Desloratadine tablets

Pharmacological action: This product is a non-sedative, long-acting tricyclic antihistamine and an active metabolite of loratadine. It can relieve symptoms related to allergic rhinitis or chronic idiopathic urticaria by selectively blocking peripheral H1 receptors. In addition, in vitro study results show that this product can inhibit the release of histamine from human mast cells. Animal studies suggest that this product is not easy to pass through the blood-brain barrier. Toxicological studies: Acute toxicity: Death occurred in rats at an oral dose of 250 mg/kg (calculated by AUC, the exposure to desloratadine and its metabolites is approximately 120 times the clinically recommended daily oral dose), and the oral LD50 of mice is 353 mg/kg (calculated by body surface area, desloratadine is approximately 290 times the clinically recommended dose). Monkeys:

The main ingredient of this product is desloratadine, and its chemical name is 8-chloro-6,11-dihydro-11-(4-piperidinyl)-5H-benzo-[5,6]-heptane[1,2-b]pyridine.

This product is a film-coated tablet, which appears white or off-white after removing the film coating.

This product is used to quickly relieve symptoms associated with allergic rhinitis, such as sneezing, runny 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 urticaria.

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

1 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 trial 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%). 2 Rare reports of allergic reactions, including allergies and rashes, have been reported after desloratadine was marketed. In addition, there have been rare reports of tachycardia, palpitations, elevated liver enzymes, and increased bilirubin.

This product is contraindicated for use by those who are allergic to the active ingredients or excipients.

Precautions for children: The efficacy and safety of desloratadine for children under 12 years old have not been determined. Precautions for pregnancy and lactation: No effect on the overall fertility of rats was found when desloratadine was given at 34 times the recommended human clinical dose. Desloratadine was not found to be teratogenic or mutagenic in animal experiments. Since there is no clinical data on the use of desloratadine by pregnant women, the safety of desloratadine during pregnancy has not been determined. Unless the potential benefits outweigh the possible risks, desloratadine should not be used during pregnancy. Desloratadine can be excreted through breast milk, so it is not recommended for lactating women to take desloratadine. Precautions for the elderly: This experiment has not been conducted and there are no reliable references.

No clinically relevant interactions were found with desloratadine in clinical trials. In multiple-dose drug interaction studies with ketoconazole, erythromycin, azithromycin, chloroxetine, and cimetidine, no clinically relevant changes in plasma concentrations were observed. However, the metabolic enzymes of desloratadine have not been determined, 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 behavior.

Seal and store in a dry place. Validity period: 36 months

5mg

30 months.

Hainan Poly Pharm. Co., Ltd.

• Founded in:

  1992-07-14

• Address:

  Guilinyang Economic Development Zone, Meilan District, Haikou City

• Tax NO.:

  91460000620000247L

• Registered Funds:

  448.350021 million yuan

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