Medication info
Dutacare Tablet 0.5 mg (Dutasteride)

Dutacare Tablet 0.5 mg (Dutasteride)

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

MFDS item code 201802827 · Approved 2018.07.06 · Insurance code 057000450

Summary

Main use
Treatment of male pattern hair loss and benign prostatic hyperplasia
Who takes it
Adults
Adult dose
The recommended dose 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 dosage 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 medicine to patients with hepatic impairment.

Ingredients

Manufacturer
The U Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss and benign prostatic hyperplasia

  • Benign prostatic hyperplasia
  • acute urinary retention
  • androgenetic alopecia
View approved original text

This medication is used to alleviate symptoms caused by benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for related surgical procedures. It is also effective for the treatment of androgenetic alopecia in adult males. It is a medication that helps with various symptoms and conditions.

How to take

Adult dose

The recommended dose 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 dosage 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 medicine 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 medication directly. In particular, because this medication may interfere with the normal genital development of male fetuses, women should avoid touching broken or crushed pieces of this medication. Children should also be cautioned to avoid touching broken pieces of this medication as it can be absorbed through the skin. This medication is not recommended for use by women or children under 18 years of age, and individuals with allergies to this medication or similar components should not use it. Adult males planning to conceive should use this medication with caution as it may affect fertility, and should consult a doctor. Patients who have difficulty urinating or severe urinary symptoms should use this medication with particular caution and should closely monitor for the occurrence of urinary retention. Patients with liver dysfunction should use this medication carefully considering the metabolic process in the liver. Additionally, patients taking strong CYP3A4 enzyme inhibitors should be cautious as the blood concentration of this medication may increase. This medication is primarily used in males and may cause erectile dysfunction, decreased libido, and ejaculation disorders as side effects related to sexual function. These side effects may persist even after discontinuation of treatment, so patients should consult a doctor if symptoms occur. Furthermore, while taking this medication, patients should regularly undergo PSA tests and digital rectal examinations to check prostate health status. This medication may lower PSA levels, so changes before and after administration should be considered when interpreting PSA test results. Patients should avoid donating blood for at least 6 months during and after taking this medication to prevent drug transmission to pregnant women. Long-term use may cause changes in male breast tissue, so it is important to inform medical personnel immediately if any abnormalities are felt in the breast. In the event of an overdose, there is no specific antidote, so if symptoms are suspected, patients should visit a medical institution for appropriate treatment. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • dizziness
  • rash
  • itching
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  • hives
  • localized swelling
  • serious skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • orofacial dyskinesia
  • vomiting
  • colon polyp
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • skin dryness
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disturbance
  • 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 air exposure and should be kept at room temperature between 1 to 30 degrees Celsius. Storing this way helps maintain the medication's effectiveness and prevent degradation.

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.