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Tolterodine Tartrate (Tolterodine Tartrate)

Trade Name : Tolterodine Tartrate

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 1 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 1 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
  • This product contains tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). It has the following structural formula:
  • CHNO M.W. 475.6
  • Tolterodine tartrate is a white, crystalline 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.
  • Each tolterodine tartrate tablet, for oral administration, contains 1 mg or 2 mg of tolterodine tartrate. In addition, each tablet contains the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide.
  • Tolterodine is a competitive muscarinic receptor antagonist. 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 the 5-hydroxymethyl derivative, a major pharmacologically active metabolite. The 5-hydroxymethyl metabolite, which exhibits an antimuscarinic activity similar to that of tolterodine, contributes significantly to the therapeutic effect. Both tolterodine and the 5-hydroxymethyl metabolite 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.
  • Tolterodine tablets were evaluated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in four randomized, double-blind, placebo-controlled, 12 week studies. A total of 853 patients received tolterodine 2 mg twice daily and 685 patients received placebo. The majority of patients were Caucasian (95%) and female (78%), with a mean age of 60 years (range, 19 to 93 years). At study entry, nearly all patients perceived they had urgency and most patients had increased frequency of micturitions and urge incontinence. These characteristics were well balanced across treatment groups for the studies.
  • The efficacy endpoints for study 007 (see ) included the change from baseline for:
  • The efficacy endpoints for studies 008, 009, and 010 (see ) were identical to the above endpoints with the exception that the number of incontinence episodes was per 24 hours (averaged over 7 days).
  • SD = Standard Deviation
  • SD = Standard Deviation
  • Tolterodine tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
  • Tolterodine tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tablets, are metabolized to 5-hydroxymethyl tolterodine.
  • Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tablets. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tablets should be discontinued and appropriate therapy promptly provided.
  • No data
  • The Phase 2 and 3 clinical trial program for tolterodine tablets included 3071 patients who were treated with tolterodine (N = 2133) or placebo (N = 938). The patients were treated with 1, 2, 4, or 8 mg/day for up to 12 months. No differences in the safety profile of tolterodine were identified based on age, gender, race, or metabolism.
  • The data described below reflect exposure to tolterodine 2 mg BID in 986 patients and to placebo in 683 patients exposed for 12 weeks in five Phase 3, controlled clinical studies. 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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and approximating rates.
  • Sixty-six percent of patients receiving tolterodine 2 mg BID reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving tolterodine were dry mouth, headache, constipation, vertigo/dizziness, and abdominal pain. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and xerophthalmia are expected side effects of antimuscarinic agents.
  • Dry mouth was the most frequently reported adverse event for patients treated with tolterodine 2 mg BID in the Phase 3 clinical studies, occurring in 34.8% of patients treated with tolterodine and 9.8% of placebo-treated patients. One percent of patients treated with tolterodine discontinued treatment due to dry mouth.
  • The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Seven percent of patients treated with tolterodine 2 mg BID discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of tolterodine were dizziness and headache.
  • Three percent of patients treated with tolterodine 2 mg BID reported a serious adverse event versus 4% of placebo patients. Significant ECG changes in QT and QTc have not been demonstrated in clinical-study patients treated with tolterodine 2 mg BID. lists the adverse events reported in 1% or more of the patients treated with tolterodine 2 mg BID in the 12 week studies. The adverse events are reported regardless of causality.
  • The following events have been reported in association with tolterodine use in worldwide postmarketing experience: :u00a0anaphylaxis and angioedema; :u00a0tachycardia, palpitations, peripheral edema; :u00a0confusion, disorientation, memory impairment, hallucinations.
  • Reports of aggravation of symptoms of dementia (e.g., 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 postmarketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably determined.
  • A 27 month-old child who ingested 5 to 7 tolterodine tablets 2 mg was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered.
  • Overdosage with tolterodine 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 ,).
  • The initial recommended dose of tolterodine tartrate tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability. 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 is 1 mg twice daily (see , ;u00a0 , , and ).
  • Tolterodine Tartrate Tablets, 1 mg, are available as white, round, unscored, biconvex, film-coated tablets, debossed with u201c93u201d on one side and u201c0010u201d on the other side containing 1 mg tolterodine tartrate, packaged in bottles of 60 (NDC 0093-0010-06) and 500 (NDC 0093-0010-05) tablets.
  • Tolterodine Tartrate Tablets, 2 mg, are available as white, round, unscored, biconvex, film-coated tablets, debossed u201c93u201d on one side and u201c18u201d on the other side containing 2 mg tolterodine tartrate, packaged in bottles of 60 (NDC 0093-0018-06) and 500 (NDC 0093-0018-05) tablets.
  • PHARMACIST: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [See USP Controlled Room Temperature].
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In India By:
  • Cipla Ltd.
  • Goa, India
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. D 4/2015
  • PATIENT INFORMATION
  • Arrayn- TOLTERODINE (Tol-TER-oh-deen) TARTRATE (TAHR-trat) TABLETS
  • Read the Patient Information that comes with tolterodine tartrate tablets 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 tablets is right for you.
  • What are tolterodine tartrate tablets?
  • Tolterodine tartrate tablets 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 tablets?
  • Do not take tolterodine tartrate tablets if you:
  • What should I tell my doctor before starting tolterodine tartrate tablets?
  • Before starting tolterodine tartrate tablets, tell your doctor about all of your medical and other conditions that may affect the use of tolterodine tartrate tablets, including:
  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Other medicines can affect how your body handles tolterodine tartrate tablets. 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.
  • 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 tablets?
  • What should I avoid while taking tolterodine tartrate tablets?
  • Medicines like tolterodine tartrate tablets can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how tolterodine tartrate tablets affect you.
  • What are possible side effects of tolterodine tartrate tablets?
  • Tolterodine tartrate tablets 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 tablets and get emergency medical help right away.
  • The most common side effects with tolterodine tartrate tablets are:
  • Tell your doctor if you have any side effects that bother you or that do not go away.
  • These are not all the side effects with tolterodine tartrate tablets. For a complete list, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
  • How do I store tolterodine tartrate tablets?
  • Keep tolterodine tartrate tablets and all medicines out of the reach of children.
  • General information about tolterodine tartrate tablets
  • Medicines are sometimes prescribed for conditions that are not mentioned in the Patient Information leaflet. Only use tolterodine tartrate tablets the way your doctor tells you. Do not give tolterodine tartrate tablets to 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 tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about tolterodine tartrate tablets that is written for health professionals. For more information about tolterodine tartrate tablets, call Teva Pharmaceuticals Medical Affairs at 1-888-838-2872.
  • What are the ingredients in tolterodine tartrate tablets?
  • Active ingredients: tolterodine tartrate
  • Inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide.
  • Manufactured In India By:
  • Cipla Ltd.
  • Goa, India
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. B 4/2015
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Arrayn- 0010
  • Tolterodine Tartrate
  • Tablets, 1 mg
  • PHARMACIST: PLEASE DISPENSE
  • WITH ATTACHED PATIENTINFORMATION LEAFLET
  • Rx only
  • 60 TABLETS
  • TEVA
  • Arrayn- 0018
  • Tolterodine Tartrate
  • Tablets, 2 mg
  • PHARMACIST: PLEASE DISPENSE
  • WITH ATTACHED PATIENTINFORMATION LEAFLET
  • Rx only
  • 60 TABLETS
  • TEVA

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