Medication info
Urodine Extended-Release 4 mg (Tolterodine L-Tartrate)

Urodine Extended-Release 4 mg (Tolterodine L-Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Tolterodine-L-Tartrate›4mg / 1 tablet
Manufacturer / importer
Aju Pharmaceuticals Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200600178 · Notified 2006.03.20

Summary

Main use
Treatment of overactive bladder (such as urgency and frequency)
Who takes it
Adults
Adult dose
Adults: Administer tolterodine L-tartrate 4 mg orally once daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: Administer 2 mg of this drug once daily. If adverse reactions occur, the dose may be reduced from 4 mg to 2 mg once daily. This drug may be taken with or without food. Swallow the dosage form whole; do not crush or split it.

Ingredients

Manufacturer
Aju Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of overactive bladder (such as urgency and frequency)

  • Urgency
  • frequency
  • urgent incontinence
View approved original text

This medication is used to treat symptoms of overactive bladder such as urgency, frequency, and urgent incontinence.

How to take

Adult dose

Adults: Administer tolterodine L-tartrate 4 mg orally once daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: Administer 2 mg of this drug once daily. If adverse reactions occur, the dose may be reduced from 4 mg to 2 mg once daily. This drug 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 certain patients. For example, patients with urinary retention symptoms where urination is difficult, those with gastric stasis symptoms associated with slow gastrointestinal motility, patients with uncontrolled angle-closure glaucoma, and patients allergic to this medication or its components should not take it. Additionally, patients with myasthenia gravis, severe ulcerative colitis, or toxic megacolon should not use this medication. This medication should be used with caution in some patients. For instance, patients at risk of urinary retention due to bladder outlet obstruction, those with controllable angle-closure glaucoma, patients with obstructive gastrointestinal disease, and those with impaired renal or liver function should exercise caution when taking this medication. Moreover, 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 those at risk of reduced gastrointestinal motility should also be cautious. This medication can cause mild side effects such as dry mouth, dyspepsia, and reduced tear production. Rarely, various adverse reactions such as confusion, drowsiness, dizziness, headache, anxiety, constipation, abdominal pain, vomiting, difficulty urinating, chest pain, and skin rash have been reported. Patients taking dementia medications should be cautious as this medication may worsen dementia symptoms. Additionally, this medication may prolong the QT interval associated with heart rate; therefore, patients with heart disease or those at risk of QT interval prolongation should be particularly careful. This also applies to patients with electrolyte imbalances or bradycardia. This medication may affect driving or operating machinery, so caution is necessary while taking it. This medication may enhance the effects when taken with other antimuscarinic medications, and there may be interactions with some drugs, so it is essential to consult with a physician or pharmacist. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should use appropriate contraception. The safety and efficacy for children have not been established; therefore, it should be used cautiously in pediatric patients. In case of overdose, serious side effects such as visual disturbances and difficulty urinating may occur, necessitating immediate medical attention and, if needed, gastric lavage or detoxification treatment. Finally, this medication should be kept out of reach of children, and transferring it to another container should be avoided as it may compromise quality.

Side effects

  • Dry mouth
  • indigestion
  • decreased tear production
  • bronchitis
  • allergic reactions
  • confusion
  • drowsiness
  • dizziness
  • headache
  • nervous hypersensitivity
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  • anxiety
  • sensory abnormalities
  • constipation
  • abdominal pain
  • intestinal gas retention
  • vomiting
  • gastroesophageal reflux
  • urinary retention
  • difficulty urinating
  • painful urination
  • chest pain
  • weight gain
  • fatigue
  • dry eyes
  • visual disturbances
  • skin flushing
  • dry skin
  • diarrhea
  • sinusitis
  • joint pain
  • anaphylactic-like reaction
  • hallucinations
  • cognitive impairment
  • memory impairment
  • tachycardia
  • palpitations
  • vascular edema
  • peripheral edema
  • urinary obstruction
  • abdominal distension
  • facial edema
  • insomnia
  • facial flushing
  • duodenal ulcer
  • apathy
  • weakness
  • itching
  • skin hypersensitivity
  • elevated γ-GTP
  • impaired vision adjustment

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

Storage

This medication is sensitive to air and humidity, so it should be stored in a tightly closed container. It is important to maintain a storage temperature below 25 degrees Celsius.

Appearance and packaging

Appearance

White round 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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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.