Medication info
Dutagren Tablet 0.5mg (Dutasteride)

Dutagren Tablet 0.5mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Kujoo Pharmaceutical Co., Ltd.
Appearance
Pale yellow, egg-shaped film-coated tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201804318 · Approved 2018.10.31 · Insurance code 669805130

Summary

Main use
Treatment of male pattern hair loss, improvement of benign prostatic hyperplasia (including reducing the risk of urinary retention)
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. Since there are no data on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
Kujoo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss, improvement of benign prostatic hyperplasia (including reducing the risk of urinary retention)

  • Benign prostatic hyperplasia
  • acute urinary retention
  • male pattern baldness
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 prostate-related surgery. It is also used to treat male pattern baldness in adult men, helping with hair health.

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. Since there are no data on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Precautions

This medication should never be handled by women, especially those who are pregnant or may become pregnant, as it can be absorbed through the skin and may pose risks to normal genital development in male fetuses. Additionally, this medication should not be used by children under 18 years of age, and care should be taken to prevent children from touching broken pieces of the tablets. This medication should be avoided or used cautiously in certain patients. For example, adult men planning to conceive should consult with a physician, as this drug may affect fertility. Patients with urinary issues or liver dysfunction need special caution when using this medication. For patients with liver impairment, this medication is metabolized slowly, requiring more careful monitoring. Furthermore, when taken in conjunction with strong CYP3A4 inhibitors, the blood levels of this medication may increase, so it is important to consult with a physician or pharmacist. During treatment, sexual side effects such as erectile dysfunction, decreased libido, and ejaculation disorders may occur, and some patients may experience breast tenderness or breast enlargement. These symptoms may persist even after discontinuing the medication, so caution is warranted. Long-term use has also reported an increase in sexual dysfunction or breast-related side effects, but a clear association with male breast cancer has not yet been established. This medication can lower PSA levels, which are important for the early detection of prostate cancer, so regular check-ups with a physician should be conducted before and during treatment. PSA level interpretations should be based on pre-treatment levels, and if levels suddenly rise, further testing may be necessary. Do not donate blood while taking this medication, and at least 6 months must pass after the last dose before donating blood is permitted. In case of overdose, no specific antidote exists, so immediate medical attention should be sought for appropriate treatment, keeping in mind that the long half-life of the drug may require prolonged monitoring. Store this medication out of reach of children, and maintain it in the original container to preserve its quality. Finally, while this medication is not known to affect driving or machine operation abilities, one should exercise caution if any unusual symptoms arise during treatment.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 76 more
  • itching
  • urticaria
  • localized swelling
  • severe skin reactions
  • angioedema
  • allergic reactions
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • heart failure
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • renal stones
  • ageusia
  • capillary dilation
  • xerostomia
  • constipation
  • cramps
  • dyskinesia of the face
  • vomiting
  • colonic polyps
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis

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

Storage

Store this medication in a tightly closed container that does not allow air to pass through, at a temperature between 1 and 30 degrees Celsius (room temperature). This helps maintain the effectiveness of the medication and prevents degradation.

Appearance and packaging

Appearance

Pale yellow, egg-shaped film-coated tablets

Package unit

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.