Medication info

Vynex Tolterodine Extended Release Tablet 4 mg (Tolterodine L-Tartrate)

Prescription medicationTabletOralApproval withdrawn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Approval withdrawn

MFDS item code 200600127 · Notified 2006.01.25

This product's status changed to Approval withdrawn on 2024.04.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder (such as urgency and frequency)
Who takes it
Adults
Adult dose
Adults: Administer 4 mg orally once daily as tolterodine-L-tartrate. Patients with renal impairment, hepatic impairment, or taking 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
Vynex Co., Ltd.

Efficacy & effects

Treatment of overactive bladder (such as urgency and frequency)

  • Urgency
  • frequency
  • urge incontinence
View approved original text

This medication is used to improve symptoms such as urgency, frequency, and urge incontinence. It helps alleviate the frequent urge to urinate caused by overactive bladder and improve the quality of life for patients. It effectively controls such symptoms to reduce discomfort in daily life. Therefore, it is used for the treatment of overactive bladder.

How to take

Adult dose

Adults: Administer 4 mg orally once daily as tolterodine-L-tartrate. Patients with renal impairment, hepatic impairment, or taking 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 patients with urinary retention or gastrointestinal obstruction symptoms. It should also not be administered to patients with uncontrolled narrow-angle glaucoma, severe myasthenia gravis, or severe ulcerative colitis. Patients with hypersensitivity to this medication or its components should avoid its use. As it contains lactose, patients with genetic problems such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication. Patients with a risk of urinary retention, those with obstructive uropathy, or those with gastrointestinal obstructive diseases should be administered this medication with caution. Patients with renal or hepatic dysfunction also require caution, and those taking specific antibiotics, antifungals, or immunosuppressants should consider the possibility of interactions. Patients with autonomic neuropathy, hiatal hernia, or risk of decreased gastrointestinal motility should also be careful. This medication may cause side effects due to its antimuscarinic effects, such as dry mouth, dyspepsia, and reduced tears. Various adverse reactions including bronchitis, allergic reactions, drowsiness, dizziness, headaches, constipation, abdominal pain, dysuria, etc., have been reported in clinical trials. Moreover, skin dryness, skin rash, visual disturbances, chest pain, fatigue, etc., may also occur. If any unusual symptoms arise while taking this medication, immediate consultation with healthcare professionals is advised. This medication can affect cardiac electrical activity, so patients with prolonged QT interval or those taking related medications should use it cautiously. In cases of electrolyte disturbances such as hypokalemia, hypomagnesemia, or hypocalcemia, caution should also be exercised when using this medication. When engaging in activities requiring alertness, such as driving or operating machinery, one should be careful because this medication may affect reaction times. When taken together with other antimuscarinic medications such as antidepressants, the effect may be enhanced, and the concentration of the drug may change due to interactions with some medications. In particular, co-administration with strong CYP3A4 inhibitors may increase blood concentrations, so caution is required. During pregnancy, its safety has not been established, and it is advisable not to administer it; women of childbearing age should use adequate contraception. During breastfeeding, as this medication may be excreted in breast milk, it is advisable to avoid its use. The safety and efficacy in pediatric patients have not been sufficiently established, so its use is not recommended. In the case of overdose, serious side effects such as vision impairment and dysuria may occur, and one should immediately visit a medical institution, where necessary gastric lavage or detoxification treatment should be carried out. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects

  • dry mouth
  • dyspepsia
  • decreased tear production
  • bronchitis
  • allergic reactions
  • confusion
  • drowsiness
  • dizziness
  • headache
  • hyperexcitability
Show 62 more
  • anxiety
  • sensory disturbances
  • constipation
  • abdominal pain
  • intestinal gas 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
  • anaphylactic-like reaction
  • hallucinations
  • disorientation
  • memory impairment
  • tachycardia
  • palpitations
  • angioedema
  • peripheral edema
  • urinary obstruction
  • abdominal pain
  • drowsiness
  • dry eye syndrome
  • hyperexcitability
  • 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 hypersensitivity
  • elevated γ-GTP
  • vision adjustment disorders
  • dysuria
  • hallucinations
  • severe agitation
  • respiratory failure
  • tachycardia
  • urinary retention
  • pupil 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 prevent air and moisture from entering, preferably at room temperature below 25 degrees Celsius. Storing it this way can help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White round film-coated tablets

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.