Medication info

Boryeong Levocetirizine Hydrochloride Tablets

Prescription medicationApproval withdrawn
Ingredient · strength
Levocetirizine Hydrochloride›Strength being verified
Manufacturer / importer
(주)보령
Appearance
White or pale yellow oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201906067 · Notified 2019.08.26

This product's status changed to Approval withdrawn on 2023.08.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms of allergic rhinitis (seasonal, perennial) and chronic urticaria
Who uses it
Adults · Children
Adult dosage
Adults and children 6 years and older: Take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once daily, regardless of meals. The dosage may be adjusted according to age and symptoms. Patients with renal impairment should adjust the dose based on kidney function (Creatinine clearance (CLCR)). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet every other day.
Children's dosage
Adults and children 6 years and older: Take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once daily, regardless of meals.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Relief of symptoms of allergic rhinitis (seasonal, perennial) and chronic urticaria

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

This medication is primarily used to relieve nasal and ocular discomfort caused by seasonal or perennial allergic rhinitis. It also helps reduce skin rashes and itching associated with chronic idiopathic urticaria. It can be used in combination with hydrocortisone topical to alleviate symptoms when itching due to dermatitis and eczema occurs. Through the relief of various allergy and skin-related symptoms, it improves the quality of life for patients.

Dosage and Administration

Adult dosage

Adults and children 6 years and older: Take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once daily, regardless of meals. The dosage may be adjusted according to age and symptoms. Patients with renal impairment should adjust the dose based on kidney function (Creatinine clearance (CLCR)). - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50): 1 tablet every other day.

Children's dosage

Adults and children 6 years and older: Take 1 tablet (5mg of Levocetirizine Hydrochloride) orally once daily, regardless of meals.

Precautions

This medicine should not be used in patients with known allergic reactions to specific components or with a history of hypersensitivity. It is also safe not to administer to patients with severely impaired kidney function or those undergoing dialysis. Women who are pregnant or potentially pregnant, as well as nursing mothers, should not take this medication. It should not be used in infants under 1 year of age, and in children under 6 years, it is recommended to administer in liquid form rather than tablet form. This tablet contains lactose, so patients with lactose intolerance or specific genetic defects in lactose metabolism should avoid taking this medication. Patients with kidney or liver problems, as well as the elderly, should use this medication cautiously as its concentration may remain high in the body. While taking this medication, symptoms such as drowsiness, fatigue, and dizziness may occur. Caution should be taken when performing activities that require alertness, such as driving or operating machinery. Using this medication alongside alcohol or other drugs that affect the central nervous system can intensify drowsiness or decreased concentration, therefore co-administration should be avoided. Patients with urinary excretion problems or those at risk of urinary retention, such as those with benign prostatic hyperplasia, should take caution when using this medication. It is advisable to stop taking this medication before undergoing allergy tests, and overdose may lead to drowsiness or agitation, with no specific antidote available, thus requiring symptomatic treatment. Elderly patients should take care when adjusting the dose as the medication may remain in the body longer due to decreased kidney function.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • swelling
  • increased blood pressure
  • angioedema
  • anaphylactic shock
  • rash
  • difficulty breathing
  • urticaria.

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • somnolence
  • fatigue
  • dizziness
  • heaviness in the head
  • excitement
  • thirst
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  • dry lips
  • nausea
  • loss of appetite
  • abdominal discomfort
  • dyspepsia
  • abdominal pain
  • gastric pain
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste abnormalities
  • tachycardia
  • arrhythmia
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • lymphocytosis
  • eosinophilia
  • monocytosis
  • thrombocytosis
  • thrombocytopenia
  • photosensitivity
  • rash
  • itching
  • vision changes.

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

Storage

This medication may be sensitive to light, so it should be stored in a tightly closed container that blocks light. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will help preserve the effectiveness and safety of the medication.

Appearance and packaging

Appearance

White or pale yellow oval film-coated tablet

Package unit

30 tablets/bottle, 100 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.