Medication info

FAMGEN Dutasteride Soft Capsule

Prescription medicationSoft capsuleOralExpired
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
FAMGEN Science Co., Ltd.
Appearance
A transparent yellowish oval soft capsule containing a colorless and transparent substance
Packaging
30 capsules/box [(15 capsules/PTPX2, 10 capsules/PTPX3)]
Approval status
Expired

MFDS item code 201906694 · Approved 2019.09.24

This product's status changed to Expired on 2024.09.24. 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 takes it
Adults
Adult dose
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 the capsule whole without chewing or splitting it. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. Since there are no data on administration of this medicine to patients with hepatic impairment, the recommended dose for these patients has not been established.

Ingredients

Manufacturer
FAMGEN Science Co., Ltd.

Efficacy & effects

Treatment of male pattern hair loss and benign prostatic hyperplasia

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

This medication is used to improve the symptoms of benign prostatic hyperplasia, lower the risk of acute urinary retention, and reduce the need for related surgeries. Additionally, it is effective for treating male pattern hair loss in adult men aged 18 to 50 years. This helps manage both prostate issues and hair loss simultaneously.

How to take

Adult dose

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

Precautions

This medication may be absorbed through the skin, so women who are pregnant or may become pregnant should avoid direct contact with this medication. If a capsule is broken and the drug comes into contact with the skin, it should be washed off immediately with soap and water. This medication should not be used in children under 18 years of age, and it should also be avoided in cases of hypersensitivity. Men planning to conceive and patients with liver impairment should use this medication with caution, and medical judgment is necessary in cases of severe urinary symptoms. During the use of this medication, erectile dysfunction, decreased libido, and ejaculation disorders may occur, and in some cases, these symptoms may persist even after discontinuation of the medication. Additionally, this medication may affect prostate cancer tests, thus regular PSA tests and monitoring by a physician are necessary. Patients taking this medication should avoid blood transfusions and can donate blood only after at least 6 months have elapsed since the last dose. This medication may interact with other drugs, particularly with CYP3A4 inhibitors, so caution is required when used in combination. There is no specific antidote for overdose, so appropriate treatment should be administered according to the symptoms. This medication should be kept out of the reach of children, and it is safest stored in the original container. It is known not to have a significant effect on driving or machine operation, but caution is necessary in case of adverse reactions.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
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  • itching
  • hives
  • localized swelling
  • 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 movement disorders
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fractures
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • musculoskeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste distortion
  • telangiectasia
  • visual disturbances
  • thirst
  • urinary abnormalities
  • hematuria
  • semen abnormalities

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 from entering. It is also important to store it at a cool temperature below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A transparent yellowish oval soft capsule containing a colorless and transparent substance

Package unit

30 capsules/box [(15 capsules/PTPX2, 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

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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.