Azithromycin Lactobionate for Injection

Azithromycin is a 15-membered macrolide antibiotic. In vitro tests have shown that azithromycin has antibacterial effects on a variety of common clinical pathogens. Gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes (group A β-hemolytic streptococci), pneumonia (streptococci), β-hemolytic streptococci (grass-green streptococci) and other streptococci, diphtheria (rod-shaped) bacilli. This product shows cross-resistance to erythromycin-resistant Gram-positive bacteria, including fecal streptococci (enterococci) and methicillin-resistant Staphylococcus aureus strains. 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. The activity of this product against the following Gram-negative bacteria depends on the strain, and sensitivity testing is required: Escherichia coli, Salmonella typhi, Enterobacter, Hydrophila, Klebsiella. Anaerobic bacteria: Bacteroides fragilis, Bacteroides, Clostridium perfringens, Peptostreptococcus, Fusobacterium necroticum, Propionibacterium acnes. Sexually transmitted disease microorganisms: Treponema pallidum, Neisseria gonorrhoeae, Haemophilus dukei. Other microorganisms: including Borrelia tenens (Lyme disease body), Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Chlamydia trachomatis, Pneumocystis carinii, Mycobacterium avium, Campylobacter, Listeria monocytogenes. The following Gram-negative bacteria are usually resistant: Proteus, Serratia, Morganella, Pseudomonas. The mechanism of action is the same as erythromycin, mainly binding to the 50S subunit of the bacterial ribosome, inhibiting RNA-dependent protein synthesis.

The main ingredient of this product is azithromycin lactobionate. Its chemical name is (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-?-L-ribopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-?-D-xylopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one lactobionate. Molecular formula: C38H72N2O12·2C12H22O12, molecular weight: 1465.59.

This product is white loose mass or powder.

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, Mycoplasma pneumoniae, Staphylococcus aureus or Streptococcus pneumoniae, which requires intravenous drip treatment first. 2. Pelvic inflammatory disease caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma hominis, which requires intravenous drip treatment first.

Dissolve this product with an appropriate amount of injection water to prepare 0.1g/ml, then add it to 250ml or 500ml of sodium chloride injection or 5% glucose injection. The final azithromycin concentration is 1.0-2.0mg/ml, and then drip it intravenously. The concentration is 1.0mg/ml, and the drip time is 3 hours; the concentration is 2.0mg/ml, and the drip time is 1 hour. 1 Treatment of community-acquired pneumonia: 0.5g for adults once a day, once a day, for at least 2 consecutive days, followed by switching to azithromycin oral preparations 0.5g a day, 7-10 days as a course of treatment. The time to switch to oral treatment should be determined by the physician based on the clinical treatment response. 2 Treatment of pelvic inflammatory disease: 0.5g for adults once a day, once a day, after 1 or 2 days of medication, switch to azithromycin oral preparations 0.25g a day, 7 days as a course of treatment. The time to switch to oral treatment should be determined by the physician based on the clinical treatment response.

1 Common adverse reactions of this product include: (1) Gastrointestinal reactions: diarrhea, abdominal pain, loose stools, nausea, vomiting, etc. (2) Local reactions: pain at the injection site, local inflammation, etc. (3) Skin reactions: rash, itching. (4) Other reactions: such as loss of appetite, dizziness or dyspnea, etc. 2 This product may also cause the following reactions: (1) Digestive system: indigestion, flatulence, mucositis, 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 aminotransferase, creatinine, lactate dehydrogenase, 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 dosage and regimen for children under 6 months old have not yet been determined. Precautions for pregnancy and lactation: Use with caution in pregnant and lactating women. Precautions for the elderly: The dosage and usage of the elderly refer to that of adults. Use with caution in the elderly and infirm.

1 When used in combination with theophylline, the latter's concentration in plasma can be increased, and attention should be paid to the detection of plasma theophylline levels. 2 When used in combination with warfarin, attention should be paid to checking the prothrombin time. 3 When used simultaneously with the following drugs, it is recommended to closely observe the patient: Digoxin increases digoxin levels. Ergotamine or dihydroergotamine causes acute ergot toxicity, with symptoms of severe peripheral vasospasm and dysesthesia (pain to touch). Triazolam enhances the pharmacological effects of triazolam by reducing its degradation. Drugs metabolized by the cytochrome P450 system increase the levels of carbamazepine, terfenadine, cyclosporine, cyclohexylbarbital, and phenytoin in serum.

Keep away from light, tightly closed and in a dry place.

0.125 g (125,000 units)

24 months

Zhejiang Zhenyuan Pharmaceutical Co., Ltd.

• Founded in:

  1997-11-19

• Address:

  No. 61, Yuedong North Road, Yuecheng District, Shaoxing City, Zhejiang Province

• Tax NO.:

  913306022547351704

• Registered Funds:

  300 million yuan

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