Vesicagen 10.66 mg (Solifenacin Tartarate)

Adult dose

The usual recommended dose for adults (including elderly patients) is 5.33mg (equivalent to 5mg of solifenacin succinate) once daily. If needed, the dose may be increased to a maximum of 10.66mg (equivalent to 10mg of solifenacin succinate) once daily. This medicine may be taken with or without food and should be swallowed whole with water. Dose adjustment is necessary for the following patients. 1. Patients with renal impairment No dose 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 5.33mg (equivalent to 5mg of solifenacin succinate) once daily. 2. Patients with hepatic impairment No dose 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 5.33mg (equivalent to 5mg of solifenacin succinate) once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5.33mg (equivalent to 5mg of solifenacin succinate).

This medication should not be used in patients with urinary retention or severe gastrointestinal disorders, myasthenia gravis, or angle-closure glaucoma. Additionally, it should not be administered to patients with allergies to this drug or its ingredients, patients undergoing hemodialysis, severe liver impairment, or severe renal impairment. It should be used with caution in patients at risk of urinary retention or with obstructive gastrointestinal diseases or decreased gastrointestinal motility. Dosage adjustment is necessary for patients with severe renal impairment, moderate liver impairment, and those taking strong CYP3A4 inhibitors. This drug may commonly cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes. In severe cases, bowel obstruction, angioedema, or anaphylactic reactions may occur, so if any abnormal symptoms appear, immediate consultation with medical staff is required. Care must be taken when driving or operating machinery due to the risk of accidents from drowsiness or blurred vision. Inform your healthcare provider if taking other anticholinergic medications, as this may enhance effects or increase side effects. Women who are pregnant or nursing should consult with a physician before use, as its safety has not been established. It is advisable not to administer to children as safety and efficacy have not been confirmed.

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, dysuria, decreased urinary flow rate, bladder after-sensation, cystitis, nasopharyngitis, 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, prolonged QT interval on electrocardiogram, abnormal liver function tests, decreased appetite, hyperkalemia, speech disorder, anaphylactic reaction, glaucoma, muscle weakness, increased serum creatinine, perforating duodenal ulcer, urinary retention, acute renal failure, bladder neck obstruction, exacerbation of renal function impairment, pneumonia, increased prostate-specific antigen, ovarian carcinoma, bile duct cancer, uterine cancer, myocardial infarction, decreased cardiac output, soft tissue infection, frequent urination, facial swelling, urinary disorders, urgency of urination, neurogenic bladder, skin tingling, generalized edema, male perineal pain, insomnia, nocturia, decreased urine volume, urinary stones, urinary incontinence, sensory disturbance, difficulty walking, limb tremors, chest tightness, chest pain, periorbital edema, edema, benign prostatic hyperplasia, male genital itching, decreased libido, erectile dysfunction, abnormal orgasm, retrograde ejaculation, hematuria, keratosis, hair loss, sinking sensation, anxiety, decreased sexual desire, back pain, vaginal bleeding, syncope, hearing impairment, thirst

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius to maintain the drug's effectiveness for a longer period.

Appearance

Light pink round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 3], 100 tablets/box [10 tablets/PTP X 10]