Product Overview
【Drug Name】
Generic Name: Desloratadine Citrate Disodium Tablets
Brand Name: Beixue
English Name: Desloratadine Citrate Disodium Tablets
Pinyin: JuDiLvLeiTaDingPian(BeiXue)
【Ingredients】
Desloratadine. Chemical Name: 8-chloro-6,11-dihydro-11-(4-azahexylcyclohexide)-5H-benzene-[5,6]cyclohepta[1,2-b]pyridine
【Appearance】
This product is a light blue, round, film-coated tablet with indentation.
【Indications】
This product is used for the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, runny nose, and nasal itching; nasal congestion/nasal obstruction; as well as 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 urticaria.
【Dosage and Administration】
Adults and adolescents aged 12 years or older: Oral administration, one tablet once daily. Food intake does not affect the efficacy of the medication.
【Adverse Reactions】
In a series of clinical trials for allergic rhinitis and chronic idiopathic urticaria, patients taking desloratadine at the recommended daily dose of 5 mg experienced a 3% higher incidence of adverse reactions compared to the placebo group. The most common adverse reactions exceeding the placebo group were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%). Rare post-marketing reports of allergic reactions, including anaphylaxis and rash, have been reported with desloratadine. Rare reports also include tachycardia, palpitations, elevated liver enzymes, hepatitis, and increased bilirubin.
【Contraindications】
This medication is contraindicated in patients with known hypersensitivity to the active ingredient or excipients of this product.
【Precautions】
1. Desloratadine has not been shown to affect the ability to drive or operate machinery.
2. Use with caution in patients with severe renal insufficiency. Please read the instructions carefully and use as directed by your doctor.
[Use in Special Populations]
Precautions for Children: The efficacy and safety of desloratadine in children under 12 years of age have not been established.
Pregnancy and Lactation Precautions: Since there are no clinical data on the use of desloratadine in pregnant women, the safety of its use during pregnancy has not been established. Desloratadine should not be used during pregnancy unless the potential benefits outweigh the possible risks. Desloratadine is excreted in breast milk; therefore, it is not recommended for breastfeeding women. Administration of 34 times the recommended human clinical dose of desloratadine did not affect the overall fertility of rats, and no teratogenic or mutagenic effects were observed in animal studies.
Precautions for the Elderly: Data on the use of desloratadine in elderly patients are lacking.
[Drug Interactions]
No clinically significant interactions of desloratadine have been found in clinical trials. In multiple-dose drug interaction studies with ketoconazole, erythromycin, azithromycin, fluoxetine, and cimetidine, no clinically significant changes in plasma concentrations were observed. However, the metabolic enzymes of desloratadine have not been identified, therefore interactions with other drugs cannot be completely ruled out. Eating or drinking grapefruit juice has no effect on the distribution of desloratadine. Concomitant use of desloratadine with alcohol does not enhance the impaired performance of alcohol.
【Pharmacological Actions】
• Regulators of activity expressed and secreted by eugenic T cells;
• Reactive oxygen species generated during polymorphonuclear neutrophil activation;
• Eosinophil adhesion and chemotaxis;
• Expression of adhesion molecules such as selectin P;
• IgE-dependent release of histamine, prostaglandin PGD2, and leukotriene LTC4;
• Acute allergic bronchospasm and allergic cough in animal models.
【Storage】
Sealed, store in a cool, dry place.
【Specifications】
8.8mg * 6 tablets
【Packaging Specifications】
Box
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20090138
【Manufacturer】
Guangzhou Hairui Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group
