Sultoni Sin Jeong 5mg (Solifenacin Succinate)

Adult dose

The usual recommended dose for adults (including the elderly) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medication may be taken with or without food and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dosage adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary for patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

This medication should not be used in patients with urinary retention or severe gastrointestinal disorders. Patients with myasthenia gravis, angle-closure glaucoma, or hypersensitivity to this medication or its components should avoid use. Patients on hemodialysis, or those with severe liver or kidney impairment should not take this medication. Patients with specific metabolic disorders such as galactose intolerance or lactase deficiency should also avoid this medication. The medication should be administered with caution in patients at risk for urinary retention or gastrointestinal obstruction and those with decreased gastrointestinal motility. Severe kidney or liver impairment patients require dosing limitation, and caution is needed when co-administered with strong CYP3A4 inhibitors. Patients taking medications that may induce gastroesophageal reflux or esophagitis should be cautious. Patients with autonomic neuropathy also need to be careful when taking this medication. This medication may cause side effects commonly associated with antimuscarinic agents, such as dry mouth, constipation, and blurred vision. Specifically, dry mouth and constipation occur more frequently at higher doses. Rarely, serious side effects such as angioedema or severe gastrointestinal obstruction have been reported; thus, patients should notify healthcare professionals immediately if unusual symptoms occur. This medication requires caution when driving or operating machinery due to symptoms like drowsiness, blurred vision, and fatigue. When taken with other anticholinergic medications, the effects may be enhanced or side effects may be more severe. Additionally, it may reduce the effect of drugs that enhance gastrointestinal motility, so caution is advised when co-administering. As this medication is metabolized by specific enzymes (CYP3A4) in the liver, co-administration with drugs that strongly inhibit this enzyme may increase drug concentrations, necessitating dosage adjustments. Such combinations should be avoided in patients with severe kidney or liver impairment. The safety of this medication during pregnancy is not established, and care should be exercised when using it; during breastfeeding, it is advisable to avoid use due to the potential excretion into breast milk. Safety and efficacy in pediatric patients have not been confirmed, and this medication should not be administered to children. In cases of overdose, central nervous system symptoms, blurred vision, and dizziness may occur, and activated charcoal or appropriate emergency care may be necessary. This medication has not been reported to pose a risk of genetic toxicity or tumorigenesis with long-term use, but any adverse reactions that occur during use should be discussed with healthcare professionals.

Dry mouth, constipation, blurred vision, urinary retention, dry eyes, fecal impaction, colonic obstruction, intestinal obstruction, angioedema, nausea, indigestion, upper abdominal pain, vomiting, urinary tract infection, influenza, pharyngitis, dizziness, depression, lower limb edema, fatigue, cough, hypertension, difficulty urinating, decreased urine flow, post-voiding bladder sensation, cystitis, rhinitis, vomiting, gastroesophageal reflux disease, intestinal obstruction, peripheral edema, headache, hallucinations, drowsiness, delirium, renal impairment, itching, rash, urticaria, vascular edema, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, polymorphic ventricular tachycardia, prolongation of QT interval on electrocardiogram, abnormal liver function tests, decreased appetite, hyperkalemia, speech disturbance, anaphylactic reaction, glaucoma, muscle weakness, facial edema, increased urination, urinary disorders, urgency to urinate, neurogenic bladder, paresthesia, diarrhea, bloating, acute renal failure, nocturia, decreased urine volume, urinary stones, incontinence, sensory abnormalities, difficulty walking, limb tremors, chest tightness, chest pain, periorbital edema, edema, benign prostatic hyperplasia, male perineal pruritus, reduced libido, erectile dysfunction, abnormal orgasm, retrograde ejaculation, hematospermia, pneumonia, keratosis, hair loss, sinking sensation, anxiety, decreased libido, ovarian carcinoma, bile duct cancer, uterine cancer, back pain, vaginal bleeding, myocardial infarction, decreased cardiac output, syncope, hearing impairment, soft tissue inflammation, headache, thirst, drowsiness

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage preserves the medication's efficacy and safety over time.

Appearance

Bright yellow round film-coated tablet

Package unit

(Domestic use) - 100 tablets/PTP [(10 tablets/PTP) x 10]