Loratadine orally disintegrating tablets

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.

This product is white tablets.

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.

Take on an empty stomach. Take out the product and place it on the tongue. No water or chewing is needed. The product will disintegrate quickly and be swallowed into the stomach with saliva. For adults and children over 12 years old, take once a day, 10 mg (1 tablet) each time.

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 12 years old have not yet been determined. Precautions for pregnancy and lactation: The safety of loratadine during pregnancy has not been determined. Loratadine can be secreted from breast milk, and antihistamines increase the risk to infants, especially newborns and premature infants, so loratadine must be used with great caution in pregnant and lactating women. Precautions for the elderly: Because the plasma concentration of elderly patients after taking the drug is higher than that of healthy people, elderly patients need to 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.

Keep in a sealed container and away from light. Validity period: tentatively 24 months.

10mg

24 months

Chongqing Kangke'er Pharmaceutical Co., Ltd.

• Founded in:

  1999-11-30

• Address:

  No. 101, Jinyu Avenue, Economic Development Park, Northern New District, Chongqing

• Tax NO.:

  91500000622044331W

• Registered Funds:

  74.491724 million yuan

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