Setizal Tablets (Levocetirizine Hydrochloride)

Adult dose

Adults and children over 6 years: Administer 1 tablet (5 mg of levocetirizine hydrochloride) orally once daily, regardless of meals. Adjust according to age and symptoms. In patients with renal impairment, dosage must be adjusted based on kidney function (creatinine clearance rate (CLCR)). The following are the recommended doses and frequencies based on creatinine clearance rate. - Mild (50 ≤ CLCR < 80): 1 tablet once daily - Moderate (30 ≤ CLCR < 50)

Child dose

Children over 6 years: Administer 1 tablet (5 mg of levocetirizine hydrochloride) orally once daily, regardless of meals.

This medication should not be used by patients with allergies or hypersensitivity to specific ingredients. It should also not be administered to patients with severely impaired kidney function or those undergoing dialysis. It is safest for pregnant or potentially pregnant women, as well as nursing mothers, to avoid this medication. It should not be given to infants under 1 year of age, and it is recommended to administer a liquid formulation rather than tablets to children under 6 years of age. This medication contains lactose, so patients with lactose intolerance or inherited lactose enzyme deficiency should avoid it. Patients with impaired kidney or liver function, and elderly patients, should use this medication cautiously as it may lead to increased blood concentration. Drowsiness, fatigue, and dizziness may occur during use, necessitating caution when driving or operating machinery. Concurrent use with alcohol or drugs affecting the central nervous system should be avoided as it can exacerbate symptoms. Patients with difficulty in urinary excretion should be cautious as this medication may worsen their symptoms. Various side effects can occur with this medication, especially in children where fever, diarrhea, vomiting, and otitis media are commonly reported. Pregnant or nursing women are advised not to take this medication due to insufficient safety studies. In elderly patients, dosages may need to be adjusted and their condition should be closely monitored as kidney function declines may prolong the drug's presence in the body. It may be helpful to temporarily discontinue this medication prior to certain clinical tests such as allergy tests. Overdose may result in symptoms such as drowsiness or restlessness, and as there is no specific antidote, treatment should be symptom-oriented. This medication is not easily removed by dialysis, so caution is necessary in case of overdose.

Serious side effects

• Urticaria
• severe swelling (edema)
• angioedema
• anaphylactic shock
• hypertension
• respiratory distress

Mild side effects

• Drowsiness
• lethargy
• headache
• numbness
• somnolence
• fatigue
• dizziness
• heaviness
• excitement
• thirst

This medication should be stored in a container that blocks light, as it is sensitive to light, and should be kept at room temperature between 1 to 30 degrees Celsius. This helps maintain the drug's effectiveness and allows for safe use.

Appearance

White or pale yellow oval film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle