Medication info
DuoDart Capsule

DuoDart Capsule

Prescription medicationHard capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsuleTamsulosin Hydrochloride›0.4mg / 1 capsule
Manufacturer / importer
GSK Korea
Appearance
An opaque yellowish-brown oblong gelatin capsule containing white to off-white pellets and orange upper part, brown lower part oblong hard capsule.
Packaging
30 capsules - 30 capsules/bottle, 90 capsules - 90 capsules/bottle
Approval status
Active

MFDS item code 202103982 · Approved 2021.05.18 · Insurance code 650003210

Summary

Main use
Treatment of symptoms of moderate to severe benign prostatic hyperplasia
Who takes it
Adults
Adult dose
Adults: The recommended dose of this medicine is 1 capsule once daily (dutasteride 0.5mg and tamsulosin hydrochloride 0.4mg), administered orally. Swallow the capsule whole approximately 30 minutes after the same meal each day. Do not chew or open the capsule. Contact with the contents of the dutasteride capsule inside the hard capsule may cause irritation of the oropharyngeal mucosa.

Ingredients

Importer
GSK Korea

Efficacy & effects

Treatment of symptoms of moderate to severe benign prostatic hyperplasia

  • Symptoms of benign prostatic hyperplasia.
View approved original text

This medication is used to treat symptoms of benign prostatic hyperplasia that range from moderate to severe. It helps with symptoms such as urinary disorders, increased urination, and nocturia caused by prostate enlargement. Relief of symptoms and improvement in quality of life can be expected with this medication.

How to take

Adult dose

Adults: The recommended dose of this medicine is 1 capsule once daily (dutasteride 0.5mg and tamsulosin hydrochloride 0.4mg), administered orally. Swallow the capsule whole approximately 30 minutes after the same meal each day. Do not chew or open the capsule. Contact with the contents of the dutasteride capsule inside the hard capsule may cause irritation of the oropharyngeal mucosa.

Precautions

This medication should not be used by women. In particular, it should not be taken by children under 18 years of age. Patients with orthostatic hypotension may experience worsening symptoms, so it is advisable not to use this medication. Patients with severely impaired liver function may also be at risk when taking this medication, and should avoid it. Use of this medication is contraindicated in patients who are allergic to this drug or its components or have hypersensitivity to ingredients such as Dutasteride and Tamsulosin. Men planning to conceive should be cautious and consult a physician, as it may affect reproductive capacity. Patients with very poor kidney function or liver abnormalities should also take it with caution. If you are taking medications that lower blood pressure or certain cardiovascular drugs, consult your doctor, as side effects may occur when used in combination. Patients with a history of orthostatic hypotension or urinary syncope should generally not take this medication, but if necessary, it should be monitored closely while using. This medication contains Yellow No. 5, so patients allergic to this ingredient should be careful. During treatment, side effects such as erectile dysfunction, decreased libido, ejaculation disorders, breast abnormalities, dizziness, depressive mood, alopecia, hirsutism, testicular pain, testicular swelling, syncope, loss of consciousness, balance disturbances, orthostatic dizziness, headache, drowsiness, nervousness, insomnia, anxiety, tingling, tachycardia, hypotension, palpitations, arrhythmia, rash, itching, nausea, vomiting, abdominal discomfort, heaviness in the stomach, abdominal pain, loss of appetite, and thirst may occur. Particularly, symptoms of heart failure may appear, so patients with heart disease should be regularly monitored. Regular examinations related to prostate cancer risk should be conducted, and caution is needed in interpreting test results as PSA levels may fluctuate. If dizziness or orthostatic hypotension symptoms occur during medication, it is important to sit or lie down immediately and stabilize. If an erection lasts longer than 4 hours, seek medical attention immediately for appropriate treatment. During treatment with this medication, blood donation should be avoided, and a minimum of 6 months must pass after the last dose to donate blood. There may be dizziness while driving or operating machinery, so caution is advised. This medication may interact with other drugs, so be sure to inform your doctor or pharmacist of any medications being taken. Store out of reach of children, and ensure that capsules do not leak onto the skin. In case of skin contact with a leaking capsule, wash immediately with soap and water.

Side effects

  • erectile dysfunction
  • changes in libido (reduction)
  • ejaculation disorder
  • breast disorder
  • dizziness
  • heart failure
  • rash
  • itching
  • hives
  • localized swelling
Show 106 more
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hypertrichosis
  • testicular pain
  • testicular swelling
  • male breast cancer
  • syncope
  • loss of consciousness
  • vertigo
  • imbalance
  • orthostatic dizziness
  • headache
  • drowsiness
  • nervousness
  • insomnia
  • decreased libido
  • restlessness
  • numbness
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • palpitations
  • arrhythmia
  • nausea
  • vomiting
  • upper abdominal discomfort
  • feeling of heaviness in the stomach
  • abdominal pain
  • loss of appetite
  • thirst
  • constipation
  • diarrhea
  • dental disorders
  • swallowing difficulties
  • oropharyngeal burning sensation
  • general fatigue
  • nasal congestion
  • nosebleed
  • swelling
  • urinary incontinence
  • dysgeusia
  • gynecomastia
  • priapism
  • infection
  • lethargy
  • back pain
  • chest pain
  • rhinitis
  • pharyngitis
  • increased cough
  • sinusitis
  • abnormal ejaculation
  • amblyopia
  • intraoperative iris tension syndrome
  • blurred vision
  • visual impairment
  • erythema multiforme
  • exfoliative dermatitis
  • Stevens-Johnson syndrome
  • photosensitivity reaction
  • dyspnea
  • ejaculatory failure
  • flushing
  • tinnitus
  • skin disorders of the tongue
  • lips
  • and facial areas
  • skin peeling
  • rarely priapism
  • kidney stones
  • hematuria
  • dysuria
  • frequent urination
  • neurogenic bladder
  • urolithiasis
  • abdominal pain
  • colitis
  • acute abdominal pain
  • small bowel diverticulitis
  • blood in stool
  • abdominal distension
  • erectile dysfunction
  • inguinal hernia
  • prostatitis
  • periorbital edema
  • low back pain
  • general weakness
  • foreign body sensation
  • peripheral edema
  • tremors
  • myelopathy
  • Parkinson's disease
  • fracture
  • shoulder impingement syndrome
  • cholangitis
  • acute alcohol intoxication
  • hyperlipidemia
  • male reproductive organ abscess
  • prostate cancer
  • angina
  • hypertension
  • mental illness
  • transient ischemic attack
  • cough

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 exposure to air or moisture, and it is best kept in a cool place at or below 25 degrees.

Appearance and packaging

Appearance

An opaque yellowish-brown oblong gelatin capsule containing white to off-white pellets and orange upper part, brown lower part oblong hard capsule.

Package unit

30 capsules - 30 capsules/bottle, 90 capsules - 90 capsules/bottle

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.