Medication info

Momodat Tablet (Dutasteride)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Intro Biopharma Co., Ltd.
Appearance
Pale yellow egg-shaped film-coated tablets
Packaging
PTP packaging - 30 tablets/PTP [(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 202008301 · Approved 2020.11.27

This product's status changed to Approval withdrawn on 2025.11.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of male-pattern hair loss and benign prostatic hyperplasia
Who takes it
Adults
Adult dose
The recommended dose of this drug is 1 tablet (0.5mg) once daily. Swallow this drug whole without chewing or splitting it. This drug may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. Since no data are available on administration of this drug to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
Intro Biopharma Co., Ltd.

Efficacy & effects

Treatment of male-pattern hair loss and benign prostatic hyperplasia

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

This medication improves the symptoms of benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgeries. It is also used to treat male pattern hair loss in adult men, promoting hair health. This effectively manages the major symptoms and issues, enhancing the quality of life for patients.

How to take

Adult dose

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

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle this medication directly or touch broken pieces. It can particularly affect the genital development of male fetuses, so women need to exercise extreme caution. Children should also avoid touching this medication's broken pieces, and it should not be administered to minors under 18 years of age. Individuals with hypersensitivity to this medication or a history of allergy to other 5α-reductase inhibitors should not take it. Adult males planning to conceive should use this medication cautiously under medical supervision due to potential effects on fertility. Patients with significant residual urine or severe urinary flow reduction, as well as those with liver function impairment, should be cautious when using this medication. Co-administration with strong CYP3A4 inhibitors may pose interaction risks, so caution is warranted. Adverse reactions related to the reproductive system such as erectile dysfunction, reduced libido, and ejaculatory disorders may occur during treatment, and breast pain or gynecomastia may appear in some patients. Most side effects are mild to moderate and tend to resolve after discontinuation of the drug. This medication decreases prostate-specific antigen (PSA) levels, so caution is needed when interpreting PSA test results, and regular prostate checks are recommended. Donating blood during treatment is only possible six months after the last dose. It can be used safely in older adults, but data for male pattern hair loss patients over 50 years old is limited. In cases of overdose, no specific antidote is available, so symptomatic supportive treatment is necessary. Keep out of reach of children and store in the original container to prevent misuse or degradation of quality. This medication is known not to affect the ability to drive or operate machinery. Pregnant or nursing women should not use this medication, and it is contraindicated for women. Patients taking this medication should consult healthcare professionals immediately if side effects 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
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • orofacial dystonia
  • vomiting
  • colonic polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • 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
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified contusions
  • surgical intervention
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorders
  • capillary fragility

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 exposure to air, and it is best to keep it at room temperature between 1°C to 30°C. This helps maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Pale yellow egg-shaped film-coated tablets

Package unit

PTP packaging - 30 tablets/PTP [(10 tablets/PTP*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.