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
Hanpoong Pharmaceutical Co., Ltd.
Appearance
Pale yellow oval film-coated tablet
Packaging
30 tablets/PTP [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201905771 · Approved 2019.08.14

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 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 for patients with renal impairment or elderly patients. The recommended dose of this medicine in patients with hepatic impairment has not been established because there are no data on its administration to such patients.

Ingredients

Manufacturer
Hanpoong Pharmaceutical 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 alopecia
View approved original text

This medication is used to treat benign prostatic hyperplasia, improving symptoms and reducing the risk of acute urinary retention. It also helps reduce the necessity for surgery due to hyperplasia. Additionally, it is effective for treating male pattern alopecia in adult men. These benefits contribute to improving the quality of life for patients.

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 for patients with renal impairment or elderly patients. The recommended dose of this medicine in patients with hepatic impairment has not been established because there are no data on its administration to such patients.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should avoid direct contact or handling of this medication. Particularly, care should be taken to avoid touching broken or crushed tablets. Children under 18 years of age should also avoid contact with this medication, and it should not be administered to them as safety and efficacy have not been established. This medication should not be given to women or children under 18, and those allergic to this medication or similar substances should not use it. Adult men planning to conceive should use this medication carefully after consulting a physician, as it may affect fertility. This medication may not be suitable for patients with difficult urinary discharge or severe urinary retention, and such cases should be monitored closely for urinary obstruction. Patients with liver dysfunction should be cautious, as the metabolism of this medication may be affected. When taken with strong CYP3A4 enzyme inhibitors, the blood concentration of this medication may increase, so caution is advised when used together. While using this medication, erectile dysfunction, decreased libido, and ejaculation disorders may occur as adverse reactions related to sexual function, and these symptoms may persist after discontinuation of the medication. In addition, breast-related adverse reactions such as gynecomastia, breast tenderness, and breast enlargement have been reported. This medication decreases PSA levels, which are important for assessing the risk of prostate cancer, so PSA results should be interpreted considering levels before and after taking the medication, and regular prostate cancer screenings are recommended. Patients taking this medication should not donate blood for at least six months after the last dose to prevent this medication from being administered to pregnant women. In case of overdose, there is no specific antidote, and appropriate supportive treatment should be provided according to symptoms, noting that this medication has a long half-life. Store it out of reach of children and in its original container to prevent misuse or quality degradation. This medication is unlikely to affect the ability to drive or operate machinery, but caution is advised in patients with heart failure. Finally, this medication must not be used by pregnant women or nursing mothers, and elderly patients or those with certain diseases should take it cautiously under medical supervision.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 79 more
  • itching
  • hives
  • localized edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • orofacial 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 infections
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • 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 closed container to prevent air ingress, preferably at room temperature between 1 and 30 degrees Celsius. This helps maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/PTP [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.