Medication info

Levocetirizine Hydrochloride Tablets

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 200808518 · Notified 2008.08.07

This product's status changed to Approval withdrawn on 2024.03.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of allergic rhinitis (seasonal, perennial), chronic urticaria, and pruritus associated with dermatitis
Who takes it
Adults · Children
Adult dose
Adults: Take 1 tablet (5mg of levocetirizine hydrochloride) once daily, orally, regardless of meals. Adjust according to age and symptoms. For patients with renal impairment, adjust the dosage based on kidney function (creatinine clearance). The dosage and frequency based on creatinine clearance are mild (50 ≤ CLCR < 80) 1 tablet once daily, moderate (30 ≤ CLCR < 50) 1 tablet every two days, severe (10 ≤ CLCR < 30) 1 tablet every three days.
Child dose
Children over 6 years: Take 1 tablet (5mg of levocetirizine hydrochloride) once daily, orally, regardless of meals, same as adults.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Relief of allergic rhinitis (seasonal, perennial), chronic urticaria, and pruritus associated with dermatitis

  • Allergic rhinitis
  • urticaria
  • itching
  • dermatitis
  • eczema
View approved original text

This medication helps alleviate the symptoms of seasonal or perennial allergic rhinitis, improve skin symptoms caused by chronic idiopathic urticaria, and relieve symptoms of dermatitis and eczema when used in conjunction with a hydrocortisone topical preparation for itching.

How to take

Adult dose

Adults: Take 1 tablet (5mg of levocetirizine hydrochloride) once daily, orally, regardless of meals. Adjust according to age and symptoms. For patients with renal impairment, adjust the dosage based on kidney function (creatinine clearance). The dosage and frequency based on creatinine clearance are mild (50 ≤ CLCR < 80) 1 tablet once daily, moderate (30 ≤ CLCR < 50) 1 tablet every two days, severe (10 ≤ CLCR < 30) 1 tablet every three days.

Child dose

Children over 6 years: Take 1 tablet (5mg of levocetirizine hydrochloride) once daily, orally, regardless of meals, same as adults.

Precautions

This medication should not be used in patients with a known allergy or hypersensitivity to any of its components. It should also not be administered to patients with severely impaired renal function or those undergoing dialysis. Women who are pregnant or may become pregnant, as well as those who are breastfeeding, should not take this medication. It should not be used in infants under 1 year of age, and liquid forms should be administered to children under 6 years of age instead of tablets. Patients with lactose intolerance should avoid this medication due to the presence of lactose in some formulations. Caution should be exercised in patients with compromised kidney or liver function, and elderly individuals, as the blood concentration of this medication may increase. Possible neurologic side effects include drowsiness, headache, dizziness, and fatigue. Gastrointestinal symptoms can include dry mouth, nausea, decreased appetite, and abdominal pain. Cardiovascular issues such as irregular heartbeat or increased blood pressure may rarely occur. Blood-related adverse reactions such as variations in blood cell counts or vasculitis have been reported. Allergic reactions may include skin rash, itching, swelling; in severe cases, anaphylactic shock may occur. Rare eye-related symptoms may include blurred vision or conjunctival hyperemia. Liver and kidney function test results may transiently increase, necessitating regular check-ups. Severe drowsiness or fatigue may occur after taking this medication, so caution is advised when driving or operating machinery. Taking this medication with alcohol or central nervous system depressants may significantly increase drowsiness and decrease concentration, so it is advisable not to combine them. Patients with difficulty urinating may experience worsened symptoms when taking this medication, requiring caution. This medication may interact with other drugs, especially alcohol, and should be avoided in such cases. Women who are pregnant or breastfeeding should not take this medication due to insufficient clinical research. Dosage adjustments are necessary for children and the elderly, particularly for older adults with diminished kidney function, starting with lower doses. Before conducting allergy skin tests, it is important to discontinue this medication to avoid affecting test results. In case of overdose, symptoms such as drowsiness or anxiety may appear, and since no specific antidote exists, treatment should be symptomatic. This medication is not effectively cleared by dialysis, so urgent medical treatment is required in case of an overdose.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • swelling
  • angioedema
  • anaphylactic shock
  • hypertension
  • difficulty breathing

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • drowsiness
  • fatigue
  • dizziness
  • heaviness in the head
  • excitability
  • dry mouth
Show 27 more
  • dry lips
  • nausea
  • decreased appetite
  • discomfort in the stomach
  • indigestion
  • abdominal pain
  • gastric pain
  • discomfort in the abdomen
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbances
  • tachycardia
  • arrhythmia
  • increased blood pressure
  • 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 special container that does not allow light to enter, and it is best kept at a temperature between 1 and 30 degrees Celsius, which helps maintain its efficacy and safety.

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.