Medication info
Dutasteride Tablet 0.5 mg (Dutasteride)

Dutasteride Tablet 0.5 mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Donggu Bio Pharmaceutical Co., Ltd.
Appearance
Yellow, oblong, film-coated tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201802932 · Approved 2018.07.13 · Insurance code 657307240

Summary

Main use
Treatment of benign prostatic hyperplasia and male pattern hair loss in adults
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 in patients with hepatic impairment has not been established because there are no data on the administration of this medicine to patients with hepatic impairment.

Ingredients

Manufacturer
Donggu Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male pattern hair loss in adults

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

This medication improves symptoms caused by benign prostatic hyperplasia and reduces the risk of acute urinary retention. Additionally, it helps decrease the necessity for surgery related to benign prostatic hyperplasia. Furthermore, it is also used for treating male pattern hair loss in adult men between the ages of 18 and 50. In summary, it is used effectively to maintain prostate health and improve symptoms of hair loss.

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 in patients with hepatic impairment has not been established because there are no data on the administration of this medicine to patients with hepatic impairment.

Precautions

This medication is absorbed through the skin, so women who are pregnant or may become pregnant should not handle it directly. In particular, touching damaged or broken pieces of this medication should be avoided, as it poses a risk of affecting the development of the external genitalia of a male fetus. This medication should not be administered to children under 18 years of age, and care should be taken to ensure that children do not come into contact with pieces of this medication. Women should not take this medication, nor should individuals with allergies to this medication or its components, or individuals with hypersensitivity to 5-alpha reductase inhibitors, be administered this drug. Adult men planning to conceive should use this medication with caution under a doctor's guidance, due to potential effects on fertility. In addition, patients with significant urinary retention or severe urinary reduction should be carefully monitored for urinary obstruction symptoms while taking this medication. Patients with liver function abnormalities should use this medication cautiously, as it may be affected by its metabolism. Patients who are chronically taking strong CYP3A4 inhibitors should be cautious, as they may experience increased blood levels of this medication. This medication is primarily used for treating benign prostatic hyperplasia and male pattern hair loss in men, and it may cause genital-related adverse reactions such as erectile dysfunction, decreased libido, ejaculation disorders, and gynecomastia during treatment. These adverse reactions may persist even after discontinuation of the medication. Long-term use of this medication does not increase the frequency of adverse reactions, but there may be a slight increase in the risk of high-grade prostate cancer, so regular prostate cancer screening is recommended. Patients taking this medication should refrain from donating blood, and at least 6 months should pass after the last dose before blood donation is allowed. Since the prostate-specific antigen (PSA) level decreases after taking this medication, PSA levels should be reassessed 3-6 months after treatment based on the initial value before administration. This medication is unlikely to affect the ability to drive or operate machinery. There is no specific antidote in cases of overdose, and due to the long half-life of the drug, appropriate supportive care is needed. Keep out of reach of children and store in the original container to prevent misuse or degradation of quality.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
Show 83 more
  • itching
  • urticaria
  • localized swelling
  • severe 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 dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • 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
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormality
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • ageusia
  • telangiectasia
  • visual disturbances
  • thirst
  • abnormal urination
  • hematuria
  • abnormal semen

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 air exposure, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow, oblong, film-coated tablet

Package unit

30 tablets (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

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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.