Medication info
Dutagen Soft Capsule 0.5 mg (Dutasteride)

Dutagen Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
An opaque, cloudy yellow oblong soft capsule filled with colorless transparent content.
Packaging
30 capsules (10 capsules/PTPX3)
Approval status
Active

MFDS item code 201503148 · Approved 2015.05.26 · Insurance code 645404390

Summary

Main use
Treatment of male-pattern hair loss and benign prostatic hyperplasia
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 this medicine whole without chewing or breaking 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 administration of this medicine to patients with hepatic impairment, the recommended dose in patients with hepatic impairment has not been established.

Ingredients

Manufacturer
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male-pattern hair loss and benign prostatic hyperplasia

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

This medication improves symptoms due to benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgeries. It is also effective for treating male pattern baldness in adult men. Therefore, it is used for both alleviating symptoms of prostatic enlargement and treating hair loss.

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 this medicine whole without chewing or breaking 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 administration of this medicine to patients with hepatic impairment, the recommended dose in patients with hepatic impairment has not been established.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not directly handle or touch this medication. If the contents of the medication come into contact with skin, wash it immediately with soap and water. Children should also be kept away from contact with the contents, and if contact occurs, they should be washed immediately. Women, children under 18, and individuals with a known allergy to this medication or similar ingredients should not take this medication. Adult men planning to conceive should carefully consider the use of this medication based on a doctor's judgment, as it may affect reproductive capacity. Patients with urinary problems or compromised liver function should exercise caution when taking this medication, especially those with severely compromised liver function. Caution is advised if taken with strong CYP3A4 inhibitors, as it may increase the blood concentration of this medication. Side effects related to the reproductive system, such as erectile dysfunction, decreased libido, and ejaculation disorders, may occur during this medication period, and these symptoms may persist after discontinuation of the medication. Rare cases of breast-related adverse reactions such as gynecomastia or breast tenderness have also been reported. This medication is used for benign prostatic hyperplasia or male pattern baldness treatment, and regular PSA tests and digital rectal exams are necessary for assessing the risk of prostate cancer. Since the PSA levels may decrease after taking this medication, they should be re-evaluated based on new standards 3-6 months later. PSA levels will return to baseline within 6 months after stopping this medication. Rare cases of worsening heart failure have been reported in patients with heart failure, but causality is unclear. Blood donation is prohibited while taking this medication, and at least 6 months must pass after the last dose before blood donation is allowed. There are no specific antidotes for overdose, so proper supportive treatment must be received if symptoms are suspected. This medication should be kept out of reach of children and stored in its original container to prevent degradation or misuse. Driving or operating machinery is not known to be affected during the use of this medication.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 75 more
  • itching
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • 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 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 infections
  • unspecified abrasions
  • surgical interventions
  • lacerations
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleeds
  • blepharitis
  • benign laryngeal neoplasms
  • kidney stones
  • dysgeusia
  • telangiectasia

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and moisture, preferably 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

An opaque, cloudy yellow oblong soft capsule filled with colorless transparent content.

Package unit

30 capsules (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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.