Medication info
Yaira Tablet 20mg (Vardenafil Hydrochloride)

Yaira Tablet 20mg (Vardenafil Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Vardenafil Hydrochloride Hydrate›23.705mg / 1 tablet
Manufacturer / importer
Jongkundang Co., Ltd.
Appearance
Orange, rectangular film-coated tablets
Packaging
10 tablets (5 tablets/PTP x 2)
Approval status
Active

MFDS item code 202002544 · Approved 2020.04.10

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults
Adult dose
Adults: Take the initial recommended dose of 10mg orally approximately 25 to 60 minutes before sexual activity. Depending on efficacy and tolerability, the dose may be increased to 20mg or decreased to 5mg. The maximum recommended dose is 20mg once daily. The maximum recommended frequency of administration is once daily. This medication may be taken with or without food; taking it with a high-fat meal may delay the onset of action. Do not exceed 5mg when coadministered with erythromycin, a CYP 3A4 inhibitor. Older adults (65 years and older): Because clearance of this medication is reduced in older adults, the initial dose should be 5mg. Depending on efficacy and tolerability, the dose may be increased to 10mg or 20mg (see 4. Adverse Reactions 10)). Patients with hepatic impairment: The initial dose for patients with mild to moderate hepatic impairment (Child-Pugh A-B) should be 5mg. Depending on efficacy and tolerability, the dose may be increased to 10mg or 20mg. Patients with renal impairment: No dosage adjustment is necessary in patients with mild to moderate renal impairment. The initial dose for patients with severe renal impairment (crCL<30ml/min) should be 5mg. Depending on efficacy and tolerability, the dose may be increased to 10mg or 20mg.

Ingredients

Manufacturer
Jongkundang Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medicine is used to treat erectile dysfunction. It effectively helps patients who wish to improve their sexual function.

How to take

Adult dose

Adults: Take the initial recommended dose of 10mg orally approximately 25 to 60 minutes before sexual activity. Depending on efficacy and tolerability, the dose may be increased to 20mg or decreased to 5mg. The maximum recommended dose is 20mg once daily. The maximum recommended frequency of administration is once daily. This medication may be taken with or without food; taking it with a high-fat meal may delay the onset of action. Do not exceed 5mg when coadministered with erythromycin, a CYP 3A4 inhibitor. Older adults (65 years and older): Because clearance of this medication is reduced in older adults, the initial dose should be 5mg. Depending on efficacy and tolerability, the dose may be increased to 10mg or 20mg (see 4. Adverse Reactions 10)). Patients with hepatic impairment: The initial dose for patients with mild to moderate hepatic impairment (Child-Pugh A-B) should be 5mg. Depending on efficacy and tolerability, the dose may be increased to 10mg or 20mg. Patients with renal impairment: No dosage adjustment is necessary in patients with mild to moderate renal impairment. The initial dose for patients with severe renal impairment (crCL<30ml/min) should be 5mg. Depending on efficacy and tolerability, the dose may be increased to 10mg or 20mg.

Precautions

This medicine is used for the treatment of erectile dysfunction and it is important to thoroughly check the patient's heart condition before use. It is not safe to use this medicine in patients with cardiovascular diseases or those for whom sexual activity is not recommended. This medicine has a vasodilating effect, which may cause a temporary drop in blood pressure, so caution is required for patients with heart or vascular problems. In particular, patients with specific heart conditions like aortic stenosis may be sensitive to this medicine. If an erection lasts for more than 4 hours after taking this medicine, patients should consult a healthcare provider immediately, as untreated cases can lead to penile tissue damage or permanent loss of erectile function. Co-administration with nitrates (such as nitroglycerin) or nitric oxide donors may result in excessive hypotension; therefore, patients taking these medications should not use this medicine. This medicine is not administered to patients with hypersensitivity to it, those with severe liver or kidney dysfunction, patients with hypotension, those who have recently experienced a heart attack or stroke, or patients with unstable angina. Furthermore, its use is restricted for adolescents under 18 and elderly patients over 75 who are taking certain medications. Patients with penile deformities, bleeding disorders, active peptic ulcers, etc., should use this medicine with caution, as the risk of hypotension may increase when used concurrently with certain antibiotics or alpha-blockers. Side effects such as headaches, dizziness, flushing due to vasodilation, dyspepsia, muscle pain, etc., may occur while taking this medicine. Rarely, visual disturbances or hearing loss have been reported; therefore, any of these symptoms should be immediately reported to a healthcare provider. This medicine is metabolized in the liver and kidneys; hence, patients with severely impaired liver function need to adjust their dosage, and it should not be given to patients with severely compromised kidney function. This medicine can interact with various drugs, especially with CYP3A4 inhibitors (e.g., some antibiotics, antifungals, HIV treatments), which can significantly increase the blood levels of this medicine, requiring dosage adjustment or prohibition of concurrent use. Grapefruit juice can also increase blood levels, so it should not be taken with this medicine. It should not be used by women who are pregnant or breastfeeding, nor by children. In cases of overdose, serious side effects may occur, necessitating immediate medical help, and renal dialysis cannot promote the excretion of this medicine. This medicine should be stored out of reach of children, and transferring it to other containers is not advisable as it can negatively affect its quality. If dizziness or vision disturbances occur after taking this medicine, avoid driving or operating machinery, and if sudden vision loss or hearing reduction happens, stop using it immediately and consult a healthcare provider.

Side effects

Headache, dizziness, vasodilation, nasal congestion, nasal obstruction, dyspepsia, diarrhea, gastrointestinal and abdominal pain, nausea, back pain, muscle tension and cramps, phosphokinase elevation, conjunctivitis, allergic swelling and angioedema, allergic reaction, sleep disturbance, anxiety, perceptual disturbance and sensory disturbance, drowsiness, syncope, memory loss, seizures, visual disturbances, eye congestion, color vision distortion, eye pain and discomfort, photophobia, increased intraocular pressure, tinnitus, vertigo, palpitations, tachycardia, angina, myocardial infarction, ventricular arrhythmias, hypotension, dyspnea, dry mouth, gastroesophageal reflux disease, gastritis, vomiting, transaminase elevation, erythema, rash, photosensitivity reaction, myalgia, increased erection, priapism, discomfort, chest pain, priapism, color vision disturbances, cerebrovascular hemorrhage, sudden cardiac death, transient ischemic attack, ventricular arrhythmias, vision loss, visual field defect, retinal vein occlusion, reduced vision, non-arteritic anterior ischemic optic neuropathy, sudden hearing loss, hearing impairment, facial flushing, rhinitis, xerostomia, myalgia, palpitations, visual disturbances, facial edema, back pain, myalgia

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

Storage

This medicine should be stored in a tightly sealed container to prevent air from entering, and it should be kept in a cool place at a temperature below 25 degrees. Proper storage can help maintain the medicine's effectiveness.

Appearance and packaging

Appearance

Orange, rectangular film-coated tablets

Package unit

10 tablets (5 tablets/PTP x 2)

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.