Azelastine hydrochloride nasal spray

Azelastine hydrochloride and its main metabolites are histamine H1 receptor antagonists with antihistamine and anti-allergic effects. Toxicological studies: Genotoxicity: No genotoxicity was found in the Ames test, DNA damage repair test, mouse lymphocyte forward mutation test, mouse micronucleus test, and rat bone marrow chromosome aberration test. Reproductive toxicity: When rats were orally administered azelastine hydrochloride at 30 mg/kg/day (240 times the maximum clinically recommended dose for intranasal administration in mg/m2), there was no effect on the fertility of male and female rats. Oral administration of 68.6 mg/kg/day (550 times the maximum clinically recommended dose for intranasal administration in mg/m2) prolonged the estrus phase of rats, and reduced mating activity and the number of pregnancies. The number of corpora lutea and implantation decreased, but the implantation rate was not affected. Oral administration of 68.6 mg/kg/day to mice showed embryotoxicity, fetotoxicity, and teratogenicity (appearance and bone abnormalities). Rats were given 30 mg/kg/day orally and found delayed ossification (underdeveloped metacarpal bones) and increased incidence of the 14th rib. Rats were given 68.6 mg/kg/day orally and caused abortion and fetal toxicity. The relevance of these bone abnormalities observed at high exposure levels to humans is unclear. It is not clear whether this product is secreted in human milk. Carcinogenicity test: Rats and mice were given azelastine hydrochloride orally at 30 mg/kg/day and 25 mg/kg/day (in mg/m2, 240 and 100 times the maximum clinically recommended dose for human intranasal administration) for 24 consecutive months, and no carcinogenicity was found.

The active ingredient of this product is azelastine hydrochloride.

This product is a colorless transparent liquid. When the valve is pressed, the liquid will spray out in mist.

Anti-allergic. Used to treat allergic seasonal rhinitis and allergic perennial rhinitis. Such as excessive nasal discharge, sneezing and nasal itching. Suitable for adults or children aged 12 years and above.

Position your head straight (avoid leaning back) and spray into your nose, 2 sprays in each nostril, 2 times a day, or as directed by your doctor.

The incidence of adverse reactions of this product is low (<2%). In clinical trials, adverse symptoms include drowsiness, dry nose, dry mouth, dreaminess, abdominal pain, dizziness, vertigo, cough, flushing, etc. Improper use (such as tilting the head back) may cause symptoms such as spicy taste, nausea, and vomiting.

It is contraindicated in patients who are allergic to azelastine hydrochloride.

Precautions for children: The dosage and usage of children over 6 years old are the same as those for adults. Precautions for pregnancy and lactation: According to nonclinical toxicology studies, although azelastine hydrochloride is not teratogenic and reproductively toxic, there is insufficient research data on its use in pregnant and lactating women. Therefore, this product should only be used when there is no appropriate choice for pregnant and lactating women. It is not known whether this product is metabolized through breast milk, but since breast milk is one of the metabolic pathways, it is recommended that lactating women avoid using it as much as possible. Precautions for the elderly: The number of clinical drug use cases in patients over 60 years old is small, so no valid conclusion can be drawn. The adverse reactions after use in patients over 60 years old and under 60 years old are similar.

This product is prohibited when drinking or using central nervous system depressants, otherwise it will aggravate central nervous system depression. Oral administration of azelastine hydrochloride (4 mg twice a day) and oral administration of cimetidine (150 mg twice a day) can increase the bioavailability of azelastine hydrochloride by 65%. Oral administration of azelastine hydrochloride and erythromycin (500 mg 3 times a day for 7 consecutive days) and ketoconazole (200 mg 2 times a day for 7 consecutive days) respectively, erythromycin has no effect on the pharmacokinetics and QT interval of azelastine hydrochloride. Ketoconazole has no effect on the QT interval, but interferes with the determination of blood concentration of azelastine hydrochloride.

Keep tightly closed in a cool, dark and dry place.

10ml:10mg, 0.07ml per press, containing 0.07mg of azelastine hydrochloride

36 months

Guizhou Yunfeng Pharmaceutical Co., Ltd.

• Founded in:

  1999-01-20

• Address:

  No. 108, Mujia Avenue, Mujia Street, Xingyi City, Qianxinan Buyi and Miao Autonomous Prefecture, Guizhou Province

• Tax NO.:

  91522300709688201J

• Registered Funds:

  36 million yuan

• Email:

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