Medication info
A-Duta Tablet 0.5 mg (Dutasteride)

A-Duta Tablet 0.5 mg (Dutasteride)

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

MFDS item code 201803731 · Approved 2018.09.14 · Insurance code 650204940

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 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 of this medicine in patients with hepatic impairment has not been established because there are no data on administration of this medicine to such patients.

Ingredients

Manufacturer
Anguk Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication improves symptoms associated with benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the necessity for related surgery. It is also used to treat male pattern hair loss in adult men.

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 of this medicine in patients with hepatic impairment has not been established because there are no data on administration of this medicine to such patients.

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 it. In particular, touching broken or crushed pieces of this medication should be avoided, and children should also be careful not to touch broken pieces of this medication. Women and children under 18 years of age should not take this medication, and patients with allergies to this medication or its ingredients should avoid its use. Adult men planning to conceive should be cautious in taking this medication as it may affect fertility, and should do so under the judgment of a physician. Patients with severe urinary disorders or liver function impairments should use caution when administering this medication, and patients taking strong CYP3A4 inhibitors should also be careful. Sexual dysfunction-related adverse reactions such as erectile dysfunction, decreased libido, and ejaculation disorders may occur during the use of this medication, and these symptoms may persist even after discontinuation. Additionally, this medication can lower PSA levels, which are important for diagnosing prostate cancer, so regular tests before and during use are necessary. Blood donation is prohibited while taking this medication, and one must wait at least 6 months after the last dose before donating blood. No special safety differences have been reported in the elderly; however, effectiveness data for treating male pattern hair loss in men over 50 is limited. In the case of overdose, no specific antidote is available, so appropriate treatment should be provided based on symptoms, and it should be kept out of reach of children. This medication is known not to affect driving or machine operation abilities, but caution should be taken if any unusual symptoms occur during use. Pregnant and breastfeeding women should not use this medication, and it is unknown whether this medication is excreted in breast milk. There is a potential for drug interactions when taking this medication with other drugs, so consultation with a doctor or pharmacist is necessary if other medications are being taken.

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
  • urticaria
  • local swelling
  • severe skin reactions
  • angioedema
  • depressive mood
  • alopecia
  • hypertrichosis
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • 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
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • fatigue
  • increased SGPT
  • 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
  • bilirubinemia
  • upper respiratory infection
  • unspecified abrasions
  • surgical intervention
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • paresthesia
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • capillary dilation
  • visual disturbances
  • thirst
  • abnormal urination
  • hematuria
  • abnormal semen

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevent deterioration.

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.