Product Overview
【Drug Name】
Generic Name: Desloratadine Tablets
Brand Name: Xinminting/Xinlitai
English Name: Desloratadine Tablets
Pinyin: Dilüleitading Pian
【Ingredients】
The main ingredient of this product is desloratadine, its chemical name is 8-chloro-6,11-dihydro-11-(4-piperidinyl)-5H-benzo-[5,6]-heptane[1,2-b]pyridine.
【Appearance】
This product is a film-coated tablet, white or off-white after removing the film coating.
【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】
1. 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%).
2. Rare post-marketing reports of allergic reactions to desloratadine, including anaphylaxis and rash, have been reported. Rare reports also include tachycardia, palpitations, elevated liver enzymes, and increased bilirubin.
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to the active ingredient or excipients.
【Precautions】
1. Desloratadine has not been shown to affect the ability to drive or operate machinery.
2. This product is contraindicated in patients with severe renal impairment.
【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: Administration of desloratadine at 34 times the recommended human clinical dose did not affect overall fertility in rats. No teratogenic or mutagenic effects of desloratadine were observed in animal studies. 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 to take desloratadine.
Precautions for the Elderly: Not yet clear.
【Drug Interactions】
No clinically significant interactions were found with desloratadine in clinical trials. In multi-dose drug interaction studies with ketoconazole, erythromycin, azithromycin, cloxacin, 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. Food or grapefruit juice consumption does not affect the distribution of desloratadine. Concomitant use of desloratadine with alcohol does not enhance the impaired behavioral effects of alcohol.
【Pharmacological Actions】
This product is a non-sedating, long-acting tricyclic antihistamine, the active metabolite of loratadine. It can relieve symptoms of allergic rhinitis or chronic idiopathic urticaria by selectively blocking peripheral H1 receptors. In addition, in vitro studies have shown that this product can inhibit the release of histamine from human mast cells. Animal studies suggest that this product does not readily cross the blood-brain barrier. Toxicological studies: Acute toxicity: Death occurred in rats at an oral dose of 250 mg/kg (based on AUC, the exposure to desloratadine and its metabolites is approximately 120 times the clinically recommended daily oral dose). The oral LD50 in mice was 353 mg/kg (based on body surface area, desloratadine is approximately 290 times the clinically recommended dose).
【Storage】
Sealed, store in a dry place.
【Specifications】
5mg*6 tablets
【Packaging Specifications】
Box
【Shelf Life】
24 months.
【Approval Number】
National Drug Approval Number H20020092
【Manufacturer】
Shenzhen Xinlitai Pharmaceutical Co., Ltd.
