Medication info
Solitair 5mg (Solifenacin Succinate)

Solitair 5mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Samik Pharmaceutical Co., Ltd.
Appearance
Light pink round film-coated tablet
Packaging
100 tablets/PTP (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 201604147 · Approved 2016.07.04 · Insurance code 644003760

Summary

Main use
Treatment of overactive bladder symptoms (urge urinary incontinence, urinary frequency, etc.)
Who takes it
Adults
Adult dose
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). 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 taking a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Samik Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (urge urinary incontinence, urinary frequency, etc.)

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

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

How to take

Adult dose

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

Precautions

This drug should not be used in patients with urinary retention symptoms. Patients with severe gastrointestinal diseases or myasthenia gravis should also avoid taking this medication. Patients with glaucoma or hypersensitivity to this medication should avoid administration. It is also advisable for patients undergoing dialysis or those with severe liver or kidney impairments to refrain from using this drug. Additionally, patients with genetic issues like lactose intolerance should be cautious. Patients at risk of urinary retention or with gastrointestinal obstructive diseases should use this medication with caution. Patients with severe renal impairment or moderate hepatic impairment should have their dosage restricted, and caution is needed when used in conjunction with strong CYP3A4 inhibitors. Patients with gastroesophageal reflux disease or autonomic neuropathy should also be careful when taking this medication. Common side effects of this drug may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Severe gastrointestinal adverse reactions may occur, particularly at high doses. Symptoms should be closely monitored, as there may be cases of discontinuing use due to adverse reactions. This drug carries a risk of cardiac side effects in patients with QT prolongation syndrome or hyperkalemia, hence caution is advised. If signs of allergic reactions such as angioedema or anaphylaxis occur, administration should be halted immediately, and appropriate treatment should be sought. There is a risk of accidents due to drowsiness or blurred vision when driving or operating machinery, so caution is required. Taking this medication alongside anticholinergic drugs may enhance its effects or exacerbate side effects. It may also reduce the effectiveness of medications that increase gastrointestinal motility. When combined with a strong CYP3A4 inhibitor, the blood concentration of this drug may increase, requiring dosage adjustment. Pregnant women should exercise caution as the safety of this drug during pregnancy has not been established, and breastfeeding women should avoid use since this drug can be excreted in breast milk. The safety for use in pediatric patients has also not been established, so this drug is not administered to children. In cases of overdose, symptoms such as severe headaches, dizziness, drowsiness, and blurred vision may occur; in this situation, immediate medical attention should be sought. Overdose may require activated charcoal administration and gastric lavage, and appropriate medicinal treatment may be necessary depending on symptoms.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
Show 102 more
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • peripheral edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colonic obstruction
  • bowel obstruction
  • vascular edema
  • anaphylactic reaction
  • 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 disturbances
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • dysuria
  • diminished urinary flow
  • bladder hypertrophy
  • cystitis
  • nasopharyngitis
  • urinary retention
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • biliary tract cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • increased urinary frequency
  • voiding dysfunction
  • urgency to urinate
  • neurogenic bladder
  • skin paresthesia
  • generalized edema
  • male perineal pain
  • insomnia
  • abdominal bloating
  • nocturia
  • reduced urine volume
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • gait disturbances
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital pruritus
  • reduced libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematuria
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased libido
  • headache
  • dry mouth
  • drowsiness
  • mydriasis
  • hallucinations
  • excessive excitement
  • convulsions
  • respiratory failure
  • tachycardia

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 sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the effectiveness of the medication for a longer duration.

Appearance and packaging

Appearance

Light pink round film-coated tablet

Package unit

100 tablets/PTP (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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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.