Levocetirizine Hydrochloride Granules

1. Pharmacological action: This product is an oral selective histamine H1 receptor antagonist. It has no obvious anticholinergic and anti-5-hydroxytryptamine effects, and its central inhibitory effect is relatively small. 2. Toxicological studies (1) Genetic toxicity: The results of the Ames test, human lymphocyte staining aberration test, mouse lymphoma test and rat micronucleus test were all negative. (2) Reproductive toxicity: The results of mouse fertility and general reproductive toxicity tests indicate that cetirizine has no damage to fertility when administered orally at a dose of 64 mg/kg (about 25 times the maximum daily oral dose recommended for adults based on body surface area). No teratogenic effects were observed when administered orally to mice, rats and rabbits at doses of 96, 225 and 135 mg/kg, respectively (about 40, 180 and 220 times the maximum daily oral dose recommended for adults, based on body surface area). However, there is currently no adequate and strictly controlled clinical research data on pregnant women. Since animal reproduction studies cannot always predict the effects of drugs on humans, this product should be taken during pregnancy only when it is really necessary. When the oral dose of lactating mice (mother rats) reaches 96 mg/Kg (based on body surface area, it is approximately equivalent to 40 times the maximum daily oral dose recommended for adults), it can cause delayed growth in the pups. Studies on Beagler dogs have shown that about 3% of the dose is excreted through breast milk. (3) Carcinogenicity: In the carcinogenicity test of rats administered orally for 2 consecutive years, no carcinogenicity was observed when the dose reached 20 mg/Kg (based on body surface area, it is approximately equivalent to 15 times the maximum daily oral dose recommended for adults, or 10 times the maximum daily dose recommended for children). In the oral carcinogenicity test of mice for two consecutive years, the dose of 16 mg/Kg (about 6 times the maximum daily oral dose recommended for adults or 4 times the maximum daily dose recommended for children) can cause an increase in the incidence of benign tumors in male animals; the dose of 4 mg/Kg (about 2 times the maximum daily oral dose recommended for adults or 4 times the maximum daily dose recommended for children) did not increase the incidence of liver tumors. The clinical significance of the above findings is not yet obvious.

Levocetirizine hydrochloride. Chemical name: R-(-)-2-[2-[4-[(4-chlorophenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride Molecular weight: C21H25ClN2O3bull;2HCl

This product is white or off-white tablets.

No data yet

Oral administration: Adults and children over 6 years old, 1 tablet once a day. Children aged 2-6 years old, 1/2 tablet once a day.

This product is well tolerated, and adverse reactions are mild and most of them can heal themselves. Common adverse reactions include drowsiness, dry mouth, headache, fatigue, etc.

It is contraindicated for those who are allergic to this product and other excipients.

Precautions for children: The safety of the drug for children under 2 years old has not been determined. Precautions for pregnancy and lactation: This product is contraindicated for pregnant and lactating women. Precautions for the elderly: The physiological functions of the elderly usually decline, so this product should be used with caution.

There is no relevant research data on the interaction between levocetirizine and other drugs, and there has been no report on the interaction between cetirizine and other drugs.

seal.

2.5mg

24 months

Honz Pharmaceutical Co., Ltd.

• Founded in:

  1994-01-20

• Address:

  No. 6, Yaogu 3rd Road, Yaogu Industrial Park, Haikou National High-tech Industrial Development Zone, Hainan Province

• Tax NO.:

  91460000708873536T

• Registered Funds:

  455.124411 yuan

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