Medication info
Oavi Tablet 10 mg (Solifenacin Succinate)

Oavi Tablet 10 mg (Solifenacin Succinate)

Prescription medicationTablet
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Unilab Pharmaceuticals Co., Ltd.
Appearance
Pink oval film-coated tablet
Packaging
28 tablets (14 tablets/PTP×2), 98 tablets (14 tablets/PTP×7)
Approval status
Active

MFDS item code 201800530 · Approved 2018.01.29 · Insurance code 649507540

Summary

Main use
Treatment of symptoms of overactive bladder (such as 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 medicine 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 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 dosage 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 strong cytochrome P450 3A4 (CYP3A4) inhibitors: For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Unilab Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of symptoms of overactive bladder (such as frequent urination and urinary urgency)

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

This medication is used to treat symptoms of overactive bladder such as urgency urinary incontinence, frequent urination, and urgency.

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 medicine 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 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 dosage 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 strong cytochrome P450 3A4 (CYP3A4) inhibitors: For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used by patients with urinary retention or severe gastrointestinal disorders. Patients with myasthenia gravis, narrow-angle glaucoma, and those allergic to this medication or its ingredients should also avoid use. It is advisable that patients receiving hemodialysis or those with severe liver or kidney dysfunction do not use this medication. Additionally, it should not be administered to individuals who genetically cannot digest certain sugars. Patients at risk of urinary retention or those concerned about gastrointestinal obstruction or decreased gastrointestinal motility should use this medication cautiously. Patients with severe kidney or liver impairment should limit their dosage and be cautious when taking it with certain medications. It should also be used carefully in individuals with gastroesophageal reflux disease or autonomic neuropathy. Common side effects when taking this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Notably, dry mouth and constipation tend to occur frequently, and symptoms may worsen with higher dosages. Rarely, serious gastrointestinal-related side effects may occur, and if any unusual symptoms arise, a healthcare professional should be notified immediately. Caution is required when using this medication as drowsiness or blurred vision may impact driving or operating machinery. When taken with other anticholinergic medications, the effects may be intensified or side effects may worsen, so caution is advised. Additionally, this medication may reduce the efficacy of drugs that promote gastrointestinal motility. This medication is metabolized in the liver, so dose adjustments are necessary when taken with strong CYP3A4 inhibitors. Patients with severely impaired kidney or liver functions should avoid using such medications concurrently. The safety of this medication has not been established in pregnant women, so caution is recommended during use. Breastfeeding women should avoid using this medication due to the possibility of it passing into breast milk. The safety and efficacy of this medication in pediatric patients have not been confirmed, hence it should not be administered to children. If an overdose occurs, immediate medical attention should be sought, and appropriate treatment based on symptoms is necessary. This medication should be used with particular caution in individuals with heart disease, QT prolongation syndrome, or hypokalemia. It is important to consult a doctor or pharmacist immediately if any unusual symptoms or side effects occur during the use of this medication.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular angioedema
  • nausea
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  • dyspepsia
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • post-void residual
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal 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
  • speech disturbance
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • elevated serum creatinine
  • perforating duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder outlet obstruction
  • worsened renal function
  • pneumonia
  • increase in prostate-specific antigen
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urinary disorders
  • urgency
  • neurogenic bladder
  • paresthesia
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • feeling of sinking
  • facial edema
  • blood clots
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital pruritus
  • decreased erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • diarrhea
  • bloating
  • nocturia
  • decreased urine volume
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • gait difficulties
  • limb tremors

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and the ideal storage temperature is between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the efficacy of the medication for a longer period and ensure safe use.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

28 tablets (14 tablets/PTP×2), 98 tablets (14 tablets/PTP×7)

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.