Medication info
Dutav 0.5 mg (Dutasteride)

Dutav 0.5 mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Aprogen Pharmaceuticals Co., Ltd.
Appearance
Pale yellow egg-shaped film-coated tablet
Packaging
30 tablets/PTP (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 201802933 · Approved 2018.07.13

Summary

Main use
Treatment of benign prostatic hyperplasia and male pattern hair loss in adults
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 tablet (0.5mg) once daily. 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 the administration of this medicine to patients with hepatic impairment.

Ingredients

Manufacturer
Aprogen Pharmaceuticals Co., Ltd.

Efficacy & effects

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

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

This medication helps improve symptoms caused by benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgery. It is also used to treat male-pattern baldness in adult men. Therefore, it is effective in improving prostate issues and baldness symptoms.

How to take

Adult dose

The recommended dose of this medicine is 1 tablet (0.5mg) once daily. 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 the administration of this medicine to patients with hepatic impairment.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle or come into contact with this medication. Particularly, caution should be exercised when touching broken or crushed tablets, and children should also be prevented from handling this medication. This medication should not be used by women or children under 18 years of age, nor by those allergic to this medication or similar ingredients. Adult men planning to conceive should consult a doctor before using this medication, as it may affect reproductive ability. Patients with severely reduced urinary output or poor liver function should exercise caution when using this medication, and caution is also advised when co-administered with strong CYP3A4 inhibitors. During the use of this medication, reproductive-related side effects such as erectile dysfunction, decreased libido, and ejaculation disorders may occur, and these symptoms may persist even after discontinuation of the drug. Additionally, some patients have reported headaches, gastrointestinal discomfort, and gynecomastia. This medication reduces PSA levels used to assess the risk of prostate cancer, so care should be taken when interpreting PSA test results, and regular testing is recommended. While taking this medication, one should avoid blood donation, and blood donation is only permissible after at least 6 months have passed since the last dose. Long-term use has been reported to potentially increase the risk of male breast cancer, so if any abnormalities in the breasts occur, a doctor should be notified immediately. There is no specific antidote for overdose, and appropriate treatment should be provided according to symptoms. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality. It is known to have no effect on driving or operating machinery. During the use of this medication, symptoms related to heart failure may manifest, so patients with heart disease should exercise caution. Finally, this medication may interact with various other drugs, so if other medications are being taken, one must consult a physician or pharmacist.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
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  • itching
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial muscle dyskinesia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified laceration
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbance
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste distortion
  • capillary dilation
  • visual disturbance
  • 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 tightly sealed container to prevent air ingress, and it is advisable to store it at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Pale yellow egg-shaped film-coated tablet

Package unit

30 tablets/PTP (10 tablets/PTP × 3)

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.