Medication info
Duteron Soft Capsule 0.5 mg (Dutasteride)

Duteron Soft Capsule 0.5 mg (Dutasteride)

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

MFDS item code 201507363 · Approved 2015.10.23 · Insurance code 645905930

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 capsule (0.5mg) once daily. Exposure to the capsule contents may cause irritation of the oropharyngeal mucosa; therefore, swallow the capsule whole without chewing or opening 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 such patients.

Ingredients

Manufacturer
Dongkwang Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and 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 improves symptoms of benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgeries. It is also used for the treatment of male pattern hair loss in adult males. Therefore, this medication is effective for prostate health and hair loss management.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Exposure to the capsule contents may cause irritation of the oropharyngeal mucosa; therefore, swallow the capsule whole without chewing or opening 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 such patients.

Precautions

This medication should not be used or come into contact with women, especially those who are pregnant or may become pregnant. It can be absorbed through the skin, so women should take extra precautions to avoid contact with any leaked capsules, and if contact occurs, they should wash immediately with soap and water. Moreover, it should not be used in individuals under 18 years of age as safety and efficacy have not been established. This medication should not be administered to those with certain allergic reactions or hypersensitivity to this drug or similar ingredients. Adult males planning to conceive, patients with liver dysfunction, and those with significantly impaired urinary function should use this medication with caution and decide on administration after consulting a doctor. Long-term use of this medication may cause sexual dysfunction or breast-related abnormalities, and some patients may experience side effects such as erectile dysfunction, decreased libido, and ejaculation disorders. These side effects may persist even after discontinuation of the drug, so caution is needed. Patients with heart disease should be particularly careful as the risk of heart failure may increase, and regular health check-ups during the course of this medication are essential. This medication may lower prostate-specific antigen (PSA) levels in blood tests, so it is important to inform the interpreting physician of this medication when interpreting PSA test results, and the results should be reassessed. Blood donation is prohibited while taking this medication, and at least 6 months must pass after the last dose before one can donate blood. This medication may interact with other drugs, so particularly those taking CYP3A4 inhibitors should consult their doctor, and caution is needed when co-administering. In case of overdose, there is no specific antidote, so immediate hospital visit is necessary for proper treatment, and the long half-life of this medication may result in prolonged symptoms. Keep this medication in a tightly closed container to prevent air exposure, and store it in a cool place below 30 degrees Celsius. This helps maintain the efficacy of the drug and prevents degradation. While this medication is known not to affect driving or machinery operation, individual responses may vary, so caution is warranted.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
Show 77 more
  • itching
  • hives
  • localized edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hypertrichosis
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • hemifacial spasm
  • 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
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • paresthesia
  • decreased testosterone
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • telangiectasia
  • sexual dysfunction

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 exposure and kept in a cool place below 30 degrees Celsius. This helps maintain the effectiveness of the medication and prevents deterioration.

Appearance and packaging

Appearance

Translucent yellow oval soft capsule containing a colorless transparent substance

Package unit

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.