Medication info

Samsung Levocetirizine (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Levocetirizine Hydrochloride›5mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
White or pale yellow oval film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201904211 · Notified 2019.06.17

This product's status changed to Approval withdrawn on 2024.01.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms such as allergic rhinitis and chronic urticaria
Who takes it
Adults · Children
Adult dose
Adults and children over 6 years old should take 1 tablet (Levocetirizine Hydrochloride 5mg) once a day orally, regardless of meals. The dosage may be adjusted based on age and symptoms. For patients with renal impairment, the dosage should be adjusted according to kidney function (creatinine clearance). - 50 ≤ CLCR < 80: 1 tablet once daily - 30 ≤ CLCR < 50: 1 tablet every 2 days - 10 ≤ CLCR < 30: 1 tablet every 3 days
Child dose
Children over 6 years old should take 1 tablet (Levocetirizine Hydrochloride 5mg) once a day orally, regardless of meals, the same as adults.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Relief of symptoms such as allergic rhinitis and chronic urticaria

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

This medication alleviates symptoms of seasonal or perennial allergic rhinitis and helps improve symptoms of chronic idiopathic urticaria. It can also be used in conjunction with topical hydrocortisone to relieve symptoms in cases of dermatitis and eczema accompanied by itching. It is effectively used to alleviate symptoms of various allergic and inflammatory diseases.

How to take

Adult dose

Adults and children over 6 years old should take 1 tablet (Levocetirizine Hydrochloride 5mg) once a day orally, regardless of meals. The dosage may be adjusted based on age and symptoms. For patients with renal impairment, the dosage should be adjusted according to kidney function (creatinine clearance). - 50 ≤ CLCR < 80: 1 tablet once daily - 30 ≤ CLCR < 50: 1 tablet every 2 days - 10 ≤ CLCR < 30: 1 tablet every 3 days

Child dose

Children over 6 years old should take 1 tablet (Levocetirizine Hydrochloride 5mg) once a day orally, regardless of meals, the same as adults.

Precautions

This medication should not be used by patients who are allergic to specific ingredients or have been sensitive to hydroxyzine or piperazine derivatives in the past. It is safest not to administer to patients with severely impaired kidney function or those on hemodialysis. Women who are pregnant or may become pregnant, as well as those who are breastfeeding, should not take this medication. It should never be given to infants under 1 year old and should only be given in liquid form to children under 6 years old, not in tablet form. This medication contains lactose, so patients who have issues digesting lactose should not use it. Caution is required for patients with compromised kidney or liver function, and elderly patients, as the concentration of this medication in the body may be higher. While taking this medication, drowsiness, fatigue, and lethargy may occur, so extra caution is needed when performing tasks that require focus like driving or operating machinery. Taking this medication with alcohol or other central nervous system depressants can exacerbate drowsiness or impaired concentration and should be avoided. Patients with urinary retention issues or conditions like benign prostatic hyperplasia should use this medication with caution. This medication can cause various side effects, commonly including drowsiness, headache, dizziness, nausea, and abdominal pain. Rarely, serious side effects such as skin rash, itching, blood abnormalities, and liver function abnormalities have been reported, so immediate medical consultation is advisable if any unusual symptoms occur. In clinical trials and post-marketing surveys, some patients taking this medication reported symptoms like fever, diarrhea, vomiting, and otitis media. During pregnancy or breastfeeding, it is safe to avoid this medication, and special caution is required for pregnant women as sufficient research has not been conducted. Children and elderly patients require dose adjustments due to different kidney functions, and especially in the elderly, it is advised to start at a low dose and monitor the condition. It is recommended to stop taking this medication 3-5 days prior to skin response tests such as allergy testing. In case of overdose, drowsiness or restlessness may occur, and since there is no specific antidote, treatment should be based on symptoms. This medication is not removed by hemodialysis, so rapid medical attention is required in case of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Anaphylaxis
  • angioedema
  • urticaria
  • breathlessness
  • hypertension
  • edema

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • sluggishness
  • fatigue
  • dizziness
  • heaviness in the head
  • excitement
  • thirst
Show 27 more
  • dry lips
  • nausea
  • loss of appetite
  • stomach discomfort
  • dyspepsia
  • abdominal pain
  • stomach ache
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disturbances
  • tachycardia
  • arrhythmias
  • elevated blood pressure
  • palpitations
  • vasculitis
  • leukopenia
  • neutropenia
  • 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

Store this medication in a container that protects it from light, as it is sensitive to light. Additionally, it is best to store it at room temperature between 1 to 30 degrees Celsius. By storing it this way, the medication's effectiveness and safety can be maintained.

Appearance and packaging

Appearance

White or pale yellow oval 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.