Medication info
Dutawin Soft Capsule 0.5 mg (Dutasteride)

Dutawin Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
(Yoo) Hanpoong Pharmaceutical Co., Ltd.
Appearance
Transparent yellow oval soft capsule containing a colorless transparent substance
Packaging
30 capsules/box [15 capsules/PTP X 2], 90 capsules/box [15 capsules/PTP X 6]
Approval status
Active

MFDS item code 201905664 · Approved 2019.08.12

Summary

Main use
Treatment of benign prostatic hyperplasia and male pattern hair loss in adults
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 this medicine whole without chewing or splitting the capsule. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. Since no data are available on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
(Yoo) Hanpoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male pattern hair loss in adults

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

This medication improves symptoms caused by benign prostatic hyperplasia and reduces the risk of acute urinary retention. It also helps decrease the need for surgery due to these symptoms. Additionally, it is used to treat male pattern hair loss in adult males aged 18 to 50 years. Therefore, it serves as an effective treatment to reduce discomfort related to prostate health and improve hair loss.

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 this medicine whole without chewing or splitting the capsule. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. Since no data are available on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Precautions

This medication can be absorbed through the skin. Therefore, women who are pregnant or may become pregnant should not handle it directly. If the capsule is broken and the medication comes into contact with the skin, it should be washed off immediately with soap and water. This medication is not to be used in children under 18 years of age, and precautions should be taken to prevent contact between children and any leaked capsules. Women or individuals allergic to this medication should not take it. Men planning to conceive should consult a doctor because this medication can affect reproductive ability. Patients with urinary problems or compromised liver function need to exercise special caution while taking this medication and closely monitor for worsening symptoms. Patients taking strong CYP3A4 enzyme inhibitors long-term should use caution when combining this medication. Sexual dysfunctions such as erectile dysfunction, decreased libido, and ejaculatory disorders can occur while taking this medication and may persist even after stopping the medication. This medication can lower PSA levels, which are used to assess the risk of prostate cancer, so PSA test results should be interpreted considering the values before and after taking this medication. Blood donation should not be done during treatment with this medication or for at least 6 months after stopping it. There have been reports of an increased risk of male breast cancer associated with long-term use of this medication, so if any abnormalities occur in the breast, a doctor should be informed immediately. There is no specific antidote for overdose, so appropriate treatment should be given based on symptoms, and recovery may take time due to the long half-life of this medication. Keep out of reach of children and store in the original container to prevent misuse or quality degradation. This medication is known not to affect driving or machinery operation, but caution is advised as it may vary from person to person.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculatory dysfunction
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 74 more
  • itching
  • urticaria
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • spasms
  • oromandibular dystonia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • lethargy
  • deep vein thrombosis
  • fatigue
  • increased 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 infection
  • detailed unspecified scratch
  • surgical intervention
  • torn wound
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • 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 or moisture ingress, and should be kept in a cool place below 30 degrees Celsius for optimal efficacy.

Appearance and packaging

Appearance

Transparent yellow oval soft capsule containing a colorless transparent substance

Package unit

30 capsules/box [15 capsules/PTP X 2], 90 capsules/box [15 capsules/PTP X 6]

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.