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.

Main ingredient: Ebastine.

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 per day orally. Children aged 6-11 years: half a tablet (5 mg) per day orally. Children aged 2-5 years: the usual dose is 2.5 mg per day orally. Children under 2 years old: the safety of this product needs further verification. No dosage adjustment is required for the elderly and patients with hepatic and renal insufficiency. 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: The safety of the drug for children has not been determined. Precautions for pregnancy and lactation: The safety of the drug for pregnant women has not been determined. Pregnant women and women who may become pregnant should weigh the pros and cons. Animal (rat) experiments show that this product can enter breast milk. Breastfeeding should be avoided during the medication period. Precautions for the elderly: Generally, the physiological functions of the elderly decline, so it is important to start taking the drug from a small dose (5 mg) once a day.

Erythromycin can increase the plasma concentration of carbastine, a metabolite of this product, by 2 times.

Seal tightly and store in a cool, dry place.

Two years