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Tolterodine Tartrate (Detrol La)

Trade Name : Detrol LA

Pharmacia and Upjohn Company LLC

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 (Detrol La) which is also known as Detrol LA and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 2 mg/1 per ml. Read more

Tolterodine Tartrate (Detrol La) 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.

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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.

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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
  • DETROL LA Capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
  • DETROL LA is 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
  • DETROL LA is not recommended for use in patients with CCr <10 mL/min. ()
  • DETROL LA is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). ()
  • The 2 mg capsules are blue-green with symbol and 2 printed in white ink.
  • The 4 mg capsules are blue with symbol and 4 printed in white ink.
  • Capsules: 2 mg and 4 mg ()
  • 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 tolterodinen
  • 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. ()
  • No data
  • Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETROL LA. ()
  • 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 Detrol LA. Advise patients not to drive or operate heavy machinery until they know how Detrol LA affects them ().
  • Myasthenia Gravis: use caution in patients with myasthenia gravis. ()
  • QT Prolongationconsider observations from the thorough QT study in clinical decisions to prescribe DETROL LA 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 Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 orn
  • No data
  • Potent CYP3A4 Inhibitors: Coadministration may increase systemic exposure to DETROL LA. Reduce DETROL LA 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 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.
  • 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.
  • DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is CHNO. Its structure is:
  • Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKvalue 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.
  • DETROL LA 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2.
  • DETROL LA 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&C Blue #2.
  • Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.
  • 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 6u20139 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 oftests, including bacterial mutation assays (Ames test) in 4 strains ofand in 2 strains ofa gene mutation assay in L5178Y mouse lymphoma cells, and chromosomal aberration tests in human lymphocytes. Tolterodine was also negativein 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 9u201312 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.
  • 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.
  • DETROL LA Capsules are supplied as follows:
  • Store at 20u00b0u201325u00b0C (68u00b0u201377u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F) [see USP Controlled Room Temperature]. Protect from light.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Antimuscarinic Effects
  • Inform patients that antimuscarinic agents such as DETROL LA may have side effects including blurred vision, dizziness, or drowsiness. Advise patients not to drive, operate machinery, or do other potentially dangerous activities until they know how DETROL LA affects them.
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0256-11.0
  • Arrayn- DE-trol el-ay)(tolterodine tartrate extended release capsules)
  • 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 forused to treat the following symptoms due to a condition called:
  • 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:
  • 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:
  • 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?
  • 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 visit www.DETROLLA.com on the Internet, or call 1-888-4-DETROL (1-888-433-8765).
  • 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.
  • This product's label may have been updated. For current full prescribing information, please visit .
  • LAB-0312-8.0Revised July 2018
  • PRINCIPAL DISPLAY PANEL - 30 Capsule 2 mg Bottle Label
  • NDC 0009-5190-01
  • 30 Capsulesn- Rx only
  • Detroln n- LA
  • 2 mg
  • Pfizern- Distributed byn- Pharmacia & Upjohn Co
  • PRINCIPAL DISPLAY PANEL - 2 mg Capsule Dose Foil Pack
  • Detroln- LA
  • 2 mg
  • Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017
  • 13803100
  • PRINCIPAL DISPLAY PANEL - 2 mg Capsule Unit Dose Carton
  • UNIT DOSE
  • Pfizer
  • Detroln- LA
  • 2 mg
  • For in-institution use only
  • 100 Capsules n n
  • PRINCIPAL DISPLAY PANEL - 30 Capsule 4 mg Bottle Label
  • NDC 0009-5191-01
  • 30 Capsulesn- Rx only
  • Detroln n- LA
  • 4 mg
  • Pfizern- Distributed byn- Pharmacia & Upjohn Co
  • PRINCIPAL DISPLAY PANEL - 4 mg Capsule Dose Foil Pack
  • Detroln- LA
  • 4 mg
  • Pharmacia & Upjohn CoDiv of Pfizer Inc, NY, NY 10017
  • 13802700
  • PRINCIPAL DISPLAY PANEL - 4 mg Capsule Unit Dose Carton
  • UNIT DOSE
  • Pfizer
  • Detroln- LA
  • 4 mg
  • For in-institution use only
  • 100 Capsules n n
  • PRINCIPAL DISPLAY PANEL - 4 mg Capsule Sample Dose Pack
  • NDC 0009-5191-99
  • Detroln- LAn- tolterodine tartrate extended release capsules
  • 4 mg
  • Detroln- LAn- tolterodine tartrate extended release capsules
  • 4 mg
  • PROFESSIONALSAMPLE u2013NOT FOR SALE
  • Protect from light
  • Detroln- LAn- tolterodine tartrate extended release capsules
  • 4 mg
  • Manufactured by:Pfizer Pharmaceuticals LLC, Puerto Rico
  • Pfizern- Distributed byn- Pharmacia & Upjohn Co
  • 11604800
  • LotExp
  • PRINCIPAL DISPLAY PANEL - 4 mg Capsule Sample Carton
  • SEE ENCLOSED EDUCATIONAL BROCHURE FOR MORE INFORMATION
  • PROFESSIONAL SAMPLE u2013 NOT FOR SALE
  • NDC 0009-5191-99 Rx only
  • Arrayn- Array
  • 4 mg
  • FOR FREE INFORMATION, CALL 1-888-846-9034 OR VISIT OUR WEB SITE www.detrolLA.com

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