Medication info

Levotidine Tablet (Levocetirizine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 201907155 · Notified 2019.10.10

This product's status changed to Approval withdrawn on 2024.03.21. 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: Administer 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day regardless of meals. Adjust as appropriate according to age and symptoms. For patients with renal impairment, adjust the dosage according to creatinine clearance (CLCR). - Mild (50 ≤ CLCR < 80): 1 tablet once a day - Moderate (30 ≤ CLCR < 50): 1 tablet twice a week - Severe (10 ≤ CLCR < 30): 1 tablet every three days
Child dose
Children aged 6 years and older: Administer 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day regardless of meals. Adjust as appropriate according to age and symptoms.

Ingredients

Manufacturer
지엘파마(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 is used to relieve symptoms associated with seasonal and perennial allergic rhinitis. It also helps manage symptoms of chronic idiopathic urticaria. It is effective in relieving itching due to dermatitis and eczema and can be used in combination with hydrocortisone topical preparations. This medication is effective in improving various allergy and skin disease symptoms.

How to take

Adult dose

Adults: Administer 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day regardless of meals. Adjust as appropriate according to age and symptoms. For patients with renal impairment, adjust the dosage according to creatinine clearance (CLCR). - Mild (50 ≤ CLCR < 80): 1 tablet once a day - Moderate (30 ≤ CLCR < 50): 1 tablet twice a week - Severe (10 ≤ CLCR < 30): 1 tablet every three days

Child dose

Children aged 6 years and older: Administer 1 tablet (Levocetirizine Hydrochloride 5mg) orally once a day regardless of meals. Adjust as appropriate according to age and symptoms.

Precautions

This medication should not be used by those who are allergic to certain components or have had hypersensitivity to hydroxizine or piperazine derivatives in the past. It should also not be administered to patients with severely impaired kidney function or those undergoing hemodialysis. It is safer for pregnant women or those who may become pregnant, as well as breastfeeding women, to avoid taking this medication. It must not be given to infants under 1 year of age, and children under 6 years should be given a liquid formulation instead of tablets. Patients with kidney or liver problems, as well as elderly individuals, should use this medication cautiously as the body concentration may increase. Taking this medication may lead to side effects such as drowsiness, fatigue, headache, and dizziness. In the gastrointestinal system, dry mouth, nausea, abdominal pain, and diarrhea may occur, so caution is advised. Rarely, cardiovascular abnormalities such as irregular heartbeats or increased blood pressure may occur. There have been reports of blood-related problems, allergic reactions, skin rashes, and visual disturbances. Liver and kidney function test values may change, so routine check-ups may be necessary. Drowsiness or lethargy may occur after taking this medication, so caution is needed when driving or operating machinery that requires concentration. Additionally, caution should be exercised to avoid increased drowsiness when taken in conjunction with alcohol or centrally acting depressants. This medication may increase the risk of urinary elimination disorders, so patients with urinary elimination problems such as spinal injuries or benign prostatic hyperplasia should be especially cautious. Taking this medication with alcohol may exacerbate side effects; therefore, it should not be combined. Interactions with other medications are relatively low, but it may affect certain drugs, so consultation with an expert is necessary if taking any other medications. Pregnant or breastfeeding women are safer not to take this medication, particularly since the drug components may be transmitted to babies through breast milk. In children, dosage adjustments are necessary for those under 12 years of age, and it must not be used in infants under 1 year of age. Elderly individuals are likely to have reduced kidney function, which may increase the drug's concentration, so it is important to start with a low dosage and monitor the condition closely. It is necessary to stop taking this medication before allergy testing to ensure accurate results. If overdosed, adults may experience severe drowsiness, while children may show restlessness and agitation. There is no specific antidote, so treatment should be symptomatic, and gastric lavage may be performed if necessary. This medication is not easily removed by hemodialysis, so immediate contact with a medical institution is recommended in case of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylactic shock
  • edema
  • increased blood pressure
  • respiratory distress
  • urticaria

Mild side effects

  • Drowsiness
  • lethargy
  • headache
  • numbness
  • sleepiness
  • fatigue
  • dizziness
  • heaviness in the head
  • excitement
  • thirst
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  • dry lips
  • nausea
  • loss of appetite
  • discomfort in the stomach
  • indigestion
  • abdominal pain
  • stomach ache
  • abdominal discomfort
  • vomiting
  • gastrointestinal disturbances
  • diarrhea
  • cheilitis
  • taste disorders
  • tachycardia
  • arrhythmia
  • increased blood pressure
  • 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 sensitive to light, so it should be stored in a container that is not exposed to light. Moreover, it is best to store the medication at room temperature between 1 to 30 degrees Celsius, rather than in extremely hot or cold places.

Appearance and packaging

Appearance

White or light yellow oval film-coated tablet

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.