Medication info
Levoceltac Tablet (Levocetirizine Hydrochloride)

Levoceltac Tablet (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 200803800 · Notified 2008.04.04

This product's status changed to Approval withdrawn on 2024.07.18. 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: 1 tablet (5 mg as levocetirizine hydrochloride), taken orally once a day, without regard to meals. Patients with renal impairment should adjust the dose according to their renal function (Creatinine clearance (CLCR(mL/min)). - Mild (50 ≤ CLCR < 80): 1 tablet once a day - Moderate (30 ≤ CLCR < 50): 1 tablet every other day - Severe (10 ≤ CLCR < 30):
Child dose
Children aged 6 years and older: 1 tablet (5 mg as levocetirizine hydrochloride), taken orally once a day, without regard to meals.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Relief of symptoms such as allergic rhinitis and chronic urticaria

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

This medication is used to relieve symptoms of seasonal or perennial allergic rhinitis and chronic idiopathic urticaria, as well as skin conditions associated with itching, such as dermatitis or eczema.

How to take

Adult dose

Adults and children aged 6 years and older: 1 tablet (5 mg as levocetirizine hydrochloride), taken orally once a day, without regard to meals. Patients with renal impairment should adjust the dose according to their renal function (Creatinine clearance (CLCR(mL/min)). - Mild (50 ≤ CLCR < 80): 1 tablet once a day - Moderate (30 ≤ CLCR < 50): 1 tablet every other day - Severe (10 ≤ CLCR < 30):

Child dose

Children aged 6 years and older: 1 tablet (5 mg as levocetirizine hydrochloride), taken orally once a day, without regard to meals.

Precautions

This medication should not be used in patients with known allergies to specific components or those who have previously experienced allergic reactions to hydroxyzine or piperazine derivatives. It is advisable not to administer this drug to patients with severely impaired renal function or those undergoing dialysis. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication. This drug should not be given to infants under 1 year of age, and for children under 6 years, it is preferable to administer in liquid form rather than tablet form. This medication contains lactose; therefore, patients with lactose intolerance or hereditary lactose metabolism disorders should avoid it. Patients with impaired kidney or liver function, as well as the elderly, should use this drug with caution, as it may remain in the body for an extended period. Taking this medication may lead to central nervous system side effects such as drowsiness, headache, and dizziness; hence, caution is advised when driving or operating hazardous machinery. Gastrointestinal discomfort may occur, and rarely, cardiac arrhythmias or hematological adverse reactions may also occur. Additionally, hypersensitivity reactions such as skin rashes, itching, and blurred vision can occur; consult a healthcare professional immediately if any abnormal symptoms are experienced. During the use of this medication, it is advisable not to consume alcohol or other drugs that affect the central nervous system. Particularly in combination with alcohol, drowsiness or decreased concentration may worsen, so caution is advised. It is safe for pregnant or breastfeeding women to avoid this drug due to the possibility of it being transmitted through breast milk. For children, dosage adjustments are necessary for those under 12 years, and it is recommended not to use the drug for infants under 1 year. Elderly patients may experience excessive accumulation of the drug in the body due to reduced kidney function, so starting at a low dose and closely monitoring their condition is recommended. It is prudent to stop taking this medication before allergy testing, as its use can affect test results. In cases of overdose, drowsiness or agitation may occur, and there is no specific antidote, so symptomatic treatment should be provided; this drug cannot be effectively removed by dialysis.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • angioedema
  • anaphylactic shock
  • rash
  • increased blood pressure
  • respiratory distress
  • urticarial reaction

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • drowsiness
  • fatigue
  • dizziness
  • heaviness in the head
  • excitement
  • thirst
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  • dry lips
  • nausea
  • loss of appetite
  • discomfort in the stomach
  • dyspepsia
  • abdominal pain
  • stomach pain
  • discomfort in the abdomen
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbance
  • tachycardia
  • arrhythmia
  • increased blood pressure
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • lymphocytosis
  • eosinophilia
  • monocytosis
  • increased platelets
  • decreased platelets
  • photosensitivity
  • rash

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

Storage

This drug may be sensitive to light, so it should be stored in a container that blocks light. Additionally, it is best to keep it at a temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy for a longer period.

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.