Tolterodine Tartarate 2 mg Tablet, 60-count
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Tolterodine is used to treat overactive bladder (a bladder condition that causes sudden urges to urinate that may be hard to control). Tolterodine is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.
Read the full MedlinePlus article ↗- Tolterodine calms the bladder by blocking the nerve signals that cause it to squeeze too often or too urgently. Most people start noticing fewer urgent trips to the bathroom and le...
- What exactly does tolterodine do, and how quickly will I notice a difference?
- Dry mouth is the most common complaint with tolterodine, and it happens because the same receptors that calm your bladder also affect your saliva glands. Sipping water frequently,...
- The dry mouth is really bothersome — is there anything I can do about it?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 27NA468985
A starch derivative made from potatoes that helps tablets and capsules break down quickly in the stomach. It absorbs water and swells, causing the medication to disintegrate so it can be absorbed properly.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tolterodine Tartrate 2 mg 00093-0018-05 | Teva | 500 tablets | $0.248 | AB | Availability likely | — |
| Tolterodine tartrate 2 mg 33342-0098-09 | Macleods | 60 tablets | $0.248 | AB | Availability likely | — |
| Tolterodine Tartrate 2 mg 59762-0800-02 | Mylan | 60 tablets | $0.248 | AB | Discontinued | — |
| Tolterodine Tartrate 2 mg 16571-0127-01 | Rising | 100 tablets | — | AB | FDA listed | — |
| Tolterodine Tartrate 2 mg 29300-0240-01 | Unichem | 100 tablets | — | AB | FDA listed | — |
| Tolterodine Tartrate 2 mg 31722-0806-01 | Camber | 10 tablets | — | AB | FDA listed | — |
| Detrol 2 mg 58151-0099-91 | Viatris | 60 tablets | — | AB | FDA listed | — |
| Tolterodine Tartarate 2 mgthis 73152-0027-60 | Athem | 60 tablets | — | AB | Discontinued | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 73152-0027-05 | 500 TABLET in 1 BOTTLE (73152-027-05) | 2020-08-03 | Inactivated by FDA |
| 73152-0027-60 You're viewing this | 60 TABLET in 1 BOTTLE (73152-027-60) | 2020-08-03 | Inactivated by FDA |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 73152-0027-60?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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 PRECAUTIONS, General, PRECAUTIONS, Reduced Hepatic and Renal Function, and PRECAUTIONS, Drug Interactions ).
⛔ Contraindications ▾
CONTRAINDICATIONS Tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.
⚠️ Warnings ▾
WARNINGS Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate tablets. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate tablets should be discontinued and appropriate therapy promptly provided.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The Phase 2 and 3 clinical trial program for tolterodine tartrate tablets included 3071 patients who were treated with tolterodine tartrate (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 tartrate 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 tartrate 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving tolterodine tartrate 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 tartrate 2 mg bid in the Phase 3 clinical studies, occurring in 34.8% of patients treated with tolterodine tartrate and 9.8% of placebo-treated patients. One percent of patients treated with tolterodine tartrate 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 tartrate 2 mg bid discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of tolterodine tartrate were dizziness and headache. Three percent of patients treated with tolterodine tartrate 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 tartrate 2 mg bid. Table 5 lists the adverse events reported in 1% or more of the patients treated with tolterodine tartrate 2 mg bid in the 12-week studies. The adverse events are reported regardless of causality.
Table 5. Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in >1% of Patients Treated with Tolterodine tartrate tablets (2 mg bid) in 12-week, Phase 3 Clinical Studies Body System Adverse Event % Tolterodine tartrate N=986 % Placebo N=683 Autonomic Nervous accommodation abnormal 2 1 dry mouth 35 10 General chest pain 2 1 fatigue 4 3 headache 7 5 influenza-like symptoms 3 2 Central/Peripheral Nervous vertigo/dizziness 5 3 Gastrointestinal abdominal pain 5 3 constipation 7 4 diarrhea 4 3 dyspepsia 4 1 Urinary dysuria 2 1 Skin/Appendages dry skin 1 0 Musculoskeletal arthralgia 2 1 Vision xerophthalmia 3 2 Psychiatric somnolence 3 2 Metabolic/Nutritional weight gain 1 0 Resistance Mechanism infection 1 0 *in nearest integer.
Post-marketing Surveillance The following events have been reported in association with tolterodine use in worldwide post-marketing experience: General: anaphylaxis and angioedema; Cardiovascular: tachycardia, palpitations, peripheral edema; Central/Peripheral Nervous: confusion, 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 worl…
🆘 Overdosage ▾
OVERDOSAGE A 27-month-old child who ingested 5 to 7 tolterodine tartrate tablets 2 mg was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered. Management of Overdosage Overdosage with tolterodine tartrate 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 PRECAUTIONS, Patients with Congenital or Acquired QT Prolongation ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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.
Pharmacokinetics Absorption In a study with 14 C-tolterodine solution in healthy volunteers who received a 5-mg oral dose, at least 77% of the radiolabeled dose was absorbed. Tolterodine immediate release is rapidly absorbed, and maximum serum concentrations (C max ) typically occur within 1 to 2 hours after dose administration. C max and area under the concentration-time curve (AUC) determined after dosage of tolterodine immediate release are dose-proportional over the range of 1 to 4 mg.
Effect of Food Food intake increases the bioavailability of tolterodine (average increase 53%), but does not affect the levels of the 5-hydroxymethyl metabolite in extensive metabolizers. This change is not expected to be a safety concern and adjustment of dose is not needed. Distribution Tolterodine is highly bound to plasma proteins, primarily α1-acid glycoprotein.
Unbound concentrations of tolterodine average 3.7% ± 0.13% over the concentration range achieved in clinical studies. The 5-hydroxymethyl metabolite is not extensively protein bound, with unbound fraction concentrations averaging 36% ± 4.0%. The blood to serum ratio of tolterodine and the 5-hydroxymethyl metabolite averages 0.6 and 0.8, respectively, indicating that these compounds do not distribute extensively into erythrocytes.
The volume of distribution of tolterodine following administration of a 1.28-mg intravenous dose is 113 ±
26.7L. Metabolism Tolterodine is extensively metabolized by the liver following oral dosing. The primary metabolic route involves the oxidation of the 5-methyl group and is mediated by the cytochrome P450 2D6 (CYP2D6) and leads to the formation of a pharmacologically active 5-hydroxymethyl metabolite.
Further metabolism leads to formation of the 5-carboxylic acid and N-dealkylated 5-carboxylic acid metabolites, which account for 51% ± 14% and 29% ± 6.3% of the metabolites recovered in the urine, respectively. Variability in Metabolism A subset (about 7%) of the population is devoid of CYP2D6, the enzyme responsible for the formation of the 5-hydroxymethyl metabolite of tolterodine. The identified pathway of metabolism for these individuals ("poor metabolizers") is dealkylation via cytochrome P450 3A4 (CYP3A4) to N -dealkylated tolterodine.
The remainder of the population is referred to as "extensive metabolizers." 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 the 5-hydroxymethyl metabolite. Excretion Following administration of a 5-mg oral dose of 14 C-tolterodine solution to healthy volunteers, 77% of radioactivity was recovered in u…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Tolterodine tartrate tablets 1 mg (White to off white, round biconvex film coated tablets, debossed “IT 89” on one side, other side is plain.) and Tolterodine tartrate tablets 2 mg (White to off white, round biconvex film coated tablets, debossed “IT 90” on one side, other side is plain.) are supplied as follows: Bottles of 60 1 mg NDC 73152-026-60 2 mg NDC 73152-027-60 Bottles of 500 2 mg NDC 73152-027-05 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] (DTL).
Manufactured for: Athem LLC East Brunswick, NJ, 08816 Rev.07/2020
📋 Description ▾
DESCRIPTION Tolterodine tartrate tablets contain 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).
The empirical formula of tolterodine tartrate is C 26 H 37 NO 7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below: 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 or 2 mg of tolterodine tartrate.
The inactive ingredients are colloidal silicone dioxide, dibasic calcium phosphate dihydrate, cellulose microcrystalline, magnesium stearate, sodium starch glycolate (pH 3.0 to 5.0), Opadry White Y-1-7000. structure
💬 Information for Patients ▾
PATIENT INFORMATION Tolterodine tartrate (tolterodine tartrate tablets) Read the Patient Information that comes with tolterodine tartrate 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 is right for you. What is tolterodine tartrate? Tolterodine tartrate is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder : Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents Urgency: a strong need to urinate right away Frequency: urinating often DETROL LA (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? Do not take tolterodine tartrate if you: Are not able to empty your bladder (urinary retention) Have delayed or slow emptying of your stomach (gastric retention) Have an eye problem called "uncontrolled narrow-angle glaucoma" Are allergic to tolterodine tartrate or to any of its ingredients. See the end of this leaflet for a complete list of ingredients Are allergic to TOVIAZ which contains fesoterodine.
What should I tell my doctor before starting tolterodine tartrate? Before starting tolterodine tartrate, tell your doctor about all of your medical and other conditions that may affect the use of tolterodine tartrate, including: Stomach or intestinal problems or problems with constipation Problems emptying your bladder or if you have a weak urine stream Treatment for an eye problem called narrow-angle glaucoma Liver problems Kidney problems A condition called myasthenia gravis If you or any family members have a rare heart condition called QT prolongation (long QT syndrome) If you are pregnant or trying to become pregnant.
It is not known if tolterodine tartrate could harm your unborn baby. If you are breastfeeding. It is not known if tolterodine tartrate passes into your breast milk or if it can harm your baby.
Talk to your doctor about the best way to feed your baby if you take tolterodine tartrate. 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.
Your doctor may use a lower dose of tolterodine tartrate if you are taking: Certain medicines for fungus or yeast infections Certain medicines for bacterial infections Sandimmune® (cyclosporine) or Velban® (vinblastine) 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? Take tolterodine tartrate exactly as your doctor tells you to take it. Your doctor will tell you how many tolterodine tartrate tablets to take and when to take them.
Do not change your dose unless told to do so by your doctor. You can take tolterodine tartrate with or without food. Take tolterodine tartrate at the same times each day.
If you miss a dose of tolterodine tartrate, just take your next regular dose at your next regular time. Do not try to make up for your missed dose. If you take too much tolterodine tartrate, call your doctor, or go to the hospital emergency room right away.
What should I avoid while taking tolterodine tartrate? Medicines like tolterodine tartrate can cause blurred vision, dizziness, and drowsi…