Medication info
Dutasteride Soft Capsules 0.5 mg (Dutasteride)

Dutasteride Soft Capsules 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOralExpired
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
QL Pharma Co., Ltd.
Appearance
A transparent light yellow oval soft capsule containing a colorless transparent liquid
Packaging
30 capsules (15 capsules/PTPX2), 30 capsules (10 capsules/PTPX3)
Approval status
Expired

MFDS item code 201501656 · Approved 2015.03.30

This product's status changed to Expired on 2025.03.30. 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 drug is 1 capsule (0.5mg) once daily. Exposure to the capsule contents may cause irritation of the oropharyngeal mucosa; therefore, swallow this drug whole without chewing or breaking it. This drug may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or in elderly patients. Since there are no data on administration of this drug to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
QL Pharma Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss and benign prostatic hyperplasia

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

This medication improves symptoms of benign prostatic hyperplasia and reduces the risk of acute urinary retention, as well as helps decrease the necessity for surgery related to the prostate. It is also used for the treatment of male pattern hair loss in adult men.

How to take

Adult dose

The recommended dose of this drug is 1 capsule (0.5mg) once daily. Exposure to the capsule contents may cause irritation of the oropharyngeal mucosa; therefore, swallow this drug whole without chewing or breaking it. This drug may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or in elderly patients. Since there are no data on administration of this drug to patients with hepatic impairment, the recommended dose in 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 this medication directly. If the capsule is broken and the medication comes into contact with the skin, it should be washed immediately with soap and water. This medication should not be used in children under 18 years of age, and individuals allergic to this medication or similar drugs should not take it. Men planning to conceive should use this medication cautiously as it may affect reproductive ability. Caution is required when administering this medication to patients with severe urinary problems or liver function abnormalities. Special care should be taken when co-administered with other medications that affect liver metabolism. During treatment, changes in sexual function, such as erectile dysfunction, decreased libido, or ejaculation disorders, may occur, and these symptoms may persist even after discontinuation of the medication. The blood test for prostate cancer (PSA levels) may show decreased levels after taking this medication, so caution is necessary when interpreting the results. Regular check-ups with a doctor are recommended while using this medication, and it is important to report any abnormal symptoms immediately. Additionally, blood donation should not be performed during the course of this medication, and blood donation is permissible at least 6 months after the last dose. There is no specific antidote for overdose, so appropriate treatment should be administered according to the symptoms, and it should be kept out of the reach of children.

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
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hypertrichosis
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • orofacial dyskinesia
  • vomiting
  • colonic polyps
  • epigastric discomfort
  • weakness
  • heart failure
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • increased SGOT
  • 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
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • nephrolithiasis
  • dysgeusia
  • telangiectasia
  • visual disturbances
  • thirst
  • urinary abnormalities
  • hematuria
  • abnormal semen

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 or moisture from entering, and it is best kept in a cool place at temperatures below 30 degrees Celsius.

Appearance and packaging

Appearance

A transparent light yellow oval soft capsule containing a colorless transparent liquid

Package unit

30 capsules (15 capsules/PTPX2), 30 capsules (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.