Medication info
Silodosin Capsule 4 mg (Silodosin)

Silodosin Capsule 4 mg (Silodosin)

Prescription medicationHard capsuleOral
Ingredient · strength
Silodosin›4mg / 1 capsule
Manufacturer / importer
Bivoron Pharmaceutical Co., Ltd.
Appearance
Opaque white hard capsule containing white to pale yellow granular or powdered contents
Packaging
60 capsules (10 capsules/PTP*6)
Approval status
Active

MFDS item code 201502417 · Approved 2015.04.23 · Insurance code 658202770

Summary

Main use
Improvement of urinary symptoms associated with benign prostatic hyperplasia
Who takes it
Adults
Adult dose
Adults: Administer one 4 mg capsule twice daily after breakfast and dinner, or two 4 mg capsules (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, initiate treatment at a low dose (one 2 mg capsule twice daily) and adjust the dose appropriately according to symptoms while monitoring the patient's condition.

Ingredients

Manufacturer
Bivoron Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of urinary symptoms associated with benign prostatic hyperplasia

  • Urination disorders
View approved original text

This medication is used to improve urination disorders that occur as a result of prostate enlargement, such as frequent urination and difficulty urinating.

How to take

Adult dose

Adults: Administer one 4 mg capsule twice daily after breakfast and dinner, or two 4 mg capsules (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, initiate treatment at a low dose (one 2 mg capsule twice daily) and adjust the dose appropriately according to symptoms while monitoring the patient's condition.

Precautions

This medication should not be used by individuals allergic to specific ingredients. It should also not be taken by individuals with severely impaired kidney function or liver function. Additionally, individuals taking certain antifungal or antibiotic medications should avoid taking this medication concurrently. Those with genetic disorders that prevent the breakdown of lactose should not use this medication. Individuals with orthostatic hypotension should use this medication cautiously, and those with slightly impaired liver or kidney function should also exercise caution. Individuals taking antihypertensive agents, other alpha-blockers, and PDE5 inhibitors should particularly monitor blood pressure changes when taking this medication together. This medication may cause side effects such as retrograde ejaculation, dry mouth, diarrhea, dizziness, nasal congestion, and lightheadedness. Rarely, serious side effects such as loss of consciousness or liver function abnormalities may occur, and if any unusual symptoms arise, immediate consultation with a doctor is necessary. Blood pressure may suddenly drop while taking this medication, so it is advised to move slowly when standing up and to be cautious while driving or performing hazardous work. Care should be taken not to overdose, and if taking blood pressure medication, blood pressure changes should be closely monitored. This medication is used to treat benign prostatic hyperplasia that needs to be distinguished from prostate cancer, so it is essential to confirm the absence of prostate cancer before use. Additionally, individuals scheduled for cataract surgery should inform their surgeon about the use of this medication. Elderly individuals may have decreased liver and kidney function, so treatment should start with a lower dosage and be closely monitored. This medication should be kept out of the reach of children, and transferring it to another container should be avoided. Finally, while this medication has been reported to carry the potential for certain cancers in some animal studies, its effects on humans are unclear; therefore, long-term use should be discussed with a physician.

Side effects

  • Ejaculatory dysfunction
  • dry mouth
  • diarrhea
  • loose stools
  • orthostatic dizziness
  • nasal congestion
  • dizziness
  • lightheadedness
  • headache
  • increased TG
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  • elevated CRP
  • increased ALT
  • increased AST
  • elevated γ-GTP
  • syncope
  • loss of consciousness
  • liver dysfunction
  • jaundice
  • erectile dysfunction
  • urinary incontinence
  • stomatitis
  • gastric discomfort
  • constipation
  • vomiting
  • nausea
  • decreased appetite
  • stomach pain
  • abdominal pain
  • abdominal bloating
  • upper abdominal discomfort
  • lower abdominal pain
  • gastric ulcer
  • gastritis
  • atrophic gastritis
  • heartburn
  • gastric burning
  • duodenal ulcer
  • increased flatulence
  • increased bowel movements
  • sensation of incomplete evacuation
  • anal discomfort
  • fatigue
  • shoulder stiffness
  • numbness in hands and feet
  • feeling of heaviness in the head
  • drowsiness
  • decreased libido
  • heavy feeling
  • mood disturbances
  • nosebleed
  • runny nose
  • cough
  • edema
  • atrial fibrillation
  • bradycardia
  • tachycardia
  • arrhythmia
  • loss of functional extra contractions
  • orthostatic hypotension
  • decreased blood pressure
  • increased blood pressure
  • rash
  • eczema
  • hives
  • itching
  • intraoperative pupil paralysis syndrome
  • blurred vision
  • eye redness
  • eye itching
  • conjunctival hemorrhage
  • elevated total bilirubin
  • increased Al-P
  • elevated LDH
  • increased BUN
  • elevated 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
  • elevated urine glucose
  • urinary crystallization
  • facial flushing
  • tinnitus
  • bitter taste
  • chest pain
  • low back pain
  • lower limb fatigue
  • sweating
  • increased serum potassium level
  • decreased total protein
  • increased prostate-specific antigen
  • elevated uric acid
  • increased urine protein
  • retrograde ejaculation
  • nasopharyngitis
  • urinary tract infection
  • urinary disturbances
  • dyspepsia
  • excessive sedation
  • decreased orgasm
  • leg numbness
  • palpitations
  • itching
  • visual disturbances
  • fever
  • chills
  • lower limb fatigue
  • chest discomfort
  • shoulder pain
  • increased serum uric acid
  • increased serum creatinine
  • frequent urination
  • exacerbation of dry mouth
  • hematuria
  • herpes zoster

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

Storage

This medication is light-sensitive, so it should be stored in a container that blocks light. Additionally, it is best to store it at a temperature between 1°C and 30°C. Proper storage can help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Opaque white hard capsule containing white to pale yellow granular or powdered contents

Package unit

60 capsules (10 capsules/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.

Questions about this medicine

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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.