GMP Certified / Levocetirizine Dihydrochloride Tablets 5mg

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 5mg
• Model NO.: Tablet
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Levocetirizine Dihydrochloride Tablets 5mg
Strength	5 mg
Packing	10*10 tablets
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Levocetirizine Dihydrochloride Tablets 5mg

Character:
This product is a white film coating. After removing the film coating, it will appear white or near-white.

Indications:
Treatment of allergy-related symptoms of allergic rhinitis (including seasonal and perennial allergic rhinitis) and chronic idiopathic urticaria.

Matters needing attention:
1. This product is not recommended for use by children under 6 years of age, as the currently available film coated tablets of this product do not allow adjustment of dosage.
2. Although there is no research data at present, the central nervous system may be affected when levocetirizine hydrochloride is taken with alcohol or central nervous system inhibitors in some sensitive patients.
3. Effects on driving and mechanical ability: Controlled clinical trials have confirmed that levocetirizine does not impair alertiveness, reflexes, and the ability to drive at recommended doses. If the patient needs to drive, engage in potentially dangerous activities or operate machinery, do not overdose and consider their reaction to this product; Combined use of alcohol or other central nervous system inhibitors may result in reduced alertness and impaired operational ability.

Pharmacology and toxicology:
Pharmacological action
This product is an oral selective histamine H1 receptor antagonist. There was no obvious anticholine and antiserotonin effect, and the central inhibitory effect was small.
Toxicological study
Genotoxicity: Ames test, human lymphocyte chromosomal aberration test, mouse lymphoma test and rat micronucleus test were all negative.
Reproductive toxicity:
The results of fertility and general reproductive toxicity tests in mice suggested that cetirizine had no damage to fertility when administered orally at a dose of 64mg/kg(about 25 times the maximum daily oral dose recommended for adults based on body surface area).
No teratogenic effects were observed in mice, rats and rabbits when the oral doses were 96, 225 and 135mg/kg, respectively (40, 180 and 220 times of the recommended maximum daily oral dose for adults based on body surface area, respectively). However, there is no sufficient and strictly controlled clinical research data on pregnant women. Since animal reproductive studies do not always predict the effects of drugs on people, this product should only be taken during pregnancy if it is really needed.
When the oral dose of lactating mice (mother mice) reached 96mg/kg(according to the body surface area, about 40 times the recommended daily oral dose for adults), the weight gain of young mice was delayed. Studies of Beagie dogs have shown that about 3% of the administered dose is excreted through milk.
Carcinogenicity: In the carcinogenicity test of oral administration in rats for 2 consecutive years, there was no carcinogenicity when the dose reached 20mg/kg(about 15 times the maximum clinical recommended daily oral dose for adults, or 10 times the maximum clinical recommended daily dose for children, based on the body surface area). In the carcinogenicity test of oral administration in mice for 2 consecutive years, the dose of 16mg/kg(according to the body surface area, about 6 times of the maximum clinical recommended daily oral dose for adults, or 4 times of the maximum clinical recommended daily dose for children) can increase the incidence of benign liver tumors in male animals. No increase in the incidence of liver tumors was observed at a dose of 4mg/kg(approximately twice the maximum clinically recommended daily oral dose for adults, or the maximum clinically recommended daily dose for children, based on body surface area). The clinical significance of these findings is unclear.


Storage:
Seal and store in a dry place