Medication info
Trulance 4 mg (Silodosin)

Trulance 4 mg (Silodosin)

Prescription medicationTabletOral
Ingredient · strength
Silodosin›4mg / 1 tablet
Manufacturer / importer
WithUs Pharmaceuticals Co., Ltd.
Appearance
White round film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 201508351 · Approved 2015.12.21 · Insurance code 660702910

Summary

Main use
Improvement of urinary symptoms associated with benign prostatic hyperplasia
Who takes it
Adults
Adult dose
Adults: Administer orally either 1 tablet of 4 mg per dose twice daily after breakfast and dinner, or 2 tablets of 4 mg (8 mg) once daily with a meal. However, increased plasma concentrations of silodosin have been reported in patients with renal impairment, and plasma concentrations may also increase in patients with hepatic impairment. Therefore, monitor the patient's condition and adjust the dose appropriately according to symptoms, such as starting at a low dose (2 mg per dose, twice daily).

Ingredients

Manufacturer
WithUs Pharmaceuticals Co., Ltd.

Efficacy & effects

Improvement of urinary symptoms associated with benign prostatic hyperplasia

  • Urinary disorders associated with benign prostatic hyperplasia
View approved original text

This medication is used to improve urinary disorders caused by benign prostatic hyperplasia.

How to take

Adult dose

Adults: Administer orally either 1 tablet of 4 mg per dose twice daily after breakfast and dinner, or 2 tablets of 4 mg (8 mg) once daily with a meal. However, increased plasma concentrations of silodosin have been reported in patients with renal impairment, and plasma concentrations may also increase in patients with hepatic impairment. Therefore, monitor the patient's condition and adjust the dose appropriately according to symptoms, such as starting at a low dose (2 mg per dose, twice daily).

Precautions

This medicine should not be used by patients who are allergic to certain ingredients. It should also not be taken by patients with severe renal impairment or liver impairment. Additionally, co-administration with certain powerful drugs may increase the serum concentration of this medicine, thereby increasing the risk of side effects, so such combinations should be avoided. Patients with orthostatic hypotension should be cautious as symptoms may worsen upon taking this medicine. Patients with weak liver or kidney function should use this medicine carefully and consult a physician if unusual symptoms occur during use. Caution is necessary when taken with antihypertensive medications, as blood pressure may drop significantly. This medicine may cause side effects such as ejaculation disorder, dizziness, dry mouth, diarrhea, headache, etc.; make sure to inform a healthcare provider if these symptoms occur during use. Particularly, if symptoms of syncope, loss of consciousness, or liver dysfunction appear, discontinue use immediately and visit the hospital. Elderly patients may have reduced body function, so starting with a low dose while monitoring their condition is recommended. The safety of this medicine during pregnancy has not been sufficiently confirmed, so women who may become pregnant should consult before taking it. Store out of reach of children, and do not transfer to another container for safety. Always verify potential drug interactions before taking this medicine and consult your doctor or pharmacist. Consistent use is required for therapeutic effect, and if symptoms do not improve, other treatment options should be considered.

Side effects

  • Ejaculatory dysfunction
  • dry mouth
  • diarrhea
  • loose stools
  • orthostatic dizziness
  • nasal congestion
  • vertigo
  • dizziness
  • headache
  • TG elevation
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  • CRP elevation
  • ALT elevation
  • AST elevation
  • γ-GTP elevation
  • syncope
  • loss of consciousness
  • liver dysfunction
  • jaundice
  • erectile dysfunction
  • urinary incontinence
  • stomatitis
  • dyspepsia
  • constipation
  • vomiting
  • nausea
  • loss of appetite
  • gastric pain
  • abdominal pain
  • abdominal distension
  • epigastric discomfort
  • lower abdominal pain
  • gastric ulcer
  • gastritis
  • atrophic gastritis
  • heartburn
  • gastric burning
  • duodenal ulcer
  • increased flatulence
  • increased bowel movements
  • sensation of incomplete bowel evacuation
  • anal discomfort
  • fatigue
  • shoulder stiffness
  • tingling in hands and feet
  • feeling of mental fog
  • drowsiness
  • decreased libido
  • heaviness in the head
  • mood disturbance
  • epistaxis
  • runny nose
  • cough
  • edema
  • atrial fibrillation
  • bradycardia
  • tachycardia
  • arrhythmia
  • paroxysmal ectopic beats
  • orthostatic hypotension
  • blood pressure decrease
  • blood pressure increase
  • rash
  • eczema
  • urticaria
  • pruritus
  • intraoperative iris dilation syndrome
  • blurred vision
  • eye congestion
  • eye itching
  • conjunctival hemorrhage
  • total bilirubin elevation
  • Al-P elevation
  • LDH elevation
  • BUN elevation
  • creatinine elevation
  • decreased white blood cell count
  • decreased red blood cell count
  • decreased hemoglobin
  • decreased hematocrit
  • increased white blood cell count
  • decreased platelet count
  • facial swelling
  • tongue swelling
  • pharyngeal swelling
  • gynecomastia
  • total cholesterol elevation
  • urinary glucose elevation
  • urine sediment
  • facial flushing
  • tinnitus
  • bitter taste
  • chest pain
  • low back pain
  • leg fatigue
  • sweating
  • flushing
  • elevated serum potassium level
  • decreased total protein
  • increased prostate-specific antigen
  • elevated uric acid
  • elevated urine protein
  • nasopharyngitis
  • urinary tract infection
  • voiding dysfunction
  • excessive sedation
  • decreased orgasm
  • leg tingling
  • palpitations
  • itching
  • visual disturbances
  • decreased platelet count
  • fever
  • chills
  • leg fatigue
  • chest discomfort
  • low back pain
  • shoulder pain
  • increased blood uric acid
  • increased blood creatinine
  • frequent urination
  • worsened dry mouth
  • hematuria
  • shingles

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

Storage

This medicine should be stored in a tightly sealed container that blocks light, at room temperature between 1 and 30 degrees Celsius. This storage method will help maintain the medicine's effectiveness.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6]

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.