Medication info
Dutasteride Soft Capsules 0.5 mg (Dutasteride)

Dutasteride Soft Capsules 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
CHD Pharmaceuticals Co., Ltd.
Appearance
A transparent brownish oval soft capsule containing a colorless transparent substance.
Packaging
30 capsules / PTPE [(15 capsules / PTPE) x 2], 30 capsules / PTPE [(10 capsules / PTPE) x 3]
Approval status
Active

MFDS item code 202203625 · Approved 2022.09.21

Summary

Main use
Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men
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 breaking 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 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 these patients.

Ingredients

Manufacturer
CHD Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men

  • Benign prostatic hyperplasia
  • acute urinary retention
  • male pattern hair loss.
View approved original text

This medication improves the symptoms of benign prostatic hyperplasia and reduces the risk of acute urinary retention. Additionally, it helps decrease the need for surgery related to prostate enlargement. It is also effectively used for the treatment of male pattern hair loss in adult males.

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 breaking 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 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 these patients.

Precautions

This medication must not be used or handled by women, especially those who are pregnant or may become pregnant. Since this medication can be absorbed through the skin, if a woman or child comes into contact with leaking capsules, it should be washed off immediately with soap and water. This medication is not to be used by children under 18 years of age. Men planning to father a child should consult a doctor before using this medication, as it can affect fertility. Patients with poor liver function should use this medication with caution. Caution is also required when used with certain drugs known as CYP3A4 inhibitors. During the use of this medication, erectile dysfunction, decreased libido, and ejaculation disorders may occur, with rare occurrences of breast tenderness or enlargement. These side effects may persist even after stopping the medication. This medication lowers PSA levels which are used for prostate cancer testing, so new reference values should be based on results taken 3-6 months after starting the medication. If there is a sudden increase in PSA levels while taking this medication, the possibility of prostate cancer should be suspected, and further testing is necessary. Blood donation is permitted only after a minimum of 6 months from the last dose of this medication. This medication is known to not affect driving or operating machinery. There is no specific antidote for overdose, so appropriate supportive care should be taken if symptoms appear. Keep this medication out of the reach of children and store it in its original container to prevent misuse or degradation of quality.

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
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • seizures
  • orofacial dystonia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • fatigue
  • elevated SGPT
  • rash
  • sexual abnormalities
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • 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
  • sensory deviations
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disturbance
  • capillary dilation
  • visual disturbances
  • thirst
  • urinary abnormalities
  • hematuria
  • semen abnormalities

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

Storage

Store this medication in a tightly sealed container to prevent air exposure, and it is recommended to keep it at a cool temperature below 30 degrees Celsius. This will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

A transparent brownish oval soft capsule containing a colorless transparent substance.

Package unit

30 capsules / PTPE [(15 capsules / PTPE) x 2], 30 capsules / PTPE [(10 capsules / PTPE) 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.