Medication info

Levocetirizine Tablets (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Levocetirizine Hydrochloride›5mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
White or pale yellow oval film-coated tablets
Packaging
[Domestic Use] 30 tablets/bottle, 300 tablets/bottle [Export Use] 60 tablets (10 tablets/PTP package x 6)
Approval status
Approval withdrawn

MFDS item code 200802913 · Notified 2008.03.17

This product's status changed to Approval withdrawn on 2024.02.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms such as allergic rhinitis and urticaria
Who takes it
Adults · Children
Adult dose
Adults: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once daily, regardless of meals. For patients with renal impairment, dosage adjustment is required according to renal function (creatinine clearance). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet once every 2 days - Severe (10 ≤ CLCR < 30): 1 tablet once every 3 days
Child dose
Children aged 6 years and older: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once daily, regardless of meals.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Relief of symptoms such as allergic rhinitis and urticaria

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

This medication is used to relieve symptoms such as sneezing and nasal congestion caused by seasonal or perennial allergic rhinitis. It also reduces itching and swelling associated with chronic idiopathic urticaria, thus alleviating symptoms. It is effective in relieving itching due to dermatitis and eczema, and is sometimes used in conjunction with hydrocortisone topical agents. It helps alleviate symptoms of various allergic and skin conditions.

How to take

Adult dose

Adults: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once daily, regardless of meals. For patients with renal impairment, dosage adjustment is required according to renal function (creatinine clearance). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet once every 2 days - Severe (10 ≤ CLCR < 30): 1 tablet once every 3 days

Child dose

Children aged 6 years and older: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once daily, regardless of meals.

Precautions

This medication should not be used in patients who have an allergic reaction to specific ingredients or have had such experiences in the past. Patients with severely impaired renal function or those undergoing dialysis, pregnant women or those who may become pregnant, and nursing women should not take this medication. It should not be used in infants under one year of age, and children under six years of age should be given the liquid form instead of tablets. This medication contains lactose, so it should not be administered to patients with genetic issues such as lactose intolerance. Patients with reduced kidney or liver function, as well as the elderly, should take it carefully as drug concentration in the blood may rise. During use, neurological symptoms such as drowsiness, headache, dizziness, as well as gastrointestinal adverse reactions like nausea, abdominal pain, and diarrhea may occur. Rarely, cardiac arrhythmia, changes in blood cell count, allergic reactions, skin rashes, and ocular symptoms may arise; if such symptoms appear, consult with medical staff immediately. Drowsiness or fatigue may occur, so activities requiring concentration such as driving or operating machinery should be performed cautiously. Avoid combining this medication with alcohol or central nervous system depressants as it may intensify drowsiness or decrease concentration. Patients with urinary excretion difficulties should be more cautious when taking this medication. If allergy tests or clinical examinations are to be conducted, stopping use is advisable as it may affect test results. In case of overdose, symptoms such as drowsiness or anxiety may appear, and due to the lack of a specific antidote, treatment will depend on the symptoms. It is difficult to remove this medication through dialysis; therefore, rapid medical intervention is needed in cases of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling
  • angioedema
  • anaphylactic shock
  • rash
  • respiratory distress
  • hypertension

Mild side effects

  • Drowsiness
  • fatigue
  • headache
  • numbness
  • mild lethargy
  • tiredness
  • dizziness
  • heaviness in the head
  • excitement
  • thirst
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  • dry lips
  • nausea
  • loss of appetite
  • stomach discomfort
  • indigestion
  • abdominal pain
  • stomach cramps
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbance
  • tachycardia
  • arrhythmia
  • hypertension
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • lymphocytosis
  • eosinophilia
  • monocytosis
  • thrombocytosis
  • thrombocytopenia
  • photosensitivity

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 prevents light exposure. Additionally, it is best to store the medication at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White or pale yellow oval film-coated tablets

Package unit

[Domestic Use] 30 tablets/bottle, 300 tablets/bottle [Export Use] 60 tablets (10 tablets/PTP package x 6)

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.