Tolterodine Tartrate

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 2.
• DOSAGE AND ADMINISTRATION 4 mg capsules taken orally once daily with water and swallowed whole ( 2.1 ) 2 mg capsules taken orally once daily with water and swallowed whole in the presence of:
• mild to moderate hepatic impairment (Child-Pugh class A or B ( 2.2 ) severe renal impairment [Creatinine Clearance (CCr) 10-30 mL/min] ( 2.2 ) drugs that are potent CYP3A4 inhibitors.
• ( 2.2 ) Tolterodine tartrate extended-release capsules are not recommended for use in patients with CCr <10 mL/min.
• ( 2.2 ) Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
• ( 2.2 )
• 2.1 Dosing Information The recommended dose of tolterodine tartrate extended-release capsules is 4 mg once daily with water and swallowed whole.
• The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for tolterodine tartrate extended-release capsules 2 mg [see CLINICAL STUDIES (14) ] .
• 2.2 Dosage Adjustment in Specific Populations For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10 - 30 mL/min), the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily.
• Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
• Patients with CCr<10 mL/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see WARNINGS AND PRECAUTIONS (5.6) and USE IN SPECIFIC POPULATIONS (8.6, 8.7) ].
• 2.3 Dosage Adjustment in Presence of Concomitant Drugs For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g. ketoconazole, clarithromycin, ritonavir], the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily [see DRUG INTERACTIONS (7.2) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The effectiveness of tolterodine tartrate extended-release capsules has not been established in pediatric patients.
• Efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710 pediatric patients (486 on tolterodine tartrate extended-release capsules, 224 on placebo) aged 5–10 years with urinary frequency and urge incontinence.
• The percentage of patients with urinary tract infections was higher in patients treated with tolterodine tartrate extended-release capsules (6.6%) compared to patients who received placebo (4.5%).
• Aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2.9% of children treated with tolterodine tartrate extended-release capsules compared to 0.9% of children treated with placebo.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• No overall differences in safety were observed between the older and younger patients treated with tolterodine.
• In multiple-dose studies in which tolterodine immediate release 4 mg (2 mg bid) was administered, serum concentrations of tolterodine and of 5-HMT were similar in healthy elderly volunteers (aged 64 through 80 years) and healthy young volunteers (aged less than 40 years).
• In another clinical study, elderly volunteers (aged 71 through 81 years) were given tolterodine immediate release 2 or 4 mg (1 or 2 mg bid).
• Mean serum concentrations of tolterodine and 5-HMT in these elderly volunteers were approximately 20% and 50% higher, respectively, than concentrations reported in young healthy volunteers.
• However, no overall differences were observed in safety between older and younger patients on tolterodine in the Phase 3, 12-week, controlled clinical studies; therefore, no tolterodine dosage adjustment for elderly patients is recommended.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 6.
• ADVERSE REACTIONS 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 > 4% and >placebo) were dry mouth, headache, constipation, and abdominal pain.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Inventia Healthcare Limited, at 1-800-270-7585 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience The efficacy and safety of tolterodine tartrate extended-release capsules was evaluated in 1073 patients (537 assigned to tolterodine tartrate extended-release capsules; 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months.
• These included a total of 1012 patients (505 randomized to tolterodine tartrate extended-release capsules 4 mg once daily and 507 randomized to placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study.
• Adverse events were reported in 52% (n=263) of patients receiving tolterodine tartrate extended-release capsules and in 49% (n=247) of patients receiving placebo.
• The most common adverse events reported by patients receiving tolterodine tartrate extended-release capsules were dry mouth, headache, constipation, and abdominal pain.
• Dry mouth was the most frequently reported adverse event for patients treated with tolterodine tartrate extended-release capsules, occurring in 23.4% of patients treated with tolterodine tartrate extended-release capsules and 7.7% of placebo-treated patients.
• Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic agents.
• A serious adverse event was reported by 1.4% (n=7) of patients receiving tolterodine tartrate extended-release capsules and by 3.6% (n=18) of patients receiving placebo.
• Table 1 lists the adverse events, regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than or equal to 1% of patients treated with tolterodine tartrate extended-release capsules 4 mg once daily.
• Table 1.
• Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in ≥1% of Patients Treated with Tolterodine Tartrate Extended-Release Capsules (4 mg daily) in a 12-week, Phase 3 Clinical Trial * in nearest integer.
• Body System Adverse Event % Tolterodine tartrate extended-release capsules n=505 % Placebo n=507 Autonomic Nervous dry mouth 23 8 General headache 6 5 fatigue 2 1 Central/Peripheral Nervous dizziness 2 1 Gastrointestinal constipation 6 4 abdominal pain 4 2 dyspepsia 3 1 Vision xerophthalmia 3 2 vision abnormal 1 0 Psychiatric somnolence 3 2 anxiety 1 0 Respiratory sinusitis 2 1 Urinary dysuria 1 0 The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment.
• Similar percentages of patients treated with tolterodine tartrate extended-release capsules or placebo discontinued treatment due to adverse events.
• Dry mouth was the most common adverse event leading to treatment discontinuation among patients receiving tolterodine tartrate extended-release capsules [n=12 (2.4%) vs. placebo n=6 (1.2%)].
• 6.2 Post-marketing Experience 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;
• Gastrointestinal : diarrhea ;
• 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 worldwide post-marketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably determined.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 17.
• PATIENT COUNSELING INFORMATION 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.
• Advise patients not to drive, operate machinery, or do other potentially dangerous activities until they know how tolterodine tartrate extended-release capsules affects them. 10320 Rev 04/25

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 3.
• DOSAGE FORMS AND STRENGTHS The 2 mg capsules are white to off white spherical to oval pellets filled in hard gelatin capsule shells of size "4" with "┐ L " imprinted in grey colour ink on opaque green colored cap and "013" imprinted in black ink on opaque white colored body.
• The 4 mg capsules are white to off white spherical to oval pellets filled in hard gelatin capsule shells of size "3" with "┐ L " imprinted in grey colour ink on opaque blue colored cap and "014" imprinted in black ink on opaque white colored body.
• Capsules: 2 mg and 4 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.
• HOW SUPPLIED/STORAGE AND HANDLING Tolterodine Tartrate Extended-release Capsules, USP are available containing 2 mg or 4 mg of tolterodine tartrate.
• The 2 mg capsule is white to off white spherical to oval pellets filled in hard gelatin capsule shells of size “4” with "┐ L " imprinted in grey color ink on opaque green colored cap and “013” imprinted in black ink on opaque white colored body.
• NDC 51407-739-30 Bottles of 30 capsules NDC 51407-739-90 Bottles of 90 capsules NDC 51407-739-05 Bottles of 500 capsules The 4 mg capsule is white to off white spherical to oval pellets filled in hard gelatin capsule shells of size “3” with "┐ L " imprinted in grey color ink on opaque blue colored cap and “014” imprinted in black ink on opaque white colored body.
• NDC 51407-740-30 Bottles of 30 capsules NDC 51407-740-90 Bottles of 90 capsules NDC 51407-740-05 Bottles of 500 capsules
• Store at 25° (77°F); excursions permitted to 15° to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
• Protect from light.

Quoted from the official label, section “How Supplied”.

What is in it

• 11.
• DESCRIPTION Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate USP.
• The active moiety, tolterodine, is a muscarinic receptor antagonist.
• The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-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.
• Tolterodine tartrate extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate.
• Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide.
• Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide.
• Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide.
• Meets USP Dissolution Test 3. tolterodine-01

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

32 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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