Medication info
Dutasteride 0.5/5 mg Tablet (Dutasteride, Tadalafil)

Dutasteride 0.5/5 mg Tablet (Dutasteride, Tadalafil)

Prescription medicationTablet
Ingredient · strength
Dutasteride›0.5mg / 1 tabletTadalafil›5mg / 1 tablet
Manufacturer / importer
Dong-A ST Co., Ltd.
Appearance
White elongated tablets
Packaging
30 tablets/box [10PTPx3]
Approval status
Active

MFDS item code 202500183 · Approved 2025.01.23

Summary

Main use
Treatment of symptoms of moderate to severe benign prostatic hyperplasia
Who uses it
Adults · Children
Adult dosage
Adults: The recommended dose is 1 tablet once daily (dutasteride 0.5mg and tadalafil 5mg), taken orally. This medicine may be taken with or without food. Swallow the tablet whole at approximately the same time each day. No dose adjustment is necessary in elderly patients. No dose adjustment is necessary in patients with mild renal impairment. This medicine is not recommended for patients with severe renal impairment. The recommended dose of this medicine in patients with hepatic impairment has not been established.
Children's dosage
Do not use in children under 18 years of age.

Ingredients

Manufacturer
Dong-A ST Co., Ltd.

Efficacy & effects

Treatment of symptoms of moderate to severe benign prostatic hyperplasia

  • Symptoms of benign prostatic hyperplasia
View approved original text

This medication is used for the treatment of symptoms of benign prostatic hyperplasia that range from moderate to severe. The condition includes symptoms such as difficulty urinating, frequent urination, and poor urine flow. Taking this medication improves these symptoms and makes the daily life of the patient more comfortable.

Dosage and Administration

Adult dosage

Adults: The recommended dose is 1 tablet once daily (dutasteride 0.5mg and tadalafil 5mg), taken orally. This medicine may be taken with or without food. Swallow the tablet whole at approximately the same time each day. No dose adjustment is necessary in elderly patients. No dose adjustment is necessary in patients with mild renal impairment. This medicine is not recommended for patients with severe renal impairment. The recommended dose of this medicine in patients with hepatic impairment has not been established.

Children's dosage

Do not use in children under 18 years of age.

Precautions

This medication must not be handled or taken by women, especially those who are pregnant or may become pregnant. This is because the components of this medication can be absorbed through the skin and may adversely affect the development of male fetal genitalia. Additionally, children under the age of 18 should not come into contact with or take this medication. If contact occurs, it should be washed off immediately with soap and water. This medication is used for the treatment of benign prostatic hyperplasia, and a medical professional must assess for other urological diseases, like prostate cancer, before treatment begins. Since sexual activity may place stress on the heart, patients with cardiovascular disease need to consult with a doctor for diagnosis and guidance before using this medication. One component of this medication may cause a rare side effect of an erection lasting longer than 4 hours; in such cases, medical attention should be sought immediately. Delayed treatment of priapism can lead to penile tissue damage and permanent erectile dysfunction. Additionally, taking this medication with nitrate medications or other antihypertensive agents may excessively lower blood pressure. Therefore, it is essential to consult a doctor. Patients who have recently experienced serious cardiovascular conditions such as myocardial infarction, acute cardiac arrest, unstable angina, or stroke should not take this medication. Patients with severely impaired liver or kidney function should use this medication with caution, and careful consideration should be given to dose adjustments or whether to take it at all. This medication can interact with other drugs, so inform your healthcare provider if you are taking any other medications. While taking this medication, regular prostate-specific antigen (PSA) tests should be conducted, as there may be an increased risk of developing prostate cancer, requiring careful monitoring. During treatment with this medication, rare side effects such as headache, dyspepsia, dizziness, myalgia, erectile dysfunction, decreased libido, and others may occur. If sudden vision loss, hearing loss, or severe allergic reactions occur, discontinue use immediately and seek medical attention. This medication is not approved for use in children and can be used in the elderly without special dosage adjustments, but caution is needed. In the event of an overdose, consult with healthcare professionals immediately and receive appropriate treatment if necessary. This medication should be stored out of reach of children and kept in its original packaging to maintain its integrity.

Side effects

COVID-19, headache, dizziness, muscle pain, joint pain, dyspepsia, palpitations, hyperlipidemia, pruritus, liver abscess, acute sinusitis, bronchitis, impetigo, herpes zoster, athlete's foot, nasopharyngitis, pharyngitis, periodontitis, chronic inflammatory demyelinating polyneuropathy, sensory loss, polyneuropathy, neuropathy, facial paralysis, paresthesia, back pain, neck pain, osteoarthritis, muscle weakness, joint disorders, plantar fasciitis, limb pain, spinal disc disorders, gastroesophageal reflux disease, colitis, inguinal hernia, irritable bowel syndrome, abdominal distension, epigastric pain, dysphagia, nausea, gastritis, diverticulosis, voice disorder, nasal congestion, dyspnea, varicose veins, hypertension, flushing, warm flushing, cataract, dry eyes, diabetic retinopathy, retinal detachment, star-shaped vitreous degeneration, lens capsule opacification, blepharitis, gout, chest discomfort, death, chest pain, urticaria, rash, hair loss, bladder mass, urge incontinence, urgency, gynecomastia in males, breast mass, breast pain, prostatic cyst, decreased hemoglobin, increased serum triglycerides, recurrent liver cancer, extranasal papilloma, colon and rectal adenoma, cholecystitis, hepatitis, hepatic steatosis, gallbladder disorders, peri-implant fracture, eye contusion, cartilage damage, ear pain, depression, Type I bipolar disorder, mixed anxiety and depressive disorder, cataract surgery, erectile dysfunction, decreased libido, ejaculation disorder, gynecomastia, testicular pain, testicular swelling, pulmonary embolism, pneumonia, orofacial dyskinesia, xerostomia, constipation, abdominal pain, insomnia, diarrhea, cramps, vomiting, colon polyp, epigastric discomfort, weakness, congestion, deep vein thrombosis, fever, chills, gastroesophageal reflux, hemorrhoids, pain, lung cancer, thromboembolic stroke, headache, epigastric pain, low back pain, nasopharyngitis, diarrhea, limb pain, muscle pain, dizziness, gastroesophageal reflux, nausea, vomiting, joint pain, muscle cramps, myasthenia, facial edema, fatigue, pain, peripheral edema, angina, chest pain, hypotension, myocardial infarction, orthostatic hypotension, palpitations, syncope, tachycardia, abnormal liver function test results, dry mouth, dysphagia, esophagitis, increased GGTP, loose stools, dry mouth, dysphagia, esophagitis, increased GGTP, loose stools, nausea, epigastric pain, vomiting, gastroesophageal reflux, hemorrhoidal bleeding, rectal bleeding, joint pain, neck pain, sensory loss, insomnia, dysesthesia, drowsiness, dizziness, renal impairment, dyspnea, epistaxis, pharyngitis, itching, rash, sweating, blurred vision, color vision abnormalities, conjunctivitis, eye pain, increased tear secretion, eyelid edema, sudden hearing loss or decrease, tinnitus, increased erection, spontaneous penile erection, priapism, angioedema, electrocardiogram abnormalities, primary sinus bradycardia, facial flushing, flushing, limb discomfort, facial edema, reduced semen, 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 protect it from air and moisture. It is best to maintain a storage temperature between 1°C and 30°C to ensure its effectiveness and safety.

Appearance and packaging

Appearance

White elongated tablets

Package unit

30 tablets/box [10PTPx3]

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.