Medication info

K-Befotable Tablet (Bepotastine Besilate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Bepotastine Besylate›10mg / 1 tablet
Manufacturer / importer
Genewon Sciences Co., Ltd.
Appearance
White film-coated tablet with a break line
Packaging
60 tablets/PTP [(10 tablets/PTP x 6)], 30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001904 · Approved 2020.03.18

This product's status changed to Approval withdrawn on 2024.09.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of allergic rhinitis, itchy skin (e.g., eczema and dermatitis), and chronic urticaria
Who takes it
Adults
Adult dose
The usual dose is 10mg of bepotastine besilate per administration, orally twice daily. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Genewon Sciences Co., Ltd.

Efficacy & effects

Relief of allergic rhinitis, itchy skin (e.g., eczema and dermatitis), and chronic urticaria

  • Perennial allergic rhinitis
  • chronic urticaria
  • pruritus
  • eczema
  • dermatitis
  • skin pruritus
  • urticaria
View approved original text

This medication is used to relieve itching associated with perennial allergic rhinitis, chronic urticaria, and various skin diseases such as eczema or dermatitis.

How to take

Adult dose

The usual dose is 10mg of bepotastine besilate per administration, orally twice daily. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication should not be used in patients with hypersensitivity to its ingredients. Patients with kidney or liver function problems or elderly patients should use this medication with caution. Taking this medication may cause neurological symptoms such as drowsiness, headache, dizziness, and gastrointestinal symptoms such as dry mouth, vomiting, and diarrhea. Moreover, side effects such as changes in blood counts, elevated liver enzymes, and skin rashes have been reported. Caution should be taken as drowsiness may occur when driving or operating dangerous machinery. Patients undergoing long-term steroid therapy should gradually reduce the steroid dosage when using this medication. Patients with reduced kidney function may experience increased blood concentration of this medication, so starting with a low dose and monitoring their condition is necessary. Patients with seasonal allergic rhinitis should begin and end administration according to the season, and if no effect is observed, long-term use should be avoided. Co-administration with other antihistamines or alcohol should be avoided. Pregnant women or those who may become pregnant are advised not to use this medication unless necessary, and they should consult their physician before use. Women who are breastfeeding should also avoid this medication while nursing. Safety in pediatric patients has not been adequately confirmed, so caution is needed. Elderly patients should use this medication with caution due to the potential increase in drug concentration resulting from decreased kidney function. Taking this medication prior to allergy testing may affect test results, so it is advisable not to take it before testing. When taking the medication, it should be removed from the packaging and taken as is, avoiding chewing or swallowing the packaging. Keep out of reach of children and store in a closed container away from moisture at a temperature below 30 degrees Celsius.

Side effects

  • Drowsiness
  • lethargy
  • headache
  • heaviness
  • dizziness
  • dry mouth
  • dry oral mucosa
  • glossitis
  • nausea
  • vomiting
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  • abdominal pain
  • discomfort in the stomach
  • diarrhea
  • fluctuations in white blood cell count
  • eosinophilia
  • increased AST (GOT)
  • increased ALT (GPT)
  • increased r-GTP
  • increased LDH
  • elevated total bilirubin
  • urine protein
  • urine glucose
  • urine hematuria
  • urine urobilinogen
  • rash
  • hypersensitivity reaction of swelling
  • thirst
  • abdominal discomfort
  • facial edema
  • increased SGOT
  • increased SGPT
  • palpitations
  • facial flushing
  • bitter taste

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

White film-coated tablet with a break line

Package unit

60 tablets/PTP [(10 tablets/PTP x 6)], 30 tablets/bottle, 300 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.