Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: Xingyuanqing Loratadine Tablets 10mg*8 tablets
Pinyin Code: XingYuanQing LvLeiTaDingPian 10mg*8Pian
【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-ethylenedimethyl)-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*8 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 or specific constitutions.
【Precautions】
1. Patients with severe hepatic impairment should use this product under the guidance of a physician.
2. Use with caution in pregnant and lactating women.
3. Discontinue use of this product 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 this product if its appearance changes.
6. Keep this product 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.
【Drug Interactions】
At therapeutic doses, erythromycin, cimetidine, and ketoconazole may increase the blood concentrations of loratadine and decarboxyethoxyloratadine, but have no significant effect on QTc, clinical laboratory tests, vital signs, or the incidence of side effects, nor do they cause sedation or syncope. The plasma concentrations of cimetidine and ketoconazole are not affected by loratadine. Loratadine increases the plasma concentration (AUC0-24h) of erythromycin by 15%, but the clinical significance of this difference is uncertain. Concomitant use of loratadine with oral contraceptives does not increase the incidence of side effects.
【Pediatric Use】
The safety of this product in children under 12 years of age has not been established.
【Use in Elderly Patients】
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, caution should be exercised when using this product in pregnant and lactating women.
【Overdosage】
Overdose of this product (40-180 mg) in adults may cause drowsiness, arrhythmia, and headache. If any of these symptoms occur, immediate symptomatic and supportive treatment should be given. Treatment measures include inducing vomiting, followed by administration of activated charcoal to adsorb unabsorbed drug. If vomiting is unsuccessful, gastric lavage with normal saline is performed, followed by catharsis 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】
Absorption is rapid after oral administration on an empty stomach. The onset of action is 1–3 hours, with maximum effect reached in 8–12 hours, and the duration of action 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% occurs as metabolites in urine and feces. In patients with chronic renal failure (creatinine clearance ≤30 ml/min), the AUC and plasma concentration of the drug are increased by approximately 73%, while the AUC of its metabolites is increased by approximately 120%. In patients with chronic alcoholic liver disease, the AUC and peak concentration of loratadine are twice that of normal individuals. The half-life (T1/2) of loratadine and its metabolites are 24 and 37 hours, respectively, which can be prolonged depending on the severity of liver disease.
【Storage】
Store in a sealed container.
【Packaging】
Aluminum-plastic packaging.
【Shelf Life】
36 months
【Approval Number】
National Drug Approval Number H20050039
【Manufacturer】
Beijing Xinghao Pharmaceutical Co., Ltd.
