Medication info

Moben Dutastatin 0.5 mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Dae Won Biotech Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/box [(PTP X 3)]
Approval status
Active

MFDS item code 202302168 · Approved 2023.07.14

Summary

Main use
Treatment of male pattern hair loss and benign prostatic hyperplasia
Who takes it
Adults
Adult dose
The recommended dose 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 for 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
Dae Won Biotech Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss and benign prostatic hyperplasia

  • Benign prostatic hyperplasia
  • acute urinary retention
  • male pattern baldness
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 prostatic hyperplasia. Furthermore, it is also used for the treatment of male pattern baldness in adult males.

How to take

Adult dose

The recommended dose 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 for 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 or touch this medication directly. In particular, care should be taken to avoid touching broken or crushed pieces of the medication, and children should also be kept from exposure to pieces of this medication. This medication should not be administered to women, children under 18 years of age, or patients with hypersensitivity to this medication or similar substances. Adult males planning to become pregnant should use this medication with caution after consulting with a physician as it may affect fertility. Patients with significant residual urine or severe urinary flow reduction should be carefully monitored for the risk of urinary retention when taking this medication. Patients with liver dysfunction may be affected in the metabolic processes of this medication, so caution is required when administering it. Co-administration with strong CYP3A4 enzyme inhibitors may increase the blood concentration of this medication, so caution should be taken when used together. This medication is primarily used for treating benign prostatic hyperplasia and male pattern baldness in males, and erectile dysfunction, decreased libido, and ejaculation disorders may occur during use. These adverse reactions may persist in some patients after administration, so caution is necessary. Regular prostate-specific antigen (PSA) tests should be conducted during the use of this medication to evaluate the risk of prostate cancer. This medication may reduce PSA levels; thus, when interpreting PSA levels, it should be compared with baseline values measured before administration. In patients with heart failure, the risk of developing heart failure may increase when this medication is used in combination with alpha-blockers. This medication must be withheld from blood donation for at least 6 months after taking to prevent administration to pregnant women. In case of an overdose, there are no specific antidotes, so appropriate supportive treatment should be received based on symptoms. Store this medication out of reach of children, and keep it in the 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
Show 68 more
  • itching
  • hives
  • localized swelling
  • serious skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • oromandibular dystonia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • increased SGOT
  • acne
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • skin diseases
  • fungal dermatitis
  • seborrhea
  • folliculitis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasions
  • surgical intervention
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • 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 closed container to prevent the ingress of air or moisture, and it is recommended to store it at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/box [(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.