Azithromycin Dispersible Tablets

Azithromycin inhibits bacterial protein synthesis by hindering bacterial transpeptidation. In vitro tests have shown that azithromycin has antibacterial effects on a variety of common pathogens in clinical practice, including: Gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes (Group A B hemolytic streptococci), Pneumococcus, α-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: influenza (haemophilus) bacilli, parainfluenzae (haemophilus) bacilli, catarrhalis (mora), Acinetobacter, Yersinia, Legionella pneumophila, Bordetella pertussis, Bordetella parapertussis, Shigella, Pasteurella, Vibrio cholerae, Parahaemolytic bacilli, 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, Duke (Haemophilus) bacillus. 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 aeruginosa. The mechanism of action is the same as erythromycin, mainly binding to the 50S subunit of the bacterial ribosome, inhibiting RNA-dependent protein synthesis.

Azithromycin

This product is white or off-white tablets.

This product is suitable for the following infections caused by sensitive bacteria: otitis media, sinusitis, pharyngitis, tonsillitis and other upper respiratory tract infections; bronchitis, pneumonia and other lower respiratory tract infections. 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 burgdorferi must be excluded).

Azithromycin dispersible tablets are used to treat infectious diseases. Disperse with water before taking and swallow directly. The course of treatment and usage are as follows: Adults: 1. For sexually transmitted diseases caused by Chlamydia trachomatis or sensitive Neisseria gonorrhoeae, only 1g of this product needs to be taken orally once. 2. For the treatment of pediatric pharyngitis and tonsillitis, take 12mg/kg of body weight once a day (maximum daily dose not exceeding 0.5g), and use it for 5 consecutive days. For the treatment of other infections: total dose of 1.5g, divided into three doses, take 0.5g of this product 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.

Patients tolerate this product well, and the incidence of adverse reactions is low. About 0.3% of patients discontinue treatment due to adverse reactions. Gastrointestinal 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 aminotransferase are seen, and the incidence is similar to that of other macrolide antibiotics and penicillins. Transient mild neutropenia has been seen, but whether it is related to azithromycin has not been confirmed.

It is contraindicated in patients who are allergic to azithromycin or any other macrolide drug.

Precautions for children: This product is suitable for children, and its usage and dosage have been described above. According to the pharmacokinetic data of children, 20 mg/kg is equivalent to the dose of 1200 mg for adults, but its Cmax value is higher. For children with streptococcal pharyngitis, a single dose of 10 mg/kg or 20 mg/kg for 3 consecutive days has been proven to be effective, but the daily dosage should not exceed 5 tablets (500 mg). In clinical trials comparing the two dosing regimens, the clinical efficacy of the two was similar, but the 20 mg/kg/day medication regimen had a stronger ability to eliminate bacteria. Of course, penicillin is still the first choice for routine treatment of streptococcal pharyngitis, including the prevention of rheumatic fever. Precautions for pregnancy and lactation: Animal reproductive toxicity studies have shown that azithromycin crosses the placenta, but there is no sign of damage to the fetus, and there is no data on the secretion of this product in breast milk. The safety of use in human pregnancy and lactation has not been confirmed so far, so this product should be used only when there is no appropriate choice for pregnant or lactating women. Precautions for the elderly: Same as adults.

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 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 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: The pharmacological effect of triazolam is enhanced by reducing the degradation of triazolam. 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.

Sealed, store in a cool, dry place.

0.1g (calculated as C38H72N2O12)

24 months.

Jinling Pharmaceutical Co., Ltd. Nanjing Jinling Pharmaceutical Factory

• Founded in:

  1996-09-16

• Address:

  No. 58, Xingang Avenue, Nanjing Economic and Technological Development Zone

• Tax NO.:

  9132019270413930XB

• Registered Funds:

  -

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