Medication info
Avodart 0.5 mg Tablet (Dutasteride)

Avodart 0.5 mg Tablet (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Kyungbo Pharmaceutical Co., Ltd.
Appearance
Pale yellow oval film-coated tablet
Packaging
30 tablets/blister [30 tablets (10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 201903628 · Approved 2019.05.31

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 tablet (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. Since no data are available on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
Kyungbo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men

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

This medication is used to improve symptoms of benign prostatic hyperplasia, reduce the risk of acute urinary retention, and decrease the need for related surgeries. It is also effective for the treatment of male pattern hair loss in adult men. Therefore, it is a drug that helps improve prostate health and treat hair loss.

How to take

Adult dose

The recommended dose of this medicine is 1 tablet (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. Since no data are available on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Precautions

This medication should never be used by women, especially those who are pregnant or may become pregnant. This drug can be absorbed through the skin, so women must be very careful when handling this medication and should avoid touching broken or crushed pieces. Additionally, this drug is not to be used in children under 18 years old. Adult men who are planning to conceive should use this drug carefully under a doctor's supervision, as it may affect fertility. Patients with urinary problems or liver issues should also use this medication with caution. Since this drug is primarily metabolized in the liver, it should be administered carefully in patients with liver disease. Caution is needed when taken with strong CYP3A4 inhibitors as it may increase drug concentration. While taking this medication, there may be side effects related to sexual function such as erectile dysfunction, decreased libido, and ejaculation issues; some patients may also experience breast tenderness or gynecomastia. Though prolonged use of this drug has not shown an increased frequency of these side effects, rare cases of heart failure or breast cancer have been reported, hence regular check-ups are necessary. During treatment with this medication, blood donation should be avoided, and it is only possible to donate blood at least 6 months after the last dose. Moreover, this drug can reduce prostate-specific antigen (PSA) levels, affecting prostate cancer diagnosis; thus, regular PSA testing should be conducted before and during treatment. There is no specific antidote for overdose, so appropriate treatment should be provided based on symptoms. This medication should be kept out of the reach of children and is safest when stored in the original container. Finally, while it does not affect the ability to drive or operate machinery, caution should be exercised if any unusual symptoms occur.

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
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • indigestion
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • seizures
  • hemifacial spasm
  • vomiting
  • colonic 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
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • telangiectasia

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture, ideally at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/blister [30 tablets (10 tablets/PTP 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.