Medication info
Dutase Tablet 0.5 mg (Dutasteride)

Dutase Tablet 0.5 mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Nexpharm Korea Co., Ltd.
Appearance
Pale yellow, oval film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201802839 · Approved 2018.07.09 · Insurance code 662503970

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 tablet (0.5mg) once daily. Swallow this drug whole without chewing or splitting it. This drug 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 drug to patients with hepatic impairment.

Ingredients

Manufacturer
Nexpharm Korea Co., Ltd.

Efficacy & effects

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

  • Benign prostatic hyperplasia
  • acute urinary retention
  • androgenetic alopecia
View approved original text

This medication helps improve symptoms caused by benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for surgery related to prostatic hyperplasia. It is also used for the treatment of androgenetic alopecia in adult males. Therefore, this medication aids in both prostate health and hair loss management.

How to take

Adult dose

The recommended dose of this drug is 1 tablet (0.5mg) once daily. Swallow this drug whole without chewing or splitting it. This drug 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 drug to patients with hepatic impairment.

Precautions

This medication should not be handled or taken by women, especially those who are pregnant or may become pregnant. It can be absorbed through the skin and may pose a risk of causing malformations in male fetuses. Additionally, children should be cautioned not to touch broken pieces of this medication. Women, children under 18, and individuals allergic to this drug or similar compounds should not take this medication. Men planning to conceive should use this medication cautiously under the guidance of a physician, as it may affect reproductive capability. Patients with urinary problems or liver impairment should also use caution while taking this medication. Since this medication is metabolized in the liver, patients with liver conditions should consult with a doctor before use, and caution should be exercised when taking it in conjunction with certain potent medications due to potential drug interactions. While taking this medication, there may be reproductive-related side effects, such as erectile dysfunction, decreased libido, and ejaculation disorders, which may persist even after discontinuation. Some patients may also experience gynecomastia or breast tenderness. This medication is used for the treatment of benign prostatic hyperplasia and androgenetic alopecia, and PSA levels may decrease in blood tests after taking it, so caution is needed when interpreting PSA levels. Patients taking this medication should undergo regular prostate examinations and immediately notify their doctor of any unusual signs. Patients receiving this medication should not donate blood for at least 6 months after the last dose. There is no specific antidote for overdose, so if symptoms occur, seek appropriate medical treatment immediately. This medication should be kept out of the reach of children and should be stored in its original container for safety. While it is unlikely to affect driving or machinery operation, caution should be exercised if abnormal reactions occur.

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
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hypertrichosis
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • orofacial dyskinesia
  • 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
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • paresthesia
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • telangiectasia
  • abnormal urine
  • hematuria
  • abnormal semen
  • gastric carcinoma

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly closed container that is airtight, preferably at a temperature between 1 degree and 30 degrees Celsius. This method of storage helps maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow, oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 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.