Product Overview
【Drug Name】
Generic Name: Fexofenadine Hydrochloride Tablets
Brand Name: Atlas
English Name: Fexofenadine Hydrochloride Tablets
【Ingredients】
Fexofenadine hydrochloride. Chemical Name: α,α-dimethyl-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-pyridinium]butyl]-phenylacetic acid hydrochloride.
【Appearance】
This product is a light red, oval, film-coated tablet. After removing the coating, it is white to off-white when wet.
【Indications】
This product is indicated for the relief of symptoms caused by seasonal allergic rhinitis and chronic idiopathic urticaria.
【Dosage and Administration】
This product is for oral administration. For adults and children over 12 years of age and the elderly: The recommended dose for seasonal allergic rhinitis is 120 mg (2 tablets) once daily; the recommended dose for chronic urticaria is 180 mg (3 tablets) once daily. For patients with impaired renal function, the initial dose is 60 mg (1 tablet) once daily. No dose adjustment is required for elderly patients and those with hepatic impairment. For children aged 6–11 years: The recommended dose for seasonal allergic rhinitis and chronic idiopathic urticaria is 30 mg (1 tablet) twice daily. For patients with renal insufficiency, the initial dose is 30 mg (half a tablet) once daily.
【Adverse Reactions】
In controlled clinical studies, the most frequently reported adverse reactions to fexofenadine were headache, somnolence, nausea, dizziness, and fatigue. These adverse reactions were similar to those observed in the placebo group. The incidence of somnolence and fatigue was 1.3%, nausea and indigestion was 1.6%, and headache and leukocytosis was 1.5%. No reports of serious cardiotoxicity caused by fexofenadine have been received.
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to it.
【Precautions】
No dose reduction is required for patients with hepatic impairment; the dose should be halved for patients with renal insufficiency.
【Pharmacological Actions】
Pharmacological Actions: This product is a second-generation H1 receptor antagonist, a carboxylated metabolite of terfenadine. It selectively blocks H1 receptors and has good antihistamine activity, but no anti-serotonin, anticholinergic, or anti-adrenaline effects. Animal studies have shown that fexofenadine tablets can selectively inhibit antigen-induced bronchospasm in sensitized guinea pigs; in rats, it can inhibit histamine release from peritoneal mast cells; it has no anti-parasympathetic neurophysiological effects or α*adrenaline receptor blocking effects; and fexofenadine has no sedative or other central nervous system effects. Therefore, it cannot cross the blood-brain barrier, does not block potassium channels in animal cardiomyocytes, does not affect the potential repolarization of cardiac function, and does not prolong the QT interval to produce cardiotoxicity. Toxicological Actions: Acute toxicity tests show that fexofenadine has low oral toxicity, with oral LD50 values greater than 5000 mg/kg in mice and rats, and greater than 2000 mg/kg in dogs. Subacute toxicity tests showed no adverse reactions in rats after continuous oral administration of 35 mg/kg for 28 days and in dogs after continuous oral administration of 100 mg/kg for 28 days. In vivo and in vitro tests indicated that fexofenadine was not carcinogenic or mutagenic. Reproductive toxicity studies showed that when rats and rabbits were administered terfenadine orally at up to 300 mg/kg, the plasma AUC values of fexofenadine were 4 times and 37 times higher than the human therapeutic value (60 mg twice daily), respectively, and no teratogenic effects were found.
【Storage】
Store below 25℃, protected from moisture.
【Specifications】
120 mg * 10 tablets
【Approval Number】
National Drug Approval Number HJ20170079/HJ20170080
【Manufacturer】
Company Name: Kunshan Longdeng Ruide Pharmaceutical Co., Ltd.
