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 this product for children under 2 years old have not yet been determined. Foreign studies have shown that the pharmacokinetic characteristics of 1-2 years old children after taking 2.5 mg of this product are similar to those of older children and adults. Precautions for pregnancy and lactation: The safety during pregnancy has not been determined, so pregnant women should use it with caution. This product can be secreted from breast milk, and antihistamines are very dangerous to infants, especially newborns and premature infants. Breastfeeding must be stopped during the medication period. Precautions for the elderly: Because the plasma concentration of elderly patients after taking the drug is higher than that of healthy people, elderly patients should pay close attention to the occurrence of adverse reactions when using this product for a long time.

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

5mg

36 months

Shijiazhuang Yuhui Pharmaceutical Co., Ltd.

• Founded in:

  2003-02-18

• Address:

  No. 19, Yangzi Road, Shijiazhuang Economic and Technological Development Zone

• Tax NO.:

  91130182746877220C

• Registered Funds:

  100 million yuan

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