Product Overview
【Drug Name】
Generic Name: Levocetirizine Hydrochloride Tablets
Brand Name: Citizenin
English Name: Levocetirizine Dihydrochloride Tablets
Pinyin: Yansuan Zuoxitiliqin Pian
【Ingredients】
The main ingredient of this product is levocetirizine hydrochloride, its chemical name is (R)-(-)-2-[2-(4-(4-chlorophenyl)benzyl)-1-piperazinyl)ethoxy]acetic acid dihydrochloride.
【Appearance】
This product is a film-coated tablet, white or off-white after removing the coating.
【Indications】
This product is used to treat allergy-related symptoms of the following diseases: allergic rhinitis (including seasonal persistent allergic rhinitis and perennial persistent allergic rhinitis) and chronic idiopathic urticaria.
【Dosage and Administration】
Oral administration. Adults and children over 6 years of age take one tablet once daily. Children aged 2-6 years take half a tablet once daily. It can be taken on an empty stomach, with or after meals.
【Adverse Reactions】
This product may cause adverse reactions in individual patients, listed in descending order of incidence: Common (1/100, 1/10): headache, drowsiness, dry mouth, fatigue. Less common (1/1000, 1/100): weakness, abdominal pain. Rare adverse reactions discovered post-marketing include: 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 hereditary diseases (including rare galactose intolerance, primary lactase deficiency, or glucose-galactose malabsorption).
【Precautions】
1. As this product cannot currently be used at half the recommended dosage, 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 confirmed 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 response to this product; concomitant use with alcohol or other central nervous system depressants may lead to decreased alertness and impaired operating ability.
【Special Populations】
Precautions for children: The safety of this product in children under 2 years of age has not been established.
Pregnancy and lactation precautions: This product is contraindicated in pregnant and lactating women.
Precautions for the elderly: Elderly individuals generally experience a decline in physiological function and should use this product with caution.
【Drug Interactions】
There are currently no studies on the 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), a 16% decrease in cetirizine clearance was found. Theophylline clearance was not altered by the concomitant use of cetirizine. Food may decrease the absorption rate of levocetirizine, but the extent of absorption is not reduced.
【Pharmacological Action】
This product is an oral selective histamine H1 receptor antagonist. It has no significant anticholinergic or anti-serotonin effects and minimal central nervous system depressant effects.
【Storage】
Protect from light, seal tightly, and store in a dry place.
【Specifications】
5mg*7 tablets
【Packaging】
Box
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20080662
【Manufacturer】
Zhejiang Yongning Pharmaceutical Co., Ltd.
