Medication info
Dutarex Soft Capsule 0.5 mg (Dutasteride)

Dutarex Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Chodang Pharmaceutical Co., Ltd.
Appearance
A transparent yellowish oval soft capsule containing a colorless transparent liquid.
Packaging
30 capsules/box [(15 capsules/PTP × 2)]
Approval status
Active

MFDS item code 201501965 · Approved 2015.04.10

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 drug is 1 capsule (0.5mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this drug whole without chewing or splitting the capsule. This drug may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose of this drug in patients with hepatic impairment has not been established because no data are available on its administration to these patients.

Ingredients

Manufacturer
Chodang Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication improves symptoms of benign prostatic hyperplasia and reduces the risk of acute urinary retention. It also helps reduce the need for surgery related to benign prostatic hyperplasia. Additionally, it is used to treat 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. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this drug whole without chewing or splitting the capsule. This drug may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose of this drug in patients with hepatic impairment has not been established because no data are available on its administration to these patients.

Precautions

This medication may be absorbed through the skin, so women who are pregnant or may become pregnant should not handle or come into contact with this medication. If the capsule breaks and the medication comes into contact with the skin, it must be washed off immediately with plenty of soap and water. This medication is not to be used in children under 18 years of age, and should not be taken by individuals allergic to this medication or similar components. Adult men planning on becoming fathers should use this medication cautiously, as it may affect reproductive ability, and must consult with a doctor beforehand. Patients with urinary issues or poor liver function should use this medication with caution and take it as directed by their physician. Additionally, caution is needed when taken with certain drugs that can affect drug concentration, particularly potent CYP3A4 inhibitors. While taking this medication, changes to sexual function may occur, including erectile dysfunction, decreased libido, and ejaculation disorders. These side effects may persist even after discontinuation of the medication, so consult a doctor if any abnormal symptoms occur. This medication can lower PSA levels used in the diagnosis of prostate cancer; thus, it is essential to inform the healthcare provider of its use before undergoing PSA tests, and regularly monitor PSA levels to assess the risk of prostate cancer. Do not donate blood during treatment, and at least 6 months should pass after the last dose before stating eligibility to donate blood. In case of overdose, there is no specific antidote, and appropriate treatment should be received according to the symptoms, as this medication has a long half-life and may have prolonged effects. Keep this medication out of reach of children, and store it in its original container to prevent misuse and degradation of quality. It does not significantly affect driving or machine operation, but caution is necessary as effects can vary by individual. This medication is prohibited for use by women, particularly those who are pregnant, as exposure can have severe effects on the fetus.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 76 more
  • itching
  • urticaria
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • orofacial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • 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 disturbance
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • capillary dilation

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 exposure, and the temperature should be maintained below 30 degrees Celsius. This way, the medication's effectiveness can be well maintained, preventing degradation.

Appearance and packaging

Appearance

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

Package unit

30 capsules/box [(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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.