Medication info
Dutasteride Soft Capsule 0.5mg (Dutasteride)

Dutasteride Soft Capsule 0.5mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Dongkuk Pharmaceutical Co., Ltd.
Appearance
A transparent pale yellow soft capsule containing a colorless, transparent substance
Packaging
30 capsules (15 capsules/PTP × 2)
Approval status
Active

MFDS item code 201506569 · Approved 2015.09.15 · Insurance code 653403330

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 of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, 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 administration of this medicine to such patients.

Ingredients

Manufacturer
Dongkuk Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medicine improves symptoms caused by benign prostatic hyperplasia and reduces the risk of acute urinary retention. Additionally, it lowers the likelihood of surgery related to hyperplasia. It is also used for the treatment of male pattern baldness, helping to improve hair health. Thus, this medication is effectively used for prostate health and hair loss treatment.

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 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 administration of this medicine to such patients.

Precautions

This medication must not be touched or taken by pregnant women or women who may become pregnant. This drug can be absorbed through the skin, so women should be careful to avoid contact with leaked capsules. If a capsule breaks and comes into contact with the skin, that area should be washed immediately with soap and water. This medication should not be used in children under 18 years of age, and people who are allergic to this medication or have hypersensitivity to similar drugs should not take it. Adult men planning to conceive should consult a doctor before use as this medication may affect fertility, and should take it cautiously. This medication should be used with caution in patients with severely impaired urinary function or liver dysfunction, as there is a risk of severe side effects, and their condition should be closely monitored. Additionally, when taken with strong CYP3A4 enzyme inhibitors, the blood concentration of this medication may change, so patients taking such medications for a long time should consult a doctor before use. This medication may cause sexual side effects such as erectile dysfunction, decreased libido, and ejaculation disorders in some patients, and these side effects may continue even after discontinuation of the medication. There is no tendency for an increase in these side effects with long-term use, but breast-related adverse reactions such as breast tenderness or breast enlargement have been reported. Patients taking this medication should have regular prostate-specific antigen (PSA) tests, and since this medication can lower PSA levels, caution is advised in interpreting test results. Patients taking this medication should not donate blood for at least 6 months after the last dose, as this is a precaution to prevent transfer to pregnant women. While this medication is reported not to affect driving or operating machinery, caution is advised as it may vary by individual. In case of overdose, there is no specific antidote, so appropriate treatment should be administered according to symptoms, and long-term observation may be necessary due to the long half-life of this medication. When storing, keep it out of reach of children and do not transfer it to another container.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
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  • itching
  • hives
  • localized edema
  • serious skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • xerostomia
  • constipation
  • cramps
  • oromandibular dystonia
  • 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 disorders
  • 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 disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • telangiectasia
  • visual disturbances
  • thirst
  • urinary abnormalities
  • hematuria
  • semen abnormalities

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 from entering, and it is important to maintain a temperature below 30 degrees. This will help preserve the drug's effectiveness for a longer time.

Appearance and packaging

Appearance

A transparent pale yellow soft capsule containing a colorless, transparent substance

Package unit

30 capsules (15 capsules/PTP × 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.