Medication info

Lesezale Tablet (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 200804915 · Notified 2008.04.29

This product's status changed to Approval withdrawn on 2024.03.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms from allergic rhinitis (seasonal, perennial), chronic urticaria, etc.
Who takes it
Adults · Children
Adult dose
Adults: orally take 1 tablet (5mg as levocetirizine hydrochloride) once daily, regardless of meals. In patients with renal impairment, adjust the dose based on renal function (Creatinine clearance (CLCR)). - Mild (50 ≤ CLCR < 80): 1 tablet once daily. - Moderate (30 ≤ CLCR < 50): 1 tablet every 2 days. - Severe (10 ≤ CLCR < 30): 1 tablet every 3 days.
Child dose
Children aged 6 and older: orally take 1 tablet (5mg as levocetirizine hydrochloride) once daily, regardless of meals. Adjust dose according to age and symptoms.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Relief of symptoms from allergic rhinitis (seasonal, perennial), chronic urticaria, etc.

  • Seasonal allergic rhinitis
  • perennial allergic rhinitis
  • chronic idiopathic urticaria
  • itching
  • dermatitis
  • eczema
View approved original text

This medication is effective in relieving symptoms of allergic diseases such as seasonal or perennial allergic rhinitis. It also reduces symptoms in patients with chronic idiopathic urticaria and helps alleviate symptoms when used in conjunction with hydrocortisone topical for dermatitis and eczema accompanied by itching. It is used to improve various allergy and skin-related symptoms.

How to take

Adult dose

Adults: orally take 1 tablet (5mg as levocetirizine hydrochloride) once daily, regardless of meals. In patients with renal impairment, adjust the dose based on renal function (Creatinine clearance (CLCR)). - Mild (50 ≤ CLCR < 80): 1 tablet once daily. - Moderate (30 ≤ CLCR < 50): 1 tablet every 2 days. - Severe (10 ≤ CLCR < 30): 1 tablet every 3 days.

Child dose

Children aged 6 and older: orally take 1 tablet (5mg as levocetirizine hydrochloride) once daily, regardless of meals. Adjust dose according to age and symptoms.

Precautions

This medication should not be used by patients who have allergies to certain ingredients or who have shown hypersensitivity to hydoxyzine or piperazine derivatives. It should not be administered to patients with severely impaired renal function or those undergoing hemodialysis. Pregnant women or women who might become pregnant, as well as nursing mothers, should not take this medication. It should not be given to infants under 1 year of age, and children under 6 years should be given liquid form instead of tablets. This tablet contains lactose, so patients with lactose intolerance or certain genetic lactose metabolism disorders should avoid taking it. Patients with kidney or liver problems and the elderly should use this medication cautiously, as it may increase blood concentration. This medication may cause CNS side effects such as drowsiness, headache, dizziness, and fatigue. Gastrointestinal symptoms may include nausea, loss of appetite, abdominal pain, and diarrhea. Rarely, heart rhythm abnormalities or blood-related adverse reactions, rash, and blurred vision may occur. After taking this medication, drowsiness or fatigue may occur, so caution is required when engaging in tasks that require attention, such as driving or operating machinery. Taking with alcohol or central nervous system depressants may intensify drowsiness; therefore, it is best to avoid doing so. This medication should be used with caution in patients with urinary excretion disorders, especially in cases of spinal cord injury or prostatic enlargement. Taking it with food may slow down absorption speed, but it does not affect the total absorption amount. It is safer for pregnant women or nursing mothers not to take this medication. For children under 12 years, safety and efficacy have not been sufficiently confirmed, so caution is needed; especially, it should not be given to infants under 1 year. The elderly may have increased blood concentration due to decreased kidney function, so they should start with a low dose and observe the condition while adjusting it. It is advisable to temporarily discontinue this medication before allergy testing, as it does not affect testing results. In case of overdose, symptoms such as drowsiness or anxiety may occur, and since there is no specific antidote, symptomatic treatment should be received. This medication is not well removed by hemodialysis, so care is needed in case of overdose.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, anaphylactic shock, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, respiratory distress, asthma attack, respiratory abnormalities accompanied by cough and fever, increased blood pressure, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, severe swelling or urinary abnormalities.

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • malaise
  • fatigue
  • dizziness
  • heaviness in the head
  • excitement
  • thirst
Show 27 more
  • dry lips
  • nausea
  • loss of appetite
  • stomach discomfort
  • indigestion
  • abdominal pain
  • stomach pain
  • abdominal discomfort
  • vomiting
  • gastrointestinal disorders
  • diarrhea
  • cheilitis
  • taste disorders
  • tachycardia
  • arrhythmia
  • hypertension
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • lymphocytosis
  • eosinophilia
  • monocytosis
  • thrombocytosis
  • thrombocytopenia
  • phototoxicity
  • rash

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. Moreover, it is recommended to store at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication.

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.