Medication info
Sunkajeong 20 mg (Tadalafil)

Sunkajeong 20 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›20mg / 1 tablet
Manufacturer / importer
Aju Pharmaceuticals Co., Ltd.
Appearance
Yellow triangular film-coated tablet
Packaging
4 tablets (2 tablets/PTP×2)
Approval status
Active

MFDS item code 201501676 · Approved 2015.03.30

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, regardless of meals. For patients in whom tadalafil 10mg does not provide sufficient efficacy, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustment is not required in elderly patients. Use in men with renal impairment Dose adjustment is not required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, regardless of meals. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on doses higher than 10mg in patients with hepatic impairment. [See section 3. Use with caution in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes Dose adjustment is not required in patients with diabetes.
Child dose
This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
Aju Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction, and sexual stimulation is necessary for it to be effective. Additionally, it is not indicated for use by women. Therefore, male patients may use it for the improvement of erectile dysfunction.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, regardless of meals. For patients in whom tadalafil 10mg does not provide sufficient efficacy, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustment is not required in elderly patients. Use in men with renal impairment Dose adjustment is not required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, regardless of meals. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on doses higher than 10mg in patients with hepatic impairment. [See section 3. Use with caution in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes Dose adjustment is not required in patients with diabetes.

Child dose

This medicine should not be used in people under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction. Before taking it, a doctor’s diagnosis and physical examination must confirm the underlying cause. Patients with heart disease should carefully evaluate their cardiovascular status before taking this medication, considering the cardiac burden from sexual activity. A prolonged erection lasting more than 4 hours is a serious side effect and requires immediate medical attention. This medication should not be used by patients taking nitrate medications, as it may cause dangerously low blood pressure. Patients who have had recent severe cardiovascular events such as myocardial infarction, heart failure, or stroke should not use this medication. Patients with hereditary retinal diseases or specific eye diseases are advised to avoid this medication. Co-administration with other erectile dysfunction medications is not recommended due to unproven safety and efficacy. Patients with severe renal or liver impairment should be cautious when taking this medication and may require dose adjustments. Combining with certain antihypertensive medications may cause lower blood pressure; therefore, interactions with concomitant medications should be verified. Alcohol intake while taking this medication can increase the risk of side effects like blood pressure drop and dizziness. This medication is not for use in women, children, or newborns. Possible side effects include headaches, dyspepsia, back pain, muscle pain, flushing, limb pain, nasopharyngitis, upper respiratory infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, generalized weakness, facial edema, fatigue, pain, peripheral edema, angina, chest pain, hypotension, orthostatic hypotension, palpitations, fainting, tachycardia, abnormal liver function test results, dry mouth, dysphagia, esophagitis, gastritis, loose stools, nausea, upper abdominal pain. If sudden changes in vision or hearing occur, discontinue use immediately and inform healthcare providers. In case of overdose, standard emergency treatment should be initiated; blood dialysis is not very helpful in excreting this medication. This medication should be kept out of the reach of children, and it is advisable to retain its original packaging. Always consult your doctor before use to discuss your health condition and current medications, and follow guidelines for safe use.

Side effects

headache, dyspepsia, low back pain, myalgia, congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, hypertension, dizziness, urinary tract infection, gastroenteritis, hypertension, dizziness, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, migraine, seizure, transient global amnesia, visual field defect, retinal vein occlusion, retinal artery occlusion, vision reduction, non-arteritic anterior ischemic optic neuropathy, sudden hearing loss or decrease, tinnitus, increased erection, spontaneous penile erection, angioedema, myocardial infarction, cardiac sudden death, stroke, chest pain, palpitations, ventricular arrhythmia, tachycardia, increased blood urea nitrogen, chest tightness, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, kidney pain, dry mouth, heartburn, drowsiness, increased leukocyte count, thrombocytopenia, anxiety, sleep disorders, decreased hemoglobin, eye pain, chest pain, arthralgia, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eye syndrome, abdominal cramps, increased bilirubin, ejaculation disorder, pain in external genitalia, erythema, itching, penile disorder, myocardial infarction, ear ringing, nosebleed, dry nose, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reaction, facial edema, fever, increased hemoglobin, chills, skeletal pain

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is also recommended to keep it at room temperature between 1°C and 30°C. Avoid storing in excessively hot or cold places, and keep it in a cool place away from direct sunlight.

Appearance and packaging

Appearance

Yellow triangular film-coated tablet

Package unit

4 tablets (2 tablets/PTP×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.

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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.