Medication info
Samsung Dutasteride Tablet 0.5 mg

Samsung Dutasteride Tablet 0.5 mg

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Samsung Pharmaceutical Co., Ltd.
Appearance
Light yellow round film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201908004 · Approved 2019.11.20 · Insurance code 642308200

Summary

Main use
Treatment of male-pattern hair loss and benign prostatic hyperplasia in adult men
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 tablet (0.5mg) once daily. Swallow this medicine 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 no data are available on administration of this medicine to patients with hepatic impairment, the recommended dose of this medicine in patients with hepatic impairment has not been established.

Ingredients

Manufacturer
Samsung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of male-pattern hair loss and benign prostatic hyperplasia in adult men

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

This medication improves symptoms of benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the likelihood of needing surgery. It is also effective for treating male pattern baldness in adult men aged 18 to 50 years. Therefore, this medication assists in prostate health and hair loss improvement.

How to take

Adult dose

The recommended dose of this medicine is 1 tablet (0.5mg) once daily. Swallow this medicine 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 no data are available on administration of this medicine to patients with hepatic impairment, the recommended dose of this medicine in patients with hepatic impairment 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. Particularly, avoid contact with broken or crushed pieces of the medication. The safety and efficacy of this medication have not been established for children under 18 years of age, so it should not be used in this population. Women, children under 18 years old, individuals allergic to this medication or similar ingredients, and individuals with certain inherited lactose-related disorders should not take this medication. Adult men who plan to conceive should use this medication cautiously, as it may affect reproductive ability, according to a doctor's judgment. Patients with urinary issues or impaired liver function need to exercise caution when taking this medication, as severe side effects such as urinary retention may occur, warranting careful observation. Additionally, since this medication is metabolized in the liver, caution is required as co-administration with strong CYP3A4 inhibitors may increase blood levels of this medication. During treatment with this medication, sexual function-related adverse reactions may occur, such as erectile dysfunction, decreased libido, and ejaculatory disorders, which may persist even after discontinuing the medication. In rare cases, allergic reactions such as skin rash, itching, hives, depression, hair loss, and testicular pain may occur. This medication can lower PSA levels, which are important for diagnosing prostate cancer, so doctors should regularly check PSA levels before and during treatment, and interpret the results with caution. Donation of blood is prohibited during treatment with this medication, and at least 6 months must pass after the last dose before donating blood. This medication is unlikely to affect driving or the ability to operate machinery. In case of overdose, there is no specific antidote; supportive treatment should be given based on symptoms, and recovery may take time due to the long half-life of the medication. Keep this medication out of the reach of children and store it in its original container to prevent misuse or degradation of quality.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
Show 79 more
  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • allergic reactions
  • depressed 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
  • spasms
  • facial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • fatigue
  • increased SGPT
  • sexual dysfunction
  • 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
  • reduced testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disturbance
  • telangiectasia

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius. This helps preserve the medication's effectiveness over time.

Appearance and packaging

Appearance

Light yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.