Dirotol SR Tablet 4 mg (Tolterodine L-tartrate)

Adult dose

Adults: Administer 4 mg of tolterodine L-tartrate orally once daily. Patients with renal impairment, hepatic impairment, or taking 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.

This medication should not be used in patients with certain bladder-related conditions. For example, it should not be administered in cases of urinary retention or gastrointestinal motility issues such as gastroparesis. Patients with uncontrolled narrow-angle glaucoma, allergies to this medication or its components, severe myasthenia gravis, severe ulcerative colitis, and toxic megacolon should also avoid this drug. As this drug contains lactose, it should not be given to patients with genetic disorders that affect lactose digestion. There are patients who require careful administration, such as those at risk of problems with urine output due to obstructed bladder neck, patients with controlled narrow-angle glaucoma, gastrointestinal obstruction diseases, or those with impaired kidney or liver function. Additionally, caution is required for patients taking strong CYP3A4 inhibitors like certain antibiotics or antifungals, those with autonomic nervous system disorders, or patients at risk of decreased gastrointestinal motility. This medication may cause side effects such as dry mouth, dyspepsia, reduced tearing, and other antimuscarinic effects. Various adverse reactions such as infections, allergic reactions, dizziness, drowsiness, headaches, constipation, urinary difficulties, chest pain, weight gain, and dry skin have also been reported. Particularly, this medication can affect the electrical activity of the heart, leading to prolonged QT interval, so patients with heart disease or a prolonged QT interval, or those with electrolyte imbalances should be careful. Care should be taken as response times may slow while driving or operating machinery. Using this medication in conjunction with other antimuscarinic drugs may increase efficacy, and interactions with certain medications may alter blood concentration, so consulting with a physician or pharmacist is necessary. The safety of this drug has not been established in pregnant women, and it may affect the fetus, so use during pregnancy should be avoided. During breastfeeding, this drug may be excreted in breast milk, making its use inadvisable. The safety and efficacy for children have not been adequately studied, thus it is preferable not to administer this drug to pediatric patients. In the event of overdose, it is essential to visit a medical institution for appropriate treatment promptly, as serious side effects may occur. Finally, this medication should be stored out of the reach of children and not transferred to other containers to maintain safety and quality.

• dry mouth
• indigestion
• decreased tear production
• bronchitis
• allergic reactions
• confusion
• drowsiness
• dizziness
• headache
• excitability

This medication should be stored in a tightly sealed container to protect it from air and moisture. Moreover, it is important to store it at room temperature, specifically below 25 degrees Celsius, to maintain its effectiveness.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle