Medication info

Levotizal Tablets (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 201603049 · Notified 2016.05.30

This product's status changed to Approval withdrawn on 2024.02.15. 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, chronic urticaria
Who takes it
Adults · Children
Adult dose
Adults: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day, regardless of meals. For patients with renal impairment, adjust the dose according to creatinine clearance (CLCR). - Mild (50 ≤ CLCR < 80): 1 tablet once a day - Moderate (30 ≤ CLCR < 50): 1 tablet every other day - Severe (10 ≤ CLCR < 30): 1 tablet every three days
Child dose
Children aged 6 years and older: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day, regardless of meals. Adjust as appropriate based on age and symptoms.

Ingredients

Manufacturer
일양바이오팜(주)

Efficacy & effects

Relief of symptoms such as allergic rhinitis, chronic urticaria

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

This medicine helps alleviate symptoms such as nasal congestion and sneezing due to seasonal or perennial allergic rhinitis. It also reduces skin rash and itching in patients with chronic idiopathic urticaria, helping them feel more comfortable. When treating dermatitis and eczema accompanied by itching, it effectively alleviates symptoms when used in conjunction with hydrocortisone topical preparations. It is used to improve discomfort from various allergies and skin-related symptoms.

How to take

Adult dose

Adults: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day, regardless of meals. For patients with renal impairment, adjust the dose according to creatinine clearance (CLCR). - Mild (50 ≤ CLCR < 80): 1 tablet once a day - Moderate (30 ≤ CLCR < 50): 1 tablet every other day - Severe (10 ≤ CLCR < 30): 1 tablet every three days

Child dose

Children aged 6 years and older: Take 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day, regardless of meals. Adjust as appropriate based on age and symptoms.

Precautions

This medication should not be used in patients with allergic reactions to specific ingredients or those who have had hypersensitivity reactions to hydroxyzine or piperazine derivatives in the past. It should not be given to patients with severely impaired kidney function or those undergoing dialysis. Women who are pregnant or may become pregnant, and those who are breastfeeding should not take this medication. It should not be administered to infants under 1 year of age, and liquid form should be used for children under 6 years instead of tablets. Additionally, this medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with impaired kidney or liver function, as well as the elderly, should take the medication cautiously as it may increase blood concentration. Drowsiness, fatigue, headache, and dizziness can occur while taking this medication, so caution is needed when driving or operating machinery. Gastrointestinal reactions such as nausea, vomiting, abdominal pain, or diarrhea may also occur. Rarely, allergic reactions such as arrhythmias, changes in blood cell count, rashes, or itching may occur, and if any unusual symptoms appear, consult a healthcare provider immediately. This medication may cause drowsiness, so it is advisable not to take it with alcohol or other central nervous system depressants. Patients with urinary excretion impairments should exercise caution when taking this medication. Because the safety of this medication has not been sufficiently proven in pregnant or breastfeeding women, they should avoid taking it. For children under 12 years, especially infants under 1 year, it is safest not to administer due to lack of experience in usage. Elderly patients should start at a lower dose and be closely monitored due to potential prolonged retention of the drug in the body due to reduced kidney function. Discontinuation of this medication before allergy testing will not affect the test results. In cases of overdose, symptoms such as drowsiness or agitation may occur, and as there is no specific antidote, appropriate treatment for symptoms is necessary. This medication is not removed by hemodialysis, so rapid medical attention is needed in case of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, swelling, angioedema → severe allergic reactions
  • Rash → severe skin reactions
  • Difficulty breathing, bronchospasm → respiratory issues
  • Hypertension → severe swelling or urination issues
  • Hepatitis, elevated AST, ALT, Al-P, total bilirubin → liver issues (jaundice)

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • fatigue
  • dizziness
  • heaviness
  • excitability
  • thirst
  • dry lips
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  • nausea
  • loss of appetite
  • discomfort in the upper abdomen
  • indigestion
  • abdominal pain
  • gastric discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbance
  • tachycardia
  • arrhythmia
  • hypertension
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • increased lymphocytes
  • elevated eosinophils
  • increased monocytes
  • thrombocytosis
  • thrombocytopenia
  • photosensitivity
  • rash

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

Storage

This medication is sensitive to light, so it should be stored in a light-protected, tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the efficacy and safety of the medication.

Appearance and packaging

Appearance

Oval film-coated tablets in white or pale yellow

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.