Medication info
Avodart Soft Capsules 0.5 mg (Dutasteride)

Avodart Soft Capsules 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
A colorless or pale yellow transparent oval soft capsule containing a colorless transparent liquid
Packaging
For domestic use - 30 capsules/PTP [10 capsules/PTP x 3], For domestic use - 90 capsules/PTP [10 capsules/PTP x 9]
Approval status
Active

MFDS item code 201803547 · Approved 2018.08.30 · Insurance code 055100610

Summary

Main use
Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men (18~50 years)
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5 mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow the capsule 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 in patients with hepatic impairment has not been established because there are no data on administration of this medicine to these patients.

Ingredients

Manufacturer
Cosmax Pharma Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men (18~50 years)

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

This medication improves symptoms caused by benign prostatic hyperplasia and helps reduce the risk of acute urinary retention and decrease the need for related surgeries. It is also used for the treatment of male pattern hair loss in adult men. Therefore, this medicine is effective for prostate health and hair loss management.

How to take

Adult dose

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

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle this drug directly. If the capsule is broken and the medication comes into contact with the skin, it should be washed off immediately with soap and water. This medication should not be used by children under the age of 18, and care should be taken to ensure that children do not come into contact with the medication. Women and children under 18, as well as patients with allergies to this medication or its ingredients, should not take this medication. Adult men planning to conceive should consult a doctor before carefully taking this medication, as it may affect fertility. Caution is also needed for patients with urinary problems or liver dysfunction when taking this medication. When taken with strong CYP3A4 enzyme inhibitors, the concentration of the drug may change, so consultation with a physician is necessary. Sexual side effects such as erectile dysfunction, decreased libido, and ejaculation disorders may occur while taking this medication, and these symptoms may persist even after stopping the medication. Rarely, adverse reactions such as skin rashes, allergic reactions, depression, hair loss, and testicular pain have been reported. Regular prostate cancer screenings and PSA level tests should be conducted while taking this medication, and caution is needed in interpreting test results as PSA levels may decrease after administration of the drug. This medication may interact with drugs that can increase drug concentrations in the blood, so inform your doctor about any other medications you are taking. Blood donation should be done at least 6 months after the last dose of this medication to prevent the drug from being transmitted to pregnant women. There is no specific antidote for overdose, so if symptoms appear, visit a medical institution immediately for proper treatment. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality. It is known not to affect driving or machine operation skills, but caution is advised in case of adverse reactions.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
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  • itching
  • hives
  • localized swelling
  • severe skin reaction
  • angioedema
  • allergic reaction
  • 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
  • facial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • heart failure
  • 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 tract infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbance
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • telangiectasia

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 and moisture ingress, and it is best kept in a cool place below 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

A colorless or pale yellow transparent oval soft capsule containing a colorless transparent liquid

Package unit

For domestic use - 30 capsules/PTP [10 capsules/PTP x 3], For domestic use - 90 capsules/PTP [10 capsules/PTP x 9]

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.