Medication info

Megaduta Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOralApproval withdrawn
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
LNC Bio Co., Ltd.
Appearance
A translucent yellow oval soft capsule containing a colorless transparent substance
Packaging
30 capsules (15 capsules/PTPX2, 10 capsules/PTPX3)
Approval status
Approval withdrawn

MFDS item code 202001802 · Approved 2020.03.16

This product's status changed to Approval withdrawn on 2024.09.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of male pattern hair loss in adults and benign prostatic hyperplasia
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because 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 dosage adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose in patients with hepatic impairment has not been established because no data are available on administration of this medicine to these patients.

Ingredients

Manufacturer
LNC Bio Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss in adults and benign prostatic hyperplasia

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

This medication improves symptoms related to benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgeries. It is also used in the treatment of male pattern baldness in adult men. Therefore, it helps effectively manage prostate problems and hair loss symptoms.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because 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 dosage adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose in patients with hepatic impairment has not been established because no data are available on administration of this medicine to these patients.

Precautions

This medication can be absorbed through the skin; therefore, women who are pregnant or may become pregnant should not touch or handle this medication. If the capsule containing this medication is broken and comes into contact with the skin, it should be washed immediately with soap and water. This medication should not be used by children under 18 years of age, and special care should be taken to keep it out of reach of children. This medication should not be administered to women, and individuals allergic to this medication or similar components should not use it. Men planning to have children should use this medication carefully after consulting a physician, as it may affect reproductive capability. Patients with urinary problems or liver dysfunction should be closely monitored under the guidance of a physician while taking this medication. Also, be cautious of interactions with specific medications (e.g., strong CYP3A4 inhibitors) and inform healthcare providers of any such medications being used. During the course of taking this medication, erectile dysfunction, decreased libido, and ejaculation disorders may occur. Consult a physician if any abnormal symptoms arise. These side effects may persist even with long-term use, so it is important to consult healthcare professionals if symptoms continue. Routine tests related to prostate cancer should be conducted, and changes in prostate-specific antigen (PSA) levels should be monitored carefully in blood tests. Donation of blood should be avoided during the course of this medication, and a minimum of 6 months should pass after the last dose before donating. There is no specific antidote for overdose, so if symptoms appear, seek medical attention immediately for proper treatment. This medication should be kept out of reach of children and stored in its original container for safety. There is no effect on driving or operating machinery, but caution is advised if any adverse reactions occur. Finally, if there are any changes in the breast, such as lumps or discharge while taking this medication, inform a physician immediately.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • heart failure
Show 76 more
  • rash
  • itching
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • allergic reactions
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dystonia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • fatigue
  • increased SGPT
  • rash
  • sexual abnormalities
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • gastric ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • capillary dilatation

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

Storage

This medication should be stored in a sealed container to prevent air ingress, maintaining a temperature below 30 degrees Celsius. By storing it this way, the efficacy of the medication can be well maintained and deterioration can be prevented.

Appearance and packaging

Appearance

A translucent yellow oval soft capsule containing a colorless transparent substance

Package unit

30 capsules (15 capsules/PTPX2, 10 capsules/PTPX3)

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.