Medication info
Dutasteride Soft Gelatin Capsule 0.5 mg (Dutasteride)

Dutasteride Soft Gelatin Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Jongkundang Co., Ltd.
Appearance
A translucent yellow oval-shaped soft gelatin capsule containing a colorless clear liquid.
Packaging
30 capsules (15 capsules/PTP X 2)
Approval status
Active

MFDS item code 201007779 · Approved 2010.12.31 · Insurance code 643305930

Summary

Main use
Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the contents of the capsule may cause irritation of the oropharyngeal mucosa, swallow the capsule whole without chewing or breaking 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 such patients.

Ingredients

Manufacturer
Jongkundang Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men

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

This medication helps to improve symptoms of benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for related surgeries. It is also effectively used for treating male pattern baldness in adult men. This drug is useful for managing both prostatic hyperplasia and male pattern baldness together.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the contents of the capsule may cause irritation of the oropharyngeal mucosa, swallow the capsule whole without chewing or breaking 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 such patients.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant must avoid exposure to it. If a capsule breaks and the medication contacts the skin, immediately wash the area thoroughly with soap and water. This drug should not be used in children under 18 years of age and should not be administered to women. Men planning to conceive should use this medication cautiously as it may affect reproductive capability and should consult a doctor. Caution is also required when using this medication in patients with urinary issues or poor liver function. This medication can interact with other drugs, so inform your doctor, especially if you are taking strong CYP3A4 inhibitors. During treatment, side effects related to sexual function such as erectile dysfunction, decreased libido, and ejaculation disorders may occur, and some patients may experience breast pain or breast enlargement. The frequency of these side effects has not increased with long-term use, but if any adverse symptoms occur during treatment, consult your healthcare provider immediately. Furthermore, this medication can lower prostate-specific antigen (PSA) levels, so caution is needed in interpreting PSA test results, and regular checks should be conducted to assess prostate health. Do not donate blood while taking this medication, and only donate blood at least 6 months after your last dose. There is no specific antidote for overdose, so if symptoms occur, seek appropriate medical treatment immediately. Store out of reach of children and keep in the original container to prevent misuse or quality degradation. This medication is unlikely to affect the ability to drive or operate machinery, but caution is advised as individual responses may vary.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculatory dysfunction
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
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  • itching
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dystonia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • 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
  • sensory disturbance
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleeds
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disturbance
  • capillary dilation
  • 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 closed container to prevent air or moisture from entering, and it should be placed in a cool place below 30 degrees Celsius for optimal efficacy.

Appearance and packaging

Appearance

A translucent yellow oval-shaped soft gelatin capsule containing a colorless clear liquid.

Package unit

30 capsules (15 capsules/PTP X 2)

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.