Medication info

Levocetirizine Tablets (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 201403253 · Notified 2014.07.18

This product's status changed to Approval withdrawn on 2024.04.02.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 such as allergic rhinitis and chronic urticaria
Who takes it
Adults · Children
Adult dose
Adults and children aged 6 years and older: Administer 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily without regard to meals. Dose may be adjusted according to age and symptoms. For patients with renal impairment, the dosing should be adjusted based on renal function (creatinine clearance (CLCR (ml/min))). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet once daily,
Child dose
Adults and children aged 6 years and older: Administer 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily without regard to meals. Dose may be adjusted according to age and symptoms.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Relief of symptoms such as allergic rhinitis and chronic urticaria

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

This medication alleviates the symptoms of seasonal or perennial allergic rhinitis. It also helps to reduce the itching associated with chronic idiopathic urticaria, thereby alleviating symptoms. Furthermore, it contributes to the relief of symptoms when used together with topical hydrocortisone for dermatitis and eczema accompanied by itching. It is effectively used for various allergic and skin disorders.

How to take

Adult dose

Adults and children aged 6 years and older: Administer 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily without regard to meals. Dose may be adjusted according to age and symptoms. For patients with renal impairment, the dosing should be adjusted based on renal function (creatinine clearance (CLCR (ml/min))). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet once daily,

Child dose

Adults and children aged 6 years and older: Administer 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily without regard to meals. Dose may be adjusted according to age and symptoms.

Precautions

This medication should not be used by individuals who have an allergic reaction to any of its components or who have had such experiences in the past. It should also not be administered to patients with severely impaired kidney function or those undergoing hemodialysis. It is safest for women who are pregnant, potentially pregnant, or nursing to avoid this medication. Infants under 1 year of age should never be given this medication, and for children under 6 years of age, it is preferable to administer it in liquid form instead of tablets. As this medication contains lactose, patients with hereditary lactose intolerance should not take it. Patients with impaired kidney or liver function, as well as the elderly, should use this medication with caution as it may remain in their system for a prolonged period. Drowsiness, fatigue, and lethargy may occur during use, so care should be taken when performing tasks requiring concentration, such as driving or operating machinery. Concurrent use of this medication with alcohol or other drugs affecting the central nervous system may exacerbate drowsiness and decrease concentration, so it is advisable to avoid such combinations. Patients with urinary excretion issues, such as those with spinal cord injuries or benign prostatic hyperplasia, should use this medication with special caution. Since this medication may influence blood test results, if an allergic skin test is planned, it is recommended to refrain from taking this medication 3 to 5 days prior to the test. In the case of overdose, symptoms such as drowsiness or anxiety may appear, and specific detoxification agents are not available, so symptomatic treatment may be necessary. This medication is not effectively removed through hemodialysis, so even in the case of overdose, hemodialysis may not be useful.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • edema
  • angioedema
  • anaphylactic shock
  • rash
  • hypertension
  • respiratory distress
  • high blood pressure

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • somnolence
  • fatigue
  • dizziness
  • heavy head
  • excitement
  • thirst
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  • dry lips
  • nausea
  • loss of appetite
  • gastrointestinal discomfort
  • dyspepsia
  • abdominal pain
  • gastric pain
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbance
  • tachycardia
  • arrhythmia
  • hypertension
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • increase in lymphocytes
  • increase in eosinophils
  • increase in monocytes
  • increase in platelets
  • decrease in platelets
  • photosensitivity
  • rash

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

Storage

This medication is sensitive to light; therefore, it should be stored in a tightly sealed container that blocks out light. Additionally, it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a long time.

Appearance and packaging

Appearance

White or light 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.