Medication info
Trutera Tablets 4 mg (Silodosin)

Trutera Tablets 4 mg (Silodosin)

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

MFDS item code 201508347 · Approved 2015.12.21 · Insurance code 646004060

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
Medika Korea 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 resulting from benign prostatic hyperplasia, specifically symptoms such as difficulty urinating or feeling of incomplete bladder emptying.

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 medication should not be used in certain patients. First, those who have had allergic reactions to any ingredients in this drug should avoid taking it. It may also be dangerous for patients with severe renal impairment or severe liver dysfunction. Patients taking strong CYP3A4 enzyme inhibitors should also avoid concurrent use of this medication. There are also patients for whom caution is warranted while using this medication. For example, individuals experiencing orthostatic hypotension may have their symptoms exacerbated and should be administered carefully. Patients with mild renal or hepatic impairment may need to proceed with caution due to the potential for increased blood concentration. Additionally, caution should be exercised when taken in conjunction with PDE5 inhibitors or other alpha-blockers. While taking this medication, various side effects may occur. The most common side effects reported include ejaculation disorders, dry mouth, diarrhea, dizziness, and nasal congestion. In severe cases, fainting or liver dysfunction may appear, and any unusual symptoms should be promptly discussed with a healthcare professional. There is a risk of dizziness or fainting related to orthostatic hypotension while on this medication, so sudden changes in posture should be approached with caution. Caution is needed when engaging in dangerous activities such as driving or working at heights. In case of overdose, significant drops in blood pressure can occur, so it is vital to adhere to prescribed dosages. Patients on antihypertensive medications should particularly monitor for changes in blood pressure, and dosage adjustments may be necessary as needed. This medication is a symptomatic treatment; if it is ineffective, alternative therapeutic options should be considered. Diseases that may resemble prostate cancer can exist, so it is essential to confirm the presence or absence of prostate cancer before starting this medication. Furthermore, patients who have upcoming cataract surgery or who have undergone it should inform their healthcare provider about the potential for intraoperative floppy iris syndrome. Elderly patients may have reduced renal and hepatic function, so it is crucial to start at a lower dose and observe their condition carefully during administration. This medication should be kept out of reach of children, and transferring it to another container may alter its quality, so caution is advised. Finally, this medication may interact with various drugs; therefore, any concurrent medications should be reported to healthcare professionals.

Side effects

  • Ejaculation disorder
  • dry mouth
  • diarrhea
  • loose stools
  • orthostatic dizziness
  • nasal congestion
  • vertigo
  • dizziness
  • headache
  • increased TG
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  • increased CRP
  • increased ALT
  • increased AST
  • increased γ-GTP
  • syncope
  • loss of consciousness
  • liver function impairment
  • jaundice
  • erectile dysfunction
  • urinary incontinence
  • stomatitis
  • gastric discomfort
  • constipation
  • vomiting
  • nausea
  • loss of appetite
  • abdominal pain
  • abdominal distension
  • upper abdominal discomfort
  • lower abdominal pain
  • gastric ulcer
  • gastritis
  • atrophic gastritis
  • heartburn
  • gastric pain
  • duodenal ulcer
  • increased flatulence
  • increased bowel movements
  • feeling of incomplete evacuation
  • anal discomfort
  • fatigue
  • shoulder stiffness
  • numbness in hands and feet
  • feeling of foggy head
  • drowsiness
  • reduced libido
  • heaviness of the head
  • mood disturbances
  • nasal bleeding
  • runny nose
  • cough
  • edema
  • atrial fibrillation
  • bradycardia
  • tachycardia
  • arrhythmia
  • loss of excitatory contractions
  • orthostatic hypotension
  • blood pressure reduction
  • blood pressure increase
  • rash
  • eczema
  • hives
  • itching
  • intraoperative iris expansion syndrome
  • blurred vision
  • eye congestion
  • eye itching
  • conjunctival bleeding
  • increased total bilirubin
  • increased Al-P
  • increased LDH
  • increased BUN
  • increased creatinine
  • 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
  • increased total cholesterol
  • increased urinary glucose
  • urinary sediment
  • facial flushing
  • tinnitus
  • bitter taste
  • chest pain
  • low back pain
  • leg fatigue
  • sweating
  • elevated serum potassium
  • decreased total protein
  • increased prostate-specific antigen
  • elevated uric acid
  • increased urinary protein
  • retrograde ejaculation
  • nasopharyngitis
  • urinary tract infection
  • voiding dysfunction
  • nausea
  • dyspepsia
  • abdominal discomfort
  • increased bowel movements
  • excessive sedation
  • decreased orgasm
  • leg numbness
  • palpitations
  • itching
  • visual disturbances
  • decreased platelet count
  • fever
  • chills
  • leg fatigue
  • chest discomfort
  • low back pain
  • shoulder pain
  • increased serum uric acid
  • increased serum creatinine
  • frequent urination
  • worsening dry mouth
  • hematuria
  • herpes zoster

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

Storage

This medication is sensitive to light, so it should be stored in a special container that does not allow light to enter. It is also essential to maintain a room temperature between 1°C and 30°C when storing the medication. This helps to appropriately preserve the drug's efficacy and safety.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP × 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.

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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.