Medication info
Avodart Soft Gelatin Capsule 0.5 mg (Dutasteride)

Avodart Soft Gelatin Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Korea Pharmbio Co., Ltd.
Appearance
An opaque, dull yellow oblong soft gelatin capsule containing a colorless transparent liquid.
Packaging
30 capsules (10 capsules × 3 PTP)/box
Approval status
Active

MFDS item code 201505703 · Approved 2015.08.13 · Insurance code 659901060

Summary

Main use
Improvement of benign prostatic hyperplasia (symptoms and risk of urinary retention, etc.); treatment of male-pattern hair loss
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Since 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 required 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
Korea Pharmbio Co., Ltd.

Efficacy & effects

Improvement of benign prostatic hyperplasia (symptoms and risk of urinary retention, etc.); treatment of male-pattern hair loss

  • Benign prostatic hyperplasia
  • 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 surgery. It is also used to treat male pattern hair loss in adult men, helping to slow down hair loss progression. Thus, this medication is effectively used for both prostate health and hair loss management.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Since 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 required 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 can be absorbed through the skin, so women who are pregnant or may become pregnant should not touch or handle it. If the capsule is broken and comes into contact with the skin, wash immediately with soap and water. Caution should also be exercised to prevent children from coming into direct contact with this medication, and if contact occurs, wash immediately. Women, children under 18 years, and individuals allergic to this drug or similar components should not use this medication. Adult men planning to conceive should use this drug cautiously as it may affect fertility and consult a doctor beforehand. Patients with urinary problems or impaired liver function need to be cautious when using this drug and should follow their physician's instructions. Since this drug is metabolized in the liver, patients with liver impairment should be especially careful. When taken with strong CYP3A4 inhibitors, drug concentration may increase, so inform your doctor if you are on such medications. While taking this drug, sexual side effects such as erectile dysfunction, decreased libido, and ejaculation disorders may occur; in some patients, breast enlargement or pain may develop. These side effects may persist even after discontinuation of the drug, so caution is advised. This medication may lower PSA levels used in prostate cancer tests, so this should be considered and discussed with a doctor before testing. Regular assessments and tests for prostate cancer risk during treatment with this medication are important. Additionally, this medication may slightly increase the risk of high-grade prostate cancer when taken long-term, hence regular examinations as directed by a physician are necessary. Blood donation should only be feasible 6 months after the last dose of this medication, so inform any donation plans in advance. There is no specific antidote for overdose, so appropriate treatment should be sought immediately at a medical facility. Children and women should not use this medication, and elderly patients require special precautions, but generally, it is safe for use. This medication is known not to affect the ability to drive or operate machinery. Finally, while this medication has not shown significant interactions with many other drugs, always inform your doctor or pharmacist of any medications you are taking.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
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  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • allergic reactions
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • xerostomia
  • constipation
  • cramps
  • orofacial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • paresthesia
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • nephrolithiasis
  • 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 from entering, and it is important to keep the temperature below 30 degrees Celsius. This will preserve the efficacy and prevent degradation of the drug.

Appearance and packaging

Appearance

An opaque, dull yellow oblong soft gelatin capsule containing a colorless transparent liquid.

Package unit

30 capsules (10 capsules × 3 PTP)/box

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.