Azithromycin Injection

Pharmacological action: Azithromycin is an azalide antibiotic, and its mechanism of action is to interfere with the synthesis of proteins (without affecting the synthesis of nucleic acids) by binding to the subunits of the 50s ribosomes of sensitive microorganisms. In vitro tests and clinical studies have shown that azithromycin is effective against the following pathogens: Gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, and hemolytic Streptococci. Azithromycin has cross-resistance to erythromycin-resistant Gram-positive bacteria. Most fecal streptococci (enterococci) and methicillin-resistant Staphylococci are resistant to this product. Gram-negative aerobic microorganisms: Haemophilus influenzae, Moraxella catarrhalis, and Mycoplasma trachomatis. In vitro tests and clinical studies have confirmed that this product can prevent diseases caused by the avian intracellular mycobacterium complex (composed of avian intracellular mycobacterium and intracellular mycobacterium). This product is ineffective against strains that produce beta-lactamase. In vitro research results have been obtained for the following microorganisms, but their clinical significance is still unclear, including Streptococcus (C, F, G), Streptococcus viridans, Bordetella pertussis, Haemophilus dukei, Legionella pneumophila, Bacteroides, Peptostreptococcus, Borrelia burgdorferi, Chlamydia pneumoniae, Treponema pallidum, Ureaplasma urealyticum, etc. Toxicological studies: Genotoxicity: The results of human lymphocyte test, mouse bone marrow micronucleus test and mouse in vitro lymphoma cell test all confirmed that this product has no mutagenic effect. Reproductive toxicity: Reproductive toxicity tests in rats and mice showed that when the dosage reached the dose level that produced moderate maternal toxicity (i.e. 200 mg/Kg/day, calculated by body surface area, about 2-4 times the human dosage of 500 mg/Kg/day), teratogenic effects were found, but no damage to fertility and fetus was found. There are currently no adequate and strictly controlled clinical trials in pregnant women. Since the results of animal reproduction studies do not always predict the situation in humans, pregnant women can only use this product when it is really necessary. It is not known whether this product is secreted in human milk. Since many drugs are secreted in human milk, lactating women should be careful when using it. Carcinogenicity: There is no research data on the carcinogenicity of this product in animals using it for a long time.

The main ingredient of this product is azithromycin, and its chemical name is: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-alpha;-L-ribopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-beta;-D-xylopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.

This product is a colorless or almost colorless clear liquid.

This product is suitable for the following infections caused by sensitive pathogenic strains: 1. Community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Staphylococcus aureus or Streptococcus pneumoniae, which requires intravenous drip treatment first. 2. Pelvic inflammatory disease caused by Chlamydia trachomatis, Gonorrhea, Mycoplasma hominis, which requires intravenous drip treatment first. If anaerobic infection is suspected, anti-anaerobic antibiotics should be used in combination.

Add this product to 250ml or 500ml of 0.9% sodium chloride injection or 5% glucose injection, so that the final azithromycin concentration is 1.0-2.0mg/ml intravenous drip, and the drip time is not less than 60 minutes. For the treatment of community-acquired pneumonia, the adult dosage is 0.5g each time, once a day, for at least 2 consecutive days. Then switch to azithromycin oral preparation 0.5g/day, and the treatment is 7-10 days as a course of treatment. The time to switch to oral treatment should be determined by the doctor based on clinical response. For the treatment of pelvic inflammatory disease, the adult dosage is 0.5g each time, once a day. After 1 or 2 days of medication, switch to azithromycin oral preparation 0.25g/day, with 7 days as a course of treatment. The time to switch to oral treatment should be determined by the doctor based on clinical response. If anaerobic infection is suspected, anti-anaerobic drugs should be used in combination.

1. Common adverse reactions of this product include: ① Gastrointestinal reactions: diarrhea, nausea, abdominal pain, loose stools, vomiting, etc.; ② Local reactions: pain at the injection site, local inflammation, etc.; ③ Skin reactions: rash, itching, etc.; ④ Other reactions: such as anorexia, dizziness or dyspnea, etc. 2. This product may also cause the following reactions: ① Digestive system: indigestion, flatulence, oral candidiasis, gastritis, etc.; ② Nervous system: headache, drowsiness, etc.; ③ Allergic reactions: bronchospasm, etc.; ④ Other reactions: abnormal taste, etc.; ⑤ Laboratory tests: increased serum ALT, AST, creatinine, LDH, bilirubin and alkaline phosphatase, decreased white blood cell, neutrophil and platelet counts.

It is contraindicated in patients who are allergic to azithromycin, erythromycin or any other macrolide drugs.

Precautions for children: The safety of this product for children or patients under 16 years old is unknown. Precautions for pregnancy and lactation: Use with caution in pregnant and lactating women. Precautions for the elderly: There is currently a lack of detailed research data.

Aluminum and magnesium-containing antacids can reduce the peak plasma concentration of oral azithromycin preparations, but do not reduce the AUC value. Oral azithromycin does not affect theophylline levels or pharmacokinetics in plasma after a single intravenous dose of theophylline. Given that currently used macrolides can increase plasma theophylline concentrations, caution should be exercised when azithromycin and theophylline are used simultaneously, and plasma theophylline levels should be monitored. Oral azithromycin does not affect the prothrombin time of a single dose of benzylpropion. However, caution should be exercised when azithromycin and benzylpropion are used simultaneously in patients, and attention should be paid to monitoring the prothrombin time. Because in clinical practice, the simultaneous use of macrolides and benzylpropion increases the efficacy of anticoagulants. It is recommended that patients be closely observed when azithromycin is used simultaneously with the following drugs: Digoxin - increases digoxin levels. Ergotamine or dihydroergotamine - symptoms of acute ergot toxicity are severe peripheral vasospasm and dysesthesia (pain on touch). Triazolam - enhances the pharmacological effect of triazolam by reducing its degradation. Cytochrome P450 system metabolites - increase the levels of carbamazepine, terfenadine, cyclosporine, cyclohexylbarbital, phenytoin, etc. in serum.

Store in a cool dark place.

5ml:0.5g (calculated as C38H72N2012)

24 months

Suzhou Pharmaceutical Factory

• Founded in:

  2006-02-14

• Address:

  No. 2-1, Dongwu South Road, Wuzhong District, Suzhou City

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  91320506138170408U

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