Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: Fulaixi Loratadine Tablets 10mg*6 tablets
Pinyin Code: FuLaiXi LvLeiTaDingPian 10mg*6Pian
【Main Ingredients】
The main ingredient and 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 or off-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】
Oral administration. Adults and children over 12 years of age: 1 tablet (10 mg) once daily. Children aged 2-12 years: Weight >30 kg: 1 tablet (10 mg) once daily. Weight ≤30 kg: Half a tablet (5 mg) once daily.
【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 in pregnant and lactating women.
3. This product should be discontinued approximately 48 hours before the skin test, as antihistamines can prevent or reduce a positive skin test reaction.
4. This product is contraindicated in patients with known hypersensitivity to it; use with caution in patients with allergic constitutions.
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 your doctor or pharmacist before using this product if you are currently using other medications.
【Drug Interactions】
Drugs that inhibit the function of hepatic drug-metabolizing enzymes can slow the metabolism of this product. Daily administration of ketoconazole 400 mg can increase the plasma concentrations of loratadine and its active metabolite descarboxyethyl loratadine, but no electrocardiographic changes were observed. Concomitant use with macrolide antibiotics, cimetidine, theophylline, etc., can also inhibit the metabolism of loratadine.
【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 impact 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】
Use with caution in pregnant and lactating women.
【Overdosage】
Not yet clear.
【Pharmacology and Toxicology】
Pharmacology: This product is a long-acting tricyclic antihistamine that competitively inhibits histamine H1 receptors, suppressing histamine-induced allergic symptoms. This product has no significant anticholinergic or central nervous system depressant effects. Toxicology: No significant teratogenic effects were observed in animal studies.
【Pharmacokinetics】
Rapid absorption after oral administration on an empty stomach. Onset of action is 1–3 hours after administration, 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. The protein binding rates of loratadine and its metabolites are 97% and 73%–77%, respectively. Hismanal and its metabolites do not readily cross the blood-brain barrier and primarily act on peripheral H1 receptor sites.
【Storage】
Store at room temperature, protected from light, and in a tightly closed container.
【Packaging】
Aluminum-plastic packaging, 6 tablets/blister/box.
【Shelf Life】
30 months
【Approval Number】
National Drug Approval Number H20050009
【Manufacturer】
Henan Jiusheng Pharmaceutical Co., Ltd.
