Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: Xingyuanjia Loratadine Tablets 10mg*6 tablets
Pinyin Code: XingYuanJia LvLeiTaDingPian10mg*6Pian / He
【Main Ingredients】
The main ingredient is loratadine. Its chemical name is: 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11-ylidene)-1-piperidinecarboxylic acid ethyl ester.
【Appearance】
This product is a white tablet.
【Indications/Main Functions】
Used to relieve symptoms associated with allergic rhinitis, such as sneezing, runny nose, nasal itching, nasal congestion, and itchy and burning eyes. After oral administration, nasal and ocular symptoms and signs are rapidly relieved. Also suitable for relieving symptoms and signs of chronic urticaria, pruritic dermatitis, and other allergic skin diseases.
【Specifications】
10mg*6 tablets
【Dosage and Administration】
1. Adults and children over 6 years of age: Oral administration, 10 mg once daily.
2. Children aged 2-5 years: 5 mg once daily.
3. Adults and children over 6 years of age with hepatic or renal failure (GFR < 30 mL/min): The starting dose is 10 mg every 2 days.
4. Children aged 2-5 years with hepatic or renal failure: The starting dose is 5 mg every 2 days.
【Adverse Reactions】
At the recommended daily dose of 10 mg, this product has not shown significant sedative effects. Common adverse reactions include fatigue, headache, drowsiness, dry mouth, gastrointestinal discomfort including nausea, gastritis, and rash. Rare adverse reactions include hair loss, allergic reactions, abnormal liver function, tachycardia, and palpitations.
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to it or those with specific constitutions.
【Precautions】
1. Patients with severe hepatic impairment should use this product under the guidance of a physician.
2. Use with caution during pregnancy and lactation.
3. Discontinue use approximately 48 hours before a skin test, as antihistamines can prevent or reduce a positive skin test reaction.
4. Contraindicated in patients with known hypersensitivity to this product; use with caution in patients with allergic constitution.
5. Do not use if the product's appearance changes.
6. Keep out of reach of children.
7. Children must use this product under adult supervision.
8. Consult a physician or pharmacist before using this product if you are currently using other medications.
【Pediatric Use】
The safety of this product in children under 12 years of age has not been established.
【Geriatric Use】
Mild to moderate hepatic and renal impairment has no significant effect on the metabolism and excretion of this drug; therefore, the dosage for elderly patients is the same as for adults.
【Use in Pregnant and Lactating Women】
The safety of this product in pregnant women has not been established, and since loratadine can be excreted into breast milk, it should be used with caution in pregnant and lactating women.
【Overdosage】
Overdose of this product (40-180 mg) in adults may cause drowsiness, arrhythmia, and headache. If these symptoms occur, immediate symptomatic and supportive therapy should be administered. Treatment includes inducing vomiting, followed by administering activated charcoal to adsorb unabsorbed drug. If vomiting is unsuccessful, gastric lavage with normal saline and catharsis should be administered to dilute the drug concentration in the intestines. Hemodialysis cannot remove loratadine, and it is not yet determined whether peritoneal dialysis can remove it.
【Pharmacology and Toxicology】
This product is a long-acting tricyclic antihistamine with rapid onset and strong effect after oral administration. It can relieve nasal or non-nasal symptoms of seasonal allergic rhinitis or treat idiopathic urticaria by selectively antagonizing peripheral H1 receptors.
【Pharmacokinetics】
It is rapidly absorbed after oral administration on an empty stomach. The drug takes effect 1–3 hours after administration, reaches its maximum effect 8–12 hours, and its effect lasts for more than 24 hours. Food can delay the peak time and increase the AUC. In normal adults, the T1/2 of loratadine is 28 (8.8–92) hours. 80% appears in urine and feces as metabolites. In patients with chronic renal failure (creatinine clearance ≤30 ml/min), the AUC and blood concentration of loratadine are increased by about 73%, while the AUC of its metabolites is increased by about 120%. In patients with chronic alcoholic liver disease, the AUC and peak concentration of loratadine are twice that of normal individuals, and the T1/2 of loratadine and its metabolites are 24 and 37 hours, respectively, which can be prolonged with the severity of liver disease.
【Shelf Life】
36 months
【Approval Number】
National Drug Approval Number H20050039
【Manufacturer】
Beijing Xinghao Pharmaceutical Co., Ltd.
