Medication info
Bialseti Tablet (Levocetirizine Hydrochloride)

Bialseti Tablet (Levocetirizine Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Levocetirizine Hydrochloride›5mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
White or pale yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201606641 · Notified 2016.11.16 · Insurance code 670500900

Summary

Main use
Relief of symptoms such as allergic rhinitis and chronic urticaria
Who takes it
Adults · Children
Adult dose
For adults and children aged 6 and older, take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once a day, regardless of meals. In patients with renal impairment, adjust the dose according to renal function (creatinine clearance). - 50 ≤ CLCR < 80: 1 tablet once a day - 30 ≤ CLCR < 50: 1 tablet once every other day - 10 ≤ CLCR < 30: 1 tablet once every three days
Child dose
For children aged 6 and older, take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once a day, regardless of meals.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Relief of symptoms such as allergic rhinitis and chronic urticaria

  • Allergic rhinitis
  • urticaria
  • dermatitis with itching
  • eczema
View approved original text

This medication is used to relieve the symptoms of allergic diseases such as seasonal or perennial allergic rhinitis. It also effectively improves the symptoms of chronic idiopathic urticaria. When treating dermatitis or eczema accompanied by itching, it helps alleviate symptoms when combined with other topical agents. It is used for the relief of symptoms of various allergic and skin disorders.

How to take

Adult dose

For adults and children aged 6 and older, take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once a day, regardless of meals. In patients with renal impairment, adjust the dose according to renal function (creatinine clearance). - 50 ≤ CLCR < 80: 1 tablet once a day - 30 ≤ CLCR < 50: 1 tablet once every other day - 10 ≤ CLCR < 30: 1 tablet once every three days

Child dose

For children aged 6 and older, take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once a day, regardless of meals.

Precautions

This medication should not be used in patients who are allergic to certain ingredients or who have a history of hypersensitivity to hydroxyzine or piperazine derivatives. It is safe not to administer to patients with severely impaired renal function or those undergoing dialysis. Women who are pregnant or may become pregnant and breastfeeding women should not take this medication. It should not be administered to infants under 1 year old, and in children under 6 years, it is recommended to administer in liquid form rather than tablets. This tablet contains lactose; hence, it should not be used in patients with genetic disorders such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with impaired renal or liver function and the elderly should use it cautiously as blood drug concentrations may increase. Taking this medication may result in neurological symptoms such as drowsiness, fatigue, headache, and dizziness, so caution is required when driving or operating machinery. Gastrointestinal symptoms may include dry mouth, nausea, abdominal pain, and diarrhea. Rarely, arrhythmias, blood-related adverse reactions, allergic reactions, and blurred vision have been reported. In children, side effects such as fever, diarrhea, vomiting, and otitis media can often appear. It is advisable not to take this medication with alcohol or drugs that affect the central nervous system, and patients at risk for urinary retention should be cautious. It is safest to avoid using this medication during pregnancy or breastfeeding. This medication is primarily excreted by the kidneys, so elderly patients or those with impaired renal function should start at a low dose, monitor their condition, and adjust the dose if necessary. It is recommended to temporarily discontinue this medication before allergy testing as it may affect test results. In the case of overdose, symptoms such as drowsiness or agitation may appear, and since there is no specific antidote, symptomatic treatment is necessary. This medication is not effectively removed by dialysis, so caution is necessary in case of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • edema
  • increased blood pressure
  • rash
  • angioedema
  • anaphylactic shock
  • respiratory distress
  • urticaria

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • somnolence
  • fatigue
  • dizziness
  • heaviness of the head
  • excitement
  • thirst
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  • dryness of the lips
  • nausea
  • loss of appetite
  • abdominal discomfort
  • dyspepsia
  • abdominal pain
  • gastric pain
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbances
  • tachycardia
  • arrhythmia
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • lymphocytosis
  • eosinophilia
  • monocytosis
  • thrombocytosis
  • thrombocytopenia
  • photosensitivity
  • rash
  • pruritus
  • visual disturbance

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

Storage

This medication is sensitive to light; therefore, it should be stored in a container that blocks light. Additionally, it is best to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

White or pale yellow oval film-coated tablet

Package unit

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.