Medication info
Neodart Soft Capsule 0.5 mg (Dutasteride)

Neodart Soft Capsule 0.5 mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
JW Pharmaceutical Co., Ltd.
Appearance
A transparent yellowish oval soft capsule containing a colorless, transparent liquid.
Packaging
30 capsules/box [(15 capsules/PTP x 2)]
Approval status
Active

MFDS item code 201007783 · Notified 2010.12.31 · Insurance code 644101840

Summary

Main use
Treatment of benign prostatic hyperplasia; treatment of androgenetic alopecia in adult men
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the contents of the capsule may cause irritation of the oropharyngeal mucosa, swallow the capsule 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. The recommended dose of this medicine in patients with hepatic impairment has not been established because there are no data on its administration to such patients.

Ingredients

Manufacturer
JW Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia; treatment of androgenetic alopecia in adult men

  • 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 related to benign prostatic hyperplasia. Additionally, it is effective in the treatment of male pattern hair loss in adult men. It is used to actively improve various male health issues.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the contents of the capsule may cause irritation of the oropharyngeal mucosa, swallow the capsule 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. The recommended dose of this medicine in patients with hepatic impairment has not been established because there are no data on its administration to such patients.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle this medication directly. If the capsule is broken and the medication contacts the skin, it should be washed off immediately with clean water and soap. This medication should not be used in children under 18 years of age, as safety and efficacy have not been established. Do not take this medication if you are allergic to it or its ingredients, or if you have hypersensitivity to 5α-reductase inhibitors. Adult men who are planning to conceive should take this medication with caution after consulting a physician, as it may affect reproductive ability. Caution is also needed for patients with severe urinary problems or poor liver function. Since this medication is metabolized in the liver, taking it with strong CYP3A4 inhibitors may increase the drug concentration. During treatment with this medication, erectile dysfunction, decreased libido, and ejaculation disorders may occur, and these side effects may persist even after discontinuation. Rarely, skin rashes, allergic reactions, hair loss, and breast pain have been reported, so consult a physician if abnormal symptoms occur. This medication may lower prostate-specific antigen (PSA) levels in blood tests, so consider the duration of use when interpreting PSA test results. PSA levels will return to baseline within 6 months after discontinuation. During treatment, avoid blood donation, and wait at least 6 months after the last dose before donating blood. Additionally, this medication is contraindicated in women and should not be taken by breastfeeding women. In case of overdose, there are no specific antidotes, so appropriate treatment should be provided based on symptoms, and note that the drug's half-life is long and may remain in the body for an extended period. Finally, store this medication in a safe place out of reach of children, and keep it in the original container to prevent misuse or degradation of quality.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 76 more
  • itching
  • hives
  • localized edema
  • serious skin reactions
  • angioedema
  • allergic reactions
  • depressive mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • asthenia
  • heart failure
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • acne
  • fungal skin disease
  • seborrhea
  • skin disorders
  • increased SGOT
  • 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
  • paresthesia
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • vasodilation

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

Storage

This medication should be stored in a sealed container that is air-tight and kept at a temperature below 30 degrees Celsius. This will help maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

A transparent yellowish oval soft capsule containing a colorless, transparent liquid.

Package unit

30 capsules/box [(15 capsules/PTP x 2)]

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.