Medication info
Moderat Soft Capsule 0.5 mg (Dutasteride)

Moderat Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
The U Pharmaceutical Co., Ltd.
Appearance
Clear and colorless or pale yellow transparent oval soft capsules containing a clear liquid.
Packaging
30 capsules/PTP [10 capsules/PTP × 3]
Approval status
Active

MFDS item code 202401943 · Approved 2024.08.13

Summary

Main use
Treatment of benign prostatic hyperplasia and male-pattern hair loss in adult men
Who takes it
Adults
Adult dose
The recommended dose of this medicine 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. Since there are no data on the administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
The U Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male-pattern hair loss in adult men

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

This medication improves symptoms caused by benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the likelihood of requiring related surgery. It is also effective for the treatment of male pattern hair loss in adult men. Therefore, it aids in both prostate health and hair loss management, enhancing quality of life.

How to take

Adult dose

The recommended dose of this medicine 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. Since there are no data on the administration of this medicine 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 touch or handle it. If the capsule is broken and the medication comes into contact with the skin, wash it off immediately with soap and water. This medication should not be used by children under 18 years of age, and care should be taken to prevent children from being exposed to the medication. Women, children under 18 years of age, and persons allergic to this medication or similar components should not take this medication. Adult men planning to conceive should consult with a physician prior to using this medication, as it may affect fertility. Patients with urinary issues or liver dysfunction should exercise caution while taking this medication, particularly to avoid symptoms of urinary retention. Since this medication is metabolized in the liver, patients with liver disease should take care when using it, as it may increase the drug concentration when taken with certain potent liver enzyme inhibitors. During the use of this medication, erectile dysfunction, decreased libido, and ejaculatory dysfunction may occur, and these symptoms may persist even after discontinuation of the medication. This medication may lower prostate-specific antigen (PSA) levels for prostate cancer testing, so it is essential to inform the healthcare professional about taking this medication when interpreting PSA test results, and regular testing is necessary. Blood donation should not be performed while taking this medication, and at least 6 months must pass after the last dose before donating blood. While a clear association with the risk of male breast cancer from long-term use has not been established, immediate consultation with a healthcare professional is required if any unusual symptoms appear in the breast. There is no specific antidote in case of overdose, so if symptoms appear, seek appropriate medical treatment immediately. Store out of reach of children and keep in the original container to prevent misuse of the medication. This medication is known not to affect driving or machine operation abilities, but individual cases may vary, and caution is warranted.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headaches
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 76 more
  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • hemifacial spasm
  • vomiting
  • colon polyps
  • epigastric discomfort
  • weakness
  • heart failure
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • acne
  • fungal dermatitis
  • seborrhea
  • skin diseases
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory tract infection
  • unspecified abrasions
  • surgical intervention
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • musculoskeletal pain
  • plantar fasciitis
  • bacterial infection
  • 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 sealed container to prevent air ingress, and kept in a cool place below 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Clear and colorless or pale yellow transparent oval soft capsules containing a clear liquid.

Package unit

30 capsules/PTP [10 capsules/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.