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 (moraxella), 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, 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 tablets.

This product is suitable for the following infections in adults and children caused by sensitive bacteria: 1. Upper respiratory tract infections: including otitis media, sinusitis, pharyngitis, tonsillitis, etc.; 2. Lower respiratory tract infections: including bronchitis, pneumonia, etc.; Note: Penicillin is a commonly used drug for the treatment of streptococcal pharyngitis and for the prevention of rheumatic fever. Azithromycin can effectively eliminate streptococci in the oropharynx, but there is currently no data on the efficacy of azithromycin in the treatment and prevention of rheumatic fever. 3. Skin and soft tissue infections; 4. Simple genital infections caused by Chlamydia trachomatis; 5. Simple genital infections caused by non-multidrug-resistant gonococci and chancroid caused by Haemophilus dukei (need to be excluded) and co-infection with Treponema pallidum; 6. Azithromycin can be used alone or in combination with rifabutin to prevent avian intracellular branched rods.

This product is a dispersible tablet, which can be taken orally/swallowed directly, or put an appropriate amount of this product into about 100ml of water, shake and disperse it, and then take it orally. 　　1. Children: The dosage for children over 2 years old is calculated by kilogram body weight. The dosage and method of administration are as follows: Under 15kg: 15-3 years old, take 100mg orally once a day for three consecutive days; 15-25kg: 3-8 years old, take 200mg orally once a day for three consecutive days; 26-35kg: 9-12 years old, take 300mg orally once a day for three consecutive days; 36-45kg: 9-12 years old, take 400mg orally once a day for three consecutive days. 　　2. Adults: For sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus dukei or sensitive gonococci, only 1.0g of this product is needed orally once a week. The dosage required for HIV-infected patients to prevent infection with Mycobacterium avium-intracellulare complex is 1.2g of this product once a week. For the treatment of other infections: total dose 1.5g, take 0.5g of this product once a day for three days. Or the total dose is the same, still 1.5g, take 0.5g on the first day, and take 0.25g of this product orally once a day from the second to the fifth day. 　　3. Patients with renal insufficiency: Patients with mild renal insufficiency (creatinine clearance 40ml/min) do not need to adjust the dose. There is no data on the use of azithromycin in patients with severe renal insufficiency. 　　4. Patients with hepatic insufficiency: For patients with mild to moderate hepatic insufficiency, the usage and dosage of this product are the same as those with normal liver function.

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. 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 dosage 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 the 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. 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 together 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 together with warfarin, attention should be paid to checking the prothrombin time. (4) When used together 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.

0.25g

24 months.