Product Overview
【Drug Name】
Generic Name: Levocetirizine Hydrochloride Tablets
Brand Name: Youze
English Name: Levocetirizine Dihydrochloride Tablets
Pinyin: YanSuanZuoXiTiLiZuoPian(YouZe)
【Ingredients】
The main ingredient of this product is levocetirizine hydrochloride. Molecular weight: C21H25ClN2O3·2HCl
【Appearance】
This product is a white film-coated tablet; after removing the coating, it is white.
【Indications】
Treatment of allergy-related symptoms of the following diseases, such as seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria.
【Dosage and Administration】
1. Route of administration: Oral.
2. Dosage and method of administration: Adults and children aged 6 years and above: Take one tablet (5mg) orally daily, on an empty stomach, with meals, or after meals.
【Adverse Reactions】
Allergic reactions, dyspnea, nausea, angioedema, pruritus, urticaria, rash, and weight gain.
【Contraindications】
1. Contraindicated in patients with hypersensitivity to any component of this product or to piperazine derivatives.
2. Contraindicated in patients with end-stage renal disease and a creatinine clearance of 10 ml/min.
3. Contraindicated in patients with specific genetic disorders (including rare galactose intolerance, primary lactase deficiency, or glucose-galactose malabsorption).
【Precautions】
1. As this product cannot currently be halved, it is not recommended for children under 6 years of age.
2. Although there is currently no research data, concomitant use of levocetirizine with alcohol or central nervous system depressants may affect the central nervous system in some sensitive patients.
3. Effects on driving and operating machinery: Controlled clinical trials have shown that levocetirizine at the recommended dose does not impair alertness, reaction time, or driving ability. If a patient needs to drive, engage in potentially hazardous activities, or operate machinery, do not overdose and consider their reaction to this product; concomitant use of alcohol or other central nervous system depressants may lead to decreased alertness and impaired operating ability. Please read the instructions carefully and use as directed by your doctor.
【Special Populations】
Precautions for Children: This product is not recommended for children under 6 years of age.
Precautions for Pregnancy and Lactation: 1. No adverse reactions were observed in animal reproductive toxicity studies of levocetirizine. There is currently no clinical data on its use in pregnant women, and its use is not recommended for pregnant women. 2. Levocetirizine is excreted in breast milk; therefore, its use is not recommended for breastfeeding women.
Precautions for the Elderly: Use under the guidance of a physician.
【Drug Interactions】
Currently, there are no studies on drug interactions of levocetirizine (including studies without CYP3A4 inducers); previous studies on the racemic mixture of cetirizine have shown no clinically relevant adverse drug interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide, and diazepam). In a study of multiple doses of cetirizine combined with theophylline (400 mg/day), cetirizine clearance decreased by 16%, while theophylline clearance remained unchanged. Food intake may decrease the absorption rate of levocetirizine, but the extent of absorption is not reduced.
【Pharmacological Action】
Pharmacological action: This product is an antihistamine with no significant anticholinergic or anti-serotonin effects and minimal central nervous system depressant effects.
【Storage】
Sealed.
【Specifications】
5 mg
【Packaging Specifications】
7 tablets/box
【Shelf Life】
36 months
