Desloratadine citrate tablets

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Desloratadine. Chemical name: 8-chloro-6,11-dihydro-11-(4-nitrogen cyclohexyl)-5H-phenyl-[5,6]cyclohepta[1,2-b]pyridine

This product is a light blue round film-coated tablet with an indentation.

This product is used to quickly relieve symptoms associated with allergic rhinitis, such as sneezing, runny nose and itchy nose; nasal congestion/stuffy nose; itchy eyes, tearing and congestion; itchy palate and cough. This product is also used to relieve symptoms associated with chronic idiopathic urticaria, such as itching, and can reduce the number and size of hives.

Adults and adolescents aged 12 years or above: Orally, once a day, 1 tablet each time. Eating does not affect the effect of the medication.

In a series of clinical trials for allergic rhinitis and chronic idiopathic urticaria, patients took desloratadine at the recommended dose of 5 mg per day, and the incidence of adverse reactions in the test group was 3% higher than that in the placebo group. The most common adverse reactions that exceeded the placebo group were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%). After desloratadine was marketed, there were rare reports of allergic reactions, including allergies and rashes. In addition, there were rare reports of tachycardia, palpitations, elevated liver enzymes, hepatitis, and increased bilirubin.

It is contraindicated for those who are allergic to the active ingredients or excipients of this product.

Precautions for children: The effectiveness and safety for pediatric patients under 12 years old have not been determined. Precautions for pregnancy and lactation: Since there is no clinical data on the use of desloratadine by pregnant women, the safety of using desloratadine during pregnancy has not been determined. Desloratadine should not be used during pregnancy unless the potential benefits outweigh the possible risks. Desloratadine can be excreted through breast milk, so it is not recommended for lactating women to take desloratadine. No effect on the overall fertility of rats was found when desloratadine was given at 34 times the recommended human clinical dose, and no teratogenic or mutagenic effects of desloratadine were found in animal experiments. Precautions for the elderly: There is still a lack of research data on the use of drugs in elderly patients.

No clinically relevant interactions with desloratadine were found in clinical trials. In multiple-dose drug interaction studies with ketoconazole, erythromycin, azithromycin, fluoxetine, and cimetidine, no clinically relevant changes in plasma concentrations of desloratadine were observed. However, the metabolic enzymes of desloratadine have not been identified, so interactions with other drugs cannot be completely ruled out. Eating or drinking grapefruit juice has no effect on the distribution of desloratadine. When desloratadine is used simultaneously with alcohol, it does not enhance the impairing effects of alcohol on human performance.

Seal tightly and store in a cool, dry place.

8.8 mg (calculated as C25H25ClN2O7Na2)

24 months

Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.

• Founded in:

  2004-04-19

• Address:

  No. 31, Xiangshan Road, Guangzhou Science City, Guangzhou Hi-Tech Industrial Development Zone

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  914401167594322396

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  $14.5 million

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