Azithromycin Fumarate Capsules

Azithromycin fumarate inhibits bacterial protein synthesis by hindering the bacterial transpeptidation process. In vitro tests have shown that azithromycin fumarate is effective against a variety of common pathogens in clinical practice. Including Gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes (Group A β-hemolytic streptococci), Pneumococcus, а-hemolytic streptococci (grass viridans streptococci group) and other streptococci, diphtheria (rod-shaped) rod Aspergillus. Azithromycin fumarate shows cross-resistance to erythromycin-resistant Gram-positive bacteria, including Streptococcus faecalis (Enterococcus) and methicillin-resistant Staphylococcus aureus strains. Gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Catarrhalis, Acinetobacter, Yersinia, Legionella pneumophila, Bordetella pertussis, Bordetella parapertussis, Vibrio cholerae, Vibrio parahaemolyticus, and Pyridomonas parapertussis. The activity of this product against the following Gram-negative bacteria depends on the strain, and sensitivity testing is required, including Escherichia coli, Typhimurium, Enterobacter, Hydrophila, Klebsiella, anaerobic bacteria; Bacteroides fragilis, Bacteroides, Clostridium perfringens, Peptostreptococcus, Fusobacterium necroticum, Propionibacterium acnes. Sexually transmitted disease microorganisms: Azithromycin fumarate is active against the following sexually transmitted disease microorganisms: Chlamydia trachomatis, Treponema pallidum, Neisseria gonorrhoeae, and Haemophilus dukei. Other microorganisms: including Borrelia burgdorferi (Lyme pathogen), Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Pneumocystis carinii, Mycobacterium avium, Campylobacter, Listeria monocytogenes. The following Gram-negative bacteria are usually resistant: Proteus, Serratia, Morganella, Pseudomonas aeruginosa.

The main ingredient of this product is azithromycin fumarate, its chemical name: 9-deoxy-9α-aza-9α-methyl-9α-erythromycin A fumarate chemical structure is as follows: Molecular formula: C38H72N2O12·C4H4O4 Molecular weight: 865.06

This product is a hard capsule, and the contents are white or off-white powder or granules.

This product is suitable for the following infections 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).

Azithromycin fumarate capsules are used to treat infectious diseases. The course of treatment and usage are as follows: Adults: For sexually transmitted diseases caused by Chlamydia trachomatis or sensitive gonococci, only 1.0g of this product is needed for oral administration. For the treatment of other infections: the total dose is 1.5g, divided into three doses; 0.5g of this product is taken once a day. Or the total dose is the same, still 1.5g, take 0.5g on the first day, and then take 0.25g of this product orally once a day from the second to the fifth day. Since food can affect the bioavailability of this product, absorption can be reduced by 50% after a full meal, it is recommended to take it orally one hour before or two hours after a meal. In case of overdose (not reported yet), gastric lavage or general supportive therapy can be performed.

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, gastrointestinal 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 not yet clear. Precautions for pregnancy and lactation: Use with caution in pregnant and lactating women. Precautions for the elderly: Not yet clear.

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.

Seal tightly and store in a cool (not exceeding 20°C) dry place.

0.25 g

Tentative 18 months

Jinzhou Jiutai Pharmaceutical Co., Ltd.

• Founded in:

  1998-09-02

• Address:

  No. 41, Tai'anli, Taihe District, Jinzhou City, Liaoning Province

• Tax NO.:

  91210700242034190P

• Registered Funds:

  40.986462 million yuan

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