Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: BaiWeiTan LvLeiTaDingPian 10mg*10 tablets
Pinyin Code: BaiWeiTan LvLeiTaDingPian 10mg*10Pian
【Main Ingredients】
Each tablet contains 10mg of loratadine, chemically named ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]-cyclohepta[1,2-b]pyridin-11-enyl)-1-piperidinecarboxylate. Excipients include: lactose, microcrystalline cellulose, sodium carboxymethyl starch, 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*10 tablets
【Dosage and Administration】
Oral administration. Adults and children over 12 years: 1 tablet (10mg) once daily. Children aged 2-12 years: Weight > 30 kg: 1 tablet (10mg) once daily. Weight ≤ 30 kg: Half a tablet (5mg) once daily.
【Adverse Reactions】
Mainly includes headache, drowsiness, fatigue, dry mouth, blurred vision, decreased or increased blood pressure, palpitations, syncope, hyperactivity, altered liver function, jaundice, hepatitis, liver necrosis, hair loss, seizures, breast enlargement, erythema multiforme, and systemic allergic reactions.
【Contraindications】
Contraindicated in patients with known hypersensitivity to this product or those with specific constitutions.
【Precautions】
1. Patients with severe hepatic impairment should use 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. Contraindicated in patients with known hypersensitivity to this product; use with caution in patients with allergic constitution.
5. Do not use if the product's appearance changes.
6. Keep out of reach of children.
7. Children must use this product under adult supervision.
8. Consult a physician or pharmacist before using this product if you are currently using other medications.
【Drug Interactions】
Drugs that inhibit hepatic drug-metabolizing enzymes can slow the metabolism of this product. Daily administration of ketoconazole 400 mg can increase the plasma concentrations of loratadine and its active metabolite descarboxyethyl loratadine, but no electrocardiographic changes were observed. Concomitant use with macrolide antibiotics, cimetidine, theophylline, etc., can also inhibit the metabolism of loratadine.
【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 be performed. Sodium sulfate (a saline laxative) may also be considered to prevent intestinal absorption. Hemodialysis does not eliminate this product; whether peritoneal dialysis eliminates this product is unclear.
【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 occurs after oral administration on an empty stomach. The drug takes effect 1–3 hours after administration, reaches its maximum effect in 8–12 hours, and its 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, and the 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 drug and its metabolites do not readily cross the blood-brain barrier and mainly act on peripheral H1 receptor sites.
【Storage】
Store in a sealed container.
【Packaging】
Pharmaceutical grade PVC rigid sheet, pharmaceutical packaging aluminum foil, 10 tablets/blister, 1 blister/box.
【Shelf Life】
48 months
【Approval Number】
National Drug Approval Number H20020174
【Manufacturer】
Sanmenxia Sainov Pharmaceutical Co., Ltd.
