Product Overview
【Drug Name】
Generic Name: Loratadine Capsules
Brand Name: Yu Hui Brand
English Name: Loratadine Capsules
Pinyin: Lüleitading Jiaonang
【Ingredients】
The main ingredient is loratadine. Chemical Name: 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cycloheptyl[1,2-b]pyridine-11-ene)-1-piperidinecarboxylic acid ethyl ester.
【Appearance】
The contents of this product are white granules.
【Indications】
For the relief of nasal or non-nasal symptoms of allergic rhinitis, such as sneezing, runny nose, nasal itching, eye itching, and burning sensation in the eyes. Also suitable for relieving symptoms and signs of chronic urticaria and other allergic skin diseases.
【Dosage and Administration】
Oral administration. Adults: One capsule (10mg) once daily; Children aged 2-12 years, weighing >30kg, one capsule (10mg) once daily. [Adverse Reactions] In controlled clinical trials, loratadine did not show clinically significant sedative or anticholinergic effects. The incidence was similar to that of placebo. Reports of drowsiness, dry mouth, weight gain, fatigue, headache, and nausea were rare.
【Contraindications】
This product is contraindicated in patients with hypersensitivity to any component or those with specific predispositions.
【Precautions】
1. Psychomotor studies have shown that this product does not produce an additive effect when taken with alcohol.
2. Antihistamines can clear or reduce positive skin reactions to all allergens; therefore, loratadine should be discontinued approximately 48 hours before a skin test.
3. This product has no effect on cardiac function, but occasional reports of arrhythmias have been reported; caution should be exercised in patients with a history of arrhythmias.
4. In patients with hepatic impairment, the elimination half-life is prolonged; please use under the guidance of a physician, at a dose of 10 mg every other day.
5. Use with caution in patients with renal insufficiency.
【Special Populations】
Precautions for Children: The safety and efficacy of this product in children under 2 years of age have not yet been established. Foreign studies have shown that the pharmacokinetic characteristics of 2.5 mg of this product in children aged 1-2 years are similar to those in older children and adults.
Pregnancy and Lactation Precautions: The safety during pregnancy has not been established; pregnant women should use this product with caution. This product can be excreted in breast milk, and antihistamines pose a significant risk to infants, especially newborns and premature infants. Breastfeeding must be discontinued during medication.
Precautions for Elderly Patients: Because plasma concentrations in elderly patients are higher than in healthy individuals, close monitoring for adverse reactions is necessary when elderly patients use this product long-term.
【Drug Interactions】
Clinical trials have shown that in healthy adults, when taking loratadine (10 mg), therapeutic doses of erythromycin, carmitidine, etc., the blood concentrations of this product and its metabolites slightly increase, while absorption, distribution, and metabolism remain largely unchanged.
【Pharmacological Action】
This product is a long-acting tricyclic antihistamine that can relieve seasonal allergic rhinitis or non-nasal symptoms by selectively antagonizing peripheral H1 receptors. Toxicological Studies: Genotoxicity: No mutagenic effect of loratadine was observed in the Ames test, positive point mutation test, DNA damage test, and chromosome aberration test. In the mouse lymphoma test, a positive result was observed in the inactive state, while a negative result was observed in the activated state. Reproductive Toxicity: Oral administration of loratadine to male rats at a dose of 64 mg/kg (approximately 50 times the maximum clinically recommended daily oral dose based on body surface area) resulted in decreased fertility, manifested as a reduced conception rate in female rats. Oral administration of loratadine at a dose of 24 mg/kg.
【Storage】
Store in a tightly closed container. Shelf life: Tentatively 36 months
【Specification】
5 mg
【Packaging Specifications】
5 mg * 20 tablets/box
【Shelf Life】
36 months
【Approval Number】
National Drug Approval Number H20080213
【Manufacturer】
Company Name: Shijiazhuang Yuhui Pharmaceutical Co., Ltd.
