Azithromycin Capsules

Azithromycin is a 15-membered macrolide antibiotic. In vitro tests have shown that azithromycin has antibacterial effects on a variety of common clinical pathogens, including: Gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes (group A beta; hemolytic streptococci), pneumonia (streptococci), hemolytic streptococci (grass viridans 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, Streptococcus, 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.

C38H72N2O12

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

(1) Acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes. (2) Sinusitis, otitis media, acute bronchitis, and acute exacerbation of chronic bronchitis caused by sensitive bacteria. (3) Pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Mycoplasma pneumoniae. (4) Urethritis and cervicitis caused by Chlamydia trachomatis and non-multi-drug resistant Neisseria gonorrhoeae. (5) Skin and soft tissue infections caused by sensitive bacteria.

Oral administration, 1 hour before or 2 hours after meals. Adult dosage: 1. For sexually transmitted diseases caused by Chlamydia trachomatis or sensitive Neisseria gonorrhoeae, only 1.0g of this product needs to be taken orally once. 2. For the treatment of other infections: On the first day, take 0.5g at a time, on the 2nd to 5th day, take 0.25g at a time; or take 0.5g at a time, for 3 consecutive days. Pediatric dosage: 1. For the treatment of otitis media and pneumonia, on the first day, take 10mg/kg of body weight at a time (maximum daily dose not exceeding 0.5g), on the 2nd to 5th day, take 5mg/kg of body weight at a time (maximum daily dose not exceeding 0.25g). 2. For the treatment of pediatric pharyngitis and tonsillitis, take 12mg/kg of body weight at a time (maximum daily dose not exceeding 0.5g), for 5 consecutive days.

Gastrointestinal reactions such as abdominal pain, diarrhea (loose stools), upper abdominal discomfort (pain or cramps), nausea, and vomiting may occur after taking the drug, and their incidence is significantly lower than that of erythromycin. Mild to moderate abdominal distension, dizziness, headache, fever, rash, joint pain and other allergic reactions may occur occasionally, while anaphylactic shock, angioedema, and cholestatic jaundice are extremely rare. A small number of patients may experience transient neutropenia and elevated serum aminotransferase.

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

Precautions for children: The efficacy and safety of 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 determined. Precautions for pregnancy and lactation: Animal experiments show that this product has no effect on the fetus, but there is still a lack of experience in its use in pregnant women, so the pros and cons must be fully weighed before using it in pregnant women. There is no data to show whether this product can be secreted into breast milk, so the use of it in lactating women must be considered with caution. Precautions for the elderly: It is not yet clear.

1 It is not suitable to take it at the same time with antacids containing aluminum or magnesium, as the latter can reduce the peak blood concentration of this product; if it must be taken together, this product should be given 1 hour before or 2 hours after taking the above drugs. 2 When used in combination with theophylline, the concentration of the latter in plasma can be increased, and attention should be paid to detecting the plasma theophylline level. 3 When used in combination with warfarin, attention should be paid to checking the prothrombin time. 4 When used simultaneously with the following drugs, it is recommended to observe the patient closely: Digoxin increases the digoxin level. Ergotamine or dihydroergotamine acute ergot toxicity, symptoms are severe peripheral vasospasm and dysesthesia (pain to touch). Triazolam enhances the pharmacological effect of triazolam by reducing the degradation of triazolam. Cytochrome P450 system metabolites increase the levels of carbamazepine, terfenadine, cyclosporine, cyclohexylbarbital, and phenytoin in serum. 5 When used in combination with rifabutin, the latter's toxicity will be increased.

Sealed, store in a cool, dry place.

0.25 g (250,000 units)

24 months.

Shandong Sibang De Pharmaceutical Co., Ltd.

• Founded in:

  2003-10-22

• Address:

  No. 3688, Longhu Road, Longshan Street, Zhangqiu District, Jinan City, Shandong Province

• Tax NO.:

  91370181755424274J

• Registered Funds:

  20 million yuan

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