Medication info
Dutasteride Soft Gel Capsule 0.5mg

Dutasteride Soft Gel Capsule 0.5mg

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Hyundai Pharmaceutical Co., Ltd.
Appearance
A translucent yellow oval soft gel capsule containing a colorless transparent substance.
Packaging
Capsule/PTP - 30 capsules/PTP [30 capsules (15 capsules/PTP x 2)]
Approval status
Active

MFDS item code 201505795 · Approved 2015.08.18 · Insurance code 642003640

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 capsule (0.5mg) once daily. Because exposure to the contents of the capsule may cause irritation of the oropharyngeal mucosa, 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 elderly patients. The recommended dose of this medicine in patients with hepatic impairment has not been established because no data are available on its use in these patients.

Ingredients

Manufacturer
Hyundai Pharmaceutical 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 alleviates the symptoms of benign prostatic hyperplasia, lowers the risk of acute urinary retention, and reduces the need for surgical interventions during treatment. Additionally, it is effective in treating male pattern baldness in adult men, thus aiding in the management of prostate health and improvement of hair loss.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the contents of the capsule may cause irritation of the oropharyngeal mucosa, 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 elderly patients. The recommended dose of this medicine in patients with hepatic impairment has not been established because no data are available on its use in these patients.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not directly touch or handle this drug. If the contents of this medication come into contact with the skin, wash it immediately with soap and water. This medication should not be used by children under 18 years of age, and care should be taken to ensure children do not come into contact with it. Women are not the target population for this medication, and it should not be administered if there is an allergy to this drug or its ingredients. Men planning to conceive should consult their doctor about this medication, as it may affect fertility. Patients with severe urinary symptoms or liver dysfunction require special caution when administering this drug. This drug is metabolized in the liver, so caution is advised for patients with liver disorders. When taken with strong CYP3A4 enzyme inhibitors, the blood concentration of this drug may increase, so care is needed when using it in combination. During the administration of this medication, erectile dysfunction, decreased libido, ejaculatory disorders, and, in some patients, breast changes may occur. If adverse reactions persist or worsen after taking this drug, consultation with healthcare professionals is required. This medication can lower prostate-specific antigen (PSA) levels, which may affect prostate cancer diagnosis, thus regular examinations are necessary. Blood donation should be avoided during the use of this drug, and at least six months should pass after the last dose before donating blood. There is no specific antidote for overdose, so appropriate treatment should be provided based on symptoms, considering the long half-life of this medication. Store out of reach of children, and keep it in its original container to prevent misuse or deterioration of quality. This drug does not significantly affect driving or operating machinery, but caution is needed as individual responses may vary. Long-term use does not greatly increase the incidence of erectile dysfunction or breast disorders; however, if any abnormal symptoms occur, consulting a physician is recommended. It is important to inform healthcare professionals immediately if new symptoms or adverse reactions develop during the use of this medication.

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 edema
  • serious skin reactions
  • angioedema
  • allergic reactions
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • dyskinesia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • asthenia
  • heart failure
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • acne
  • fungal dermatosis
  • 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 infection
  • unspecified abrasion
  • surgical intervention
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infections
  • purpura
  • nosebleeds
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • 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 from entering, and it is best to maintain a temperature below 30 degrees. Proper storage can help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

A translucent yellow oval soft gel capsule containing a colorless transparent substance.

Package unit

Capsule/PTP - 30 capsules/PTP [30 capsules (15 capsules/PTP x 2)]

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.