Product Overview
【Drug Name】
Generic Name: Loratadine Capsules
Brand Name: BoKe Loratadine Capsules 10mg*6 Capsules
Pinyin Code: BoKe LvLeiTaDingJiaoNang 10mg*6Li
【Main Ingredients】
Each capsule contains 10 mg of loratadine.
【Appearance】
This product is a capsule containing white or off-white granules or powder.
【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 Capsules
【Dosage and Administration】
Oral administration. Adults and children over 12 years of age: 1 capsule (10 mg) once daily. Children aged 2-12 years: Weight 30 kg: 1 tablet (10 mg) once daily.
【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 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 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 properties change.
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.
9. The safety and efficacy of this product in children under 6 years of age have not been established. Please consult your doctor or pharmacist.
10. Patients with hepatic or renal insufficiency should reduce the dosage. The recommended dosage is 10 mg once every two days, or use under the guidance of a doctor.
11. Because plasma concentrations are higher in elderly patients than in healthy individuals, close monitoring for adverse reactions is necessary when elderly patients use this product long-term.
12. 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 includes inducing vomiting, followed by administration of activated charcoal to absorb unabsorbed medication. If vomiting is unsuccessful, gastric lavage with saline solution should be 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 this product.
【Drug Interactions】
1. Concomitant use of ketoconazole, macrolide antibiotics, cimetidine, theophylline, etc., may increase the plasma concentration of loratadine and should be used with caution. 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 yet 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, this product should be used with caution in pregnant and lactating women.
【Overdosage】
Not yet known.
【Pharmacology and Toxicology】
This product is a highly effective, long-acting tricyclic antihistamine and a selective peripheral H1 receptor antagonist. It can relieve various symptoms caused by allergic reactions.
【Pharmacokinetics】
Not yet known.
【Storage】
Store in a sealed container.
【Shelf Life】
30 months
【Approval Number】
National Drug Approval Number H20051636
【Manufacturer】
Guangxi Houde Big Health Industry Co., Ltd.
