Medication info
Silodosin Capsule 8 mg (Silodosin)

Silodosin Capsule 8 mg (Silodosin)

Prescription medicationHard capsuleOral
Ingredient · strength
Silodosin›8mg / 1 capsule
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
An opaque white hard capsule containing white to pale yellow granules or powder.
Packaging
30 capsules/box [10 capsules/PTP x 3]
Approval status
Active

MFDS item code 201504347 · Approved 2015.07.02 · Insurance code 643507340

Summary

Main use
Improvement of voiding disorders associated with benign prostatic hyperplasia
Who takes it
Adults
Adult dose
Administer orally to adults as 4mg twice daily after breakfast and dinner, or 8mg 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 initiate treatment at a low dose (2mg per dose, twice daily), with further dose reduction as appropriate according to symptoms.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of voiding disorders associated with benign prostatic hyperplasia

  • Benign prostatic hyperplasia
  • urinary disorders
View approved original text

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

How to take

Adult dose

Administer orally to adults as 4mg twice daily after breakfast and dinner, or 8mg 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 initiate treatment at a low dose (2mg per dose, twice daily), with further dose reduction as appropriate according to symptoms.

Precautions

This medication should not be administered to certain patients. For example, patients with an allergy to the ingredients of this drug, severely impaired renal function, serious liver dysfunction, or those taking specific strong medications should not use this drug. Additionally, patients with genetic disorders affecting lactose intolerance should not take this drug. Caution should be exercised when using this drug in patients with orthostatic hypotension, impaired liver or renal function, and those taking certain medications. Side effects, such as ejaculation disorders, dry mouth, diarrhea, dizziness, nasal congestion, and headaches, may occur, as well as serious side effects like liver dysfunction or blood pressure drops, so careful monitoring is advised. In particular, because there may be a rapid drop in blood pressure, care should be taken to avoid overdosing on this medication, and patients on antihypertensive medications should closely monitor changes in their blood pressure. While this drug can help relieve symptoms, it is not a treatment for the underlying cause, and if there is no effect, other treatment options should be considered. Before taking this drug, it is essential to check for prostate cancer, and patients scheduled for cataract surgery should inform their healthcare provider, as it may affect their eye condition during surgery. This drug may interact with other medications, so if you are taking any other medications, be sure to inform your doctor or pharmacist. For the elderly, physical functions may be weakened, so the dosage should be adjusted appropriately and administered cautiously. Lastly, this medication should be kept out of reach of children, and it should not be transferred to other containers.

Side effects

Sexual dysfunction, dry mouth, diarrhea, loose stools, orthostatic dizziness, nasal congestion, lightheadedness, dizziness, headache, elevated triglycerides, increased CRP, elevated ALT, elevated AST, increased γ-GTP, syncope, loss of consciousness, liver dysfunction, jaundice, erectile dysfunction, urinary incontinence, stomatitis, gastric discomfort, constipation, vomiting, nausea, loss of appetite, gastric pain, abdominal pain, abdominal bloating, epigastric discomfort, lower abdominal pain, gastric ulcer, gastritis, atrophic gastritis, heartburn, gastric burning, duodenal ulcer, increased flatulence, increased bowel movement, feeling of incomplete evacuation, anal discomfort, fatigue, shoulder stiffness, numbness in hands and feet, feeling of heaviness in the head, drowsiness, decreased libido, heaviness, malaise, nosebleed, runny nose, cough, edema, atrial fibrillation, palpitations, tachycardia, arrhythmia, premature ventricular contractions, orthostatic hypotension, blood pressure drop, blood pressure increase, rash, eczema, hives, itching, intraoperative pupillary dilation syndrome, blurred vision, eye redness, eye itching, conjunctival hemorrhage, elevated total bilirubin, increased Al-P, elevated LDH, elevated BUN, increased creatinine, decreased white blood cell count, decreased red blood cell count, reduced hemoglobin levels, decreased hematocrit, increased white blood cell count, decreased platelet count, facial swelling, tongue swelling, pharyngeal edema, gynecomastia, elevated total cholesterol, increased urinary glucose, urine sediment, facial flushing, tinnitus, bitter taste, chest pain, lower back pain, sensation of leg fatigue, sweating, hot flashes, elevated serum potassium levels, decreased total protein, increased prostate-specific antigen, elevated uric acid, increased urine protein, nasopharyngitis, urinary tract infection, urination disorder, excessive sedation, decreased orgasm, leg numbness, palpitations, itching, visual disturbances, fever, chills, leg fatigue, chest discomfort, shoulder pain, elevated serum uric acid, increased serum creatinine, frequent urination, worsened dry mouth, hematuria, shingles

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

Storage

This drug is sensitive to light, so it should be stored in a tightly sealed container that blocks light. It is also crucial to maintain the drug's efficacy by storing it at room temperature, between 1°C and 30°C.

Appearance and packaging

Appearance

An opaque white hard capsule containing white to pale yellow granules or powder.

Package unit

30 capsules/box [10 capsules/PTP x 3]

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.