Azithromycin Tablets

1. 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), Pneumococcus, hemolytic streptococci (grass-green streptococci) and other streptococci, diphtheria (rod-shaped) bacilli. 2. This product shows cross-resistance to erythromycin-resistant Gram-positive bacteria, including Streptococcus faecalis (enterococci) and methicillin-resistant Staphylococcus aureus strains. 3. 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. 4. 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. 5. Anaerobic bacteria: Bacteroides fragilis, Bacteroides, Clostridium perfringens, Peptostreptococcus, Fusobacterium necroticum, Propionibacterium acnes. 6. Sexually transmitted disease microorganisms: Treponema pallidum, Neisseria gonorrhoeae, Haemophilus dukei. 7. Other microorganisms: including Borrelia tenens (Lyme), Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Chlamydia trachomatis, Pneumocystis carinii, Mycobacterium avium, Campylobacter, Listeria monocytogenes. 8. The following Gram-negative bacteria are usually resistant: Proteus, Serratia, Morganella, Pseudomonas. 9. The mechanism of action is the same as that of erythromycin, which mainly binds to the 50S subunit of bacterial ribosomes and inhibits 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.

This product is suitable for the following infections caused by sensitive bacteria: 1. Lower respiratory tract infections such as bronchitis and pneumonia; 2. Skin and soft tissue infections; acute otitis media; 3. Upper respiratory tract infections such as sinusitis, pharyngitis, and tonsillitis (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). 4. Azithromycin can be used for simple genital infections caused by Chlamydia trachomatis in sexually transmitted diseases in men and women. 5. Azithromycin can also be used for simple genital infections caused by non-multidrug-resistant gonococci and chancroid caused by Haemophilus dukei (co-infection with Treponema pallidum must be excluded).

1. Azithromycin should be taken orally once a day, swallowed whole, and can be taken with food. 2. The course of treatment and usage of azithromycin tablets for the treatment of various infectious diseases are as follows: For sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus dukei or sensitive gonococci, only 1.0g of this product is needed orally once. 3. 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, 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. Patients with renal insufficiency Patients with mild and moderate renal insufficiency (glomerular filtration rate 10-80ml/min) do not need to adjust the dose, and patients with severe renal insufficiency (glomerular filtration rate < 10ml/min) should follow the doctor's advice. Patients with mild renal insufficiency (creatinine clearance 40ml/min) do not need to adjust the dose. 4. There is no data on the use of azithromycin in patients with severe renal insufficiency. Patients with Hepatic Insufficiency For patients with mild to moderate hepatic insufficiency, the usage and dosage of this product are the same as those for patients with normal liver function.

Although it cannot be confirmed that all events are caused by azithromycin, we still report here all adverse events collected during clinical trials and post-marketing reports. Patients tolerate this product well and the incidence of adverse reactions is low. The following adverse events were observed in clinical trials: 1. Gastrointestinal: nausea, vomiting, diarrhea, loose stools, abdominal discomfort (pain or cramps), flatulence. Hematopoietic function: Transient neutropenia was occasionally seen in clinical trials, but there is no information indicating that it is related to azithromycin. 2. Liver/gallbladder: Abnormal liver function. Skin/appendages: rash and angioedema, etc. 3. Special senses: Some patients have experienced hearing impairment including hearing loss, tinnitus and/or deafness after taking azithromycin. According to survey studies, this phenomenon is related to patients' continuous high-dose use of this product. Through follow-up of these patients, it was found that the hearing of most patients can be restored. After marketing, other adverse events reported during the use of this product include: 4. Systemic reactions: There have been reports of general weakness but it has not been confirmed to be related to this product. Others include fatigue, general malaise, candidiasis and anaphylactic shock (rarely fatal). 5. Cardiovascular system: Palpitations and arrhythmias, including ventricular tachycardia (same as other macrolides), have been reported, but it has not been confirmed to be related to azithromycin, hypotension. 6. Central and peripheral nervous system: dizziness/vertigo, convulsions (similar to other macrolides), headache, increased activity, drowsiness, paresthesia, drowsiness, increased syncope. 7. Gastrointestinal tract: loss of appetite, anorexia, dyspepsia, constipation, pseudomembranous colitis, pancreatitis, rare tongue discoloration, nausea, vomiting/diarrhea (rarely leading to rare dehydration), loose stools, dyspepsia, abdominal discomfort (pain or cramps), constipation, abdominal distension, pseudomembranous colitis and rare tongue discoloration. 8. Systemic: There are reports of general weakness but it has not been confirmed that it is related to this product. Others include candidiasis and allergies (rarely fatal). 9. Urogenital system: interstitial nephritis and acute failure. 10. Hematopoietic function: thrombocytopenia. Hepatobiliary system: Azithromycin has been reported to cause liver dysfunction such as hepatitis and cholestatic jaundice, occasionally causing liver necrosis and liver failure, but rarely causing death, and the causal relationship has not been determined. 11. Musculoskeletal: joint pain. 12. Psychiatric: aggressive reaction, nervousness, anxiety, and worry. 13. Reproductive system: vaginitis. 14. Skin/auxiliary organs: allergic reactions such as itching, rash, photosensitivity, edema, urticaria, and angioedema. Rare severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epithelial necrosis have been reported. 15. Sense organs: There are reports that macrolide antibiotics can damage patients' hearing. Some patients have experienced hearing impairment including hearing loss, tinnitus and/or deafness after taking azithromycin. According to research, this phenomenon is related to the continuous high-dose use of this product by patients. Through follow-up of these patients, it was found that the hearing of most patients can be restored. 16. Special senses: There are rare reports of azithromycin causing taste changes. Blood leukocytes/reticuloendothelial system: Transient neutropenia was occasionally seen in clinical trials, but there is no information indicating that it is related to azithromycin.

This product is contraindicated in patients with a history of allergy to azithromycin or other macrolide antibiotics.

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 should not be taken at the same time as antacids containing aluminum or magnesium, as the latter can reduce the peak blood concentration of this product; 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 the plasma can be increased, and attention should be paid to detecting 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 - increases digoxin levels. Ergotamine or dihydroergotamine - acute ergot toxicity, symptoms are severe peripheral vasospasm and dysesthesia (pain to touch). Triazolam - the pharmacological effect of triazolam is enhanced by reducing the degradation of triazolam. Cytochrome P450 system metabolizers - increase serum

Sealed, store in a dry place.

0.25g

24 months.

Hubei Newland Pharmaceutical Co., Ltd.

• Founded in:

  2001-04-27

• Address:

  No. 36 Dongwu Avenue, Wujiashan Taiwanese Investment Zone, Dongxihu District, Wuhan (6)

• Tax NO.:

  91420112726149349L

• Registered Funds:

  30 million yuan

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