Loratadine Dispersible Tablets

Pharmacological action: This product is a long-acting tricyclic antihistamine that can relieve seasonal allergic rhinitis or non-nasal symptoms by selectively binding to peripheral H1 receptors. Toxicological studies: Genetic toxicity: No mutagenic effect of loratadine was observed in the Ames test, forward point mutation test, DNA damage test, and chromosome aberration test. In the mouse lymphoma test, positive results were observed in the inactive state and negative results in the activated state. Reproductive toxicity: Oral administration of loratadine to male rats at a dose of 64 mg/kg (approximately 50 times the clinically recommended maximum daily oral dose, calculated based on body surface area) can cause decreased fertility, as manifested by a decrease in the pregnancy rate of female rats. Oral administration of loratadine at a dose of 24 mg/kg

The main ingredient is loratadine. Chemical name: 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cycloheptyl[1,2-b]pyridine-11-ene)-1-piperidinecarboxylic acid ethyl ester.

This product is white to off-white tablets.

It is used to relieve nasal or non-nasal symptoms of allergic rhinitis, such as sneezing, runny nose, itchy nose, itchy eyes and burning eyes, etc. It is also suitable for alleviating the symptoms and signs of chronic urticaria and other allergic skin diseases.

Oral administration: 10 mg once a day for adults and children over 12 years old. Children aged 2-12 years: 10 mg once a day for children weighing more than 30 kg and 5 mg once a day for children weighing ≤ 30 kg.

1. Common adverse reactions include fatigue, headache, drowsiness, dry mouth, gastrointestinal discomfort (including nausea, gastritis) and rash. Occasionally, drowsiness, forgetfulness and facial and extremity edema in the morning are seen. Rare adverse reactions include blurred vision, decreased or increased blood pressure, syncope, epileptic seizures, breast enlargement, hair loss, allergic reactions, abnormal liver function, tachycardia, palpitations, hyperkinesia, jaundice, hepatitis, liver necrosis, erythema multiforme, etc. 2. Literature reports that in a randomized controlled clinical trial involving approximately 300 children aged 6-12 years, loratadine 10 mg was taken orally once a day for 8-15 consecutive days. Among them, 188 children used loratadine syrup 10 mg/day. The types and frequencies of adverse reactions are similar to those in adults. Chlor

This product is contraindicated for patients who are allergic to any ingredient or have special physical conditions.

Precautions for children: The safety and efficacy of this product for children under 2 years old have not been determined. Foreign studies have shown that the pharmacokinetic characteristics of 1-2 years old children after taking 2.5 mg of this product are similar to those of older children and adults. Precautions for pregnancy and lactation: The safety during pregnancy has not been determined, so pregnant women should use it with caution. This product can be secreted from breast milk, and antihistamines are very dangerous to infants, especially newborns and premature infants. Breastfeeding must be stopped during the medication period. Precautions for the elderly: Because the plasma concentration of elderly patients after taking the drug is higher than that of healthy people, elderly patients should pay close attention to the occurrence of adverse reactions when using this product for a long time.

1. Taking ketoconazole, macrolide antibiotics, cimetidine, theophylline and other drugs at the same time will increase the concentration of loratadine in plasma and should be used with caution. Other drugs known to inhibit liver metabolism should be used with caution before clear interaction with loratadine. 2. If you are taking other drugs, please consult a doctor or pharmacist before using this product.

Keep in a light-proof and airtight container. Validity period: tentatively 24 months.

5 mg

24 months

Beijing SL Pharmaceutical Co., Ltd.

• Founded in:

  1994-12-24

• Address:

  4th Floor, Building 1, Bitongyuan, No. 69, Fushi Road, Haidian District, Beijing

• Tax NO.:

  91110000102299779W

• Registered Funds:

  1,027.35 million yuan

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