Medication info
Inodart Soft Capsule 0.5 mg (Dutasteride)

Inodart Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Teragen Etex Co., Ltd.
Appearance
Colorless or pale yellow transparent oval soft capsule containing a colorless transparent liquid
Packaging
30 capsules/PTP [10 capsules/PTP x 3]
Approval status
Active

MFDS item code 202500167 · Approved 2025.01.22

Summary

Main use
Improvement of benign prostatic hyperplasia and treatment of male pattern hair loss in adult men
Who takes it
Adults
Adult dose
The recommended dose is 1 capsule (0.5mg) once daily. Swallow the capsule 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 elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on the administration of this medicine to such patients.

Ingredients

Manufacturer
Teragen Etex Co., Ltd.

Efficacy & effects

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

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

This medication helps to improve symptoms caused by benign prostatic hyperplasia and reduces the risk of acute urinary retention, while also lowering the necessity for related surgical procedures. Additionally, it is used for the treatment of male pattern hair loss in adult men, aiding in the prevention of hair loss progression and promoting hair growth. Therefore, it effectively aids in the improvement of prostate health and hair loss treatment.

How to take

Adult dose

The recommended dose is 1 capsule (0.5mg) once daily. Swallow the capsule 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 elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on the administration of this medicine to such patients.

Precautions

This medication can be absorbed through the skin; therefore, women who are pregnant or may become pregnant should not handle or come into contact with this medication. If a capsule is broken and comes into contact with the skin, wash the area immediately with soap and water. Moreover, children under 18 should not take or handle this medication, and if contact occurs, they should be washed immediately. This medication is prohibited for use in women and children under 18, and those allergic to this medication or its ingredients should also refrain from using it. Adult men planning to conceive should consult a doctor before using this medication due to its potential impact on reproductive ability. Patients with prostate-related symptoms should verify that no other urological conditions exist before taking this medication, and regular prostate cancer checks should be conducted during treatment. This medication may lower serum PSA levels; therefore, it is important to establish a new baseline for PSA levels and monitor them within 3 to 6 months after starting treatment. Side effects related to sexual function, such as erectile dysfunction, decreased libido, and ejaculation disorders, may occur during treatment, and these symptoms may persist even after discontinuing the medication. Patients with heart failure or liver dysfunction should use caution when taking this medication, and care should also be taken when using this medication in conjunction with strong CYP3A4 enzyme inhibitors. Patients should not donate blood during the course of treatment and must wait at least 6 months after the last dose before donating. There is no specific antidote for overdose, so immediate medical attention should be sought if symptoms appear. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or degradation of quality. This medication is known not to affect the ability to drive or operate machinery, but caution is advised if abnormal reactions occur.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 73 more
  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • depression
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial muscle spasms
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • heart failure
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • palpitations
  • seborrhea
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbance
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • capillary dilation

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

Storage

This medication should be stored in a tightly closed container to prevent air from entering, and it is recommended to keep it in a cool place below 30 degrees Celsius. This way, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

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

Package unit

30 capsules/PTP [10 capsules/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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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.