Medication info
Dutasteride Tablet 0.5mg (Dutasteride)

Dutasteride Tablet 0.5mg (Dutasteride)

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

MFDS item code 201906325 · Approved 2019.09.05 · Insurance code 625201940

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 is 1 tablet (0.5 mg) once daily. Swallow this medicine whole without chewing or splitting it. It may be taken with or without food. Dose adjustment is not necessary in patients with renal impairment or in elderly patients. Since there are no data on the use of this medicine in patients with hepatic impairment, the recommended dose for these patients has not been established.

Ingredients

Manufacturer
White Life Science Co., Ltd.

Efficacy & effects

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

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

This medication helps improve symptoms of benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for surgery. It is also used to treat male pattern baldness in adult men, promoting hair health. These effects contribute to improving patients' quality of life.

How to take

Adult dose

The recommended dose is 1 tablet (0.5 mg) once daily. Swallow this medicine whole without chewing or splitting it. It may be taken with or without food. Dose adjustment is not necessary in patients with renal impairment or in elderly patients. Since there are no data on the use of this medicine in patients with hepatic impairment, the recommended dose for these patients has not been established.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle or come into direct contact with it. Handling broken or crushed pieces of this medication may be particularly dangerous. This medication should not be used in children under 18 years old, and it is not to be administered to women. Administration should be avoided in case of allergy to this medication or similar components. Adult men planning to conceive should use this medication cautiously as it may affect reproductive ability, under the guidance of a physician. Patients with high residual urine volume or severe reduction in urine flow should be monitored closely for urinary retention when using this medication. Patients with liver dysfunction should use this medication cautiously as it may affect its metabolism and excretion processes. When taken with strong CYP3A4 inhibitors, this medication's blood concentration may increase; thus, patients who chronically take these drugs should be particularly cautious when using this medication. The most common side effect of this medication is sexual dysfunction, including erectile dysfunction, decreased libido, and ejaculation disorders, which may persist even after discontinuation. Additionally, some patients may experience adverse reactions such as headaches, gastrointestinal discomfort, breast tenderness, or gynecomastia. During medication, regular blood tests should be conducted to check the prostate-specific antigen (PSA) levels, which may decrease after taking this medication; therefore, this should be considered when interpreting test results. This medication may increase the risk of high-grade prostate cancer, so patients should be regularly evaluated for prostate cancer risk. This medication may raise the risk of heart failure; however, an overall increase in the incidence of cardiovascular adverse reactions has not been reported so far. Patients taking this medication should not donate blood, and it is permissible to donate blood only after at least 6 months after the last dose. There is no specific antidote for overdose; thus, appropriate supportive treatment should be provided if symptoms are suspected. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or deterioration in quality. It is known not to affect the ability to drive or operate machinery, but individual responses may vary, so caution is necessary. Patients taking this medication must inform healthcare professionals immediately if they notice any lumps in the breasts or unusual secretions. Finally, this medication should not be administered to women, and its use is not recommended in breastfeeding women.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 66 more
  • itching
  • hives
  • local edema
  • serious 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
  • orofacial dyskinesia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • muscle weakness
  • deep vein thrombosis
  • drowsiness
  • hyperbilirubinemia
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • fatigue
  • increased SGPT
  • increased SGOT
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • folliculitis
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • telangiectasia
  • sexual dysfunction
  • decreased testosterone
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • hyperuricemia

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

Storage

This medication should be stored in a sealed container that prevents air ingress, ideally at room temperature between 1 to 30 degrees Celsius. Storing it in this manner helps maintain its effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

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.