Ebastine Tablets

Pharmacological action: Ebastine is a histamine H1 receptor antagonist. This product is metabolized to carbastine in the body, which has a selective antagonistic effect on histamine H1 receptors, can inhibit the release of histamine, and has very weak H1 receptor antagonism and anticholinergic effects on the central nervous system. Toxicological effects: Repeated administration: Rats were orally administered 1.5, 15, and 150 mg/kg/day for 52 consecutive weeks. Foam cells accumulated in the alveolar cavity of the animals in the high-dose group, and the corpus luteum was missing in the ovaries of female rats, and cysts were formed. The non-toxic dose of this test was 15 mg/kg/day. Dogs were orally administered a decreasing dose of 150, 90, and 60 mg/kg/day for 52 weeks, and thymus atrophy, mild degeneration of lymph nodes, and degeneration of lymphocytes occurred. Reproductive toxicity: Ebastine was given to rats before and during early pregnancy. At the toxic dose of 150 mg/kg/day for the parent animals, the fertility and fetal development of the animals were not affected. When rats were given ebastine during the period of organogenesis, the fetal weight decreased and the growth of the newborn pups was inhibited at a maternal toxic dose of 100 mg/kg/day, but no teratogenicity was observed. When rabbits were given ebastine during the period of organogenesis, one mother died and one miscarried at a maternal toxic dose of 120 mg/kg/day, but there was no effect on the fetus and no teratogenic effect was observed. When rats were given ebastine during the perinatal and lactation period, the growth of the pups born in the 200 mg/kg/day group was inhibited, the food intake was reduced, and the vaginal development was delayed.

The main ingredient of this product is: Ebastine. Its chemical name is: 4-diphenylmethoxy-1-[3-(p-tert-butylbenzoyl)propyl]piperidine. Its structural formula is: Molecular formula: C32H39NO2 Molecular weight: 469.62

This product is a film-coated tablet, which appears white after removing the coating.

Indicated for allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis. Symptomatic treatment of chronic idiopathic urticaria.

Adults and children over 12 years old: one or two tablets orally once a day. Children aged 6-11 years: half a tablet (5 mg) orally once a day. Children aged 2-5 years: the usual dose is 2.5 mg orally once a day. Children under 2 years old: the safety of this product needs further verification. No dosage adjustment is required for the elderly and patients with liver and kidney dysfunction. For patients with severe liver failure, the daily dosage is strictly prohibited to exceed 10 mg/day.

1. Allergic reactions, rare rash and edema. 2. Digestive tract, dry mouth and stomach discomfort. 3. Abnormal liver function, occasionally elevated GPT and ALP. 4. Rare tachycardia. 5. Sometimes drowsiness, occasionally headache and dizziness. 6. Occasionally eosinophilia.

Patients who are allergic to ebastine or any ingredient in the tablets.

Precautions for children: This product is suitable for children over 2 years old, and the dosage for children over 12 years old is the same as that for adults. Children aged 6-11 years: 5 mg/tablet orally once a day. Children aged 2-5 years: The usual dosage is 2.5 mg orally once a day. Children under 2 years old: The safety of this product needs further verification. For adverse reactions to children's medication, please refer to [Adverse Reactions]. Precautions for pregnancy and lactation: There is still insufficient verification of the safety of ebastine for pregnant women. Animal experimental studies have shown that ebastine has no direct or indirect harmful effects on embryonic development in the early, middle and late stages of pregnancy. It has not been found to have teratogenic effects in animal experiments. However, no human trials have been conducted. Therefore, ebastine can only be used in pregnant women when absolutely necessary. It is not clear whether ebastine is secreted in breast milk, so it is contraindicated during lactation. Precautions for the elderly: Generally, the physiological functions of the elderly decline, so it should be noted that the medication should be started with a small dose (5 mg) once a day.

Studies have shown that when ebastine is used in combination with ketoconazole or erythromycin (both of which are known to prolong the QT interval), there are pharmacokinetic and pharmacodynamic interactions that increase the blood concentration of ebastine - although the QT interval is only prolonged by 10ms compared to the above two drugs used alone. Therefore, ebastine should be used with caution in patients taking ketoconazole or erythromycin at the same time. When ebastine is taken with food, the blood concentration and its basic active product after metabolism increase by 1.5-2.0 under the influence of certain factors. However, this increase does not affect the time when its blood concentration reaches its peak. Taking it with food does not affect the clinical efficacy of ebastine. Ebastine affects the results of skin tests, so skin tests can only be performed 5 to 7 days after stopping ebastine. In addition, the effects of some other antihistamines may be exaggerated after taking ebastine.

Store in a dry place below 30℃ and away from light.

10 mg

Two years