Azelastine Hydrochloride Tablets

Pharmacological action: Azelastine hydrochloride and its main metabolites are histamine H1 receptor antagonists with antihistamine effects. Toxicological studies: Genetic toxicity: No genetic toxicity 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: Oral administration of azelastine hydrochloride at 30 mg/kg/day to rats had no effect on the fertility of male and female rats. When taken orally at 68.6 mg/kg/day, the estrous cycle of rats was prolonged, mating activity and the number of pregnancies were reduced, the number of corpora lutea and embryo implantation decreased, but the pre-implantation loss did not increase. Oral administration of 68.6 mg/kg/day to mice showed embryotoxicity and fetal

The main ingredient is: Azelastine hydrochloride. The chemical name is: 4-(4-chlorobenzyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-1(2H)-2,3-phthalazinone hydrochloride.

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

Used to treat allergic rhinitis.

Take 1 mg each time, orally twice a day after breakfast and before bedtime, or as directed by your doctor.

According to foreign literature reports, in extremely rare cases, the inflamed nasal mucosa may be irritated by the spray. This phenomenon can be described as burning, itching and sneezing. In a few cases, it may cause nosebleeds. In the case of improper use (head tilted back, see the dispensing guide), a bitter taste may enter the mouth, which may sometimes cause nausea and vomiting. Seasonal allergic rhinitis: The adverse reaction data of azelastine hydrochloride nasal spray were obtained from 6 controlled clinical studies of 391 patients who were given azelastine hydrochloride nasal spray twice a day, 2 sprays per nostril, for 2 days to 8 weeks. In the placebo-controlled efficacy trial, patients who received azelastine hydrochloride nasal spray discontinued the drug due to adverse reactions.

It is contraindicated for those who are allergic to azelastine hydrochloride and other excipients; it is contraindicated for pregnant and lactating women; it is contraindicated for children under 6 years old.

Precautions for children: There is no safety and efficacy data for the use of this product in children under 12 years old. Precautions for pregnancy and lactation: Reproductive toxicity studies of azelastine hydrochloride have shown that it has no effect on fertility. Since there is insufficient data on clinical drug use in pregnant women, this product should only be used when there is no appropriate choice for pregnant women. It is not known whether this product is metabolized through breast milk, but since breast milk is one of the metabolic pathways of drugs, it is recommended that breastfeeding women avoid using this product as much as possible. Precautions for the elderly: The number of clinical drug use cases in patients over 60 years old is small, and no valid conclusions can be drawn. However, adverse reactions after medication in patients over 60 years old are similar to those in patients under 60 years old.

1 When this product is used simultaneously with alcohol or other central nervous system depressants, it may cause decreased vigilance and central nervous system damage, so simultaneous use should be avoided. 2 Cimetidine (400 mg twice a day) can increase the Cmax and AUC of oral azelastine hydrochloride (4 mg twice a day) by an average of approximately 65%. Ranitidine hydrochloride (150 mg twice a day) has no effect on the pharmacokinetics of azelastine. 3 Drug interaction studies were conducted by taking azelastine hydrochloride orally and erythromycin or ketoconazole at the same time, and their effects on the heart were evaluated by measuring the QT interval. Oral erythromycin (500 mg, 3 times a day for 7 days) had no effect on the pharmacokinetics or QTc of azelastine.

Sealed and stored in a cool place. Validity period: tentatively 24 months.

1mg

24 months

Sichuan Mingxing Pharmaceutical Co., Ltd.

• Founded in:

  2001-12-28

• Address:

  No. 1 Mingyue West Road, Suining Economic and Technological Development Zone

• Tax NO.:

  915109007348810707

• Registered Funds:

  228.75 million yuan

• Email:

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