Medication info
Dutalin 0.5 mg (Dutasteride)

Dutalin 0.5 mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Korea Sintx Pharmaceutical Co., Ltd.
Appearance
Pale yellow round film-coated tablet
Packaging
30 tablets/box [30 tablets (10 tablets/PTPX3)]
Approval status
Active

MFDS item code 201907785 · Approved 2019.11.07 · Insurance code 623006290

Summary

Main use
Improvement of benign prostatic hyperplasia; treatment of male pattern hair loss 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 breaking it. It may be taken with or without food. No dose adjustment is necessary for patients with renal impairment or elderly patients. Since there are no data on administration of this medication to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
Korea Sintx Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of benign prostatic hyperplasia; treatment of 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 helps improve symptoms caused by benign prostatic hyperplasia, reduce the risk of acute urinary retention, and lower the need for related surgeries. It is also used for the treatment of male pattern hair loss in adult males. Therefore, it is effectively used for prostate health and hair loss management.

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 breaking it. It may be taken with or without food. No dose adjustment is necessary for patients with renal impairment or elderly patients. Since there are no data on 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, so women who are pregnant or may become pregnant should not handle it directly. In particular, because this drug may affect the normal development of male reproductive organs in a male fetus, women should not handle broken or crushed tablets. Additionally, this medication should not be used by children or adolescents under 18, and care should be taken to prevent children from coming into contact with it. This drug should not be administered to patients with certain genetic problems, such as those with lactose intolerance or glucose-galactose malabsorption. Adult males planning to conceive should use this medication cautiously and consult a physician since it may affect fertility. Patients with high post-void residual urine or severely reduced urine flow should be carefully monitored for the risk of urinary obstruction when using this medication. This medication should be administered cautiously to patients with poor liver function and should be used with caution if taken with other strong CYP3A4 inhibitors. Sexual dysfunction such as erectile dysfunction, decreased libido, and ejaculation disorders may occur during treatment with this medication, and these symptoms may persist after discontinuation. Rarely, breast-related adverse reactions such as breast tenderness or gynecomastia may occur. This medication can significantly reduce PSA levels, which are important for screening for prostate cancer, so a new baseline should be established 3-6 months after administration when interpreting PSA test results. If PSA levels increase during treatment, the possibility of prostate cancer should be considered, and further testing may be required. Blood donation should be prohibited for at least 6 months while taking this medication to prevent exposure of the drug to pregnant women. There is no specific antidote for overdose, so appropriate supportive treatment should be provided based on symptoms, taking into account the long half-life of the drug. The medication should be stored out of the reach of children and should not be transferred to another container from its original packaging. This medication is known to have little effect on the ability to drive or operate machinery, but caution is advised as individual responses may vary. Finally, this medication is contraindicated for women and children, and special precautions should be taken to avoid exposing pregnant women to this drug.

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
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hypertrichosis
  • 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
  • dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • folliculitis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified laceration
  • surgical intervention
  • torn wound
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste distortion
  • capillary dilatation
  • visual disturbances
  • fatty liver
  • thirst
  • abnormal urination
  • hematuria
  • abnormal semen

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius to effectively preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/box [30 tablets (10 tablets/PTPX3)]

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.