Medication info
Dutactec Soft Capsule 0.5 mg (Dutasteride)

Dutactec Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Daewon Pharmaceutical Co., Ltd.
Appearance
For domestic use: translucent yellowish transparent oval soft capsules containing colorless transparent contents. For export: opaque cloudy yellow rectangular soft capsules containing colorless transparent contents.
Packaging
30 capsules (15 capsules/PTPX2)
Approval status
Active

MFDS item code 201205829 · Notified 2012.06.22 · Insurance code 671805270

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 this medicine 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 in elderly patients. The recommended dose of this medicine in patients with hepatic impairment has not been established because no data are available on its use in these patients.

Ingredients

Manufacturer
Daewon 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 associated with benign prostatic hyperplasia and reduces the risk of acute urinary retention. It also decreases the need for surgery related to this condition. Additionally, it is used for the treatment of male pattern hair loss in adult men. In other words, it helps take care of prostate health and alleviates hair loss symptoms.

How to take

Adult dose

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

Precautions

This medication must not be handled or taken by women, especially those who are pregnant or may become pregnant, as it can be absorbed through the skin and pose risks to the development of male fetal genitalia. If a capsule leaks and comes into contact with the skin, it should be washed off immediately with soap and water. Children under 18 years of age must also not take or come into contact with this medication, as safety and effectiveness have not been confirmed in pediatrics. Individuals who have an allergic reaction to this medication or have hypersensitivity to its components should not take it. Adult men planning to conceive should consult a doctor before taking this medication as it may affect reproductive capability. Patients with difficulties in urinary excretion or liver dysfunction should take caution when using this medication and should do so under a physician's supervision. Since this medication is metabolized in the liver, caution is necessary when taken with strong CYP3A4 inhibitors as it may increase serum concentration. Regular monitoring of PSA levels for prostate cancer screening should be conducted while taking this medication, as it may lower PSA levels, which could affect the interpretation of tests. This medication may cause sexual side effects such as erectile dysfunction, decreased libido, and ejaculation disorders, which may persist even after discontinuation. Rarely, long-term use may result in breast-related abnormal symptoms such as breast tenderness or breast enlargement, so inform a doctor if abnormal symptoms occur. Do not donate blood while taking this medication and avoid donating blood for at least 6 months after discontinuation. In case of overdose, as there is no specific antidote, appropriate supportive treatment should be provided based on symptoms, and caution is needed considering the long half-life of this medication. Keep this medication out of reach of children and store it in its original container to prevent misuse or quality deterioration. Lastly, while this medication is known not to affect driving or operating machinery, individual responses may vary, so caution is necessary.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculatory dysfunction
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 63 more
  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressive mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • orofacial dystonia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • fatigue
  • elevated SGPT
  • elevated SGOT
  • acne
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • seborrhea
  • skin disorders
  • folliculitis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • dysesthesia
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste distortion
  • 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 exposure, and it is recommended to keep the temperature below 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

For domestic use: translucent yellowish transparent oval soft capsules containing colorless transparent contents. For export: opaque cloudy yellow rectangular soft capsules containing colorless transparent contents.

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

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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.