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.

The main ingredient of this product is azithromycin. Other scientific names are (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy 3-C-methyl-3-O-methyl-a-L-ribopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-b-D-xylopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Molecular formula: C38H72N2O12 Molecular weight: 749

This product is 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. The course of treatment and usage are as follows: Adults: For sexually transmitted diseases caused by Chlamydia trachomatis or sensitive Neisseria gonorrhoeae, only 1.0g (4 tablets) of this product is needed for oral administration at a single time. For the treatment of other infections: the total dose is 1.5g (6 tablets), divided into three doses, and 0.5g (2 tablets) of this product is taken once a day. Or the total dose is the same, still 1.5g (6 tablets), take 0.5g (2 tablets) on the first day, and then take 0.25g (1 tablet) of this product orally once a day from the second to the fifth day. For the treatment of pharyngitis and tonsillitis in children, take 12mg/kg of body weight per day (maximum daily dose not exceeding 0.5g), and use it for 5 consecutive days.

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, which are generally 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. There is no data on the safety and efficacy of this product for the prevention of avian intracellular mycobacterium complex in children. 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 dose should not exceed 500 mg. In clinical trials comparing the two dosing regimens, the clinical efficacy of the two was similar, but the 20 mg/kg/day dosing regimen had a stronger ability to eliminate bacteria. Of course, penicillin is still the first choice for routine treatment of streptococcal pyogenic 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. There is no data on the secretion of this product in breast milk. The safety of use during pregnancy and lactation has not been confirmed so far, so this product should only be used when pregnant or lactating women have no other options. Precautions for the elderly: Same as for 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 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 observe the patient closely: 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 (touch pain). 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.

0.25g (250,000 units)

24 months.

Dalian Wanda Commercial Management Group Co.,Ltd

• Founded in:

  1997-08-28

• Address:

  No. 8 Yaogu 2nd Road, Xiuying District, Haikou City

• Tax NO.:

  914601002939678125

• Registered Funds:

  173.85895 million yuan

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