Azithromycin Tablets

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 b-hemolytic streptococci), Pneumococcus, a-hemolytic streptococci (grass-green streptococci) and other streptococci, diphtheria (rod-shaped) bacilli. This product shows cross-resistance to erythromycin-resistant Gram-positive bacteria, including Streptococcus faecalis (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 Pseudomonas. 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.

This product is a white tablet or film-coated tablet, which appears white or off-white after removing the coating.

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 at a single time; ② For the treatment of other infections: 0.5g is taken at a time on the first day, 0.25g is taken at a time on the second to fifth day; or 0.5g is taken 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 second to fifth 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: Regardless of the type of infection, it is recommended that the total dose of azithromycin in children should not exceed 1500 mg. Azithromycin tablets are only suitable for children weighing more than 45 kg, and the usage and dosage are the same as those for adults. Pediatric pharmacokinetic data suggest that the 20 mg/kg dose for children is equivalent to the 1200 mg dose for adults, but its Cmax value is higher. Precautions for pregnancy and lactation: Animal reproductive studies have shown that azithromycin can cross 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 and its safety for use in pregnant and lactating people, so this product can only be used when pregnant or lactating women have no appropriate choice. Precautions for the elderly: The method of administration and dosage are the same as those 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 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.

Sealed, store in a dry place.

0.25 g

24 months.

Shanxi Huayuan Pharmaceutical Biotechnology Co., Ltd.

• Founded in:

  2011-11-02

• Address:

  Shuozhou Huairen County High-tech Industrial Park

• Tax NO.:

  911406245861569410

• Registered Funds:

  80 million yuan

• Email:

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