Medication info
Dutapren Tablet 0.5 mg (Dutasteride)

Dutapren Tablet 0.5 mg (Dutasteride)

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

MFDS item code 202002131 · Approved 2020.03.27 · Insurance code 678601700

Summary

Main use
Treatment of benign prostatic hyperplasia and androgenetic alopecia 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 regardless of meals. No dosage adjustment is necessary for patients with renal impairment or elderly patients. Since there are no data on the administration of this medicine to patients with hepatic impairment, the recommended dose of this medicine in patients with hepatic impairment has not been established.

Ingredients

Manufacturer
Dasan Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men

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

This medication improves symptoms caused by benign prostatic hyperplasia and reduces the risk of sudden urinary retention. It also helps to lower the need for surgery related to benign prostatic hyperplasia. In addition, it is effective for the treatment of male pattern hair loss in adult men. Thus, this drug is used to improve various male health issues.

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 regardless of meals. No dosage adjustment is necessary for patients with renal impairment or elderly patients. Since there are no data on the administration of this medicine to patients with hepatic impairment, the recommended dose of this medicine in patients with hepatic impairment has not been established.

Precautions

This drug is absorbed through the skin; therefore, women who are pregnant or may become pregnant should avoid touching or handling this drug. Care should be taken especially with broken or crushed pieces of this drug. Children should also avoid touching broken pieces of this drug. This drug should not be used by women or children under 18 years of age, nor by patients who have allergies to this drug or similar ingredients. Adult men planning to conceive should use this drug with caution after consulting a physician, as it may affect reproductive ability. Patients with urinary issues or impaired liver function should be cautious when using this medication and closely monitor any related symptoms. If taken with strong CYP3A4 enzyme inhibitors, the blood concentration of this drug may change, so caution is advised during concomitant use. During the use of this drug, reproductive system adverse reactions such as erectile dysfunction, decreased libido, ejaculation disorders, and gynecomastia may occur, and some adverse reactions may persist even after discontinuation. The prostate-specific antigen (PSA) level may decrease during blood tests, so PSA levels should be re-evaluated for interpretation after taking this medication. This drug may slightly increase the risk of high-grade prostate cancer, so it is important to have regular screenings for prostate cancer. Blood donation is prohibited for at least 6 months during the use of this drug to prevent its transfer to pregnant women. In case of overdose, as there is no antidote, appropriate treatment should be provided according to symptoms, taking into account the drug's long half-life. Store out of reach of children and in the original container to prevent misuse or degradation of quality. Although this drug is unlikely to affect the ability to drive or operate machinery, caution is necessary in case of adverse reactions. The frequency of adverse reactions does not significantly increase with long-term use, but if abnormal symptoms appear, consult with medical personnel.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculatory dysfunction
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 65 more
  • itching
  • urticaria
  • localized swelling
  • severe skin reactions
  • angioedema
  • feeling depressed
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dystonia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • chill
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • increased SGOT
  • acne
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • skin diseases
  • folliculitis
  • fungal dermatitis
  • seborrhea
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormality
  • decreased testosterone
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • capillary dilation

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

Storage

This drug should be stored in a sealed container to prevent air and moisture from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Pale yellow egg-shaped film-coated tablet

Package unit

- - 30 tablets/box [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.