Medication info
Hydrate Soft Capsule 0.5mg (Dutasteride)

Hydrate Soft Capsule 0.5mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Huons Co., Ltd.
Appearance
Yellowish rectangular soft capsule filled with colorless transparent contents
Packaging
30 capsules - 10 capsules/PTP [(10 capsules/PTP packaging x 3)], 90 capsules - 10 capsules/PTP [(10 capsules/PTP packaging x 9)]
Approval status
Active

MFDS item code 202106074 · Approved 2021.08.20 · Insurance code 670608790

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. As 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 older patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on the use of this medicine in these patients.

Ingredients

Importer
Huons 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 drug helps improve symptoms associated with benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for surgery related to hyperplasia. Additionally, it is used in adult men for the treatment of male pattern hair loss to prevent hair loss progression and improve hair health. It is effectively used for various male health issues.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. As 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 older patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on the use of this medicine in these patients.

Precautions

This medication may be absorbed through the skin; therefore, women who are pregnant or may become pregnant should not handle this medication. If the capsule is broken and the medication comes into contact with the skin, wash it immediately with soap and water. This medication should not be used by children under 18 years of age, and care should be taken to ensure that children do not come into contact with the medication. Women, individuals under 18, and those allergic to this drug or similar components should not use it. Adult men planning to conceive should use this medication cautiously based on a doctor's judgment, as it may affect reproductive capacity. Patients with urinary problems or severe decrease in urination should be careful when using this medication and should be closely monitored for any signs of urinary retention. Patients with liver dysfunction should also use this medication with caution. Patients taking strong CYP3A4 enzyme inhibitors for an extended period may need to be cautious as this medication's blood concentration may increase. While taking this medication, genital-related side effects such as erectile dysfunction, decreased libido, and ejaculation disorders may occur, and these symptoms may persist even after discontinuation of the medication. This drug is used for the treatment of benign prostatic hyperplasia and male pattern hair loss, but regular PSA tests and digital rectal examinations are necessary to evaluate the risk of prostate cancer. PSA levels may decrease while taking this medication, so initial values need to be reset when interpreting PSA test results. Blood donation should not occur within six months after dosage, and measures should be taken to prevent transfer of this medication to pregnant women. This medication is known not to affect driving or the ability to operate machinery. There is no specific antidote for overdose, so appropriate supportive treatment is necessary based on symptoms, and caution is needed as the half-life of the medication is long. Store out of reach of children and keep in the original container to prevent quality deterioration and misuse.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 78 more
  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • allergic reactions
  • depressed mood
  • alopecia
  • hypertrichosis
  • 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 dyskinesia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • elevated SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory tract infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • nephrolithiasis
  • dysgeusia
  • capillary dilation

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 it is important to keep the temperature below 30 degrees. This storage method helps maintain the medication's effectiveness for a prolonged period.

Appearance and packaging

Appearance

Yellowish rectangular soft capsule filled with colorless transparent contents

Package unit

30 capsules - 10 capsules/PTP [(10 capsules/PTP packaging x 3)], 90 capsules - 10 capsules/PTP [(10 capsules/PTP packaging x 9)]

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.