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
HLB Pharmaceuticals Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets per box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201901097 · Approved 2019.02.22 · Insurance code 647303640

Summary

Main use
Treatment of male pattern hair loss and benign prostatic hyperplasia 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 necessary in patients with renal impairment or older adults. 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
HLB Pharmaceuticals Co., Ltd.

Efficacy & effects

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

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

This medication is effective in improving the symptoms of benign prostatic hyperplasia, reducing the risk of acute urinary retention, and decreasing the necessity for related surgeries. It is also used to treat male pattern hair loss in adult men, mitigating the progression of hair loss. Therefore, it is used as a drug that helps in both prostate health and hair loss management.

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 older adults. 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 used or touched by women, especially those who are pregnant or may become pregnant. The drug can be absorbed through the skin and has a risk of affecting the development of the male fetus's genitalia. Care should be taken to avoid children touching pieces that are broken or fractured. Women and children under 18 years should not take this medication, nor should anyone allergic to this drug or similar compounds. Adult men planning to conceive should consult a doctor as this drug may affect fertility. Patients with severe urinary obstruction or significant reduction in urinary flow should use caution when administering this drug and should closely monitor for urinary retention symptoms. Patients with liver dysfunction should also be cautious when taking this medication. Close monitoring is required when taken with potent CYP3A4 inhibitors as this may increase the blood concentration of the drug. This medication is primarily used for the treatment of benign prostatic hyperplasia or male pattern hair loss, and side effects such as sexual dysfunction (erectile dysfunction, decreased libido, ejaculation disorders), gynecomastia, headache, and gastrointestinal discomfort may occur during treatment. These side effects may persist even after discontinuing use. Additionally, this drug lowers PSA levels, which is important for prostate cancer risk assessment, so caution is needed when interpreting PSA tests. Regular prostate cancer testing is recommended while taking this drug. This medication is prohibited from being donated for at least 6 months after use to prevent transmission to pregnant women during blood transfusions. There is no specific antidote for overdose, and appropriate treatment is necessary according to symptoms. This drug should be kept out of reach of children and stored in its original container for safety. It is known to have no effect on the ability to drive or operate machinery. Patients with heart failure should be cautious when taking this medication in combination with alpha-blockers as it may increase the risk of heart failure. While this drug has minimal interactions with other medications, caution should be exercised when taken with CYP3A4 inhibitors, and no significant clinical issues have been reported when used with common antihypertensives, anticoagulants, or heart medications.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
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  • itching
  • hives
  • localized edema
  • serious skin reactions
  • angioedema
  • allergic reactions
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • 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 disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • gustatory distortion
  • capillary dilation

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. Proper storage will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets per box [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.