Medication info

Tirizine 10 mg (Cetirizine Hydrochloride)

OTC medicationTabletApproval withdrawn
Ingredient · strength
Cetirizine Hydrochloride›10mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
White oval film-coated tablet
Packaging
10 tablets/box [10 tablets/PTP x 1]
Approval status
Approval withdrawn

MFDS item code 200003096 · Notified 2000.06.21

This product's status changed to Approval withdrawn on 2025.08.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of allergy symptoms such as allergic rhinitis, conjunctivitis, and chronic urticaria
Who uses it
Adults · Children
Adult dosage
Adults and children over 6 years of age should take 10 mg of cetirizine hydrochloride orally once daily before bedtime. In cases of sensitivity to adverse reactions, it can be divided into 5 mg doses taken in the morning and evening. Dosage should be adjusted appropriately based on age and symptoms, and patients with renal impairment should have their dosing intervals and amounts adjusted according to renal function.
Children's dosage
For children over 6 years of age, administer 10 mg orally once daily before bedtime. Children with renal impairment should have their dosage adjusted individually based on renal clearance and body weight.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Relief of allergy symptoms such as allergic rhinitis, conjunctivitis, and chronic urticaria

  • Seasonal allergic rhinitis
  • perennial allergic rhinitis
  • allergic conjunctivitis
  • chronic idiopathic urticaria
  • pruritus
  • eczema
  • dermatitis
View approved original text

This medication helps relieve seasonal allergic rhinitis, perennial allergic rhinitis, allergic conjunctivitis, chronic idiopathic urticaria, and pruritus. Additionally, it is effective in improving symptoms when used with hydrocortisone ointment in the treatment of eczema and dermatitis. It is used for various allergic and skin-related conditions.

Dosage and Administration

Adult dosage

Adults and children over 6 years of age should take 10 mg of cetirizine hydrochloride orally once daily before bedtime. In cases of sensitivity to adverse reactions, it can be divided into 5 mg doses taken in the morning and evening. Dosage should be adjusted appropriately based on age and symptoms, and patients with renal impairment should have their dosing intervals and amounts adjusted according to renal function.

Children's dosage

For children over 6 years of age, administer 10 mg orally once daily before bedtime. Children with renal impairment should have their dosage adjusted individually based on renal clearance and body weight.

Precautions

This medication should not be taken by individuals with allergies to certain ingredients or a history of hypersensitivity. Patients with severely impaired renal function and children under 6 years old should not use this medication. Individuals with lactose intolerance or specific genetic disorders should also refrain from taking this medication. It is important not to take this medication in conjunction with certain drugs, such as theophylline or ritonavir, as they may affect the efficacy of the medication. Taking this medication with alcohol can exacerbate side effects and should be avoided. Patients with kidney or liver problems, elderly patients, individuals with epilepsy, and women who are pregnant or breastfeeding should consult a physician or pharmacist before use. Especially, elderly patients with decreased kidney function may have elevated blood concentrations of this medication and may require dosage adjustments. There are insufficient safety data for pregnant women, so caution is advised, and breastfeeding women should be aware that this medication may be excreted in breast milk. If severe side effects or abnormal symptoms occur while taking this medication, it should be stopped immediately, and medical personnel should be consulted. In case of overdose, confusion, drowsiness, headache, and urinary issues may occur, and there is no specific antidote, so treatment should be symptomatic. It is advisable to discontinue this medication before allergy testing and caution is needed while driving or operating machinery. Taking this medication with food may delay absorption but does not significantly affect its efficacy. Lastly, keep this medication out of the reach of children, and store it in its original container to maintain its safety and quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Confusion
  • diarrhea
  • dizziness
  • fatigue
  • headache
  • malaise
  • dilated pupils
  • itching
  • anxiety
  • sedation
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  • drowsiness
  • stupor
  • tachycardia
  • tremors
  • urinary retention
  • sleepiness
  • headache
  • occasional malaise
  • numbness
  • weakness
  • anxiety
  • sensory disturbances
  • mild and transient lethargy
  • fatigue
  • dizziness
  • heavy-headedness
  • excitement
  • convulsions
  • movement disorders
  • muscle tension abnormalities
  • fainting
  • tremors
  • aggressiveness
  • confusion
  • depression
  • hallucinations
  • insomnia
  • tic disorders
  • amnesia

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is best to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP x 1]

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.