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Mizolastine extended-release tablets

Function and Efficacy

Caution should be exercised when used in combination with drugs that inhibit liver oxidation, such as cimetidine, cyclosporine, and nifedipine. The plasma concentration of this product can be moderately increased when used in combination with macrolide antibiotics or systemic imidazole antifungal drugs.

Ingredients

The chemical name of mizolastine: 2-[[[1-[(4-fluorophenyl)methyl]-1hydrogen-benzimidazol-2-yl]-4-piperidinyl]methyl-amino]-4(3hydrogen)-pyrimidinone, molecular formula: C24H25FN6O, molecular weight: 432.5.

Name Description Content CAS NO. Manufacturer
MizolastineIngredients

Caution should be exercised when used in combination with drugs that inhibit liver oxidation, such as cimetidine, cyclosporine, and nifedipine. The plasma concentration of this product can be moderately increased when used in combination with macrolide antibiotics or systemic imidazole antifungal drugs.

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108612-45-9 5

Appearance

This product is a special-shaped film-coated tablet, which appears white after removing the film coating.

Indication

Seasonal and perennial allergic rhinitis, allergic conjunctivitis, urticaria and other symptoms of allergic reactions.

Usage and Dosage

Oral administration. The recommended dose for adults, including the elderly and children over 12 years old is 1 tablet (10 mg) once a day.

Adverse Reactions

This product has no central nervous system sedative and anticholinergic effects. Symptoms such as drowsiness, fatigue, headache, dry mouth, diarrhea and indigestion are occasionally seen. Hypotension, tension, depression, decreased neutrophil count and elevated liver transaminases have occurred in individual cases. There have been reports of weight gain associated with increased appetite.

Precautions

1. Allergic to mizolastine. 2. Concurrent use of macrolide antibiotics or systemic imidazole antifungal drugs (which may increase the blood concentration of mizolastine). 3. Liver dysfunction. 4. Clinically significant heart disease or history of symptomatic arrhythmias or bradycardia. 5. Cases of or suspected QT interval prolongation, or electrolyte disorders, especially hypokalemia. 6. Concurrent use of drugs known to prolong the QT interval, such as Class I and Class III antiarrhythmic drugs.

Special Population Medication

Precautions for children: There is no safety data for children under 12 years old. Precautions for pregnancy and lactation: Animal test results show that there is no direct or indirect harmful effect on embryonic or fetal development, pregnancy process and perinatal development, but there is a lack of experience in human pregnancy, so it is recommended that pregnant and lactating women should avoid using it. Precautions for the elderly: The elderly may be particularly sensitive to the sedative effect of this product and its potential effect on cardiac repolarization.

Drug Interactions

Caution should be exercised when used in combination with drugs that inhibit liver oxidation, such as cimetidine, cyclosporine, and nifedipine. The plasma concentration of this product can be moderately increased when used in combination with macrolide antibiotics or systemic imidazole antifungal drugs.

Storage

Keep tightly closed.

Packaging Specification

10mg

Validity Period

24 months

Manufacturer

Zhejiang Zhongyi Pharmaceutical Co., Ltd.

  • Founded in:

    2006-01-26
  • Address:

    No. 279, Lvgu Avenue, Shuige Industrial Zone, Zhejiang Province
  • Tax NO.:

    91331100773112151W
  • Registered Funds:

    40.5 million yuan
  • Email:

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