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Tolterodine Tartrate (Tolterodine Tartrate)

Trade Name : Tolterodine Tartrate

Teva Pharmaceuticals USA, Inc.

CAPSULE, EXTENDED RELEASE

Strength 2 mg/1

TOLTERODINE TARTRATE Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tolterodine Tartrate (Tolterodine Tartrate) which is also known as Tolterodine Tartrate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2 mg/1 per ml. Read more

Tolterodine Tartrate (Tolterodine Tartrate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [].
  • Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ()
  • No data
  • 4 mg capsules taken orally once daily with water and swallowed whole. ()
  • 2 mg capsules taken orally once daily with water and swallowed whole in the presence of:n
  • Tolterodine tartrate extended-release capsules are not recommended for use in patients with CCr <10 mL/min. ()
  • Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). ()
  • The 2 mg capsules are light green with u201c7163u201d imprinted on the body and u201cTEVAu201d imprinted on the cap.
  • The 4 mg capsules are aqua blue with u201c7164u201d imprinted on the body and u201cTEVAu201d imprinted on the cap.
  • Capsules: 2 mg and 4 mg ()
  • Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. 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 [].
  • Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. 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. ()
  • No data
  • Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate extended-release capsules. ()
  • Urinary Retention: use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ()
  • Gastrointestinal Disorders: use caution in patients with gastrointestinal obstructive disorders or decreased gastrointestinal motility because of the risk of gastric retention. ()
  • Controlled Narrow-Angle Glaucoma: use caution in patients being treated for narrow-angle glaucoma. ()
  • Central Nervous System Effects: Somnolence has been reported with tolterodine tartrate extended-release capsules. Advise patients not to drive or operate heavy machinery until they know how tolterodine tartrate extended-release capsules affect them ()
  • Myasthenia Gravis: use caution in patients with myasthenia gravis. ()
  • QT Prolongation: consider observations from the thorough QT study 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. ()
  • 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 u22654% and >placebo) were dry mouth, headache, constipation, and abdominal pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Potent CYP3A4 Inhibitors: Coadministration may increase systemic exposure to tolterodine tartrate extended-release capsules. Reduce tolterodine tartrate extended-release capsules dose to 2 mg once daily. ()
  • Other Anticholinergics (antimuscarinics): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects. ()
  • No data
  • Renal Impairment:
  • Hepatic Impairment:
  • Overdosage with tolterodine tartrate extended-release 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 [].
  • 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.
  • Tolterodine Tartrate Extended-Release Capsules contain Tolterodine Tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of Tolterodine Tartrate, USP is ()-,-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine -hydrogen tartrate. The structural formula of Tolterodine Tartrate, USP is:
  • CHNOu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0M.W. 475.6
  • Tolterodine Tartrate, USP is a white to creamy powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3.
  • Tolterodine Tartrate Extended-Release Capsules for oral administration contains 2 mg or 4 mg of Tolterodine Tartrate, USP. Inactive ingredients include: ethylcellulose, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, propylene glycol, shellac glaze, sugar spheres (which contain sucrose and corn starch), titanium dioxide, and triethyl citrate. Additionally, the 2 mg strength contains D&C yellow 10 and FD&C green 3; the 4 mg strength contains brilliant blue FCF-FD&C blue 1.
  • No data
  • 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 to 9 times, 7 times, and 11 times the clinical exposure to the pharmacologically active components of tolterodine tartrate extended-release capsules (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 tests, including bacterial mutation assays (Ames test) in 4 strains of and in 2 strains of a gene mutation assay in L5178Y mouse lymphoma cells, and chromosomal aberration tests in human lymphocytes. Tolterodine was also negative in the bone marrow micronucleus test in the mouse.
  • In female mice treated for 2 weeks before mating and during gestation with 20 mg/kg/day (about 9 to 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.
  • Tolterodine tartrate extended-release capsules, 2 mg were evaluated in 29 patients in a Phase 2 dose-effect study. Tolterodine tartrate extended-release capsules, 4 mg were 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 tolterodine tartrate extended-release capsules, 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 tolterodine tartrate extended-release capsules 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 tolterodine tartrate extended-release capsules are summarized in .
  • Tolterodine Tartrate Extended-Release Capsules are available as follows:
  • 2 mg: A hard gelatin capsule with a light green opaque cap and body, filled with white to off-white pellets, imprinted on body with u201c7163u201d and cap with u201cTEVAu201d in bottles of 30 (NDC 0093-7163-56), 90 (NDC 0093-7163-98), and 500 (NDC 0093-7163-05).
  • 4 mg: A hard gelatin capsule with an aqua blue opaque cap and body, filled with white to off-white pellets, imprinted on body with u201c7164u201d and cap with u201cTEVAu201d in bottles of 30 (NDC 0093-7164-56), 90 (NDC 0093-7164-98), and 500 (NDC 0093-7164-05).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from light.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Antimuscarinic Effects
  • Inform patients that antimuscarinic agents such as tolterodine tartrate extended-release capsules may have side effects including blurred vision, dizziness, or drowsiness. u00a0Advise patients not to drive, operate machinery, or do other potentially dangerous activities until they know how tolterodine tartrate extended-release capsules affects them.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777600, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. B 10/2018
  • Tolterodine (tol TER ah den) Tartrate Extended-Release Capsules
  • Read the Patient Information that comes with tolterodine tartrate extended-release capsules before you start using them 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 tolterodine tartrate extended-release capsules is right for you.
  • What are tolterodine tartrate extended-release capsules?
  • Tolterodine tartrate extended-release capsules are a prescription medicine for used to treat the following symptoms due to a condition called :
  • Tolterodine tartrate extended-release capsules 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 tolterodine tartrate extended-release capsules?
  • Do not take tolterodine tartrate extended-release capsules if:
  • What should I tell my doctor before starting tolterodine tartrate extended-release capsules?
  • Before starting tolterodine tartrate extended-release capsules, 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 tolterodine tartrate extended-release capsules. Your doctor may use a lower dose of tolterodine tartrate extended-release capsules if you are taking:
  • 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 tolterodine tartrate extended-release capsules?
  • What are possible side effects of tolterodine tartrate extended-release capsules?
  • Tolterodine tartrate extended-release capsules 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 tolterodine tartrate extended-release capsules and get emergency medical help right away.
  • 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.
  • Do not drive, operate machinery, or do other dangerous activities until you know how tolterodine tartrate extended-release capsules affect 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 tolterodine tartrate extended-release capsules. For a complete list, ask your doctor or pharmacist.
  • How do I store tolterodine tartrate extended-release capsules?
  • General Information about tolterodine tartrate extended-release capsules
  • Medicines are sometimes prescribed for conditions that are not in the patient information leaflet. Only use tolterodine tartrate extended-release capsules the way your doctor tells you. Do not share them with other people even if they have the same symptoms you have. They may harm them.
  • This leaflet summarizes the most important information about tolterodine tartrate extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about tolterodine tartrate extended-release capsules that is written for health professionals. You can also call 1-888-838-2872.
  • What are the ingredients in tolterodine tartrate extended-release capsules?
  • Active ingredient: tolterodine tartrate
  • Inactive ingredients: ethylcellulose, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, propylene glycol, shellac glaze, sugar spheres (which contain sucrose and corn starch), titanium dioxide, and triethyl citrate. Additionally, the 2 mg strength contains D&C yellow 10 and FD&C green 3; the 4 mg strength contains brilliant blue FCF-FD&C blue 1.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777600, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. B 10/2018
  • No data
  • No data

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