Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: Yibang Loratadine Tablets 10mg*10s
Pinyin Code: ZuoBang LvLeiTaDingPian 10mg*10s
【Main Ingredients】
Each tablet contains 10 mg of loratadine. Its chemical name is: 4-(8-chloro-6,6-dihydro-11H-benzo[5,6]cycloheptyl[1,2-b]pyridine-11ene)-1-piperidinecarboxylic acid ethyl ester
【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 skin diseases, and other allergic skin diseases.
【Specifications】
10mg*10 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】
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 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 400mg 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, if the patient is conscious, vomiting can be induced. Gastric lavage with normal saline and administration of activated charcoal to adsorb the drug can be performed. Sodium sulfate (a saline laxative) can also be considered to prevent intestinal absorption. Hemodialysis cannot eliminate this product; whether peritoneal dialysis can eliminate this product is unclear.
【Pharmacology and Toxicology】
Pharmacologically, this product is a long-acting tricyclic antihistamine that inhibits allergic symptoms caused by histamine. It competitively inhibits histamine H1 receptors, thus inhibiting allergic symptoms caused by histamine. This product has no significant anticholinergic or central nervous system depressant effects. Animal toxicology studies showed no significant teratogenic effects. This product is an H1 receptor antagonist, highly selective for peripheral H1 receptors, with weak affinity for central H1 receptors, and can inhibit the release of leukotrienes and histamine from mast cells. This product has a rapid onset and long duration of action; its antihistamine effect is stronger than astemizole and terfenadine, and it has good anti-allergic activity.
【Pharmacokinetics】
Rapidly absorbed orally. In healthy adults, a 10 mg dose once daily for 10 days resulted in peak concentration (Tmax) times of 1.3 h for this product and 2.5 h for its main metabolite, decarboxyethoxyloratadine. With a single dose, food increased the AUC of loratadine and decarboxyethoxyloratadine by 40% and 15%, respectively, and delayed Tmax by 1 h; peak concentration was not affected by food. Within 10 days of administration, approximately 80% of the drug is distributed proportionally in urine and feces as metabolites. In almost all patients, the AUC of the metabolites is higher than that of the parent drug. For healthy adults (n=54), the mean elimination half-lives (t?) of loratadine and decarboxyethoxyloratadine are 8.4 h (3-20 h) and 28 h (8.8-92 h), respectively. Steady-state plasma concentrations are generally reached on day 5. Due to the first-pass effect of loratadine, there are significant individual differences in pharmacokinetic parameters.
【Storage】
Protect from light, store in a sealed container.
【Packaging】
Aluminum-plastic packaging, 10 tablets/blister/box.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20045777
【Manufacturer】
Jiangsu Yabang Aipusen Pharmaceutical Co., Ltd.
