Levocetirizine Hydrochloride Tablets

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 small. Toxicological studies: Genetic toxicity: The results of the Ames test, human lymphocyte staining aberration test, mouse lymphoma test and rat micronucleus test of this product were all negative. Reproductive toxicity: The results of mouse fertility and general reproductive toxicity tests indicate that cetirizine has no damage to fertility when the oral dose reaches 64 mg/kg (about 25 times the maximum daily oral dose recommended for adults according to body surface area). No teratogenic effects were observed when the oral doses of mice, rats and rabbits reached 96, 225 and 135 mg/kg respectively (about 40, 180 and 220 times the maximum daily oral dose recommended for adults according to 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 can only be taken during pregnancy when it is really necessary. When the oral dose of lactating mice (mother mice) 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 offspring. Studies on Beagler dogs have shown that about 3% of the dose is excreted through breast milk. Carcinogenicity: In the carcinogenicity test of rats administered orally for two 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.

The main ingredient of this product is levocetirizine hydrochloride, and its chemical name is (R)-(-)-2-[2-(4-(4-chlorophenyl)benzyl)-1-piperazinyl)ethoxy]acetic acid dihydrochloride.

This product is white or off-white tablets.

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 colds.

Oral administration: Adults and children over 6 years old, take 1 tablet once a day. Children aged 2-6 years old, take half a 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 are no drug interaction studies using this product. Racemic cetirizine has no interaction with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide, and diazepam.

Sealed and stored in a dry place.

5mg

24 months

Nanyang Tianheng Pharmaceutical FACTORY of Beijing Tianheng Pharmaceutical Institute

• Founded in:

  2002-03-25

• Address:

  East Section of South Ring Road, Dengzhou City, Henan Province

• Tax NO.:

  914113817374160007

• Registered Funds:

  3 million yuan

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