Loratadine Capsules

Pharmacological action: This product is a long-acting tricyclic antihistamine that can relieve seasonal allergic rhinitis or non-nasal symptoms by selectively binding to peripheral H1 receptors. Toxicological studies: Genetic toxicity: No mutagenic effect of loratadine was observed in the Ames test, forward point mutation test, DNA damage test, and chromosome aberration test. In the mouse lymphoma test, positive results were observed in the inactive state and negative results in the activated state. Reproductive toxicity: Oral administration of loratadine to male rats at a dose of 64 mg/kg (approximately 50 times the clinically recommended maximum daily oral dose, calculated based on body surface area) can cause decreased fertility, as manifested by a decrease in the pregnancy rate of female rats. Oral administration of loratadine at a dose of 24 mg/kg

The main ingredient is loratadine. Chemical name: 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cycloheptyl[1,2-b]pyridine-11-ene)-1-piperidinecarboxylic acid ethyl ester.

The contents of this product are white granules.

It is used to relieve nasal or non-nasal symptoms of allergic rhinitis, such as sneezing, runny nose, itchy nose, itchy eyes and burning eyes, etc. It is also suitable for alleviating the symptoms and signs of chronic urticaria and other allergic skin diseases.

Oral administration. Adults: once a day, one tablet (10 mg) each time; children aged 2 to 12 years, weighing > 30 kg, one tablet (10 mg) each time, once a day.

In controlled clinical trials, loratadine did not demonstrate clinically significant sedation or anticholinergic effects, the incidence of which was similar to placebo, and reports of somnolence, dry mouth, weight gain, fatigue, headache, and nausea were rare.

This product is contraindicated for patients who are allergic to any ingredient or have special physical conditions.

Precautions for children: The safety and efficacy of loratadine for children under 2 years old have not yet been determined. Precautions for pregnancy and lactation: So far, there is no clinical data on the use of loratadine in pregnant women; in addition, loratadine can be secreted from breast milk, and histamine is more dangerous to infants, especially newborns and premature infants. Therefore, pregnant and lactating women should use this product with caution. Precautions for the elderly: There is no significant difference in the distribution of loratadine in elderly patients over 60 years old compared with young adult patients.

Clinical trials have shown that when healthy adults simultaneously take loratadine (10 mg), therapeutic doses of erythromycin, carmitidine and other drugs, the blood concentration of this product and its metabolites increases slightly, and there is no significant change in its absorption, distribution and metabolism.

Store in a sealed container. Validity period: tentatively 36 months

10mg

24 months

Sichuan Luye Pharmaceutical Industry Co., Ltd.

• Founded in:

  2000-12-21

• Address:

  No. 6 and No. 8, Section 2, Wangjiang Road, Yutang Town, Longmatan District, Luzhou City

• Tax NO.:

  91510500723205632X

• Registered Funds:

  36.1 million yuan

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