Medication info

Levocetirizine Hydrochloride Tablets

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 200806361 · Notified 2008.06.09

This product's status changed to Approval withdrawn on 2024.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms associated with seasonal and perennial allergic rhinitis (hay fever), chronic idiopathic urticaria, etc.
Who takes it
Adults · Children
Adult dose
Adults and children aged 6 years and older: Take 1 tablet (5 mg of Levocetirizine Hydrochloride) once daily, orally, regardless of meals. In patients with renal impairment, the dose should be adjusted according to kidney function (creatinine clearance). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet, every other day - Severe (10 ≤ CLCR < 30): 1 tablet, once every three days
Child dose
Adults and children aged 6 years and older: Take 1 tablet (5 mg of Levocetirizine Hydrochloride) once daily, orally, regardless of meals. In patients with renal impairment, the dose should be adjusted according to kidney function (creatinine clearance).

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

Relief of symptoms associated with seasonal and perennial allergic rhinitis (hay fever), chronic idiopathic urticaria, etc.

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

This medication is used for seasonal or persistent perennial allergic rhinitis, helping relieve symptoms such as nasal congestion and sneezing. It also aids in reducing skin rash and swelling caused by chronic idiopathic urticaria. It contributes to symptom relief when used in conjunction with topical hydrocortisone for skin dermatitis and eczema accompanied by itching. It is effective in treating various allergic symptoms and skin disorders.

How to take

Adult dose

Adults and children aged 6 years and older: Take 1 tablet (5 mg of Levocetirizine Hydrochloride) once daily, orally, regardless of meals. In patients with renal impairment, the dose should be adjusted according to kidney function (creatinine clearance). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet, every other day - Severe (10 ≤ CLCR < 30): 1 tablet, once every three days

Child dose

Adults and children aged 6 years and older: Take 1 tablet (5 mg of Levocetirizine Hydrochloride) once daily, orally, regardless of meals. In patients with renal impairment, the dose should be adjusted according to kidney function (creatinine clearance).

Precautions

This medication should not be used by patients who have had allergies or hypersensitivity to specific ingredients. Patients with severely reduced renal function or undergoing hemodialysis should not take this medication. It is not safe to administer to pregnant women or women who may become pregnant, as well as to breastfeeding women. Infants under 1 year old should not use this medication, and children under 6 years old should be given liquid forms instead of tablets. Patients with certain genetic issues such as lactose intolerance should also avoid taking the tablet form of this medication. Patients with weakened kidney or liver function, as well as the elderly, may need to be cautious with this medication due to the possibility of increased blood concentration. This medication may cause side effects such as drowsiness, headache, dizziness, as well as gastrointestinal symptoms such as indigestion, nausea, and abdominal pain. Rarely, abnormalities in heart rhythm, changes in blood components, allergic reactions, visual disturbances, and liver or kidney dysfunctions have been reported. Particularly in children, symptoms such as fever, diarrhea, vomiting, and otitis media may occur frequently. Drowsiness or fatigue may occur after taking this medication, so caution is advised when driving or performing tasks that require concentration. Avoid taking this medication with alcohol or drugs that affect the central nervous system, as this may worsen symptoms. Patients at risk of urinary obstruction should use this medication cautiously, as it may have effects on them. This medication may increase the central nervous system depressant effect when taken with alcohol; therefore, it is safe to avoid concurrent use. It is advisable not to use this medication during pregnancy due to the lack of established safety, and it should not be taken during breastfeeding as it may be excreted in breast milk. Children, especially infants under 1 year old, should not take this medication due to lack of experience. The elderly should start with a lower dose and closely monitor their condition, as reduced kidney function may lead to prolonged presence of the drug in the body. Do not take this medication for a certain period before allergy tests, as it may affect test results. In case of overdose, symptoms such as drowsiness and agitation may occur, and since there is no specific antidote, treatment and support based on symptoms are necessary. This medication is not effectively removed by hemodialysis, thus hemodialysis is not effective in cases of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • angioedema
  • anaphylactic shock
  • hypertension
  • respiratory distress
  • hives

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • somnolence
  • fatigue
  • dizziness
  • heaviness
  • excitation
  • thirst
Show 26 more
  • dry lips
  • nausea
  • loss of appetite
  • abdominal discomfort
  • indigestion
  • stomach pain
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste alterations
  • tachycardia
  • arrhythmia
  • hypertension
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • lymphocytosis
  • eosinophilia
  • monocytosis
  • 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 special container that prevents light exposure. Additionally, it is important to store it at room temperature, between 1°C and 30°C, in order to maintain its efficacy.

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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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.