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.

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--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.

The content of this product is white or off-white crystalline powder.

It 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).

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 at a time. 2. For the treatment of other infections: 0.5g on the first day, 0.25g on the second to fifth day, or 0.5g on the first day for 3 consecutive days. Pediatric dosage: 1. For the treatment of otitis media and pneumonia, 10mg/kg on the first day, 5mg/kg on the second to fifth day.

Patients tolerate this product well, and the incidence of adverse reactions is low. About 0.3% of patients discontinue treatment due to adverse reactions. Digestive tract reactions account for the majority of adverse reactions, and the main symptoms include diarrhea (loose stools), upper abdominal discomfort (pain or cramps), nausea, vomiting, and occasional abdominal distension. Generally, they are mild to moderate. Occasionally, reversible increases in liver transaminases are seen.

Azithromycin capsules are contraindicated in patients with a history of allergy to azithromycin or other macrolide antibiotics.

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 be taken at the same time with antacids containing aluminum or magnesium, as the latter can reduce the peak blood concentration of this product by 30%, but there is no effect on the total bioavailability; if it must be used 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 the detection of plasma theophylline levels. 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 closely observe the patient: Digoxin: It has been reported that some macrolide antibiotics can reduce the intestinal metabolism of digoxin. Therefore, when the two drugs are used together, attention should be paid to the possibility of increased digoxin blood concentration. Ergotamine or dihydroergotamine: Acute ergot toxicity, symptoms are severe peripheral vasospasm and dysesthesia (pain when touching objects). Triazolam: By reducing the degradation of triazolam, the pharmacological effect of triazolam is enhanced. Drugs metabolized by the cytochrome P450 system increase the levels of carbamazepine, terfenadine, cyclosporine, cyclohexylbarbital, and phenytoin in serum. 5 When used in combination with rifabutin, it increases the toxicity of the latter.

Keep away from light and store in a sealed container.

0.25g

24 months.

Dalian Tianyu Pharmaceutical Co., Ltd.

• Founded in:

  1997-09-16

• Address:

  Houshi, Jinzhou District, Dalian City, Liaoning Province

• Tax NO.:

  91210213241831622W

• Registered Funds:

  7.01427 million yuan

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