Medication info
Daewoong Bio Dutasteride Tablet 0.5 mg

Daewoong Bio Dutasteride Tablet 0.5 mg

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Daewoong Bio Co., Ltd.
Appearance
Pale yellow egg-shaped film-coated tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201802873 · Approved 2018.07.10 · Insurance code 694001760

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
Daewoong Bio Co., Ltd.

Efficacy & effects

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

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

This medication helps to improve symptoms caused by benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for related surgery. It is also used for the treatment of male pattern baldness in adult men. This way, it effectively supports both prostate health and hair loss management, thereby enhancing quality of life.

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 can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle this drug directly. Especially, they should avoid touching broken or crushed pieces of the medication, and children should also be kept away from contact. This medication should not be administered to women, children under 18 years of age, or patients with allergies to this medication or similar drugs. Adult men planning to conceive should use this medication cautiously, as it may affect fertility, under the doctor's guidance. Patients experiencing urinary outflow difficulty or with liver dysfunction need to be cautious when using this medication, and it should be administered with care to those with liver impairment. Additionally, caution is required if taken with strong CYP3A4 enzyme inhibitors, as drug concentrations may increase. While using this medication, side effects related to sexual function such as erectile dysfunction, decreased libido, ejaculation disorders, and gynecomastia may occur, and some side effects may persist even after discontinuing the medication. Regular examinations for prostate cancer should be conducted before and during treatment, as this drug can lower PSA levels in the blood, affecting the interpretation of test results. Blood donation should not be done while taking this medication, and at least 6 months must elapse after the last dose before donating blood. Although long-term use has not been associated with increased rates of sexual dysfunction or breast abnormalities, rare cases of male breast cancer have been reported, necessitating close observation for changes in breast tissue. There is no specific antidote for overdose, so appropriate supportive treatment must be provided according to symptoms. This medication must be stored out of the reach of children and kept in its original container to prevent misuse or quality deterioration. It is known not to affect driving or machine operating abilities, but care is needed in patients with heart failure. Interactions with other drugs are relatively few; however, caution is necessary when used with CYP3A4 inhibitors, and there have been no significant problems reported with combinations of various medications. Women should not use this medication, especially pregnant women, as it may pose risks to the fetus. Safety for children under 18 years has not been established, and use is prohibited. It can be used in the elderly without special dose adjustments; however, the efficacy in male pattern baldness patients over 50 years has not been adequately studied. Regular check-ups and monitoring for side effects are necessary while taking this medication, following the physician's guidance.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 84 more
  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dystonia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • 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 tract infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • capillary dilation
  • visual disturbances
  • thirst
  • urinary abnormalities
  • hematuria
  • semen abnormalities

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 air or moisture from entering, preferably at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow egg-shaped 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.