Medication info
Levocetirizine (Levocetirizine Hydrochloride)

Levocetirizine (Levocetirizine Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Levocetirizine Hydrochloride›5mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
White or yellowish oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201700463 · Notified 2017.01.25

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. Dosage may be adjusted according to age and symptoms. Patients with renal impairment should adjust the dose based on their kidney function (creatinine clearance). Creatinine clearance 50 ≤ CLCR < 80: 1 tablet once daily. Creatinine clearance 30 ≤ CLCR < 50: 1 tablet every other day. Creatinine clearance 10 ≤
Child dose
Pediatric patients aged 6 years and older: take 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily regardless of meals.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Relief of symptoms such as allergic rhinitis and chronic urticaria

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

This medication relieves symptoms of seasonal and perennial allergic rhinitis and reduces discomfort caused by chronic idiopathic urticaria. It also helps alleviate symptoms associated with dermatitis and eczema when used together with topical hydrocortisone. In other words, it is used for treating allergic rhinitis, chronic urticaria, and itchy skin.

How to take

Adult dose

Adults: take 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily regardless of meals. Dosage may be adjusted according to age and symptoms. Patients with renal impairment should adjust the dose based on their kidney function (creatinine clearance). Creatinine clearance 50 ≤ CLCR < 80: 1 tablet once daily. Creatinine clearance 30 ≤ CLCR < 50: 1 tablet every other day. Creatinine clearance 10 ≤

Child dose

Pediatric patients aged 6 years and older: take 1 tablet (5 mg of Levocetirizine Hydrochloride) orally once daily regardless of meals.

Precautions

This medication should not be administered to certain patients. Those who are allergic to this product, or have a history of hypersensitivity to it, hydroxyzine, or piperazine derivatives should not use it. Patients with severe kidney impairment or those on hemodialysis should not take this medication. It is also not administered to pregnant women or those who may become pregnant, and breastfeeding women. For infants under 1 year of age, it should never be used, and for children under 6 years, it should be given in liquid form instead of tablets. Additionally, this tablet contains lactose and should not be used in patients with hereditary lactose intolerance. Patients with decreased kidney or liver function, as well as elderly individuals, should use with caution as the blood concentration of this medication may increase. Drowsiness, headaches, dizziness, tiredness, and other CNS side effects may occur during use. Gastrointestinal issues such as dry mouth, nausea, abdominal pain, and diarrhea may arise. Rarely, cardiovascular issues like increased heart rate or arrhythmia may also occur. Blood-related side effects may include leukopenia or platelet anomalies. Allergic reactions such as skin rash, itching, and edema may appear, and in rare cases, photosensitivity or anaphylactic shock can occur. Blurred vision or eye congestion has also been reported. Liver and kidney function test results may temporarily rise. Caution is necessary because this medication can cause drowsiness or fatigue while driving or operating machinery. Taking it together with alcohol or other CNS depressants may exacerbate these symptoms, so avoiding concurrent use is recommended. Patients at risk for urinary retention, such as those with spinal injuries or prostatic hypertrophy, should be careful while using this medication. Taking it with food does not alter the effectiveness but may slow absorption. It is safer for pregnant or breastfeeding women to avoid this medication. Especially during breastfeeding, as it may pass into breast milk, it should be avoided. Children under 12 have not had sufficient safety and efficacy established, so caution should be taken, and infants under 1 year should not use it. Elderly individuals may have decreased kidney function, leading to a higher blood concentration, so they should start at a lower dose and monitor conditions for adjustments. This medication may affect the results of allergy skin tests, so it is best to stop taking it 3 to 5 days before testing. In case of overdose, adults may experience severe drowsiness, while children may show restlessness and anxiety followed by drowsiness. There is no specific antidote, so treatment involves alleviating symptoms, and gastric lavage may be performed if necessary. This medication is not effectively removed by hemodialysis, so reliance on dialysis is not advised.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, edema, angioedema → severe allergic reaction.
  • Rash → severe skin adverse reaction.
  • Difficulty breathing, bronchospasm → respiratory issues.
  • Hepatitis, increased total bilirubin, elevated AST, elevated ALT → liver abnormalities (jaundice).
  • Numbness, headache, seizures, altered consciousness, visual disturbances, tremors, fainting → severe neurological symptoms.
  • Edema, urinary retention, urinary disorders → severe edema or urinary abnormalities.
  • Increased blood pressure → severe edema or urinary abnormalities.

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • drowsiness
  • fatigue
  • dizziness
  • heavy feeling
  • agitation
  • dry mouth
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  • dry lips
  • nausea
  • appetite loss
  • discomfort in the stomach
  • dyspepsia
  • abdominal pain
  • stomach ache
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbances
  • 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 should be stored in a tightly closed container that protects it from light, and the storage temperature should be maintained at room temperature between 1 degree and 30 degrees. Storing it this way will help maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

White or yellowish oval film-coated tablet

Package unit

30 tablets/bottle, 100 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.