Product Overview
【Drug Name】
Generic Name: Loratadine Granules
Brand Name: Renomin Loratadine Granules 5mg*12 sachets
Pinyin Code: LeiNuoMin LvLeiTaDingKeLi
【Main Ingredients】
Each sachet contains 5mg of loratadine. Excipients: sucrose, lactose, sodium carboxymethyl cellulose.
【Appearance】
This product is white granules with a sweet taste.
【Indications/Main Functions】
Used to treat seasonal allergic rhinitis (relief of nasal or non-nasal symptoms) and idiopathic urticaria.
【Specifications】
5mg*12 sachets
【Dosage and Administration】
Dissolve in warm water and take orally.
Adults: Once daily, 2 sachets (10mg) each time; Children aged 2-12 years, weight ≤30kg, once daily, 2 sachets (10mg) each time; weight ≤30kg, once daily, 1 sachet (5mg) each time.
【Adverse Reactions】
At the recommended daily dose of 10 mg, this product did not show 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 this product or any of its components.
【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. 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. If you are currently using other medications, please consult your doctor or pharmacist before using this product.
【Drug Interactions】
1. Concomitant use of 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 with caution until their interaction with loratadine is clearly established.
2. Drug interactions may occur when used with other medications; please consult your doctor or pharmacist for details.
【Pediatric Use】
The safety and efficacy of loratadine in children under 2 years of age have not been established.
【Use in Elderly Patients】
There is no significant difference in the distribution of loratadine use between elderly patients over 60 years of age and younger adult patients.
【Use in Pregnant and Lactating Women】
To date, there is no clinical data on the use of loratadine in pregnant women. Furthermore, loratadine can be excreted in breast milk, and histamine poses a significant risk to infants, especially newborns and premature infants. Therefore, pregnant and lactating women should use this product with caution.
【Overdosage】
Overdose of this product in adults (40–180 mg) may cause symptoms such as drowsiness, tachycardia, and headache. Overdose in children (>10 mg) may cause extrapyramidal symptoms and palpitations. In these cases, emetics and activated charcoal adsorption can be used.
【Pharmacology and Toxicology】
Loratadine is an oral, long-acting tricyclic antihistamine with selective action against peripheral H1 receptors. As a third-generation antihistamine, it is characterized by rapid onset and potent effect. Studies in guinea pigs showed that the duration of action of this product is 18-24 hours. Studies on its central nervous system effects showed that this product has little or no inhibitory or anticholinergic effect on mice, rats, dogs, and monkeys. No significant teratogenic effects were observed in animal studies.
【Pharmacokinetics】
Loratadine is rapidly absorbed from the gastrointestinal tract after oral administration. In healthy adults, after a single oral dose of 10, 20, or 40 mg, the plasma concentrations are 5, 11, and 26 μg/L, respectively, 1-1.5 hours later. This product is extensively metabolized in the body, and its main metabolite, descarboxyethoxyloratadine (DCL), has a strong anti-H1 receptor activity. The half-lives of this product and descarboxyethoxyloratadine are 12 and 18 hours, respectively. The binding rate of this product to plasma proteins is approximately 98%, while the binding rate of descarboxyethoxyloratadine is lower, at 73%-76%. This product and its metabolites can be detected in breast milk, but the amount that crosses the blood-brain barrier is small. This product and its metabolites are excreted in urine and feces. Approximately 27% is excreted in urine 24 hours after administration; after 10 days, approximately 40% is excreted in urine and 42% in feces.
【Storage】
Store protected from light and in a sealed container.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20041708
【Manufacturer】
Hainan Xinsitong Pharmaceutical Co., Ltd.
