Medication info
Uliphenazone 5mg (Solifenacin Succinate)

Uliphenazone 5mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Teragen Etex Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201501302 · Approved 2015.03.12 · Insurance code 698502960

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urinary frequency and urgency)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug may be taken with or without food and should be swallowed whole with water. Dosage adjustment is required in the following patients. 1. Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh Class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4(CYP3A4) inhibitors In patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Teragen Etex Co., Ltd.

Efficacy & effects

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

  • Urinary urgency
  • frequent urination
  • urge incontinence
View approved original text

Symptoms of overactive bladder such as urinary urgency, frequent urination, and urge incontinence can cause significant inconvenience in daily life. This medication helps relax the bladder muscles, alleviating sudden and strong urges to urinate. Additionally, it reduces the frequency of urination, thereby improving the quality of life for patients. Through treatment, symptoms of overactive bladder can be effectively managed. This medication is particularly used to improve symptoms such as urge incontinence.

How to take

Adult dose

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

Precautions

This medication should not be used in patients with urinary retention symptoms. It is also not safe for patients with serious gastrointestinal diseases such as toxic megacolon or severe myasthenia gravis. Additionally, it should be avoided in patients with narrow-angle glaucoma, those allergic to this medication or its components, patients undergoing hemodialysis, and patients with severe liver or kidney impairments. Patients with certain genetic metabolic disorders should also avoid this medication. Patients at risk for urinary retention or with gastrointestinal obstructive diseases, as well as those at risk for reduced gastrointestinal motility, should use this medication with caution. Patients with severe kidney or liver impairment, or those taking strong CYP3A4 inhibitors, also require dosage limitations or careful monitoring. Moreover, patients taking medications that may exacerbate gastroesophageal reflux or esophagitis, and those with autonomic neuropathy should exercise caution. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Serious side effects such as gastrointestinal obstruction can occur with high doses, hence caution is warranted. Patients with QT prolongation syndrome or hyperkalemia are at risk for cardiac arrhythmias and should use this medication carefully. If serious allergic reactions such as angioedema or anaphylaxis occur, the medication should be discontinued immediately and appropriate treatment sought. Before taking this medication, the cause of frequent urination should be accurately evaluated, and antimicrobial therapy should be administered if a urinary tract infection is present. Caution should be exercised due to the risk of accidents from drowsiness or blurred vision when driving or operating machinery. Taking this medication with other anticholinergic drugs may enhance effects or worsen side effects, so caution is advised when combined. Additionally, it may reduce the efficacy of medications that promote gastrointestinal motility. This medication is primarily metabolized by the CYP3A4 enzyme, so taking it with strong CYP3A4 inhibitors may increase medication concentration and risk of side effects. Therefore, when combined with such medications, dosage should be limited or avoided. Safety during pregnancy has not been established, so it should be used cautiously during pregnancy, and because this medication may be excreted in breast milk, it is advisable to avoid use during breastfeeding. Safety and efficacy in pediatric patients have also not been established, so it should not be administered to children. In case of overdose, induce vomiting should be avoided, and appropriate treatment such as activated charcoal administration is necessary. Symptoms affecting the central nervous system or cardiac arrhythmias may occur, requiring professional medical intervention.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • dyspepsia
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • leg swelling
  • fatigue
  • cough
  • hypertension
  • urinary difficulties
  • decreased urine flow
  • post-void residual
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • kidney impairment
  • itching
  • rash
  • hives
  • vascular swelling
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorder
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased urine output
  • urinary disorders
  • urgency
  • neurogenic bladder
  • skin numbness
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urinary output
  • urinary stones
  • incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital swelling
  • edema
  • benign prostatic hyperplasia
  • male perineal itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • sensation of sinking
  • anxiety
  • decreased sexual desire
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • thirst
  • drowsiness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 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.

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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.