Medication info
Dutapro Tablet (Dutasteride)

Dutapro Tablet (Dutasteride)

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

MFDS item code 202000571 · Approved 2020.02.03

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 older adults. Since there are no data on administration of this medicine to patients with hepatic impairment, the recommended dose for these patients has not been established.

Ingredients

Manufacturer
IntraBio Pharma Co., Ltd.

Efficacy & effects

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

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

This medication helps improve symptoms of benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the necessity for related surgeries. It is also used to treat male pattern hair loss in adult males aged 18 to 50 years. Therefore, it is effectively used for male urogenital health and hair loss management.

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 older adults. Since there are no data on administration of this medicine to patients with hepatic impairment, the recommended dose for these patients has not been established.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle this medication directly. Particular care should be taken to avoid touching broken or shattered pieces of this medication, and if contact occurs, hands should be washed immediately. Children should also be kept from touching broken pieces of this medication, and it should not be administered to children under the age of 18. Women must not take this medication, and it should also not be administered to individuals allergic to this medication or any of its components. Adult men planning to conceive should exercise caution as this medication may affect fertility, and consultation with a physician is essential before considering its use. Patients with large residual urine volumes or severe reductions in urinary flow should be monitored closely as there could be issues such as urinary retention upon taking this medication. Patients with liver dysfunction should be cautious when administering this medication as it may affect hepatic metabolism. Furthermore, when taken with strong CYP3A4 inhibitors, the concentration of this medication in the blood may increase, necessitating careful management when used in combination. While on this medication, side effects related to sexual function such as erectile dysfunction, decreased libido, and ejaculation disorders may occur, and these symptoms may persist even after discontinuation of the medication. Breast-related side effects have also been reported, including breast tenderness or gynecomastia, so any abnormal symptoms should be reported to healthcare professionals. Regular prostate-specific antigen (PSA) tests should be conducted to monitor for prostate cancer risk while taking this medication, and PSA levels may decrease after taking this medication, so this should be considered when interpreting test results. This medication may increase the risk of high-grade prostate cancer with prolonged use, so regular examinations with healthcare professionals are necessary. Patients taking this medication should refrain from donating blood for at least six months after the last dose, to prevent the medication from being transmitted to a pregnant woman. No specific antidote exists for overdose, so if symptoms occur, immediate medical attention should be sought. This medication should be stored out of reach of children, and should be kept in its original container to prevent misuse or degradation of quality. While the likelihood of affecting driving or machinery operation is low, unusual reactions may occur in individuals, so care should be taken. There may be interaction possibilities with other medications, so patients must inform their healthcare provider of any other medications they are taking.

Side effects

  • erectile dysfunction
  • reduced libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 79 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
  • allergies
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • xerostomia
  • constipation
  • cramps
  • oromandibular dystonia
  • vomiting
  • colon 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 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 disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • nephrolithiasis
  • taste disorders
  • 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 and moisture, and it is safest to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/PTP [(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.