Medication info

Dutasteride 0.5 mg Tablet

Prescription medicationTabletOralExpired
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
(株) U&Life Science
Appearance
Pale yellow, oval-shaped film-coated tablet
Packaging
30 tablets/PTP[((10 tablets/PTP) x 3)]
Approval status
Expired

MFDS item code 202000329 · Approved 2020.01.21

This product's status changed to Expired on 2025.01.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men
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 needed in patients with renal impairment or elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on administration of this medicine to these patients.

Ingredients

Manufacturer
(株) U&Life Science

Efficacy & effects

Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men

  • Benign prostatic hyperplasia
  • acute urinary retention
  • male pattern hair loss
View approved original text

This medication helps to improve the symptoms of benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the necessity for related surgery. It is also used to treat male pattern hair loss in adult men, being effective in improving hair loss. This medication allows for management of both prostate health and hair condition.

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 needed in patients with renal impairment or elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on administration of this medicine to these patients.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should avoid touching or handling it. In particular, contact with broken or crushed pieces of this medication should be avoided, and precautions should be taken to ensure that children do not touch broken pieces of it. This medication is not to be administered to women or children under 18 years of age. Patients with hypersensitivity or allergies to this medication or similar drugs should also avoid its use. Adult men planning to conceive should use this medication cautiously as it may affect fertility; usage should be determined by a doctor's judgment. Patients with urinary tract issues or poor liver function should be cautious when using this medication, and especially careful administration is required for those with liver disorders. Caution is necessary when taken with strong CYP3A4 inhibitors as it may alter the drug concentration. During treatment, erectile dysfunction, decreased libido, and semen disorders may occur, and these symptoms may persist even after discontinuation. Breast-related adverse reactions such as breast tenderness or gynecomastia have also been reported. Long-term use may increase the risk of high-grade prostate cancer; therefore, regular prostate examinations and monitoring of PSA levels are necessary. Blood donation is prohibited for at least 6 months during the use of this medication to prevent the medication from being passed to pregnant women. There are no specific antidotes for overdose, so appropriate supportive treatment based on symptoms is necessary. This medication should be kept out of reach of children and stored in its original container to prevent misuse or quality degradation. It is known not to affect driving or the ability to operate machinery, but caution is required as individual responses may vary. Pregnant women or nursing mothers should not use this medication as its safety has not been established. Patients receiving this medication should be regularly evaluated for prostate cancer and other urological diseases, and it is important to consult a doctor regarding changes in PSA levels.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
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  • itching
  • urticaria
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • xerostomia
  • constipation
  • cramps
  • orofacial dyskinesia
  • vomiting
  • colon polyp
  • epigastric discomfort
  • fatigue
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • tiredness
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • gastric ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified laceration
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbance
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • nephrolithiasis
  • taste disorder
  • telangiectasia

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 exposure to air and kept at a temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow, oval-shaped film-coated tablet

Package unit

30 tablets/PTP[((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.