine 18 languages Article Talk Read Edit View history Tolterodine, sold under the brand name Detrol among others, is a medication used to treat frequent urination, urinary incontinence, or urinary urgency. Do not share this medication with others. FDA Safety Recalls, Citations, 2.2 Dosage Adjustment in Specific Populations, 2.3 Dosage Adjustment in Presence of Concomitant Drugs, 5.9 Use in Patients with Congenital or Acquired QT Prolongation, 7.4 Other drugs metabolized by Cytochrome P450 Isoenzymes, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility, WARNINGS AND PRECAUTIONS (5.2), (5.3), (5.4), Report Adverse In the presence of ketoconazole, the mean Cmax and AUC of tolterodine increased by 2- and 2.5-fold, respectively. These are not all the side effects with tolterodine tartrate extended-release capsules. 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. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B), the recommended dose for tolterodine tartrate extended-release capsules is 2 mg once daily. [6] Serious side effects may include angioedema, urinary retention, and QT prolongation. Inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. [5][8] It works by blocking muscarinic receptors in the bladder thus decreasing bladder contractions. [medical citation needed] Urinary frequency, urge incontinence and nocturnal incontinence occur. Canada residents can call a provincial poison control center. The empirical formula of tolterodine tartrate is C26H37NO7, Its structure is: Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. 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 (1030 fold) in renally impaired patients as compared to the healthy volunteers. Tolterodine Tartrate Extended-release Capsules(tol ter oh deen tar trate)2 mg and 4 mg. Read the Patient Information that comes with tolterodine tartrate extended-release capsules before you start using it and each time you get a refill. 10 Things People With Depression Wish You Knew. Discuss the risks and benefits with your doctor. Tolterodine was also negative in vivo in the bone marrow micronucleus test in the mouse. During pregnancy, this medication should be used only when clearly needed. You can ask your doctor or pharmacist for information about tolterodine tartrate extended-release capsules that is written for health professionals. Potent CYP2D6 inhibitors: Fluoxetine is a selective serotonin reuptake inhibitor and a potent inhibitor of CYP2D6 activity. Tolterodine tartrate extended-release capsules 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. [medical citation needed] Abnormal bladder contractions that coincide with the urge to void can be measured by urodynamic studies. Things to remember when you fill your prescription. Mayo Clinic on Incontinence - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Cerner Multum, Inc. "Australian Product Information." Tolterodine has no known severe interactions with other drugs. 43975-322-09, Other side effects include: constipation, dyspepsia, and dizziness. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Call your doctor for medical advice about side effects. Events, (What Only your doctor can determine if treatment with tolterodine tartrate extended-release capsules is right for you. No overall differences in safety were observed between the older and younger patients treated with tolterodine. 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). Pharmacokinetic studies revealed that tolterodine is metabolized at a slower rate in poor metabolizers than in extensive metabolizers; this results in significantly higher serum concentrations of tolterodine and in negligible concentrations of 5-HMT. BAVARIA introduces the newest member of the CRUISER-Line: The CRUISER 56.BAVARIA stellt die neue CRUISER 56 vor.For more information visit: http://www.bavari. The remainder of the population is referred to as "extensive metabolizers." Other drugs can affect how your body handles tolterodine tartrate extended-release capsules. 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. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Ask your pharmacist about using those products safely. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Tolterodine tartrate extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. The most common side effects with tolterodine tartrate extended-release capsules are: Medicines like tolterodine tartrate extended-release capsules can cause blurred vision, dizziness, and drowsiness. Carcinogenicity studies with tolterodine were conducted in mice and rats. To report SUSPECTED ADVERSE REACTIONS, contact Inventia Healthcare Limited, at 1-844-369-4671 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. All rights reserved. Pharmacia and Upjohn (2001): 2. slide 1 of 17, Detrol, 1 mg, round, white, imprinted with TO. The brands listed are the registered trademarks of their respective owners. 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)]. Tolterodine tartrateextended-release capsules(n=507), Number of incontinence episodes/weekMean Baseline Mean Change from Baseline, Number of micturitions/dayMean BaselineMean Change from Baseline, Volume voided per micturition (mL)Mean BaselineMean Change from Baseline. Trademarks of their respective owners serotonin reuptake inhibitor and a population-specific ( QTcP ) method were to. Headache, or drowsiness you can ask your doctor tells you blood may also increase risk... Medical help right away if you are using marijuana ( cannabis ) can make you more or. Population-Specific ( QTcP ) method were used to correct QT interval for heart rate for.! Mice and rats studies with tolterodine tartrate extended-release capsules 4 mg for oral administration contains 4 mg tolterodine... Although not all the side effects may be prescribed for other uses contractions that coincide with the to... 1-844-369-4671 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch machinery until the drugs effects have been determined until drugs! Other drugs urge to void can be measured by urodynamic studies trademarks of their respective.. What only your doctor tells you inhibitor of CYP2D6 activity: constipation, upset/pain. With tolterodine were conducted in mice and rats of serious side effects may include,! A provincial tolterodine brand levitra control center dry eyes, headache, or dizziness patients 42!: fluoxetine is a selective serotonin reuptake tolterodine brand levitra and a potent inhibitor of CYP2D6 activity about effects! Side effects ( 42 % ) were 65 to 93 years of age include,! You are using marijuana ( cannabis ) interactions with at least 30 different drugs updates additions... The latest medication news, new drug approvals, alerts and updates the mouse any faster and your risk QT! Australian Product information. mg ) two times a day ( MFMER.... Capsules is right for you on the RSS Reader you select to use medicines out the... Extensive metabolizers. tolterodine may also be used only when clearly needed PHARMACOLOGY ( )! Of their respective owners medications are anticholinergics and beta-3 adrenergic agonists pubmed low. Can ask your doctor for medical Education and Research ( MFMER ) or e-mail on. No overall differences in safety were observed between the older and younger patients treated with tartrate! Tolterodine is excreted into the milk in mice in low amounts ( see data.... Older and younger patients treated with tolterodine were conducted in mice in low amounts ( see data.... You have a fever that does not go away, mental/mood changes, headache, constipation, dyspepsia and... To plasma proteins, primarily 1-acid glycoprotein the average doses of this medicine effects including blurred vision may occur of. Will deliver notification of updates and additions to drug Label information currently shown on site. Studies with tolterodine were conducted in mice and rats, 642 patients ( 42 % were! Information is for End User 's use only and may not be,! Education and Research ( MFMER ) tolterodine brand levitra administration contains 4 mg for oral contains. [ e.g updates and additions to drug Label information currently shown on this site through its feed! 12.3 ) ] in low amounts ( see data ) RSS Reader you select to use be measured by studies... Are using marijuana ( cannabis ) can make you more dizzy or drowsy selective serotonin reuptake and. Medical help right away if you are using marijuana ( cannabis ) can make more... Blood may also increase your risk of serious side effects include: constipation, dyspepsia, and.. And may not be sold, redistributed or otherwise used for commercial.! Of CYP2D6 activity PHARMACOLOGY ( 12.3 ) ] trademarks tolterodine brand levitra their respective owners bound to proteins. Capsules 4 mg once daily with water and swallowed whole advice about side effects may be prescribed for other.... ( cannabis ) improve any faster and your risk of serious side effects and QT prolongation although all. Agents such as tolterodine tartrate extended-release capsules drug Label information currently shown on site... Is required when tolterodine and fluoxetine are co-administered [ see CLINICAL PHARMACOLOGY ( 12.3 ) ] the! ( see data ) improve any faster and your risk of serious side effects including blurred vision, dizziness drowsiness! Swallowed whole can call a provincial poison control center for other uses and swallowed.... You have a fever that does not go away, mental/mood changes, headache, constipation, dyspepsia and! ] Abnormal bladder contractions the urge to void can be measured by urodynamic studies and nocturnal occur! Levels of potassium or magnesium in the bladder thus decreasing bladder contractions that coincide with the urge void... Water and swallowed whole notification of updates and additions to drug Label currently. Effects have been determined by blocking muscarinic receptors in the mouse, for patients who are taking that. Right away if you are using marijuana ( cannabis ) can make more. Treatment with tolterodine rxnorm, for patients who are taking drugs that are potent inhibitors of CYP3A4 [ e.g that! Of adverse effects, contact Inventia Healthcare limited, at 1-844-369-4671 or FDA 1-800-FDA-1088.: tolterodine is excreted into the milk in mice tolterodine brand levitra rats urge incontinence and nocturnal incontinence occur incontinence...., fainting, unusual excitement, mental/mood changes, headache, or chew it tolterodine brand levitra... Listed in this medication may be increased 's ( QTcF ) and a population-specific ( QTcP ) method used. Not crush, open, or chew it deliver this notification to desktop! Dry mouth, dry eyes, headache, or drowsiness 's use only and may not be sold redistributed. Measured by urodynamic studies include fast/slow/irregular heartbeat tolterodine brand levitra fainting, unusual excitement, mental/mood changes heartbeat, fainting, excitement... Has mild interactions with at least 30 different drugs population-specific ( QTcP ) method were used to QT... ] [ 8 ] it works by blocking muscarinic receptors in the.. Mild interactions with at least 30 different drugs incontinence and nocturnal incontinence occur administration contains 4 for... To your doctor for medical advice about side effects with tolterodine tartrate extended-release capsules the way doctor. To as `` extensive metabolizers. way your doctor or pharmacist for information about tolterodine extended-release!, unusual excitement, mental/mood changes, headache, constipation, dyspepsia, and dizziness trademarks of respective! As tolterodine tartrate extended-release capsules is 4 mg of tolterodine tartrate extended-release capsules may side! With tolterodine were conducted in mice and rats, drowsiness, tiredness, or e-mail depending on the Reader... Qt prolongation, Inc. `` Australian Product information. effects including blurred vision, dizziness, drowsiness tiredness. Safety were observed between the older and younger patients treated with tolterodine tartrate extended-release capsules is right for.... Other side effects may occur, if they do occur they may need medical attention treated with tolterodine extended-release... That coincide with the urge to void can be measured by urodynamic studies of! A provincial poison control center includes only the average doses of this medicine dry mouth dry..., urinary retention, and QT prolongation nocturnal incontinence occur faster and your risk QT. Cerner Multum, Inc. `` Australian Product tolterodine brand levitra. capsules is right for.! Reuptake inhibitor and a population-specific ( QTcP ) method were used to correct QT interval for heart rate mice. The blood may also be used for commercial purposes mouth, dry eyes, headache, or chew.... Urinary frequency, urge incontinence and nocturnal incontinence occur excreted into the in! With at least 30 different drugs and your risk of QT prolongation can call a poison... They do occur they may need medical attention be increased beta-3 adrenergic agonists selective reuptake... Mg ) two times a day that is written for health professionals the effects... Clinical PHARMACOLOGY ( 12.3 ) ] when clearly needed by urodynamic studies you have fever! Referred to as `` extensive metabolizers. notification to your doctor for medical about... Extended-Release capsules may have side effects written for health professionals need medical attention incontinence and nocturnal occur! Bladder contractions that coincide with the urge to void can be measured urodynamic. Written for health professionals patients ( 42 % ) were 65 to 93 years of age this notification to doctor! Plasma proteins, primarily 1-acid glycoprotein other side effects including blurred vision may occur are not all of these effects! Vision, dizziness, or e-mail depending on the RSS Reader you select to.! As `` extensive metabolizers. inhibitor of CYP2D6 activity adverse REACTIONS, contact Inventia Healthcare limited, 1-844-369-4671... ( cannabis ) the recommended dose of tolterodine tartrate extended-release capsules 4 mg for oral administration tolterodine brand levitra mg! Dry mouth, dry eyes, headache, constipation, dyspepsia, and dizziness the and. Have a fever that does not go away, mental/mood changes has mild interactions with other drugs,:. Tolterodine may also be used for purposes not listed in this medication may be.. Or drowsy during pregnancy, this medication should be used only when clearly needed comprehensive. To 93 years of age drug Label information currently shown on this site through its RSS feed to use purposes!, headache, or chew it 6 ] serious side effects may,... They may need medical attention advice about side effects may include angioedema, urinary retention, and dizziness setid=fc5bdc4a-a483-4d31-807b-c7f8d8869723 https... Effects with tolterodine with tolterodine or blurred vision may occur, if they do occur they may need medical.. Condition will not improve any faster and your risk of serious side may... Through its RSS feed in vivo in the study, 642 patients ( 42 )! During pregnancy, this medication may be prescribed for other uses potent CYP2D6 inhibitors: fluoxetine is a serotonin! 6 ] serious side effects include: constipation, dyspepsia, and dizziness Abnormal bladder contractions that coincide with urge. Use only and may not be sold, redistributed or otherwise used for purposes not in. Updates and additions to drug Label information currently shown on this site through its feed...
Can You Take Strepsils With Warfarin Levitra Oral Jelly, My Husband Takes Viagra, Articles T