Medication info
Dutasteride Tablets 0.5 mg (Dutasteride)

Dutasteride Tablets 0.5 mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Unimed Pharmaceuticals Co., Ltd.
Appearance
Light yellow, round, film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202002957 · Approved 2020.04.24 · Insurance code 649508660,651205440

Summary

Main use
Treatment of male-pattern hair loss and benign prostatic hyperplasia 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 with or without food. No dose adjustment is necessary in patients with renal impairment or older adults. The recommended dose in patients with hepatic impairment has not been established because no data are available on administration of this medicine to these patients.

Ingredients

Manufacturer
Unimed Pharmaceuticals Co., Ltd.

Efficacy & effects

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

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

This medication helps improve symptoms caused by benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for prostate-related surgery. It is also used for the treatment of male pattern baldness in adult males. This drug supports both prostate 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. The recommended dose in patients with hepatic impairment has not been established because no data are available on administration of this medicine to these patients.

Precautions

This medication can be absorbed through the skin; therefore, women who are pregnant or may become pregnant should not touch or handle this medication. Special caution should be taken as this drug may affect the normal development of the reproductive organs in male fetuses; women should avoid touching broken tablet fragments. Additionally, children under 18 years should not use this medication, and individuals allergic to this medication or its components should not take it. This drug contains lactose; consequently, people with lactose intolerance or related genetic disorders should not use it. Adult males planning to conceive should consult a doctor before use since this medication may affect fertility. Patients with urinary issues or compromised liver function need to be cautious when using this drug and should be careful when combined with certain medications due to potential drug interactions. During treatment, changes in sexual function may occur, such as erectile dysfunction, decreased libido, and ejaculation disorders, and these symptoms may persist even after discontinuation of the drug. Long-term use may also result in breast-related symptoms like tenderness or enlargement, so patients should notify their physician of any abnormal signs. This medication may interfere with prostate cancer screening, so regular checks on prostate health are necessary before and during usage. Blood donation during treatment is prohibited, and at least 6 months should elapse after the last dose before donating blood. In case of overdose, as there is no specific antidote, appropriate treatment according to symptoms should be administered, and recovery may take time due to the drug's prolonged half-life. Store this medication out of reach of children, in the original container to prevent degradation or misuse. It is known not to affect driving or operating machinery, but caution is advised as this may vary by individual.

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
  • serious skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • indigestion
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • unspecified laceration
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • telangiectasia

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

Storage

This medication may be sensitive to air or moisture; thus, it should be stored in a tightly sealed container. It is advisable to maintain room temperature between 1°C and 30°C to preserve the drug's effectiveness and safety over time.

Appearance and packaging

Appearance

Light yellow, round, film-coated tablet

Package unit

30 tablets/box [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.