Medication info

Dutasteride 0.5 mg (Dutasteride) Tablets

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
Pale yellow round film-coated tablets
Packaging
PTP - 30 tablets/box [(30 tablets (10 tablets/PTP) x 3)]
Approval status
Active

MFDS item code 202503311 · Approved 2025.12.18

Summary

Main use
Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men
Who takes it
Adults
Adult dose
The recommended dose is 1 tablet (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it. It may be taken with or without food. No dose adjustment is necessary for patients with renal impairment or elderly patients. The recommended dose has not been established for patients with hepatic impairment because no data are available on administration of this medicine to such patients.

Ingredients

Manufacturer
Cosmax Pharma Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men

  • Benign prostatic hyperplasia
  • acute urinary retention
  • androgenetic alopecia
View approved original text

This medication improves symptoms caused by benign prostatic hyperplasia and reduces the risk of acute urinary retention. It also helps decrease the need for surgery related to benign prostatic hyperplasia. Additionally, it is used for the treatment of androgenetic alopecia in adult men. Therefore, this drug is effectively used for prostate health and hair loss management.

How to take

Adult dose

The recommended dose is 1 tablet (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it. It may be taken with or without food. No dose adjustment is necessary for patients with renal impairment or elderly patients. The recommended dose has not been established for patients with hepatic impairment because no data are available on administration of this medicine to such patients.

Precautions

This drug can be absorbed through the skin, so women who are pregnant or may become pregnant should not directly touch or handle this medication. In particular, care should be taken when handling broken or crushed pieces of this drug, as they may be harmful to a fetus. This medication should not be used in children under 18 years of age, and care should be taken to ensure that children do not have access to it. Women should not take this drug, and administration should be avoided in cases of allergy to any of its components. Patients with certain genetic disorders such as lactose intolerance should not take this medication. Adult men planning to conceive should discuss with their doctor, as this drug may affect reproductive ability. Patients with severely impaired urinary function or liver dysfunction should be cautious when administering this drug. Since this medication is metabolized in the liver, patients taking strong CYP3A4 inhibitors should be mindful of possible drug interactions. While taking this medication, sexual side effects such as erectile dysfunction, decreased libido, and ejaculation disorders may occur, and these symptoms may persist even after discontinuation. Prolonged use may result in breast-related adverse effects, such as breast tenderness or enlargement, necessitating regular monitoring. This medication may lower prostate-specific antigen (PSA) levels, so care should be taken when interpreting PSA test results, and regular testing is recommended. This drug may increase the risk of high-grade prostate cancer, so patients using it should undergo periodic evaluations for prostate cancer risk. Blood donation is prohibited for at least 6 months while taking this drug to prevent transfer to pregnant women. There is no specific antidote for overdose, so appropriate supportive treatment is necessary based on symptoms. This medication should be stored out of the reach of children and kept in its original container for safety. It is known not to affect driving or operating machinery, although individual differences may occur, so caution is advised. In patients with heart failure, the risk of heart failure may increase when this medication is combined with other drugs, so careful observation is necessary. While significant drug interactions have not been reported with this medication when combined with various drugs, caution is required with some drugs. It is contraindicated in pregnant women, and nursing mothers should also avoid taking this medication.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 79 more
  • itching
  • urticaria
  • localized swelling
  • serious skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dystonia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • abnormal sensations
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • telangiectasia

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow round film-coated tablets

Package unit

PTP - 30 tablets/box [(30 tablets (10 tablets/PTP) x 3)]

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.