Product Overview
【Drug Name】
Generic Name: Ebastine Tablets
Brand Name: Kaisiting
English Name: Ebastine Tablets
Pinyin: YiBaSiTingPian(KaiSiTing)
【Ingredients】
The main ingredient of this product is ebastine, whose chemical name is: 4-diphenylmethoxy-1-[3-(p-tert-butylbenzoyl)propyl]piperidine. Molecular Formula: C32H39NO2 Molecular Weight: 469.62 Molecular Weight: C32H39NO2
【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】
Adults and children over 12 years of age: One or two tablets once daily orally.
Children aged 6-11 years: Half a tablet (5mg) once daily orally. Children aged 2-5 years: The usual dose is 2.5 mg orally once daily. Children under 2 years: The safety of this product needs further verification. No dose adjustment is required for elderly patients and patients with hepatic or renal insufficiency. For patients with severe hepatic failure, the daily dose must not exceed 10 mg/day.
【Adverse Reactions】
Foreign literature reports that in patients over 12 years of age, adverse reactions occurring in greater than 1% include: headache (7.9%), drowsiness (3%), and dry mouth (2.1%). In children under 12 years of age, side effects observed in greater than 1% include headache (11.7%), dry mouth (2.6%), and drowsiness (1.25%). In children over 12 years of age, adverse effects reported in less than 1% include: abdominal pain, indigestion, epistaxis, rhinitis, sinusitis, nausea, and insomnia. In children under 12 years of age, other adverse effects reported in less than 1% include: increased appetite, diarrhea, rash, irritability, mood swings, hyperactivity, changes in taste, and weakness.
【Contraindications】
Patients with known hypersensitivity to ebastine or any component of the tablets.
【Precautions】
Caution should be exercised when using this medication in patients with known cardiac risk factors, such as QT prolongation syndrome, hypokalemia, or those taking drugs that prolong the QT interval or CYP3A4 enzyme inhibitors, such as pyrrole antifungals and macrolide antibiotics (see Drug Interactions). Because ebastine works within 1 to 3 hours after administration, it is not suitable for emergency treatment of acute allergic reactions as a single drug. Effects on driving and machine operation: Extensive research has shown that it has no effect on the psychomotor system at the recommended therapeutic dose. One trial studying the effect of ebastine on driving ability showed that doses below 30 mg of ebastine had no adverse effect on driving ability. Based on the above conclusions, ebastine at therapeutic doses has no effect on the ability to drive or operate machinery. Please read the instructions carefully and use as directed by your doctor.
【Special Populations】
Children's Precautions: This product is suitable for children aged 2 years and older. Children aged 12 years and older should follow the same dosage and administration as adults. Children aged 6-11 years: 5 mg/tablet orally once daily. Children aged 2-5 years: The usual dose is 2.5 mg orally once daily. Children under 2 years: The safety of this product requires further verification. Please see [Adverse Reactions] for details on adverse reactions in children.
Pregnancy and Lactation Precautions: The safety of ebastine in pregnant women lacks sufficient verification. Animal studies have shown that ebastine has no direct or indirect harmful effects on embryonic development in early, mid, and late pregnancy, and no teratogenic effects have been found in animal studies. However, no human studies have been conducted, so ebastine should only be used in pregnant women when absolutely necessary. It is unclear whether ebastine is excreted in breast milk, therefore it is contraindicated during lactation.
Elderly Precautions: There were no statistically significant differences in pharmacokinetics between elderly subjects and young adult volunteers. The dosage and administration for elderly patients are the same as for adult patients, and no dose adjustment is required.
【Pharmacological Action】
Ebastine has a rapid and long-lasting histamine inhibitory effect and a high affinity for histamine H1 receptors. When administered orally, ebastine and its metabolites cannot cross the blood-brain barrier. This explains the mild sedative effect of ebastine on the central nervous system observed during the trial. The experimental data indicate that ebastine is a potent, long-acting, highly selective histamine H1 receptor antagonist and does not antagonize cholinergic receptors in the central nervous system. Preclinical safety data show that no toxic effects of ebastine were found in routine pharmacological safety studies. Repeat-dose studies did not reveal any toxicity, reproductive toxicity, potential carcinogenicity, or reproductive side effects.
【Storage】
Store below 30°C, protected from light.
【Specifications】
10 mg
【Packaging】
10 tablets/box in aluminum-plastic packaging
【Shelf Life】
36 months
