Product Overview
【Drug Name】
Generic Name: Mizolastine Sustained-Release Tablets
Brand Name: Onijie
English Name: Mizolastine Sustained-Release Tablets
Pinyin: Mizuoqiting Huanshi Pian
【Ingredients】
Chemical name of mizolastine: 2-[[[1-[(4-fluorophenyl)methyl]-1-hydro-benzimidazol-2-yl]-4-piperidinyl]methyl-amino]-4(3-hydro)-pyrimidinone, Molecular formula: C24H25FN6O, Molecular weight: 432.5.
【Appearance】
This product is a non-standard film-coated tablet, white after removing the film coating.
【Indications】
Seasonal and perennial allergic rhinitis, allergic conjunctivitis, urticaria and other allergic reaction symptoms.
【Dosage and Administration】
Oral administration. The recommended dose for adults, including the elderly and children over 12 years of age, is one tablet (10 mg) once daily.
【Adverse Reactions】
This product has no central sedative or anticholinergic effects. Occasionally, symptoms such as drowsiness, fatigue, headache, dry mouth, diarrhea, and indigestion may occur. Isolated cases have reported hypotension, nervousness, depression, decreased neutrophil count, and elevated liver transaminases. Weight gain associated with increased appetite has been reported.
【Contraindications】
1. Hypersensitivity to mizolastine.
2. Concomitant use of macrolide antibiotics or systemic imidazole antifungals (which may increase mizolastine blood concentrations).
3. Hepatic dysfunction.
4. Clinically significant cardiac disease or a history of symptomatic arrhythmias or bradycardia.
5. Cases with or suspected QT interval prolongation, or electrolyte disturbances, especially hypokalemia.
6. Concomitant use of known QT interval prolonging drugs, such as class I and class III antiarrhythmic drugs.
【Precautions】
1. Do not chew the tablet.
2. Most patients can drive or perform tasks requiring concentration after taking mizolastine; however, to identify individuals with adverse reactions to the drug, it is recommended to assess individual responsiveness before driving or performing complex tasks.
【Special Populations Use】
Precautions for Children: Safety data for use in children under 12 years of age are lacking.
Pregnancy and Lactation Precautions: Animal studies have shown no direct or indirect harmful effects on embryonic or fetal development, pregnancy, or perinatal development. However, experience with human use during pregnancy is lacking; therefore, it is recommended that pregnant and lactating women avoid use.
Precautions for the Elderly: Elderly individuals may be particularly sensitive to the sedative effects and potential impact on cardiac repolarization of this product.
【Drug Interactions】
Caution should be exercised when using this product in combination with drugs that inhibit hepatic oxidation, such as cimetidine, cyclosporine, and nifedipine. Concomitant use with macrolide antibiotics or systemic imidazole antifungals may result in a moderate increase in plasma concentrations of this product.
【Pharmacological Action】
Caution should be exercised when using this product in combination with drugs that inhibit hepatic oxidation, such as cimetidine, cyclosporine, and nifedipine. Concomitant use with macrolide antibiotics or systemic imidazole antifungals may result in a moderate increase in plasma concentrations of this product.
【Storage】
Store in a tightly closed container.
【Specification】
10mg
【Packaging Specification】
10mg*7 tablets/box
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20061294
【Manufacturer】
China Resources Sanjiu Pharmaceutical Co., Ltd.
