Medication info

Dutam Soft Capsule 0.5mg (Dutasteride)

Prescription medicationApproval withdrawn
Ingredient · strength
Dutasteride›Strength being verified
Manufacturer / importer
Mothers Pharmaceutical Co., Ltd.
Appearance
A yellow transparent oval soft capsule containing a colorless transparent substance
Packaging
30 capsules/PTP [(15 capsules/PTP x 2, 10 capsules/PTP x 3)]
Approval status
Approval withdrawn

MFDS item code 202002686 · Approved 2020.04.16

This product's status changed to Approval withdrawn on 2023.04.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of male-pattern hair loss and benign prostatic hyperplasia
Who uses it
Adults
Adult dosage
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Since exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this medicine whole without chewing or splitting the capsule. This medicine may be taken with or without food. No dose adjustment is necessary for 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 for these patients has not been established.

Ingredients

Manufacturer
Mothers Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male-pattern hair loss and benign prostatic hyperplasia

  • Benign prostatic hyperplasia
  • acute urinary retention
  • androgenetic alopecia
View approved original text

This medication improves the symptoms of patients with benign prostatic hyperplasia and helps to reduce the risk of acute urinary retention and the necessity for related surgeries. It is also used for the treatment of androgenetic alopecia in adult men aged 18 to 50. Overall, it is effective for men's prostate health and hair loss issues.

Dosage and Administration

Adult dosage

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Since exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this medicine whole without chewing or splitting the capsule. This medicine may be taken with or without food. No dose adjustment is necessary for 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 for 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 this medication. If the capsule breaks and comes into contact, the area should be washed immediately with water and soap. Children should also avoid contact with this medication, and if contact occurs, they should wash it off immediately. This medication should not be administered to women and children under 18 years of age, and those allergic to this medication or its components should not use it. Adult men planning to conceive should consult a doctor as this medication may affect fertility, and use it with caution. Patients with severe urinary problems or impaired liver function should use this medication with caution, and symptoms should be carefully monitored. The blood concentration of this medication may increase when used with strong CYP3A4 enzyme inhibitors, so caution is advised. During use, side effects related to sexual function such as erectile dysfunction, decreased libido, and ejaculation problems may occur, and these symptoms may persist even after discontinuation of the medication. Also, breast enlargement, headache, gastrointestinal discomfort, and dizziness have been reported as adverse reactions. This medication is known not to increase sexual dysfunction or breast disorders with long-term use, but the relation to male breast cancer is unclear. Regular prostate cancer screening should be conducted during the course of this medication, and caution is needed in interpreting test results as blood PSA levels may decrease. Donation of blood is prohibited during the course of this medication and can only be done at least 6 months after the last dose. There is no specific antidote for overdose, so appropriate treatment should be sought based on symptoms. Keep out of reach of children and store in the original container to prevent misuse or quality deterioration. It is known not to affect driving or operating machinery. This medication is contraindicated for women, especially those who are pregnant should be careful to avoid exposure to this medication. No specific safety issues have been reported for the elderly, but it should be used as directed by a physician.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • testicular pain
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  • testicular swelling
  • rash
  • itching
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergies
  • fever
  • congestion
  • heart failure
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified laceration
  • surgical intervention
  • torn wound
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • telangiectasia
  • xerostomia
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colon polyps
  • myasthenia
  • deep vein thrombosis
  • pneumonia
  • pulmonary embolism
  • lung cancer
  • thrombotic stroke
  • pharyngitis
  • increased SGPT
  • increased SGOT
  • acne
  • skin disorders
  • folliculitis
  • palpitations
  • fungal dermatitis
  • seborrhea
  • warts
  • drowsiness
  • hyperbilirubinemia
  • pharyngitis
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • epistaxis
  • taste disorder

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 exposure to air, and at a cool place below 30 degrees. This will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

A yellow transparent oval soft capsule containing a colorless transparent substance

Package unit

30 capsules/PTP [(15 capsules/PTP x 2, 10 capsules/PTP x 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.