Medication info
Duta and Soft Capsule 0.5mg (Dutasteride)

Duta and Soft Capsule 0.5mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
KIMS Pharmaceutical Co., Ltd.
Appearance
Transparent or translucent soft oval capsules containing a colorless transparent liquid or pale yellow.
Packaging
30 capsules/PET [(10 capsules/PET x 3)]
Approval status
Active

MFDS item code 202401516 · Approved 2024.06.21

Summary

Main use
Treatment of male pattern hair loss and benign prostatic hyperplasia
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it, as exposure to the capsule contents may cause irritation of the oropharyngeal mucosa. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or older patients. The recommended dose of this medicine in patients with hepatic impairment has not been established, as no data are available on its use in these patients.

Ingredients

Manufacturer
KIMS Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss and benign prostatic hyperplasia

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

This medication helps improve the symptoms of benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for surgery. It is also used for the treatment of male pattern baldness in adult men. Therefore, it is effective for enhancing prostate health and managing hair loss.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it, as exposure to the capsule contents may cause irritation of the oropharyngeal mucosa. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or older patients. The recommended dose of this medicine in patients with hepatic impairment has not been established, as no data are available on its use in these patients.

Precautions

This medication can be absorbed through the skin; therefore, women who are pregnant or may become pregnant should avoid touching or handling this medication. If the capsule is broken and the medication comes into contact with the skin, it should be washed immediately with soap and water. Children under 18 years of age should not use this medication, and care must be taken to keep it out of the reach of children. This medication should not be administered to women and patients under 18 years of age, nor should anyone who is allergic to this medication or its ingredients use it. Men planning to conceive should use this medication cautiously after consulting their doctor, as it may affect reproductive ability. Patients with severe urinary obstruction or liver function issues should exercise caution when using this medication and closely monitor for adverse effects. This medication may alter drug concentrations when used in combination with other drugs, especially strong CYP3A4 inhibitors, so caution is advised. During the course of using this medication, erectile dysfunction, decreased libido, and ejaculation disorders may occur, and some side effects may persist even after discontinuation of the medication. Long-term use may present breast-related unusual symptoms such as breast tenderness or enlargement, so patients should inform their doctor of any such symptoms. While using this medication, the PSA levels for prostate cancer testing may decrease, thus it is necessary to consider this when interpreting PSA test results and to undergo regular testing. Patients taking this medication should refrain from donating blood for at least 6 months after the last dose to prevent transmission of the drug to pregnant women during transfusions or blood donations. Though it is known not to affect driving or machinery operation, individual variations may occur, so caution is advised. There is no specific antidote for overdose; therefore, if symptoms appear, it is essential to seek medical attention immediately for appropriate treatment. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or degradation of quality.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation dysfunction
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
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  • itching
  • urticaria
  • local swelling
  • severe skin reactions
  • angioedema
  • depressive 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
  • facial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • fatigue
  • elevated SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • elevated SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • gastric ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • unspecified abrasions
  • surgical intervention
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • telangiectasia
  • visual disturbance
  • thirst
  • urinary abnormalities
  • hematuria
  • abnormal semen

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 from entering and should be kept in a cool place below 30 degrees Celsius. This helps maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

Transparent or translucent soft oval capsules containing a colorless transparent liquid or pale yellow.

Package unit

30 capsules/PET [(10 capsules/PET 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.