Medication info
Setirizine Tablets (Levocetirizine Hydrochloride)

Setirizine Tablets (Levocetirizine Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Levocetirizine Hydrochloride›5mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
White or off-white circular film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200804797 · Notified 2008.04.28 · Insurance code 651202590

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 and older: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once a day, regardless of meals. Patients with renal impairment should adjust the dose according to renal function (eGFR). - Normal renal function (≥ 90 mL/min): 1 tablet, once daily - Mild renal impairment (60 -< 90 mL/min): 1 tablet, once daily - Moderate renal impairment (30 -< 60 mL/min):
Child dose
Children aged 6 and older: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once a day, regardless of meals.

Ingredients

Manufacturer
삼천당제약(주)

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 the symptoms of seasonal or perennial allergic rhinitis and chronic idiopathic urticaria. Additionally, it enhances the effects of hydrocortisone topical agents in reducing itching caused by dermatitis or eczema. It helps improve a variety of allergy and skin-related symptoms.

How to take

Adult dose

Adults and children aged 6 and older: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once a day, regardless of meals. Patients with renal impairment should adjust the dose according to renal function (eGFR). - Normal renal function (≥ 90 mL/min): 1 tablet, once daily - Mild renal impairment (60 -< 90 mL/min): 1 tablet, once daily - Moderate renal impairment (30 -< 60 mL/min):

Child dose

Children aged 6 and older: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once a day, regardless of meals.

Precautions

This medicine should not be used by patients who have had an allergic reaction or hypersensitivity to specific ingredients. It should not be administered to patients with severely impaired kidney function or those undergoing dialysis. Women who are pregnant or may become pregnant, as well as nursing mothers, should avoid using this medication. It should not be administered to infants under 1 year old, and it is recommended to give liquid form to children under 6 years old instead of tablets. Patients with lactose intolerance or certain genetic lactose metabolism disorders should avoid this medication containing lactose. Patients with reduced kidney or liver function, as well as the elderly, should use this medication with caution as the blood concentration may increase. This medication may cause drowsiness, fatigue, headache, or dizziness; caution is needed when driving or operating machinery. Gastrointestinal symptoms such as dyspepsia, nausea, or abdominal pain may occur, and severe symptoms should be discussed with a doctor. Rarely, abnormal heartbeats or blood-related adverse reactions may occur, so any unusual symptoms should be immediately reported to healthcare professionals. Taking this medication along with alcohol or central nervous system depressants may worsen drowsiness or decrease concentration, so it is best to avoid simultaneous use. Pregnant and nursing women should avoid this medication as its safety has not been sufficiently established. Dosing for children and elderly may need adjustments depending on physical condition, and it is essential to follow a healthcare professional's instructions. This medication can affect allergy tests, so it is recommended to stop taking it prior to testing. In case of overdose, symptoms such as drowsiness or agitation may occur, and there is no specific antidote; treatment should be symptomatic. Because this medication is difficult to remove by dialysis, rapid medical intervention is necessary in case of overdose.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, anaphylactic shock, severe rash with fever, blisters, skin peeling, pain in the oral/ocular mucosa, severe skin adverse reactions, asthma attacks, respiratory abnormalities accompanied by cough+fever, difficulty breathing, visual disturbances, hepatitis, yellowing of skin or eyes (jaundice), extreme drowsiness, sudden and severe headaches, seizures, confusion of consciousness,

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • fatigue
  • dizziness
  • heaviness in head
  • excitement
  • thirst
  • dry lips
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  • nausea
  • loss of appetite
  • discomfort in the stomach
  • dyspepsia
  • abdominal pain
  • stomach ache
  • discomfort in the abdomen
  • vomiting
  • gastrointestinal disorders
  • diarrhea
  • cheilitis
  • taste disturbance
  • 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 is light-sensitive and should be stored in a tightly closed container that blocks light. It is best to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness and safety for a long time.

Appearance and packaging

Appearance

White or off-white circular 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.