Azithromycin fine granules

Pharmacological action Azithromycin inhibits bacterial protein synthesis by hindering the bacterial transpeptidation process. In vitro tests have shown that azithromycin is effective against a variety of common clinical pathogens, including: Gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, α-hemolytic Streptococcus (grass viridans Streptococcus) and other streptococci, Corynebacterium diphtheriae. Gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Acinetobacter, Yersinia, Legionella pneumophila, Bordetella pertussis, Bordetella parapertussis, Shigella, Pasteurella, Vibrio cholerae, Parahaemolyticus, Shigella-like Pyrimonas. Anaerobic bacteria: Bacteroides fragilis, Bacteroides, Clostridium perfringens, Peptostreptococcus, Fusobacterium necroticum, Propionibacterium acnes. Other microorganisms: Chlamydia trachomatis, Treponema pallidum, Neisseria gonorrhoeae, Haemophilus dukeii, Borrelia tenens (Lyme disease agent), Mycoplasma pneumoniae, Mycoplasma hominis, urea-decomposing ureaplasma, Pneumocystis carinii, Mycobacterium avium, Campylobacter, Listeria monocytogenes. Azithromycin shows cross-resistance to erythromycin-resistant Gram-positive bacteria, including Enterococcus faecalis and various methicillin-resistant Staphylococci. The following Gram-negative bacteria are usually resistant: Proteus, Serratia, Morganella, Pseudomonas aeruginosa. Toxicology studies Repeated dose toxicity: Intracellular phospholipid accumulation was observed in certain tissues of mice, rats and dogs after multiple administrations of this product. The dog dose expressed in mg/kg was only twice the recommended adult dose. This phenomenon was confirmed in most organ tissues (such as eyes, dorsal ganglia, liver, gall bladder, kidneys, spleen and pancreas) when the rat dose was equivalent to the recommended adult dose. This effect is still visible after treatment is stopped. The same degree of phospholipid accumulation in tissues can be observed in newborn rats and dogs when the product is given daily for 10 to 30 days. Based on pharmacokinetic data, the rat dose of 30 mg/kg has a Cmax value of 1.3 μg/ml (6 times higher than the Cmax value of 0.216 μg/ml at the pediatric dose of 10 mg/kg), and there is phospholipid accumulation. Similarly, the dog dose of 10 mg/kg has a Cmax value of 1.5 μg/ml (7 times higher than the Cmax value at the pediatric dose), and there is such a manifestation. In terms of body surface area, the doses of 30 mg/kg (135 mg/m2) for rats and 10 mg/kg (79 mg/m2) for dogs are approximately 0.4 times and 0.6 times the recommended dose for pediatric patients with an average body weight of 25 kg, respectively. These findings are meaningful in animals, but are not yet clear in humans. Genetic toxicity: Standard laboratory tests including mouse lymphoma test, human lymphocyte chromosome aberration test, mouse bone marrow chromosome aberration test did not find potential mutagenicity. Reproductive toxicity: There is no evidence of damage to fertility with this product. Rats and mice were given a dose of 200 mg/kg/day (4 times and 2 times the daily dose of 500 mg for humans, respectively, based on body surface area) that was appropriately higher than the maternal toxicity, and no damage to the fetus was observed. However, adequate and strictly controlled tests have not yet been conducted in pregnant women. Since the results of animal reproduction studies cannot always predict the situation in humans, this product can only be used during pregnancy when it is confirmed to be necessary. It is not clear whether this product is excreted in human milk. Since most drugs can be excreted through human milk, this product should be used with caution in lactating women. Carcinogenicity: Long-term potential carcinogenicity studies have not yet been conducted on animals.

The main ingredient of this product is azithromycin. Chemical name: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xyl-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Chemical structure: Molecular formula: C38H72N2O12 Molecular weight: 749.00

This product is white or off-white fine granules.

This product is suitable for the following infections in adults and children caused by sensitive bacteria: upper respiratory tract infections such as otitis media, sinusitis, pharyngitis, tonsillitis, and lower respiratory tract infections such as bronchitis and pneumonia. Skin and soft tissue infections. Simple genital infections caused by Chlamydia trachomatis. Simple genital infections caused by non-multi-drug resistant gonococci (co-infection with Treponema pallidum must be excluded).

Usage: This product is a fine granule. When using, add this product to an appropriate amount of cold boiled water and take it orally after dissolving. Adult dosage: On the first day, take 0.5g once a day; on the second to fifth days, take 0.25g once a day. Or take 0.5g once a day for 3 consecutive days. For urethritis or cervicitis caused by chlamydia, take 1g as a single dose orally. Pediatric dosage: 1. For the treatment of otitis media and pneumonia: On the first day, take 10mg/kg once a day (maximum daily dose not exceeding 0.5g); on the second to fifth days, take 5mg/kg once a day (maximum daily dose not exceeding 250mg). Or administer as follows: body weight/kg 1st day 2nd to 5th day 15-250.2g, 0.1g at a time, 26-350.3g, 0.15g at a time, 36-450.4g, 0.2g at a time, 2. Treatment of pediatric pharyngitis and tonsillitis: 12mg/kg once a day (maximum daily dose not exceeding 0.5g), for 5 consecutive days. 3. The dosage and administration method for children under 6 months have not been established.

Gastrointestinal reactions such as abdominal pain, diarrhea, nausea, and vomiting may occur after taking this drug, and the incidence is significantly lower than that of erythromycin. Allergic reactions such as dizziness, headache, fever, rash, and joint pain may occasionally occur, while anaphylactic shock and angioneurotic edema are extremely rare. A small number of patients may experience transient neutropenia and elevated serum aminotransferase.

1. Patients with a history of allergy to azithromycin and other macrolide antibiotics are contraindicated. 2. Elderly, children, and pregnant women should use with caution.

Precautions for children: The efficacy and safety of the drug in treating otitis media, community-acquired pneumonia in children under 6 months old and pharyngitis or tonsillitis in children under 2 years old have not been established. Precautions for pregnancy and lactation: Use with caution in pregnant or lactating women. Precautions for the elderly: Use with caution in the elderly.

1. Avoid taking it at the same time with antacids containing aluminum or magnesium, because it can reduce the peak blood concentration of this product. If it must be used together, azithromycin should be given 1 hour before or 2 hours after taking the above drugs. 2. When used in combination with aminophylline, carbamazepine, and digoxin, the blood concentration of the latter should be monitored. 3. When used in combination with warfarin, the prothrombin time should be checked. 4. When used simultaneously with the following drugs, it is recommended to observe the patient closely: Digoxin - increases digoxin levels. Ergotamine or dihydroergotamine - acute ergot toxicity, symptoms are severe peripheral vasospasm and dysesthesia (pain when touching objects). Triazolam - the pharmacological effect of triazolam is enhanced by reducing the degradation of triazolam. Cytochrome P450 system metabolizers - increase the levels of carbamazepine, terfenadine, cyclosporine, cyclohexylbarbital, and phenytoin in serum.

Sealed, store in a dry place.

0.1g (100,000 units)

Tentative 18 months

Hangzhou Guoguang Pharmaceutical Co., Ltd.

• Founded in:

  2000-03-22

• Address:

  No. 258, No. 12 Street, Hangzhou Economic and Technological Development Zone, Zhejiang Province

• Tax NO.:

  91330100720055560A

• Registered Funds:

  75.5 million yuan

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