Medication info
Setinjal Tablets 5 mg (Levocetirizine Hydrochloride)

Setinjal Tablets 5 mg (Levocetirizine Hydrochloride)

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

MFDS item code 200804360 · Notified 2008.04.21 · Insurance code 670102300

Summary

Main use
Relief of symptoms such as allergic rhinitis and chronic urticaria
Who takes it
Adults · Children
Adult dose
Adults and children 6 years and older: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once a day, regardless of meals. For patients with kidney impairment, the dose should be adjusted according to renal function (estimated glomerular filtration rate (eGFR)), with normal kidney function (≥90 mL/min) and mild impairment (60-<90 mL/min) taking 1 tablet once daily, moderate impairment (30-<60 mL/min) taking 1 tablet every 2 days, and severe impairment
Child dose
Children 6 years and older: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once a day, regardless of meals.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Relief of symptoms such as allergic rhinitis and chronic urticaria

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

This medication is used to relieve the symptoms of seasonal and perennial allergic rhinitis and to improve the symptoms of chronic idiopathic urticaria and skin disorders such as dermatitis and eczema accompanied by itching.

How to take

Adult dose

Adults and children 6 years and older: Take 1 tablet (Levocetirizine Hydrochloride 5 mg) orally once a day, regardless of meals. For patients with kidney impairment, the dose should be adjusted according to renal function (estimated glomerular filtration rate (eGFR)), with normal kidney function (≥90 mL/min) and mild impairment (60-<90 mL/min) taking 1 tablet once daily, moderate impairment (30-<60 mL/min) taking 1 tablet every 2 days, and severe impairment

Child dose

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

Precautions

This drug should not be used in patients who are allergic to specific ingredients or who are hypersensitive to hydroxyzine or piperazine derivatives. It is safe to avoid this drug in patients with very poor kidney function or those undergoing dialysis, as well as in pregnant women or women who may become pregnant, and in nursing mothers. This drug should not be used in infants under 1 year of age, and children under 6 years should take the liquid form instead of the tablets. This drug contains lactose, so patients with lactose intolerance or certain genetic lactose digestion enzyme deficiencies should avoid taking it. Patients with reduced kidney or liver function, as well as elderly individuals, should use this drug with caution as it may increase blood concentration. This drug may cause central nervous system symptoms such as drowsiness, fatigue, headache, and dizziness, so caution is advised when driving or operating hazardous machinery. Additionally, taking this drug with alcohol or other central nervous system depressants may exacerbate drowsiness or impaired concentration, so it is best to avoid this combination. Patients with urinary function issues should be cautious, as this drug may worsen urinary retention. As with other antihistamines, this medication should not be taken with excessive alcohol, and while there are few drug interactions, certain medications should be used with caution. Pregnant or nursing women are advised not to take this drug, particularly since there is a possibility of the drug being transferred through breast milk. For children, those under 12 years should adhere to the recommended dosages, and it is advisable not to use it in infants under 1 year of age. Elderly patients may retain the drug longer due to reduced kidney function, so starting with a lower dose is recommended, and if adverse effects occur, the dose should be reduced or discontinued. It is advisable to stop taking this drug before allergy testing, and in cases of overdose, symptoms such as drowsiness or agitation may occur, requiring immediate medical assistance. This drug is not removed by dialysis; therefore, supportive treatment is necessary in cases of overdose.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, numbness, urination

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • dullness
  • fatigue
  • dizziness
  • heaviness in head
  • excitement
  • thirst
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  • dry lips
  • nausea
  • loss of appetite
  • discomfort in upper abdomen
  • dyspepsia
  • abdominal pain
  • stomach ache
  • discomfort in abdomen
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • altered taste
  • tachycardia
  • arrhythmia
  • increased blood pressure
  • palpitations
  • vasculitis
  • decreased white blood cells
  • decreased neutrophils
  • increased lymphocytes
  • increased eosinophils
  • increased monocytes
  • increased platelets
  • decreased platelets
  • photosensitivity
  • rash

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

Storage

This medication is sensitive to light, so it should be stored in a container that blocks light. Additionally, it is important to store it at a temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

White or yellowish oval film-coated tablets

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.