Medication info

Urotrol 2 mg Tablets (Tolterodine L-Tartrate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Tolterodine-L-Tartrate›2mg / 1 tablet
Manufacturer / importer
Daewon Pharmaceutical Co., Ltd.
Appearance
White, biconvex, round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3), 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 200501595 · Notified 2005.10.17

This product's status changed to Approval withdrawn on 2024.02.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder (e.g., urinary urgency and frequency)
Who takes it
Adults
Adult dose
Adults: Administer tolterodine L-tartrate 2 mg 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 those taking ketoconazole or another potent CYP3A4 inhibitor: A dose of 1 mg twice daily is recommended.

Ingredients

Manufacturer
Daewon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder (e.g., urinary urgency and frequency)

  • Urgency
  • frequency
  • urge incontinence
View approved original text

This medication is used to improve symptoms of overactive bladder such as urgency, frequency, and urge incontinence. It alleviates situations where there is a sudden urge to urinate, making it difficult to hold, and reduces the discomfort in daily life. It helps manage these symptoms to enhance the quality of life of patients.

How to take

Adult dose

Adults: Administer tolterodine L-tartrate 2 mg 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 those taking ketoconazole or another potent CYP3A4 inhibitor: A dose of 1 mg twice daily is recommended.

Precautions

This medication should not be used by patients with urinary retention. Individuals with gastric stasis due to slow gastrointestinal motility should also refrain from taking this medication. This medication is not administered to patients with uncontrolled narrow-angle glaucoma as it may worsen intraocular pressure. Patients with a history of allergic reactions to this medication or its components should not take this drug. Individuals with myasthenia gravis should not use this medication as it may exacerbate symptoms. Additionally, patients with severe ulcerative colitis or toxic megacolon should not take this medication. Patients with significant bladder outlet obstruction at risk of urinary retention or those with controlled narrow-angle glaucoma should use this medication cautiously. It should also be taken with care by patients with gastrointestinal obstructive diseases or impaired kidney or liver function. Caution is required when taken with certain antibiotics, antifungals, immunosuppressants, etc., as the concentration of this medication may increase. Patients with autonomic neuropathy, esophageal hernia, or those at risk of decreased gastrointestinal motility should use this medication cautiously. This medication may cause side effects such as dry mouth, dyspepsia, decreased tear production. Various adverse reactions including bronchitis, allergic reactions, dizziness, headache, constipation, abdominal pain, difficulty urinating, fatigue, vision abnormalities, dry skin, etc., have been reported in clinical trials. Rarely, serious allergic reactions, hallucinations, memory impairment, heart rhythm abnormalities, and vascular edema may occur. If any abnormal symptoms occur while taking this medication, consult a physician immediately. This medication can prolong the QT interval related to heartbeats, so patients with heart disease or those taking QT-prolonging medications should be cautious. Caution is also needed in cases of electrolyte abnormalities such as hypokalemia, hypomagnesemia, and hypocalcemia. Attention must be paid as reaction times may slow when driving or operating machinery. Taking other antimuscarinic drugs may enhance its effects and interactions may occur with certain medications, so inform your doctor of any medications you are taking. Particularly, caution should be exercised when combined with CYP3A4 inhibitors as the blood concentration of this medication may increase. Pregnant women are advised not to take this medication, and women of childbearing age should use appropriate contraception while taking it. It is also safer for nursing mothers to avoid this medication. The safety and efficacy of this medication in children have not been adequately confirmed, so it is advised not to use it in children. In case of overdose, symptoms such as difficulty in controlling vision, difficulty urinating may occur, and appropriate treatment should be sought immediately in a hospital. This medication should be stored out of the reach of children, and it is safer to keep it in its original container as transferring it to another container may alter its quality.

Side effects

  • Dry mouth
  • indigestion
  • decreased tears
  • bronchitis
  • allergic reactions
  • confusion
  • drowsiness
  • dizziness
  • headache
  • hypersensitivity
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  • anxiety
  • sensory disturbances
  • constipation
  • abdominal pain
  • intestinal pneumatosis
  • vomiting
  • gastroesophageal reflux
  • urinary retention
  • dysuria
  • painful urination
  • chest pain
  • weight gain
  • fatigue
  • dry eye syndrome
  • visual disturbances
  • skin flushing
  • dry skin
  • diarrhea
  • sinusitis
  • arthralgia
  • anaphylactic-like reactions
  • hallucinations
  • disorientation
  • memory impairment
  • tachycardia
  • palpitations
  • angioedema
  • peripheral edema
  • urinary obstruction
  • abdominal pain
  • drowsiness
  • dry eye syndrome
  • hypersensitivity
  • vomiting
  • dysuria
  • edema
  • visual disturbances
  • diarrhea
  • dizziness
  • fatigue
  • gastric ulcer
  • abdominal distension
  • facial edema
  • sensory disturbances
  • insomnia
  • confusion
  • facial flushing
  • dry skin
  • duodenal ulcer
  • apathy
  • weakness
  • itching
  • skin sensitivity
  • γ-GTP abnormalities
  • visual regulation disorder
  • dysuria

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

Storage

This medication should be stored in a tightly sealed container to prevent air ingress, and it should be kept in a cool place at a temperature below 25 degrees Celsius. Storing it this way helps maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

White, biconvex, round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 300 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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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.