Medication info

Vesina 10 mg (Solefenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Korea Prime Pharma Co., Ltd.
Appearance
Bright pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201604104 · Approved 2016.06.30 · Insurance code 663607050

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urinary frequency and urgency)
Who takes it
Adults
Adult dose
For adults (including elderly patients), the recommended dose is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). For patients with severe renal impairment (creatinine clearance≤30ml/min), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), use with caution and do not exceed 5mg 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 5mg.

Ingredients

Manufacturer
Korea Prime Pharma Co., Ltd.

Efficacy & effects

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

  • Urgency incontinence
  • frequent urination
  • urgency
View approved original text

This medication is used to treat symptoms of overactive bladder, including urge incontinence, frequent urination, and urgency. It alleviates excessive contractions of the bladder, enhances uncomfortable symptom relief, and reduces the frequent urge to urinate. It helps alleviate the sudden urge to urinate that patients may experience in daily life. Moreover, this medication stabilizes bladder function, contributing to an improved quality of life. Therefore, it is used effectively to address various symptoms caused by overactive bladder.

How to take

Adult dose

For adults (including elderly patients), the recommended dose is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). For patients with severe renal impairment (creatinine clearance≤30ml/min), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), use with caution and do not exceed 5mg 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 5mg.

Precautions

This medication should not be used in patients with certain conditions. For example, patients with urinary retention, severe gastrointestinal disorders, myasthenia gravis, angle-closure glaucoma, known allergy to this medication or its components, patients undergoing hemodialysis, and those with severe liver or kidney dysfunction should not take this medication. Furthermore, patients at risk of urinary retention or with gastrointestinal obstruction, slow gastrointestinal motility, severe kidney and liver impairment, those taking strong CYP3A4 inhibitors, patients with certain hernias or gastroesophageal reflux disease, patients with autonomic neuropathy, etc. should exercise caution when using this medication. Taking this medication can result in various side effects such as dry mouth, constipation, blurred vision, urinary difficulties, and dry eyes. Dry mouth and constipation are notably the most common, and serious gastrointestinal side effects have been reported with high doses. Other symptoms may include dizziness, fatigue, cough, and hypertension. This medication carries a risk of inducing cardiac rhythm disturbances, thus patients with heart disease or electrolyte imbalances should be cautious. Additionally, severe allergic reactions such as angioedema or anaphylaxis may occur, and if such symptoms arise, treatment should be discontinued immediately, and medical attention sought. Prior to taking this medication, other causes of urinary problems must be thoroughly identified, and if a urinary tract infection is present, appropriate antibiotic treatment should be initiated first. The effects of this medication usually begin after about 4 weeks. Caution is required when driving or operating machinery, as blurred vision, drowsiness, and fatigue may occur. This medication may enhance the effects or increase the side effects when taken with other anticholinergic drugs. It may also decrease the effectiveness of medications that stimulate gastrointestinal motility. This medication is metabolized in the liver by certain enzymes (CYP3A4), and taking it with drugs that strongly inhibit this enzyme may increase the blood concentration of this medication, elevating the risk of side effects; hence dose adjustments may be necessary. The safety of this drug in pregnant women is not well established, so caution is advised for pregnant patients. Nursing mothers are advised to avoid taking this medication as it can be transmitted through breast milk and could harm the baby. This medication has not been confirmed safe or effective for children and should not be used in this population. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and immediate medical treatment should be sought. Appropriate emergency measures such as gastric lavage or activated charcoal administration are necessary in cases of overdose.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vasogenic edema
  • nausea
Show 84 more
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • post-void dribbling
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • pruritus
  • rash
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorders
  • anaphylaxis
  • glaucoma
  • muscular weakness
  • facial edema
  • frequent urination
  • voiding dysfunction
  • urgency
  • neurogenic bladder
  • skin paresthesia
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine volume
  • sensory disturbances
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital pruritus
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematochezia
  • pneumonia
  • keratosis
  • hair loss
  • feeling of heaviness
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue inflammation
  • headache
  • thirst
  • drowsiness

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is advisable to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright pink round film-coated tablets

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.