Levocetirizine Hydrochloride Dispersible Tablets

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 small. Toxicological studies: Genetic toxicity: The results of the Ames test, human lymphocyte chromosome aberration test, mouse lymphoma test and rat micronucleus test were all negative. 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 (approximately 25 times the maximum daily oral dose recommended for adults based on body surface area). The oral doses for mice, rats and rabbits were 96, 225 and 135 mg/kg, respectively (approximately 25 times the maximum daily oral dose recommended for adults, based on body surface area).

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.

Treat allergy-related symptoms of the following diseases, such as seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria.

Oral administration. Dissolve in a small amount of water and take orally or swallow directly. Adults and children over 6 years old: once a day, one tablet (5 mg) each time. Can be taken on an empty stomach or during or after a meal.

This product may cause adverse reactions such as headache, drowsiness, dry mouth, fatigue, weakness, abdominal pain, etc. in some patients.

1. Contraindicated in patients with advanced renal disease with creatinine clearance <10 ml/min. 2. Contraindicated in patients with special genetic diseases (suffering from rare galactose intolerance, primary intestinal lactase deficiency (Lapplactase) or glucose-lactose malabsorption).

Precautions for children: The safety of the drug for children under 2 years old has not been determined. Precautions for pregnancy and lactation: No adverse reactions were observed in animal reproductive toxicity studies with levocetirizine, and there is no clinical data on its use in pregnant women. It is not recommended for pregnant women to use this product. Levocetirizine is secreted in breast milk, so it is not recommended for lactating women to use this product. 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.

Store in a sealed container. Validity period: tentatively 24 months.

5mg

24 months

Lunan BETTER Pharmaceutical Co., Ltd.

• Founded in:

  2003-12-16

• Address:

  No. 209, Hongqi Road, Linyi City

• Tax NO.:

  91371300756399007K

• Registered Funds:

  115 million yuan

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