Medication info
Prodat Soft Capsule 0.5 mg (Dutasteride)

Prodat Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Genewon Science Co., Ltd.
Appearance
A yellowish, transparent oval soft capsule containing a colorless, transparent content.
Packaging
30 capsules (15 capsules/PTPX2)
Approval status
Active

MFDS item code 201601191 · Approved 2016.02.29 · Insurance code 671704980

Summary

Main use
Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men (18~50 years)
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 dose adjustment is necessary in patients with renal impairment or elderly patients. As 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
Genewon Science Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men (18~50 years)

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

This drug improves the symptoms of benign prostatic hyperplasia, reduces the risk of acute urinary retention, and helps decrease the need for surgery. It is also used for the treatment of male pattern hair loss in adult males.

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 dose adjustment is necessary in patients with renal impairment or elderly patients. As 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 drug can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle or touch this drug. If the capsule breaks and the medication contacts the skin, wash it immediately with soap and water. Children should also avoid contact with this drug, and immediate washing is important in case of contact. Women, children under 18, and those allergic to this drug or similar ingredients should not use this drug. Adult males planning to conceive should use this drug cautiously, as it may affect reproductive ability, under medical supervision. Patients with urinary problems or poor liver function should be cautious while taking this drug and follow a physician's instructions. Taking this drug with strong CYP3A4 enzyme inhibitors may increase drug concentration, so must consult a physician if taking such medications. Abnormal reactions including sexual dysfunction, breast pain, or breast enlargement may occur while taking this drug; inform your doctor if any abnormal symptoms arise. This drug can lower prostate-specific antigen (PSA) levels in blood tests, so consider this when interpreting test results. Regularly check prostate health while taking this drug and consult medical staff immediately if there are abnormal symptoms. Do not donate blood while taking this drug, and at least 6 months must pass after the last dose before donation is possible. There is no specific antidote in case of overdose, so seek appropriate medical care immediately if symptoms occur. This drug should be kept out of the reach of children and stored in its original container to prevent misuse or quality degradation. It is known not to significantly affect driving or machine operation, but caution should be exercised as individual reactions may vary. The treatment for male pattern hair loss has only been proven effective in men under 50, and safety in older individuals has not been established. This drug is contraindicated for use by pregnant women or nursing mothers.

Side effects

  • erectile dysfunction
  • reduced libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 81 more
  • itching
  • hives
  • localized swelling
  • serious skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • indigestion
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disturbance
  • capillary dilation
  • visual disturbances
  • fatty liver
  • thirst
  • abnormal urination
  • hematuria
  • abnormal semen
  • gastric adenocarcinoma

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

Storage

Store this drug in a tightly sealed container to prevent air ingress, maintaining a temperature below 30 degrees Celsius. Proper storage helps retain the drug's efficacy for a longer time.

Appearance and packaging

Appearance

A yellowish, transparent oval soft capsule containing a colorless, transparent content.

Package unit

30 capsules (15 capsules/PTPX2)

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

No questions yet.

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.