Medication info

Levocetirizine Tablets (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202004003 · Notified 2020.05.28

This product's status changed to Approval withdrawn on 2024.03.07. 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 chronic urticaria
Who takes it
Adults · Children
Adult dose
Adults: Take 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily, regardless of meals. Patients with renal impairment should adjust the dose based on kidney function (creatinine clearance). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet twice daily - Severe (10 ≤ CLCR < 30): 1 tablet three times daily
Child dose
Children over 6 years: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once daily, regardless of meals.

Ingredients

Manufacturer
(주)킴스제약

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 helps relieve symptoms caused by seasonal or perennial allergic rhinitis and improves symptoms associated with chronic idiopathic urticaria. It can also be used together with hydrocortisone topical preparations for the treatment of dermatitis and eczema accompanied by itching. It is used for alleviating various allergic and skin disease symptoms.

How to take

Adult dose

Adults: Take 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily, regardless of meals. Patients with renal impairment should adjust the dose based on kidney function (creatinine clearance). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet twice daily - Severe (10 ≤ CLCR < 30): 1 tablet three times daily

Child dose

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

Precautions

This medication should not be used in patients with known allergies to any of the ingredients or who have experienced hypersensitivity reactions. It should not be administered to patients with severely impaired kidney function or those undergoing dialysis. It is also advisable for pregnant women, those who may become pregnant, and breastfeeding women to avoid taking this medication. Infants under 1 year of age should not be given this medicine, and children under 6 years should be administered in liquid form instead of tablets. Since this tablet contains lactose, it should not be used in patients with lactose intolerance or related genetic conditions. Patients with reduced kidney or liver function, as well as the elderly, should use this medication with caution, as it may remain in the body for a longer duration. Be cautious when driving or operating machinery as this medication can cause drowsiness, headache, or dizziness. Using this medication with alcohol or central nervous system depressants may increase drowsiness and impair concentration, so it is advisable not to take them together. Patients with urinary function issues or those at risk of urinary retention, such as benign prostatic hyperplasia, should exercise special caution when using this medication. As with other antihistamines, the risk of side effects may increase when combined with alcohol. It is safest for pregnant or breastfeeding women not to take this medication due to insufficient studies. Children should use appropriate dosages adjusted for age and weight, and this medication should not be used in infants under 1 year of age. Elderly patients may experience prolonged retention of the drug in the body due to reduced kidney function, so it is advisable to start at a lower dose and monitor their condition. Stopping this medication for a certain period before allergy tests can help avoid affecting test results. In case of an overdose, symptoms such as drowsiness or agitation may occur, and as there are no specific antidotes, supportive treatment should be sought. This medication is not removed by dialysis, so proper medical management is needed in cases of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (angioedema)
  • Chest tightness, difficulty breathing, respiratory distress, bronchospasm
  • Cold sweat, pallor → Anaphylactic shock
  • Severe rash with fever, blisters, peeling skin, pain in mucous membranes of the mouth and eyes → Severe skin adverse reaction
  • Yellowing of the skin or eyes (jaundice), extreme lethargy → Liver abnormality
  • Sudden and severe headache, lightning headache, seizures, confusion, visual disturbances

Mild side effects

  • Drowsiness, lethargy, headache, numbness, fatigue, dizziness, heaviness in the head, excitement
  • Dry mouth, dry lips, nausea, loss of appetite, abdominal discomfort, dyspepsia, abdominal pain, stomach discomfort, vomiting, gastrointestinal disturbances, diarrhea, cheilitis, taste disturbances
  • Tachycardia, arrhythmia, increased blood pressure, palpitations
  • Vasculitis, leukopenia, neutropenia, lymphocytosis, eosinophilia, monocytosis, thrombocytosis, thrombocytopenia
  • Photosensitivity, rash, itching

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

Storage

This medication should be stored in a tightly closed container that can block light, at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the drug over time.

Appearance and packaging

Appearance

White or pale yellow oval film-coated tablets

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.