[Baixin Ha] 60ml Baixin Ha has no cardiotoxic effect to reassure mothers

【 Drug name 】

Generic name: Desloratadine syrup

Product Name: Desloratadine syrup (Baixin Ha)

Desloratadine Syrup

Full Pinyin code: DiLvLeiTaDingTangJiang(BaiXinHa)

[Main Ingredients] Each bottle contains loratadine 60mg. The excipients are propylene glycol, glycerin, citric acid monohydrate, sodium benzoate, sugar, peach flavor and purified water.

【 component 】

Chemical name: 4-(8-chloro-5, 6-dihydro-11H-benzene)

[Nature] This product is orange yellow clear viscous liquid.

[Indications/Indications] for the relief of systemic and local symptoms of chronic urticaria and allergic rhinitis.

[Specification Model] 60ml

[Usage and dosage] Children 1 to 5 years old: oral, once daily, 2.5ml each time Children 6 to 11 years old: oral, once daily, 5ml each time adult box Adolescents (12 years or older: oral,) once daily, 10ml each time desloratadine can be taken with food.

“In the pediatric clinical trial, desloratadine syrup was given to 246 children aged 6 months to 11 years, and the overall incidence of adverse events was similar to that of placebo between the ages of 2 and 11 years. The most common and higher adverse events in children aged 6 months to 2 years were diarrhea (3.7%), fever (2.3%), and insomnia (2.3%).” “In a series of clinical trials for the indication of chronic idiopathic filling of the allergic rhinitis box, patients taking desloratadine at the recommended dose of 5mg per day had a 3% higher incidence of adverse effects in the experimental group than in the placebo group, with the most common adverse effects exceeding those in the placebo group being fatigue (1.2%), dry mouth (0.8%), and headache (0.6%).” “Anaphylactic reactions including anaphylaxis and rash, tachycardia, palpitations, elevated liver enzymes, hepatitis, and increased bilirubin have been rarely reported after the introduction of desloratadine.”

[Contraindication] It is forbidden for those who are allergic to the active ingredients or excipients of this product.

1. Because antihistamines can remove or reduce the skin’s positive reaction to all allergens, they should be stopped 48 hours before any skin allergy test. 2. It is contraindicated in patients with severe renal insufficiency. 3. Patients with liver injury, bladder neck obstruction, urethral distension, prostatic hypertrophy and glaucoma should follow the doctor’s advice. Please read the instructions carefully and follow the instructions.

The safety of this product in children younger than 1 year of age has not been established.

“Use in older patients” is unclear.

The safety of desloratadine consumption during pregnancy has not been established because of the lack of clinical data on the use of desloratadine in women, and desloratadine should not be used during pregnancy unless the potential benefits outweigh the possible risks. Desloratadine is excreted through breast milk and is not recommended for lactating women. The administration of desloratadine at a dose of 34 times the recommended dose in human was not found to affect the overall fertility of rats, and no aberration box mutagenic effect was found in animal experiments.

[Drug Interactions] No clinically relevant interactions with desloratadine were found in the clinical trials. (See instructions for details)

[Overdose] Standard treatment to remove unabsorbed active substances should be considered in overdose cases, and symptomatic and supportive care is recommended. In a multi-dose clinical trial in adults and adolescents, subjects received up to 45mg of desloratadine (9 times the clinically used dose), and no clinically relevant ibuprofen was seen. Desloratadine cannot be ruled out by hemodialysis, and whether it can be ruled out by peritoneal dialysis is unclear.

[Pharmacology and Toxicology] This product is a highly effective and long-lasting tricyclic antihistamine, which is a selective peripheral H1 receptor antagonist. It can relieve various symptoms caused by allergic reactions.

[Pharmacokinetics] It is rapidly absorbed by oral administration in a fasting state. It took effect 1 ~ 3 hours after administration, reached its maximum effect 8 ~ 12 hours after administration, and lasted for more than 24 hours. Food can delay drug peak time and increase AUC(absorption). The T1/2 of loratadine in normal adults was 28(8.8-92) hours. 80% occur as metabolites in urine and feces. In patients with chronic renal failure (creatinine clearance ≤30ml/ minute), drug AUCs and plasma concentrations increased by about 73%, whereas AUCs of their metabolites increased by about 120%. The AUC and peak concentration of loratadine in patients with chronic alcoholic liver disease were twice that of normal subjects. The T1/2 of loratadine and its metabolites were 24 and 37 hours, respectively, which could be prolonged with the severity of liver disease. The protein binding rates of loratadine and its metabolites were 97% and 73%-77%, respectively. “It and its metabolites do not cross the blood-brain barrier and act primarily at the peripheral H1 receptor site.”

【 Storage 】 Sealed.

[Package] 60ml/box.

[Effective period] 36 months

[Approval No.] H20100009

【 Manufacturer 】 Wante Pharmaceutical (Hainan) Co., LTD

【 Demand Note 】

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