Medication info
Inphenazine 5mg (Solifenacin Succinate)

Inphenazine 5mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Introvio Pharma Co., Ltd.
Appearance
Bright yellow round film-coated tablets
Packaging
PTP packaging - 100 tablets/PTP [(10 tablets/PTP*10)]
Approval status
Active

MFDS item code 201603499 · Approved 2016.06.15 · Insurance code 052400120

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urge urinary incontinence and urinary frequency)
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 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 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 5mg once daily. 2. Patients with hepatic impairment No dosage 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 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Introvio Pharma Co., Ltd.

Efficacy & effects

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

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

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

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 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 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 5mg once daily. 2. Patients with hepatic impairment No dosage 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 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor 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 in patients with urinary retention, severe gastrointestinal conditions, myasthenia gravis, or narrow-angle glaucoma. Additionally, it should not be administered to individuals allergic to this drug or its ingredients, patients undergoing dialysis, or those with severe liver or kidney impairment. Caution is needed in patients at risk for urinary retention, gastrointestinal obstructive disease, or reduced gastrointestinal motility. Patients with severe renal or hepatic impairment should be careful not to exceed the maximum daily dose and dosage adjustment may be required with certain medications. While taking this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur. Particularly, the incidence of side effects is higher with the 10mg dosage, so adherence to the dosage is important. If serious allergic reactions such as angioedema or anaphylaxis occur, administration should be stopped immediately, and treatment should be sought. Caution is required while driving or operating machinery, as drowsiness, blurred vision, and fatigue may occur. This medication may have enhanced efficacy or exacerbated side effects when used with other anticholinergic drugs, hence consultation with a physician is necessary. Additionally, as this drug is metabolized in the liver, co-administration with strong CYP3A4 inhibitors may increase blood concentrations, requiring dosage adjustments. Pregnant women should use this medication cautiously since its safety in pregnancy has not been established, and breastfeeding individuals are advised to avoid its use. Pediatric use should be avoided due to unconfirmed safety and efficacy.

Side effects

Dry mouth, constipation, blurred vision, urinary retention, dry eyes, fecal impaction, colonic obstruction, intestinal obstruction, angioedema, nausea, 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, itching, rash, hives, vascular edema, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, polymorphic ventricular tachycardia, prolongation of QT interval on electrocardiogram, abnormal liver function tests, decreased appetite, hyperkalemia, dysphonia, anaphylactic reaction, glaucoma, muscle weakness, frequent urination, urinary disorders, urgency, neurogenic bladder, paresthesia, diarrhea, abdominal distension, acute renal failure, nocturia, decreased urinary output, sensory abnormalities, generalized edema, chest tightness, periorbital edema, edema, male perineal pain, benign prostatic hyperplasia, male genital itching, erectile dysfunction, insomnia, anxiety, decreased libido, back pain, vaginal bleeding, myocardial infarction, decreased cardiac output, syncope, hearing impairment, soft tissue infection, headache, dry mouth, drowsiness

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's efficacy for a longer time.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

PTP packaging - 100 tablets/PTP [(10 tablets/PTP*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.