Medication info
Bytral XL 10 mg Tablet (Alfuzosin Hydrochloride)

Bytral XL 10 mg Tablet (Alfuzosin Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Alfuzosin Hydrochloride›5mg / 1 tablet
Manufacturer / importer
Bionex Co., Ltd.
Appearance
This medication is a film-coated tablet consisting of a total of three layers, with one white layer inserted between two yellow layers, shaped as a convex circular tablet.
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200708592 · Notified 2007.07.25 · Insurance code 643100960

Summary

Main use
Treatment of symptoms of benign prostatic hyperplasia; adjunctive use with a catheter for associated acute urinary retention
Who takes it
Adults
Adult dose
The recommended dose is 10mg once daily, taken immediately after the evening meal. Do not chew; swallow the tablet whole. When administered as adjunctive therapy to catheterization for acute urinary retention associated with benign prostatic hyperplasia, the recommended dose is 10mg once daily, taken after a meal starting on the first day of catheterization. Take for 2-3 days while the catheter is in place and for 1 day after catheter removal, for a total of 3-4 days.

Ingredients

Manufacturer
Bionex Co., Ltd.

Efficacy & effects

Treatment of symptoms of benign prostatic hyperplasia; adjunctive use with a catheter for associated acute urinary retention

  • Functional symptoms of benign prostatic hyperplasia
  • acute urinary retention
View approved original text

This medication is used for the treatment of functional symptoms due to benign prostatic hyperplasia. It is also used as an adjunct therapy during catheterization in cases of acute urinary retention associated with benign prostatic hyperplasia. Therefore, it helps improve symptoms related to prostatic enlargement.

How to take

Adult dose

The recommended dose is 10mg once daily, taken immediately after the evening meal. Do not chew; swallow the tablet whole. When administered as adjunctive therapy to catheterization for acute urinary retention associated with benign prostatic hyperplasia, the recommended dose is 10mg once daily, taken after a meal starting on the first day of catheterization. Take for 2-3 days while the catheter is in place and for 1 day after catheter removal, for a total of 3-4 days.

Precautions

This medication contains the ingredient Alfuzosin and should not be used in certain patients. For example, patients who are allergic to Alfuzosin or other ingredients in this medication, patients with orthostatic hypotension, severely compromised liver function, severely impaired kidney function, bowel obstruction, those already taking other alpha-blockers, and patients taking certain potent drugs known as CYP3A4 inhibitors should not be administered this medication. Caution is particularly needed when using this medication. In the first few hours, blood pressure may suddenly drop, leading to symptoms such as dizziness, fatigue, and sweating; if such symptoms occur, one should lie down and rest. Elderly patients may experience these hypotensive symptoms more frequently and should therefore be more vigilant. Moreover, patients already taking blood pressure medication, those with symptoms of orthostatic hypotension, patients with angina, or those with heart-related issues should be given this medication cautiously, and it should be discontinued if symptoms worsen. Side effects of this medication may include dizziness, headaches, nausea, abdominal pain, constipation, fatigue, and erectile dysfunction. Rarely, severe symptoms such as skin rash, low blood pressure, or cardiac arrhythmias may occur, and immediate consultation with medical personnel is necessary if any abnormal symptoms arise. This medication is an alpha-blocker, and it may cause difficulty in dilating pupils during cataract surgery; therefore, it is important to inform medical personnel ahead of scheduled surgeries. The tablet should be swallowed whole, as crushing or chewing it may alter its effects. Caution is warranted when taken with other blood pressure medications or nitrate agents, as the blood pressure-lowering effect may become too strong. The safety of this medication during pregnancy or breastfeeding has not been established, and it is not recommended for children. Dizziness or weakness may occur upon initial administration, so caution is advised when driving or operating machinery. In cases of overdose, immediate hospitalization for appropriate treatment is necessary, and this medication is not removed by dialysis. Finally, this medication should be stored out of the reach of children and should not be transferred to another container for safety.

Side effects

  • Fainting
  • dizziness
  • headache
  • vertigo
  • syncope
  • tachycardia
  • angina
  • intraoperative floppy iris syndrome
  • upper respiratory tract infection
  • bronchitis
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  • sinusitis
  • pharyngitis
  • rhinitis
  • nausea
  • abdominal pain
  • dyspepsia
  • constipation
  • diarrhea
  • vomiting
  • hepatocellular liver damage
  • cholestatic liver disease
  • skin rash
  • pruritus
  • hives
  • angioedema
  • weakness
  • fatigue
  • pain
  • edema
  • chest pain
  • erectile dysfunction
  • priapism
  • hypotension
  • flushing
  • facial flushing
  • thrombocytopenia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at a room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication and ensure safe use.

Appearance and packaging

Appearance

This medication is a film-coated tablet consisting of a total of three layers, with one white layer inserted between two yellow layers, shaped as a convex circular tablet.

Package unit

30 tablets/bottle

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.