Product Overview
[Drug Name]
Generic Name: Mizolastine Sustained-Release Tablets
Brand Name: Minzhilin
English Name: Mizolastine Sustained-Release Tablets
Pinyin: MinZhiLin (MiZuoSiTingHuanShiPian)
[Ingredients]
Mizolastine.
[Appearance]
This product is a non-standard film-coated tablet, white after removing the coating.
[Indications]
This product is a long-acting histamine H1 receptor antagonist, suitable for adults or children over 12 years of age with urticaria and other skin allergic symptoms, seasonal allergic rhinitis (hay fever), and perennial allergies.
[Dosage and Administration]
This product is for oral administration. The recommended dose for adults, including the elderly and children over 12 years of age, is one tablet (10mg) once daily.
[Adverse Reactions]
Occasionally: Drowsiness and fatigue (usually transient), increased appetite with weight gain. Rarely: Dry mouth, diarrhea, abdominal pain (including indigestion), or headache. Rarely observed cases: hypotension, vagal nerve abnormalities (potentially causing syncope), anxiety, depression, decreased white blood cell count, elevated liver enzymes. Extremely rare allergic reactions, angioedema, generalized rash, urticaria, pruritus, and hypotension.
[Contraindications]
1. Hypersensitivity to mizolastine.
2. Concomitant use of macrolide antibiotics or systemic imidazole antifungals (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. Indications/Therapeutic Uses: Seasonal and perennial allergic rhinitis, allergic conjunctivitis, urticaria, and other symptoms of allergic reactions. 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. In rare cases, low blood pressure, anxiety, depression, and neutrophils may occur.
[Precautions]
1. Do not chew the medication.
2. Most patients can drive or perform tasks requiring concentration after taking mizolastine; however, to identify individuals with adverse reactions, it is recommended to assess individual responsiveness before driving or performing complex tasks. Please read the instructions carefully and use as directed by your doctor.
[Special Populations]
Children's Precautions: 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.
Elderly Precautions: Use in elderly patients is the same as in adults. Elderly patients may be more sensitive to the potential sedative effects and cardiac repolarization effects of mizolastine.
[Drug Interactions]
Caution should be exercised when using this drug in combination with hepatic oxidative inhibitors such as cimetidine, cyclosporine, and nifedipine. Concomitant use with macrolide antibiotics or systemic imidazole antifungals may moderately increase plasma concentrations.
[Pharmacological Action]
Mizolastine is a non-sedating antihistamine that blocks histamine H1-receptors in gastrointestinal, vascular, and respiratory effector cells. It also stabilizes mast cells. Absorption: Rapid absorption from the gastrointestinal tract after oral administration, reaching peak plasma concentration in 1.5 hours. Distribution: Protein binding: 98%. Metabolism: Glucose acidification (major pathway) or metabolism via cytochrome P450 isoenzyme CYP3A4 to form inactive hydroxylated metabolites. Excretion: Elimination half-life: 13 hours.
[Storage]
Store in a tightly closed container.
[Packaging Specifications]
10 mg x 7 tablets/box
[Shelf Life]
24 months
[Manufacturer]
Sanofi (Hangzhou) Pharmaceutical Co., Ltd.
