【 Drug name 】
Generic name: Loratadine tablets
Product Name: Loratadine tablets (Hui Nourish)
English name: Loratadine Tablets
Full Pinyin code: LvLeiTaDingPian(HuiZiYang)
[Main ingredients] This product contains loratadine 10 mg per tablet, auxiliary ingredients: starch, lactose, microcrystalline cellulose, povidone K30, magnesium stearate.
【 Appearance 】 This product is white or off-white tablets.
It is used to relieve the symptoms associated with allergic rhinitis, such as sneezing, runny nose, nasal itching, nasal congestion, and itching and burning sensation in the eyes. Nasal and ocular symptoms and signs were rapidly relieved after oral administration. It is also used to relieve the symptoms and signs of chronic urticaria, pruritus and other allergic skin diseases.
[Specification Model] 10mg*6s
[Usage and dosage] orally. Adults and children over 12 years old: 1 tablet (10mg) once a day. Children aged 2-12 years: weight > 30 kg: 1 tablet (10 mg) once a day. Body weight ≤30 kg: 1 time a day, half a tablet (5 mg).
[Adverse reactions] At the recommended dose of 10 mg/day, no significant sedative effect was observed. Common adverse events included fatigue, headache, somnolence, dry mouth, gastrointestinal discomfort including nausea, gastritis, and rash. The rare adverse reactions included alopecia, allergic reaction, abnormal liver function, tachycardia and palpitation.
【 Taboo 】 is not clear.
1. For patients with severe hepatic insufficiency, please use it under the guidance of a doctor. 2. Use with caution in pregnant and lactating women. Breastfeeding should be stopped during the medication period. 3. Stop using this product about 48 hours before skin test, because antihistamines can prevent or reduce the occurrence of positive skin test reactions. 4. This product should not be used in allergic patients, and should be used with caution in allergic patients. 5. Do not use this product when its properties have changed. 6. Keep the product out of reach of children. 7. Children must be under adult supervision. The safety of this product in children younger than 12 years of age has not been established. 8. Consult your doctor or pharmacist before using this product if you are using other medicines.
The safety of this product in children younger than 12 years of age has not been established.
[Medication in elderly patients] When liver and kidney function is mildly or moderately impaired, the metabolism and excretion of this drug are not significantly affected, so the dosage of this drug in elderly patients is the same as that in adults.
[Medication for pregnant and lactating women] Use with caution for pregnant women. Breastfeeding should be stopped during the medication period.
[Drug interactions] 1. Taking ketoconazole, macrolide antibiotics, cimetidine, theophylline and other drugs at the same time will increase the concentration of loratadine in plasma, which should be used with caution. Other drugs known to inhibit hepatic metabolism should be used with caution without a clear interaction with loratadine. 2. Please consult your doctor or pharmacist for details about possible drug interactions when used with other drugs.
[Drug overdose] In case of overdose poisoning, if the patient is awake, emetic can be given. The stomach can be washed with normal saline, and the drugs can be adsorbed with activated charcoal. A salt laxative (sodium sulfate) may also be considered to block absorption in the intestine. It is not eliminated by hemodialysis, and whether peritoneal dialysis can eliminate it is not clear.
Pharmacology: This drug is a long-acting tricyclic antihistamine, which competitively inhibits histamine H1 receptor and inhibits allergic symptoms caused by histamine. This product has no obvious anticholinergic and central inhibitory effect. Toxicology: No obvious teratogenic effect was observed in animal experiments.
[Pharmacokinetics] It is rapidly absorbed by oral administration in a fasting state. It took effect 1 ~ 3 hours after administration, reached its maximum effect 8 ~ 12 hours after administration, and lasted for more than 24 hours. Food can delay drug peak time and increase AUC. The T1/2 of loratadine in normal adults was 28 (8.8-92) hours. 80% are present in urine and feces as metabolites. Patients with chronic renal failure (creatinine clearance ≤ 30ml/ min), the AUC and plasma concentration of the drug increased by about 73%, while the AUC of its metabolites increased by about 120%. The AUC and peak concentration of loratadine in patients with chronic alcoholic liver disease were twice that of normal subjects. The T1/2 of loratadine and its metabolites were 24 and 37 hours, respectively, which could be prolonged with the severity of liver disease. The protein binding rates of loratadine and its metabolites were 97% and 73%-77%, respectively. It and its metabolites do not easily cross the blood-brain barrier and mainly act at the peripheral H1 receptor site.
【 Storage 】 Shade, seal and store.
[Package] Aluminum plastic packaging, 6 pieces/board/box.
[Effective period] 36 months
[Approval No.] H20050233
【 Manufacturer 】 Venturepharma Pharmaceutical (Xiamen) Co., LTD. (formerly Mejis Pharmaceutical (Xiamen) Co., LTD.)