Product Overview
【Drug Name】
Generic Name: Loratadine Dispersible Tablets
Brand Name: LeiNing Loratadine Dispersible Tablets 5mg*6 tablets
Pinyin Code: LeiNing LvLeiTaDingFenSanPian5mg*6Pian
【Main Ingredients】
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
【Indications/Main Functions】
Used to relieve 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.
【Specifications】
5mg*6 tablets
【Dosage and Administration】
Oral administration. Adults and children over 12 years of age: 10mg once daily. Children aged 2-12 years: Weight > 30 kg, 10 mg once daily; Weight ≤ 30 kg, 5 mg once daily.
【Adverse Reactions】
1. Common adverse reactions include fatigue, headache, drowsiness, dry mouth, gastrointestinal discomfort (including nausea and gastritis), and rash. Occasionally, drowsiness, forgetfulness, and morning facial and peripheral edema may occur. Rare adverse reactions include blurred vision, decreased or increased blood pressure, syncope, seizures, breast enlargement, hair loss, allergic reactions, abnormal liver function, tachycardia, palpitations, hyperactivity, jaundice, hepatitis, liver necrosis, and erythema multiforme.
2. Literature reports that in a randomized controlled clinical trial involving approximately 300 children aged 6-12 years, oral loratadine 10 mg once daily for 8-15 days was administered. 188 children used loratadine syrup 10 mg/day. The types and frequencies of adverse reactions were similar to those in adults. Chlorine
【Contraindications】
This product is contraindicated in patients with hypersensitivity to any component or those with specific constitutions.
【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.
【Drug Interactions】
1. Concomitant use with ketoconazole, macrolide antibiotics, cimetidine, theophylline, etc., may increase the plasma concentration of loratadine; caution should be exercised when using these medications. Other drugs known to inhibit hepatic metabolism should be used cautiously in combination with loratadine until their interaction with loratadine is clearly established.
2. If you are taking other medications, please consult your doctor or pharmacist before using this product.
【Pharmacology and Toxicology】
Pharmacological Action: This product is a long-acting tricyclic antihistamine that can relieve seasonal allergic rhinitis or non-nasal symptoms by selectively inhibiting peripheral H1 receptors.
Toxicological Studies:
Genetic Toxicity: Loratadine showed no mutagenic effect in the Ames test, positive point mutation test, DNA damage test, and chromosomal aberration test. In the mouse lymphoma test, it showed a positive result in the inactive state and a negative result 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 recommended daily oral dose based on body surface area) resulted in decreased fertility, manifested as a reduced conception rate in female rats. The oral dose of loratadine is up to 24 mg/kg.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20060157
【Manufacturer】
Beijing Shuanglu Pharmaceutical Co., Ltd.
