Medication info

Neostil SR Tablets 4 mg (Tolterodine L-tartrate)

Prescription medicationTabletOralApproval withdrawn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Approval withdrawn

MFDS item code 200707946 · Notified 2007.07.10

This product's status changed to Approval withdrawn on 2024.04.09.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 (e.g., urinary urgency and frequency)
Who takes it
Adults
Adult dose
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 of this medicine 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
McNulty Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Urinary urgency
  • frequency
  • urge incontinence
View approved original text

This medication is used to alleviate symptoms of overactive bladder, such as urinary urgency, frequency, and urge incontinence. It works by regulating the activity of the bladder muscles, which are hyperactive, thereby reducing symptoms and discomfort in patients' daily lives. This treatment helps to stabilize bladder function and prevent recurrence of symptoms. As a result, it effectively improves patients' quality of life and maintains comfortable urination.

How to take

Adult dose

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 of this medicine 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 or gastric retention symptoms. Additionally, it should not be administered to patients with uncontrolled angle-closure glaucoma, allergy to this drug or its components, severe myasthenia gravis, severe ulcerative colitis, or toxic megacolon. Caution is warranted for patients with bladder outlet obstruction that may pose a risk of urinary retention, controlled angle-closure glaucoma, gastrointestinal obstructive diseases, or impaired kidney or liver function. Furthermore, it should be used carefully in patients taking strong CYP3A4 inhibitors, such as certain antibiotics or antifungals, patients with autonomic neuropathy, patients with hiatal hernia, and those at risk for decreased gastrointestinal motility. This medication may cause side effects such as dry mouth, dyspepsia, and reduced tears, and in rare cases, various adverse reactions have been reported, including confusion, drowsiness, dizziness, headaches, constipation, urinary difficulty, skin rash, etc. It may cause cardiac problems related to QT interval prolongation; therefore, special caution should be taken in patients with heart disease, electrolyte imbalances or those taking medications that prolong the QT interval. This medication may affect the ability to drive or operate machinery, so caution is advised during use. When used with other antimuscarinic drugs, effects may be enhanced, so consultation with a doctor is necessary, and careful attention should be paid when combined with certain enzyme inhibitors as it may increase drug concentration. Its safety has not been established in pregnant women; therefore, it is advisable not to use it. Fertile women should use adequate contraception. Breastfeeding women are also advised against using this medication. The safety and efficacy in children have not been sufficiently studied, so its use should be avoided. In case of overdose, serious side effects such as vision problems or urinary difficulty may occur, hence it is vital to seek medical attention immediately.

Side effects

  • Dry mouth
  • indigestion
  • decreased tear production
  • bronchitis
  • allergic reactions
  • confusion
  • drowsiness
  • dizziness
  • headache
  • hypersensitivity
Show 55 more
  • anxiety
  • paresthesia
  • constipation
  • abdominal pain
  • intestinal gas retention
  • vomiting
  • gastroesophageal reflux
  • urinary retention
  • dysuria
  • pain during urination
  • chest pain
  • weight gain
  • fatigue
  • dry eye syndrome
  • visual disturbances
  • skin flushing
  • dry skin
  • diarrhea
  • sinusitis
  • joint pain
  • anaphylaxis-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 swelling
  • paresthesia
  • insomnia
  • confusion
  • facial flushing
  • dry skin
  • duodenal ulcer
  • apathy
  • weakness
  • itching
  • skin hypersensitivity
  • γ-GTP elevation
  • vision adjustment disorder

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to avoid direct sunlight and store it at cool room temperature of 25 degrees Celsius or lower.

Appearance and packaging

Appearance

White, round, film-coated tablets

Package unit

30 tablets per 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.