Medication info
CM Dutasteride Soft Capsule 0.5mg (Dutasteride)

CM Dutasteride Soft Capsule 0.5mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
Transparent pale yellow soft capsule containing a colorless, transparent liquid
Packaging
30 capsules (10 capsules/PTP x 3, 15 capsules/PTP x 2)
Approval status
Active

MFDS item code 201601737 · Approved 2016.03.31 · Insurance code 648604240

Summary

Main use
Improvement of benign prostatic hyperplasia; treatment of male-pattern hair loss in adult men
Who takes it
Adults
Adult dose
Take 1 capsule (0.5mg) once daily. Swallow the capsule whole without chewing or splitting it, as exposure to its contents may cause irritation of the oropharyngeal mucosa. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose has not been established for patients with hepatic impairment because no data are available on use of this medicine in these patients.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of benign prostatic hyperplasia; treatment of male-pattern hair loss in adult men

  • Benign prostatic hyperplasia
  • acute urinary retention
  • androgenetic alopecia
View approved original text

This medication improves symptoms associated with benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the necessity for related surgeries. It is also used for the treatment of androgenetic alopecia in adult males.

How to take

Adult dose

Take 1 capsule (0.5mg) once daily. Swallow the capsule whole without chewing or splitting it, as exposure to its contents may cause irritation of the oropharyngeal mucosa. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose has not been established for patients with hepatic impairment because no data are available on use of this medicine in these patients.

Precautions

This medication is absorbed through the skin, so women who are pregnant or may become pregnant should not touch or handle this medication. If the capsule is broken and comes into contact with the skin, the area should be washed immediately with soap and water. This medication is not for use in children under the age of 18, and children must be cautioned against contact with the contents of broken capsules. Women or anyone under 18 years old, and individuals allergic to this medication or its components, should not take it. Adult males planning to conceive should use this medication cautiously as it may affect fertility, and should consult a doctor. Caution is also needed for patients with severely impaired urinary function or poor liver function when using this medication. Additionally, it may alter drug levels when taken with certain medications, so patients should inform their doctor if they are on potent CYP3A4 inhibitors. Sexual dysfunction such as erectile dysfunction, decreased libido, and ejaculation problems may occur during treatment; breast enlargement or tenderness may occur in some cases. Most adverse reactions are mild, and discontinuing the therapy often leads to recovery, but some symptoms may persist. This medication lowers PSA levels used in prostate cancer screening, so inform healthcare providers about this medication when undergoing PSA tests, and regular check-ups are recommended. Blood donation should be avoided for at least 6 months after taking this medication, to prevent drug transfer to pregnant women. It does not affect driving or operating machinery, but caution should be exercised in case of dizziness or other unusual symptoms. There is no specific antidote for overdose, so if symptoms are suspected, immediate medical attention should be sought. This medicine should be kept out of the reach of children and stored in its original container to prevent misuse or degradation.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
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  • itching
  • hives
  • local edema
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • indigestion
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • weakness
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • 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
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • capillary dilation
  • 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 closed container to prevent air or moisture from entering, preferably in a cool place below 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Transparent pale yellow soft capsule containing a colorless, transparent liquid

Package unit

30 capsules (10 capsules/PTP x 3, 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.