Medication info

Dutasteride Soft Capsule 0.5 mg

Prescription medicationSoft capsuleOralExpired
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Jungheon Pharmaceutical Co., Ltd.
Appearance
A translucent yellowish transparent oval soft capsule containing a colorless transparent substance.
Packaging
30 capsules (15 capsules/PTPX2, 10 capsules/PTPX3)
Approval status
Expired

MFDS item code 201902612 · Approved 2019.04.25

This product's status changed to Expired on 2024.04.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of male pattern hair loss in adults and benign prostatic hyperplasia
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 capsule (0.5mg) once daily. Since exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this medication whole without chewing or splitting it. This medication may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. Since there are no data on the administration of this medication to patients with hepatic impairment, the recommended dose for these patients has not been established.

Ingredients

Manufacturer
Jungheon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss in adults and benign prostatic hyperplasia

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

This medication helps improve the symptoms of benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the necessity for surgery related to these conditions. It is also used to treat male pattern hair loss in adult males. This contributes to improving men's health and quality of life.

How to take

Adult dose

The recommended dose of this medication is 1 capsule (0.5mg) once daily. Since exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this medication whole without chewing or splitting it. This medication may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. Since there are no data on the administration of this medication to patients with hepatic impairment, the recommended dose for 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 touch or handle this drug. If the capsule leaks and comes into contact with the skin, it should be washed off immediately with soap and water, and children should be kept away from contact with this medication. Women, children under 18, and those with allergies to this medication or similar ingredients should not take this medication. Men planning to conceive should take this medication cautiously under medical supervision because it may affect reproductive ability. Patients with urinary issues or liver function abnormalities need to be careful when taking this drug, and particularly when taken with other strong medications, consultation with a physician is advised. This drug may affect sexual function, leading to symptoms like erectile dysfunction, decreased libido, and ejaculation disorders, which may persist even after discontinuation of the medication. Long-term use may result in breast abnormalities, so any changes in the breast should be reported to a physician immediately. This drug may affect prostate cancer tests, so regular prostate examinations and periodic PSA level checks should be performed both before and during treatment. Blood donation is not allowed during this treatment, and blood can only be donated at least 6 months after the last dose. There is no specific antidote for overdose; therefore, if symptoms are suspected, the patient should visit a hospital immediately for appropriate treatment. Keep out of reach of children, and store in the original container to prevent quality deterioration or misuse. This medication is known not to affect driving or machine operation ability, but caution is necessary as it may vary by individual. If any adverse reactions or discomfort occur during treatment, it is essential to consult a healthcare professional immediately.

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
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • rash
  • fatigue
  • increased SGPT
  • increased SGOT
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • fractures
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • viral infection
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste distortion
  • capillary dilation
  • pharyngitis
  • appendicitis
  • fractures
  • viral infection
  • pharyngitis
  • appendicitis
  • fatty liver
  • chest pain
  • palpitations
  • pneumonia
  • pulmonary embolism
  • lung cancer
  • thrombotic stroke

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 kept in a cool place below 30 degrees Celsius. This way, the efficacy of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

A translucent yellowish transparent oval soft capsule containing a colorless transparent substance.

Package unit

30 capsules (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.