Medication info

Dutarget Tablet (Dutasteride)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
Pale yellow round film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTPX3)]
Approval status
Approval withdrawn

MFDS item code 202001381 · Approved 2020.02.27

This product's status changed to Approval withdrawn on 2023.10.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of male pattern hair loss and benign prostatic hyperplasia
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 patients with hepatic impairment.

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss and benign prostatic hyperplasia

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

This medication is used to improve symptoms caused by benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for related surgeries. Additionally, it is effective in treating androgenetic alopecia in adult men. Through these various effects, it helps improve the quality of life for patients.

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 patients with hepatic impairment.

Precautions

This medication must not be handled or taken by women, especially those who are pregnant or may become pregnant. This is because the drug can be absorbed through the skin, posing a risk of birth defects in male fetuses. Furthermore, precautions should be taken to ensure that children do not touch broken or crushed pieces of this medication. This medication is not to be administered to women and children under 18 years of age. Also, individuals with an allergy to this medication or its ingredients should not use it. Patients with a genetically specific lactase deficiency should also avoid this medication. Adult men planning to conceive should use this medication carefully under the guidance of a physician, as it may affect reproductive ability. Patients with high residual urine volume or severe urinary reduction symptoms should be observed closely for the risk of urinary retention when using this medication. Patients with liver dysfunction should also use this medication with caution. Care should be taken when taken with strong CYP3A4 inhibitors, as the drug concentration may increase. During the administration of this medication, sexual dysfunction such as erectile dysfunction, decreased libido, or ejaculation disorders may occur, and gynecomastia may develop in some patients. These adverse reactions may persist even after discontinuation of the medication. This medication is used for the treatment of benign prostatic hyperplasia and androgenetic alopecia, and it has been reported that long-term use does not increase the incidence of sexual dysfunction or breast disorders. However, there may be a slight increase in the risk of high-grade prostate cancer during the course of this medication, necessitating regular prostate cancer screening. Patients taking this medication should refrain from donating blood and must wait at least 6 months after the last dose before they can donate blood. This medication is known to have no effect on driving or operating machinery. In case of overdose, no specific antidote exists, so appropriate supportive treatment should be received according to symptoms, and consideration should be given to the long half-life of this medication. This medication should be kept out of reach of children and stored in its original container to prevent misuse or deterioration.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 79 more
  • pruritus
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • depressive mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • hemifacial spasm
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • sexual abnormalities
  • pharyngitis
  • appendicitis
  • fractures
  • viral infection
  • acne
  • dermatophyte infection
  • 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
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • paresthesia
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • capillary dilation

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Avoid storing in places that are too hot or too cold.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTPX3)]

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

No questions yet.

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.