Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: Shuntaxin Loratadine Tablets 10mg*6 tablets
Pinyin Code: ShunTaXin LvLeiTaDingPian 10mg*6Pian
【Main Ingredients】
Each tablet contains 10 mg of loratadine. Excipients include: sodium dodecyl sulfate, starch, microcrystalline cellulose, povidone K30, sodium carboxymethyl starch, talc, and magnesium stearate. Chemical Name: 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylic acid ethyl ester.
【Appearance】
This product is a white or off-white tablet.
【Indications/Main Functions】
1. 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.
2. It is 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.
1. Adults and children over 12 years of age: 1 tablet (10 mg) once daily.
2. Children aged 2–12 years:
Weight 30 kg: 1 tablet (10 mg) once daily.
Weight ≤30 kg: Half a tablet (10 mg) once daily.
【Adverse Reactions】
1. At the recommended daily dose of 10 mg, this product has not shown significant sedative effects.
2. 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. (See package insert for other details).
【Contraindications】 This product is contraindicated in patients with known hypersensitivity to any of its ingredients.
【Precautions】
1. Patients with severe hepatic impairment should use this product under the guidance of a physician.
2. Use with caution during pregnancy and lactation.
3. Discontinue use 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.
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 impairment should reduce the dosage; a dose of 10 mg every two days is recommended, or use under the guidance of a physician.
11. Because plasma concentrations of loratadine are higher in elderly patients than in healthy individuals, close monitoring for adverse reactions is necessary when using this product long-term in elderly patients.
12. Overdose of this product (40-180 mg) in adults may cause drowsiness, arrhythmia, and headache. If these symptoms occur, immediate symptomatic and supportive therapy should be administered. Treatment includes inducing vomiting, followed by administration of activated charcoal to absorb the absorbed drug. If vomiting is unsuccessful, gastric lavage with normal saline, catharsis, and dilution of the drug concentration in the intestines should be performed. 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】
As directed by your doctor.
【Use in Elderly Patients】
As directed by your doctor.
【Use in Pregnant and Lactating Women】
As directed by your doctor.
【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.
【Packaging】
10mg*6 tablets/box.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20051688
【Manufacturer】
Shandong Tianshun Pharmaceutical Co., Ltd.
