Medication info

Dutasteride Tablet 0.5 mg (Dutasteride)

Prescription medicationTabletOralExpired
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
KS Pharmaceutical Co., Ltd.
Appearance
Pale yellow oval film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Expired

MFDS item code 202003543 · Approved 2020.05.15

This product's status changed to Expired on 2025.05.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of benign prostatic hyperplasia and treatment of male pattern hair loss (men aged 18~50)
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 tablet (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose of this medicine in patients with hepatic impairment has not been established because there are no data on its administration to such patients.

Ingredients

Manufacturer
KS Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of benign prostatic hyperplasia and treatment of male pattern hair loss (men aged 18~50)

  • Benign prostatic hyperplasia
  • risk of acute urinary retention
  • male pattern baldness
View approved original text

This medication helps alleviate symptoms of benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgery, providing overall therapeutic assistance. Additionally, it is used for the treatment of male pattern baldness in adult men, contributing to hair loss improvement. Therefore, this drug is effectively used for the treatment of benign prostatic hyperplasia and male pattern baldness.

How to take

Adult dose

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

Precautions

This medication is absorbed through the skin, so women who are pregnant or may become pregnant should not touch or take this drug. Care should also be taken to avoid touching broken or crushed pieces of this medication, and children should be kept away from exposure to this drug. Women, children under 18 years of age, and individuals allergic to this drug or similar substances should not use this medication. Men planning to conceive should take this drug cautiously under a doctor's guidance, as it may affect reproductive ability. Patients with urinary issues or poor liver function should exercise caution while using this drug, and potential drug interactions may occur when combined with specific medications, so consulting a specialist is advised. Side effects related to sexual function may arise during the use of this drug, such as erectile dysfunction, decreased libido, and ejaculation disorders, and some patients may experience breast pain or breast enlargement. These side effects may persist even after long-term use; if unusual symptoms occur, consult a doctor. Furthermore, this drug may affect the blood test results (PSA) used for prostate cancer screening, potentially causing a decrease in levels, so caution is needed when interpreting test results. Blood donation should be avoided during the use of this medication, and at least 6 months must pass after the last dose before donation is permitted. While it does not affect driving or machine operation, caution is recommended for patients with heart failure. There is no specific antidote for overdose, so if symptoms occur, immediate medical assistance should be sought for proper treatment. Keep out of reach of children and store in the original container to prevent misuse or quality degradation.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 79 more
  • itching
  • hives
  • localized edema
  • 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
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • gastric ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • 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 prevent air from entering, and it is recommended to keep it at room temperature between 1°C and 30°C. Proper storage ensures that the drug's composition remains unchanged and safe for use.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablets

Package unit

30 tablets/box [(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.