Medication info

Tolterodine SR Tablet 4 mg (Tolterodine L-Tartrate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Tolterodine-L-Tartrate›4mg / 1 tablet
Manufacturer / importer
Jungheon Pharmaceutical Co., Ltd.
Appearance
White, round, extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201501796 · Approved 2015.04.02

This product's status changed to Approval withdrawn on 2024.05.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder (urgency, frequency, etc.)
Who takes it
Adults
Adult dose
(Tablets) Adults: Administer 2 mg of tolterodine L-tartrate orally twice daily. However, based on the patient's response and tolerability, the dose may be reduced from 2 mg to 1 mg per dose, administered twice daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: A dose of 1 mg per administration, twice daily, is recommended. (Extended-release tablets) (Extended-release capsules) Adults: Administer 4 mg of tolterodine L-tartrate orally once daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: Administer 2 mg once daily. If adverse reactions occur, the dose may be reduced from 4 mg to 2 mg once daily. This medicine may be taken with or without food. Swallow the dosage form whole; do not crush or split it.

Ingredients

Manufacturer
Jungheon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder (urgency, frequency, etc.)

  • Urge incontinence
  • urinary frequency
  • urgency
View approved original text

This medication is used to treat symptoms of overactive bladder such as urge incontinence, urinary frequency, and urgency. It alleviates the discomfort of needing to urinate frequently due to overactive bladder and helps control sudden urges to urinate, thereby improving the quality of daily life. By relieving these symptoms, it aids in comfortable living.

How to take

Adult dose

(Tablets) Adults: Administer 2 mg of tolterodine L-tartrate orally twice daily. However, based on the patient's response and tolerability, the dose may be reduced from 2 mg to 1 mg per dose, administered twice daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: A dose of 1 mg per administration, twice daily, is recommended. (Extended-release tablets) (Extended-release capsules) Adults: Administer 4 mg of tolterodine L-tartrate orally once daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: Administer 2 mg once daily. If adverse reactions occur, the dose may be reduced from 4 mg to 2 mg once daily. This medicine may be taken with or without food. Swallow the dosage form whole; do not crush or split it.

Precautions

This medication should not be used in patients with urinary retention. It is also not safe to administer to patients with gastrointestinal motility disorders characterized by gastric stasis. Patients with uncontrolled narrow-angle glaucoma may experience adverse effects from this medication, so it should not be administered. Patients who have had allergic reactions to this medication or its components should not take it. This medication may exacerbate symptoms in patients with myasthenia gravis, so it should not be given. Avoid use in patients with severe ulcerative colitis or toxic megacolon. Precaution is advised for patients at high risk for urinary retention, such as those with bladder outlet obstruction or controlled narrow-angle glaucoma. Caution is also needed for patients with impaired renal or liver function. Drug interactions may occur when taken with certain antibiotics, antifungals, or immunosuppressants, so consultation with a physician is necessary. Patients with autonomic neuropathy, hiatal hernia, or risks of decreased gastrointestinal motility should also be cautious. Common side effects of this medication may include dry mouth, dyspepsia, and decreased tear production. Rarely, dizziness, drowsiness, headache, constipation, urinary difficulty, dry skin, and a variety of adverse reactions may occur. Severe allergic reactions or cardiovascular abnormalities have also been reported, so if symptoms are severe, immediate medical consultation is required. This medication may affect cardiac electrical activity, so patients with certain heart conditions or electrolyte imbalances should be cautious. Caution is also necessary when driving or operating machinery, as reaction times may be slower. Concurrent use with other antimuscarinic medications may enhance effects and interactions may occur with certain drugs, so it is essential to inform the prescribing physician about all medications being taken. The safety of this medication during pregnancy has not been established, so it is best to avoid use, and women of childbearing age should use appropriate contraception. Nursing mothers are also advised to avoid this medication, as it may be excreted in breast milk. The safety and efficacy of this medication in pediatric patients have not been sufficiently confirmed; therefore, it is generally not recommended for use in children. In cases of overdose, symptoms such as visual disturbances, urinary difficulty, and severe central nervous system symptoms may occur, requiring immediate medical attention. This medication should be stored out of reach of children, and it is important to not transfer it to another container to maintain quality.

Side effects

  • Dry mouth
  • indigestion
  • decreased tear production
  • bronchitis
  • allergic reactions
  • confusion
  • drowsiness
  • dizziness
  • headache
  • nervousness
Show 62 more
  • anxiety
  • paresthesia
  • constipation
  • abdominal pain
  • gastrointestinal air retention
  • vomiting
  • gastroesophageal reflux
  • urinary retention
  • dysuria
  • painful urination
  • chest pain
  • weight gain
  • fatigue
  • dry eyes
  • visual disturbances
  • skin flushing
  • dry skin
  • diarrhea
  • sinusitis
  • joint pain
  • anaphylactoid reaction
  • hallucinations
  • disorientation
  • memory impairment
  • tachycardia
  • palpitations
  • angioedema
  • peripheral edema
  • urinary obstruction
  • abdominal pain
  • drowsiness
  • dry eyes
  • nervousness
  • vomiting
  • dysuria
  • edema
  • visual disturbances
  • diarrhea
  • dizziness
  • fatigue
  • gastric ulcer
  • abdominal distension
  • facial edema
  • paresthesia
  • insomnia
  • confusion
  • facial flushing
  • dry skin
  • duodenal ulcer
  • apathy
  • weakness
  • itching
  • dermal hypersensitivity
  • abnormal γ-GTP
  • visual accommodation disorders
  • hallucinations
  • severe agitation
  • convulsions
  • respiratory failure
  • tachycardia
  • urinary retention
  • pupillary dilation

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture and kept at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

White, round, extended-release film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.