Medication info
Dutam 0.5 mg Tablet (Dutasteride)

Dutam 0.5 mg Tablet (Dutasteride)

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

MFDS item code 202003666 · Approved 2020.05.20

Summary

Main use
Treatment of male pattern hair loss and benign prostatic hyperplasia in adult men
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet (0.5mg) once daily. 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 in these patients has not been established.

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

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

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

This medication helps improve symptoms of benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for surgery. It is also used in the treatment of male pattern hair loss in adult men. Therefore, it is effective for prostate health management and hair loss treatment.

How to take

Adult dose

The recommended dose of this medication is 1 tablet (0.5mg) once daily. 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 in these patients has not been established.

Precautions

This medication can be absorbed through the skin; therefore, women who are pregnant or may become pregnant should not touch or use this medication under any circumstances. It is particularly dangerous as this medication can affect the normal genital development of male fetuses. Care should be taken to avoid contact with broken or crushed pieces of this medication, and children should also not be exposed to this medication. Women, children under 18 years, and individuals allergic to this medication or similar components should not take this medication. Adult men planning to conceive should consult a doctor as this medication may affect fertility and should be used with caution. Special precautions are also necessary for patients with urinary obstruction or poor liver function. This medication may interact with other drugs, so it is essential to inform the doctor if you are taking powerful CYP3A4 inhibitors and use caution during polypharmacy. While taking this medication, erectile dysfunction, decreased libido, and ejaculation disorders may occur, and these symptoms may persist after discontinuation of the medication. Regular blood tests to check prostate-specific antigen (PSA) levels are necessary; this medication lowers PSA levels, so care is needed when interpreting test results. Blood donation is prohibited while taking this medication, and a minimum of 6 months after the last dose is required before one can donate blood. Long-term use has been reported to increase the risk of changes in breast tissue or high-grade prostate cancer, so any unusual symptoms should be discussed with a healthcare provider immediately. There is no specific antidote for overdose, so if symptoms appear, you should seek appropriate medical treatment promptly. This medication should be kept out of the reach of children and stored in the original container for safety. Although this medication is known not to affect the ability to drive or operate machinery, individual variations may occur, so caution is necessary.

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 edema
  • severe 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
  • facial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • 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
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • capillary telangiectasia

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 exposure to air or moisture. Additionally, it is important to store it at room temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

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.