Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: Baymin Loratadine Tablets 10mg*6 tablets
Pinyin Code: LvLeiTaDingPian
【Main Ingredients】
Each tablet contains 10 mg of loratadine. Excipients include: starch, lactose, microcrystalline cellulose, povidone K30, and magnesium stearate.
【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】
Not yet clear.
【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. Contraindicated in patients with known hypersensitivity to this product; use with caution in patients with allergic constitution.
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.
【Drug Interactions】
1. Concomitant use with 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 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 effect 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 women. Breastfeeding should be discontinued during medication. [Overdosage] In case of overdose, vomiting can be induced if the patient is conscious. Gastric lavage with normal saline and administration of activated charcoal to adsorb the drug can also be considered. Sodium sulfate (a saline laxative) can also be used to prevent intestinal absorption. Hemodialysis cannot eliminate this product, and it is unclear whether peritoneal dialysis can eliminate it.
【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 loratadine 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. This product and its metabolites do not readily cross the blood-brain barrier and mainly act on peripheral H1 receptor sites.
【Storage】
Protect from light and store in a sealed container.
【Packaging】
Aluminum-plastic packaging, 6 tablets/blister/box.
【Shelf Life】
18 months
【Approval Number】
National Drug Approval Number H20050233
【Manufacturer】
Wanquan Wante Pharmaceutical (Xiamen) Co., Ltd. (formerly Meijishi Pharmaceutical (Xiamen) Co., Ltd.)
