Product Overview
【Drug Name】
Generic Name: Ebastine Tablets
Brand Name: Sudi
English Name: Ebastine Tablets
Pinyin: Yibasiding Pian
【Ingredients】
Main Ingredient: Ebastine.
【Appearance】
This product is a film-coated tablet, white after removing the coating.
【Indications】
Suitable for allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis. Symptomatic treatment of chronic idiopathic urticaria.
【Dosage and Administration】
Oral administration. The adult dose is one tablet (10mg) once daily.
【Adverse Reactions】
1. Allergic reactions, rarely skin rash or edema.
2. Gastrointestinal side effects, occasionally 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.
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to it or its excipients.
【Precautions】
1. Use with caution in patients with hepatic impairment or a history of hepatic impairment.
2. Use with caution while driving or operating machinery.
【Special Populations】
Pediatric Precautions: The safety of this product in children has not been established.
Pregnancy and Lactation Precautions: The safety of this product in pregnant women has not been established. Pregnant women and women who may become pregnant should weigh the risks and benefits. Animal (rat) studies have shown that this product can pass into breast milk; breastfeeding should be avoided while taking this product.
Elderly Precautions: Elderly individuals typically experience a decline in physiological function; therefore, it is advisable to start with a small dose (5 mg) once daily.
【Drug Interactions】
Erythromycin can increase the plasma concentration of its metabolite, carbastine, by two times.
【Pharmacological Action】
Pharmacological Action: Ebastine is a histamine H1 receptor antagonist. This product is metabolized in vivo to carbastine, which has selective antagonistic effects on histamine H1 receptors, inhibiting histamine release. Its antagonistic effect on H1 receptors in the central nervous system and its anticholinergic effect are very weak. Toxicological effects: Repeated administration: In rats, oral administration of 1.5, 15, and 150 mg/kg/day for 52 consecutive weeks resulted in foam cell aggregation in the alveolar cavities of animals in the high-dose group, absence of the corpus luteum in the ovaries of female rats, and cyst formation. The no-toxicity dose in this experiment was 15 mg/kg/day. In dogs, oral administration of decreasing doses of 150, 90, and 60 mg/kg/day for 52 weeks resulted in thymic atrophy, mild lymph node degeneration, and lymphocyte degeneration. Reproductive toxicity: In rats, administration of ebastine before and during early pregnancy, at a parental toxic dose of 150 mg/kg/day, did not affect animal fertility or fetal development. In rats during organogenesis, administration of ebastine, at a maternal toxic dose of 100 mg/kg/day, resulted in reduced fetal weight and inhibited growth in newborn pups, but no teratogenicity was observed. In rabbits administered ebastine during organogenesis at a maternally toxic dose of 120 mg/kg/day, one mother died and one aborted, but there was no effect on the fetus, and no teratogenic effects were observed. In rats administered ebastine during the perinatal and lactation periods, pups born in the 200 mg/kg/day group showed inhibited growth, reduced food intake, and delayed vaginal development.
【Storage】
Sealed, store in a cool, dry place.
【Specifications】
10 mg
【Packaging Specifications】
10 mg/tablet, 7 tablets/box
【Shelf Life】
24 months
【Manufacturer】
Company Name: Jiangsu Lianhuan Pharmaceutical Co., Ltd. Abbreviation: Jiangsu Lianhuan Pharmaceutical
