Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Tolterodine Tartrate Extended-Release Capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14) ] .
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
The 2 mg capsules are opaque light green with “ ”on the cap and “132” on the body in black ink. The 4 mg capsules are opaque powder blue with “ ” on the cap and “131” on the body in black ink.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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 [see WARNINGS AND PRECAUTIONS (5.2) , (5.3) , (5.4) ].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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.
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
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 [see WARNINGS AND PRECAUTIONS (5.9) and CLINICAL PHARMACOLOGY (12.2) ] . 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.
11 DESCRIPTION
DESCRIPTION SECTION
Tolterodine Tartrate Extended-Release Capsules, USP 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 C 26 H 37 NO 7 , . Its structure is: Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK a 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 capsule contains 2 mg or 4 mg of tolterodine tartrate with the following inactive ingredients: ethylcellulose, hypromellose, medium-chain triglycerides, oleic acid, sugar spheres (composed of corn starch and sucrose) and talc. The capsule shell contains FD&C Blue No.1, FD&C Red No.40 (4 mg), gelatin, titanium dioxide and ferric oxide yellow (2 mg). The imprinting ink contains ferrosoferric oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
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 Table 4. Table 4. 95% Confidence Intervals (CI) for the Difference between Tolterodine Tartrate Extended-Release Capsules (4 mg daily) and Placebo for Mean Change at Week 12 from Baseline * Tolterodine Tartrate Extended-Release Capsules (n=507) Placebo (n=508) † Treatment Difference, vs. Placebo (95% CI) Number of incontinence episodes/week Mean Baseline 22.1 23.3 -4.8 ‡ Mean Change from Baseline –11.8 (SD 17.8) –6.9 (SD 15.4) (–6.9, –2.8) Number of micturitions/day Mean Baseline 10.9 11.3 -0.6‡ Mean Change from Baseline –1.8 (SD 3.4) –1.2 (SD 2.9) (–1.0, –0.2) Volume voided per micturition (mL) Mean Baseline 141 136 20‡ Mean Change from Baseline 34 (SD 51) 14 (SD 41) (14, 26) SD=Standard Deviation. * Intent-to-treat analysis. † 1 to 2 patients missing in placebo group for each efficacy parameter. ‡ The difference between tolterodine tartrate extended-release capsules and placebo was statistically significant.
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Tolterodine Tartrate Extended-Release Capsules, USP are supplied as follows: The 2 mg capsule with opaque light green cap and body, imprinted with “ ” on the cap and “132” on the body in black ink, containing white to off-white pellets. Bottles of 30 capsules with child-resistant closure, NDC 70436-160-04 Bottles of 90 capsules with child-resistant closure, NDC 70436-160-06 Bottles of 500 capsules, NDC 70436-160-02 The 4 mg capsule with opaque powder blue cap and body, imprinted with “ ” on the cap and “131” on the body in black ink, containing white to off-white pellets. Bottles of 30 capsules with child-resistant closure, NDC 70436-161-04 Bottles of 90 capsules with child-resistant closure, NDC 70436-161-06 Bottles of 500 capsules, NDC 70436-161-02
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Distributed by: Slate Run Pharmaceuticals, LLC Columbus, Ohio 43215 Rev. 09/2025 10000227/04
SPL PATIENT PACKAGE INSERT SECTION
SPL PATIENT PACKAGE INSERT SECTION
PATIENT INFORMATION Tolterodine Tartrate Extended-Release Capsules (tol-TER-oh-deen TAR-trate) Read the Patient Information that comes with tolterodine tartrate extended-release capsules 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 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 adults used to treat the following symptoms due to a condition called overactive bladder : Having a strong need to urinate with leaking or wetting accidents (urge urinary incontinence). Having a strong need to urinate right away (urgency). Having to urinate often (frequency). 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: You have trouble emptying your bladder (also called “urinary retention”). Your stomach empties slowly (also called “gastric retention”). You have an eye problem called “uncontrolled narrow-angle glaucoma”. You are allergic to tolterodine tartrate extended-release capsules or to any of its ingredients. See the end of this leaflet for a complete list of ingredients. You are allergic to TOVIAZ ® (fesoterodine fumarate), which contains fesoterodine. 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: Have any stomach or intestinal problems. Have trouble emptying your bladder or you have a weak urine stream. Have an eye problem called narrow-angle glaucoma. Have liver problems. Have kidney problems. Have a condition called myasthenia gravis. Or any family members have a rare heart condition called QT prolongation (long QT syndrome). Are pregnant or trying to become pregnant. It is not known if tolterodine tartrate extended-release capsules could harm your unborn baby. Are breastfeeding. It is not known if tolterodine tartrate extended-release capsules pass into your milk and if it can harm your child. 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: Certain medicines for fungus or yeast infections such as Nizoral ® (ketoconazole), Sporanox ® (itraconazole), or Monistat ® (miconazole). Certain medicines for bacteria infections such as Biaxin ® (clarithromycin). Certain medicines for treatment of HIV infection such as Norvir ® (ritonavir), Invirase ® (saquinavir), Reyataz ® (atazanavir). Sandimmune ® (cyclosporine) or Velban ® (vinblastine). 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? Take tolterodine tartrate extended-release capsules exactly as prescribed. Your doctor will prescribe the dose that is right for you. Do not change your dose unless told to do so by your doctor. Take tolterodine tartrate extended-release capsules once a day with liquid. Swallow the whole capsule. Tell your doctor if you cannot swallow a capsule. Tolterodine tartrate extended-release capsules can be taken with or without food. Take tolterodine tartrate extended-release capsules the same time each day. If you miss a dose of tolterodine tartrate extended-release capsules, begin taking tolterodine tartrate extended-release capsules again the next day. Do not take 2 doses of tolterodine tartrate extended-release capsules in the same day. If you took more than your prescribed dose of tolterodine tartrate extended-release capsules, call your doctor or poison control center, or go to the hospital emergency room. 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: Dry mouth Headache Constipation Stomach pain 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? Store tolterodine tartrate extended-release capsules at room temperature, 20° to 25°C (68° to 77°F); brief periods permitted between 15° to 30°C (59° to 86°F). Protect from light. Keep in a dry place. Keep tolterodine tartrate extended-release capsules and all medicines out of the reach of children. 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 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 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. For more information you can call Slate Run Pharmaceuticals, LLC at 1-888-341-9214. What are the ingredients in tolterodine tartrate extended-release capsules? Active ingredients: tolterodine tartrate Inactive ingredients: ethylcellulose, hypromellose, medium-chain triglycerides, oleic acid, sugar spheres (composed of corn starch and sucrose) and talc. The capsule shell contains FD&C Blue No.1, FD&C Red No.40 (4 mg), gelatin, titanium dioxide and ferric oxide yellow (2 mg). The imprinting ink contains ferrosoferric oxide, potassium hydroxide and shellac. For additional copies of the Medication Guide, please visit www.slaterunpharma.com/products/ . Distributed by: Slate Run Pharmaceuticals, LLC Columbus, Ohio 43215 Rev. 09/2025
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 30 Capsules 2 mg Bottle Label NDC 70436-1060-04 30 Capsules Rx only Tolterodine Tartrate Extended-Release Capsules 2 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 90 Capsules 2 mg Bottle Label NDC 70436-1060-06 90 Capsules Rx only Tolterodine Tartrate Extended-Release Capsules 2 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 500 Capsules 2 mg Bottle Label NDC 70436-1060-02 500 Capsules Rx only Tolterodine Tartrate Extended-Release Capsules 2 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 30 Capsules 4 mg Bottle Label NDC 70436-1061-04 30 Capsules Rx only Tolterodine Tartrate Extended-Release Capsules 4 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 90 Capsules 4 mg Bottle Label NDC 70436-1061-06 90 Capsules Rx only Tolterodine Tartrate Extended-Release Capsules 4 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 500 Capsules 4 mg Bottle Label NDC 70436-1061-02 500 Capsules Rx only Tolterodine Tartrate Extended-Release Capsules 4 mg
