Product Overview
【Drug Name】
Generic Name: Levocetirizine Hydrochloride Tablets
Brand Name: Haosijia
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 white or off-white tablet.
【Indications】
Used to relieve allergic symptoms of allergic diseases, such as: allergic rhinitis (including allergic symptoms of the eyes), urticaria, angioedema, contact dermatitis, insect bite dermatitis, and other allergic diseases of the skin and mucous membranes; used to relieve allergic symptoms during a cold.
【Dosage and Administration】
Oral administration. Adults and children over 6 years of age: once daily, one tablet each time. Children aged 2-6 years: once daily, half a tablet each time. 【Adverse Reactions】 This product is well tolerated, with mild adverse reactions that often resolve spontaneously. Common adverse reactions include drowsiness, dry mouth, headache, and fatigue.
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to this product or any of its excipients.
【Precautions】
1. Use with caution in patients with hepatic impairment or a history of hepatic impairment.
2. Use with caution while working at heights, driving, or operating machinery.
3. Avoid concurrent use with sedatives.
4. Avoid using this product after consuming alcohol.
5. Reduce the dosage appropriately for patients with impaired renal function.
【Special Populations】
Children: The safety of this product in children under 2 years of age has not been established.
Pregnancy and Lactation: This product is contraindicated in pregnant and lactating women.
Elderly: Elderly individuals generally experience a decline in physiological function and should use this product with caution.
【Drug Interactions】
There are no studies on drug interactions using this product. Racemic cetirizine does not interact with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide, or diazepam. [Pharmacological Action] This product is an oral selective histamine H1 receptor antagonist. It has no significant anticholinergic or anti-serotonin effects, and its central nervous system depressant effect is relatively small. Toxicological Studies: Genotoxicity: The Ames test, human lymphocyte staining aberration test, mouse lymphoma test, and rat micronucleus test results for this product were all negative. Reproductive Toxicity: The results of mouse fertility and general reproductive toxicity tests indicate that cetirizine at an oral dose of up to 64 mg/kg (approximately 25 times the maximum recommended daily oral dose for adults based on body surface area) does not impair fertility. No teratogenic effects were observed in mice, rats, and rabbits at oral doses of 96, 225, and 135 mg/kg (approximately 40, 180, and 220 times the maximum recommended daily oral dose for adults based on body surface area, respectively). However, there is currently no sufficient and strictly controlled clinical data on pregnant women. Because animal reproductive studies cannot always predict the effects of drugs on humans, this product should only be taken during pregnancy when absolutely necessary. In lactating mice (mothers), oral administration of doses up to 96 mg/kg (approximately 40 times the maximum recommended daily oral dose for adults, calculated based on body surface area) caused growth retardation in pups. Studies in Beagler dogs showed that approximately 3% of the administered dose was excreted in milk. Carcinogenicity: In a two-year oral carcinogenicity study in rats, no carcinogenicity was observed at doses up to 20 mg/kg (approximately 15 times the maximum recommended daily oral dose for adults, or 10 times the maximum recommended daily oral dose for children, calculated based on body surface area). In a two-year oral carcinogenicity study in mice, a dose of 16 mg/kg (approximately 6 times the maximum recommended daily oral dose for adults or 4 times the maximum recommended daily oral dose for children, based on body surface area) increased the incidence of benign tumors in male animals; a dose of 4 mg/kg (approximately 2 times the maximum recommended daily oral dose for adults or children, based on body surface area) did not show an increase in the incidence of liver tumors. The clinical significance of these findings is not yet clear.
【Storage】
Sealed, store in a dry place.
【Specifications】
5mg*12 tablets
【Packaging Specifications】
Box
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20060677
【Manufacturer】
Beijing Tianheng Pharmaceutical Research Institute Nanyang Tianheng Pharmaceutical Factory
