Medication info

Venashinjung 5 mg (Solifenacin Succinate)

Prescription medicationTabletExpired
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
Bright yellow round film-coated tablets
Packaging
100 tablets (10 tablets/PTP x 10)
Approval status
Expired

MFDS item code 201900674 · Approved 2019.01.25

This product's status changed to Expired on 2024.01.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (e.g., frequent urination and urinary urgency)
Who uses it
Adults
Adult dosage
The usual recommended dose for adults (including elderly patients) 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. 1. Patients with renal impairment No dose adjustment is necessary in 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 dose adjustment is necessary in 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.

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

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

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

This medication is used to alleviate the major symptoms of overactive bladder such as urinary urgency, frequency, and urge incontinence. It helps to improve uncomfortable urinary symptoms caused by overactive bladder, thereby enhancing the quality of life for patients. It effectively controls these symptoms, reducing discomfort in daily life. Therefore, it is used for the treatment of overactive bladder symptoms.

Dosage and Administration

Adult dosage

The usual recommended dose for adults (including elderly patients) 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. 1. Patients with renal impairment No dose adjustment is necessary in 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 dose adjustment is necessary in 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.

Precautions

This medication should not be used in patients with urinary retention symptoms. Patients with severe gastrointestinal disorders, myasthenia gravis, or angle-closure glaucoma should also avoid using this medication. It is contraindicated for individuals allergic to this medication or its ingredients, patients undergoing dialysis, and those with severe liver or kidney function impairment. Patients with certain genetic metabolic disorders should also refrain from using this medication. In patients with severe urinary outlet obstruction or gastrointestinal obstruction, and those with moderate to severe renal or liver function impairment, this medication should be used with caution. Common side effects include dry mouth, constipation, blurred vision, urinary retention, dry eyes, dizziness, depression, nausea, indigestion, upper abdominal pain, vomiting, urinary tract infection, influenza, pharyngitis, lower limb edema, fatigue, cough, hypertension, difficulty in urination, decreased urine flow, bladder outlet obstruction, cystitis, rhinitis, vomiting, gastroesophageal reflux disease, intestinal obstruction, peripheral edema, headache, hallucinations, drowsiness, delirium, kidney disorders, itching, rash, angioedema, erythema multiforme, exfoliative dermatitis, and serious allergic reactions may occur, particularly with high-dose administration, necessitating caution. Patients should be careful while driving or operating machinery as this medication may cause drowsiness or fatigue. Patients with QT prolongation syndrome or hyperkalemia are at risk for cardiac arrhythmias and should be cautious. If serious allergic reactions such as angioedema or anaphylaxis occur, the medication should be discontinued immediately, and appropriate treatment should be sought. This medication is metabolized by specific enzymes; therefore, dosage adjustments are necessary when taken with strong CYP3A4 inhibitors. Pregnant women and nursing mothers should be cautious when taking this medication, and its safety in children has not been established, so it is advisable not to use it in pediatric patients. In the case of overdose, appropriate detoxification treatment is required, and professional treatment should be sought for serious symptoms.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
Show 69 more
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • bladder distention
  • cystitis
  • rhinopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucination
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice impairment
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • polyuria
  • voiding dysfunction
  • urgency incontinence
  • neurogenic bladder
  • skin numbness
  • diarrhea
  • abdominal distension
  • acute renal failure
  • nocturia
  • decreased urine volume
  • sensory disturbance
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • erectile dysfunction
  • insomnia
  • anxiety
  • headache
  • thirst
  • drowsiness

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. Avoid extremely hot or cold places, and it is best to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 10)

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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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.