Medication info

Angkuk Dutasteride Soft Capsule 0.5mg (Dutasteride)

Prescription medicationSoft capsuleOralApproval withdrawn
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Angkuk Pharmaceutical Co., Ltd.
Appearance
A transparent yellowish oval soft capsule containing a colorless transparent liquid.
Packaging
30 capsules/PTP [(15 capsules/PTPX2, 10 capsules/PTPX3)]
Approval status
Approval withdrawn

MFDS item code 202004018 · Approved 2020.05.29

This product's status changed to Approval withdrawn on 2024.10.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of male pattern hair loss and benign prostatic hyperplasia
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow the capsule 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 of this medicine has not been established in patients with hepatic impairment because no data are available on its use in these patients.

Ingredients

Manufacturer
Angkuk Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss and benign prostatic hyperplasia

  • Symptoms of benign prostatic hyperplasia
  • risk of acute urinary retention
  • male pattern baldness.
View approved original text

This medication improves symptoms caused by benign prostatic hyperplasia and reduces the risk of sudden difficulty urinating. It also helps to reduce the need for surgery as a result. Additionally, it is used in the treatment of male pattern baldness in adult men. Overall, it contributes to addressing both urological symptoms and hair loss issues.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow the capsule 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 of this medicine has not been established in patients with hepatic impairment because no data are available on its use in these patients.

Precautions

This medication must not be handled or taken by women, especially those who are pregnant or may become pregnant, as it can be absorbed through the skin and potentially affect the development of the external genitalia of a male fetus. Children, especially those under 18 years, should not use this medication and should be cautious to avoid contact with it. If the capsule leaks and comes into contact with the skin, it must be washed immediately with soap and water. This medication is contraindicated in certain patients. For example, women and children under 18, and individuals who are allergic to this drug or similar medications should not use it. Adult men planning to conceive, patients with a high residual urine volume or significant decrease in urinary flow, patients with poor liver function, and patients taking strong CYP3A4 enzyme inhibitors should exercise special caution when using this drug. While taking this medication, sexual dysfunction side effects may occur, and erectile dysfunction, decreased libido, and ejaculation disorders have been reported. These symptoms may persist even after discontinuation of the medication, so consultation with a physician is advised. Long-term use may lead to breast-related side effects such as breast tenderness or breast enlargement, and the relationship with male breast cancer occurrence is still unclear. This drug may increase the risk of prostate cancer, so men taking it should regularly check their prostate health through prostate-specific antigen (PSA) testing and digital rectal exams. During and at least 6 months after taking this medication, blood donation should be avoided to prevent it being transmitted through transfusion to pregnant women. There is no specific antidote for overdose, so appropriate supportive treatment should be received if symptoms appear, and this medication has a long half-life, which means it can remain in the body for an extended period. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality. The potential for drug interactions exists, particularly for patients taking CYP3A4 inhibitors, and consultation with a physician or pharmacist is necessary before use. The likelihood of affecting driving or machine operation skills is low, but caution is needed if side effects occur. This drug may affect male fertility, and long-term use may result in decreased sperm count or semen volume, so this should also be considered.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 75 more
  • itching
  • urticaria
  • localized edema
  • severe skin reactions
  • vascular edema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • xerostomia
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • gastric ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasions
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • capillary dilatation

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 exposure to air or moisture. Additionally, it is important to store it at a cool temperature below 30 degrees Celsius to maintain its efficacy and safety.

Appearance and packaging

Appearance

A transparent yellowish oval soft capsule containing a colorless transparent liquid.

Package unit

30 capsules/PTP [(15 capsules/PTPX2, 10 capsules/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.