Medication info
Dutatel Tablet 0.5 mg (Dutasteride)

Dutatel Tablet 0.5 mg (Dutasteride)

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

MFDS item code 201907286 · Approved 2019.10.16 · Insurance code 673400130

Summary

Main use
Treatment of benign prostatic hyperplasia and androgenetic alopecia 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 breaking 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
QL Pharma Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men

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

This medication improves symptoms caused by benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgeries. It is also effective for treating male pattern baldness in adult men aged 18 to 50 years. It is used to help improve health by addressing various symptoms.

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 breaking 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 handle it. Care should be taken to avoid touching broken or crushed tablets. Do not use this medication in children under 18 years of age, and ensure children do not come into contact with it. Do not administer to patients with a history of allergic reactions to this medication or hypersensitivity to its ingredients. Patients with genetic issues related to lactose should not take this medication. Adult men planning to conceive should use this medication cautiously, as it may impact fertility, under a doctor's guidance. Patients with severe urinary issues or liver dysfunction should use this medication with special caution. Caution is required when taken with strong CYP3A4 inhibitors, as drug concentrations may increase. During treatment, erectile dysfunction, decreased libido, and ejaculation disorders may occur, which may persist even after discontinuation. Long-term use may cause breast pain or gynecomastia, and any changes should be reported to a doctor immediately. Since this medication reduces PSA levels associated with prostate cancer risk, caution is needed when interpreting PSA test results, and regular testing is recommended. Donating blood is prohibited for at least 6 months after last use of this medication. In case of overdose, there is no specific antidote, so seek immediate medical attention for appropriate treatment. Keep out of the reach of children and store in the original container to prevent degradation and misuse. This medication is unlikely to affect driving or machinery operation, but caution is still advised as effects may vary per individual. Observe for rare side effects during treatment, such as allergic reactions, depression, hair loss, and testicular pain. No specific drug interactions have been reported, but consult with a doctor if you are taking strong CYP3A4 inhibitors or specific medications.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculatory dysfunction
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • heart failure
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  • rash
  • itching
  • urticaria
  • local edema
  • serious skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • oromandibular dystonia
  • vomiting
  • colorectal polyp
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • elevated SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • elevated 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 disturbance
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • capillary dilation

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

Storage

Store this medication in a tightly closed container to prevent air from entering, at a temperature between 1 degree and 30 degrees Celsius. Proper storage maintains the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

Light yellow oval film-coated tablet

Package unit

PTP - 30 tablets/PTP [(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.

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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.