Medication info

Setinjale Liquid (Levocetirizine Hydrochloride)

Prescription medicationSolution경구
Ingredient · strength
Levocetirizine Hydrochloride›0.05g / 100mL
Manufacturer / importer
(주)팜젠사이언스
Appearance
Colorless transparent solution in a brown glass or plastic bottle
Packaging
500 milliliters per bottle
Approval status
Active

MFDS item code 200807005 · Notified 2008.06.25 · Insurance code 670102321

Summary

Main use
Relief of symptoms of allergic rhinitis and chronic urticaria
Who takes it
Adults · Children
Adult dose
Adults and children aged 6 years and older: 5 mg (10 mL as a liquid) of levocetirizine hydrochloride, taken orally once a day, regardless of meals. Adults with renal impairment should adjust the dosage based on their kidney function (estimated glomerular filtration rate (eGFR)). - Normal kidney function (≥ 90 mL/min): 1 dose of 5 mg, once a day. - Mild renal impairment (60 -< 90 mL/min): 1 dose of 5 mg, once a day. -
Child dose
Children aged 2 years or older but less than 6 years: 1.25 mg (2.5 mL as a liquid), taken orally twice a day. Children aged 1 year or older but less than 2 years: 1.25 mg (2.5 mL as a liquid), taken orally once a day.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Relief of symptoms of allergic rhinitis and chronic urticaria

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

This medication is used to relieve symptoms caused by seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. It can also be used in conjunction with hydrocortisone topical agents for the treatment of dermatitis and eczema accompanied by itching, primarily applicable to adults and children aged 6 years or older. It effectively alleviates these symptoms, helping to make the patient's daily life more comfortable.

How to take

Adult dose

Adults and children aged 6 years and older: 5 mg (10 mL as a liquid) of levocetirizine hydrochloride, taken orally once a day, regardless of meals. Adults with renal impairment should adjust the dosage based on their kidney function (estimated glomerular filtration rate (eGFR)). - Normal kidney function (≥ 90 mL/min): 1 dose of 5 mg, once a day. - Mild renal impairment (60 -< 90 mL/min): 1 dose of 5 mg, once a day. -

Child dose

Children aged 2 years or older but less than 6 years: 1.25 mg (2.5 mL as a liquid), taken orally twice a day. Children aged 1 year or older but less than 2 years: 1.25 mg (2.5 mL as a liquid), taken orally once a day.

Precautions

This medication should not be used by patients who have had allergies or hypersensitivity to specific ingredients. Patients with end-stage renal disease or those undergoing dialysis should not take this medication. This medication should not be administered to infants under 1 year of age, and for children under 6 years old, the liquid form should be used instead of tablets. The liquid form contains maltitol, so patients who cannot properly break down fructose due to congenital issues should avoid taking it. Patients with kidney or liver function problems, as well as elderly individuals, should use this medication with caution as blood levels may rise. Various neurological symptoms such as drowsiness, headache, dizziness, and fatigue may occur after taking this medication. Gastrointestinal side effects may include dry mouth, nausea, abdominal pain, and diarrhea. Heart rate may increase or become irregular, and in rare cases, blood pressure may rise or palpitations may occur. Hematologic adverse reactions have been reported, including decreased white blood cell counts and changes in platelet levels. Allergic reactions such as rash, itching, swelling, and in severe cases, anaphylactic shock may occur, so caution is advised. Eye-related symptoms may include blurred vision, conjunctival injection, and ocular motility abnormalities. Liver and kidney function abnormalities may occur, so regular monitoring may be required. In children, symptoms such as fever, diarrhea, vomiting, and otitis media may commonly occur. After taking this medication, drowsiness or fatigue may occur, so caution is required for activities like driving or operating machinery. Taking this medication along with alcohol or other drugs affecting the central nervous system may exacerbate drowsiness or decrease concentration, so it should be avoided. Patients with urinary retention disorders or prostatic hyperplasia should use this medication with caution due to the risk of urinary retention. Patients with epilepsy or at risk of seizures should use this medication cautiously as symptoms may worsen after taking it. The liquid contains preservatives and sweeteners, which may cause allergic reactions or health issues, and thus caution is necessary. Pregnant women should carefully consider the potential effects on the fetus when using this medication. Lactating women should be cautious as this medication may be excreted in breast milk, which may cause adverse reactions in infants. Experience with this medication in infants under 1 year of age is limited; therefore, it is safer to avoid administering it to them. Elderly individuals may have reduced kidney function, so the dosage of this medication should be adjusted appropriately, and if any unusual symptoms occur, they should discontinue use and consult a doctor. For some clinical tests, including allergy tests, it is advisable to temporarily discontinue this medication. In case of overdose, symptoms such as drowsiness or agitation may occur, and no specific antidote is available, so symptomatic treatment should be provided. This medication is not removed by dialysis, so appropriate medical measures should be taken quickly in the event of overdose.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, rash, angioedema, anaphylactic shock, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory disturbances with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures,

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • agitation
  • drowsiness
  • fatigue
  • dizziness
  • heaviness in the head
  • excitement
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  • thirst
  • dryness of the lips
  • nausea
  • loss of appetite
  • discomfort in the stomach
  • indigestion
  • abdominal pain
  • gastric discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • altered taste
  • tachycardia
  • arrhythmia
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • lymphocytosis
  • eosinophilia
  • monocytosis
  • thrombocytosis
  • thrombocytopenia
  • photosensitivity
  • rash
  • pruritus

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

Storage

This medication should be stored in a tightly sealed container that blocks light, and it is important to keep it at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

Colorless transparent solution in a brown glass or plastic bottle

Package unit

500 milliliters per 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.