| Generic Name |
Azithromycin Capsules |
| Strength |
250mg |
| Packing |
6 Capsules/box |
| Origin |
China |
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Registration service by our team
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Product name:
Azithromycin Capsules 250mg
Character:
This product is a capsule, the content is white or white crystalline powder.
Indications:
1. Acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes.
2. Acute attacks of sinusitis, otitis media, acute bronchitis and 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-multidrug-resistant Neisseria gonorrhoeae.
5. Skin and soft tissue infection caused by sensitive bacteria.
Adverse reactions:
This product is generally well tolerated, the incidence of adverse reactions is low, mostly mild to moderate reversible reactions.
1. Common adverse reactions are:
(1) Gastrointestinal reactions: diarrhea, nausea, abdominal pain, loose stools, vomiting, etc. :
(2) Skin reaction: rash, cancer itch, etc.;
(3) Other reactions: such as anorexia, vaginitis, dizziness or dyspnea.
2. The following < were also observed in clinic. 1% adverse reactions:
(1) Digestive system; Dyspepsia, flatulence, mucositis, oral candidiasis, gastritis, etc.
(2) Nervous system: headache, lethargy, etc.
(3) Allergic reactions: bronchospasm, etc.
(4) Other reactions: abnormal taste, etc.
3. The following adverse reactions were also observed after the oral preparation was launched, and the correlation between them and this product is still unclear.
(1) Allergic reactions: arthralgia, angioneurotic edema, urticaria, photoallergy;
(2) Cardiovascular system: arrhythmia, ventricular tachycardia:
(3) Gastrointestinal tract: rare pseudomembranous enteritis, tongue staining;
(4) genitourinary system: interstitial nephritis, acute renal failure;
(5) Hematopoietic system: thrombocytopenia;
(6) hepatobiliary system: Achilomyces has been reported to cause hepatitis and cholestatic jaundice, occasionally causing liver necrosis and liver failure, but rarely causing death, the causal relationship has not been determined;
(7) psychoneurotic system: aggressive reaction, neuroticism, anxiety, anxiety, headache, lethargy, dizziness: vertigo, convulsion, hyperactivity;
(8) Skin/accessory tissue: Rare severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal lytic necrosis have been reported;
(9) Sensory organs: It has been reported that macrolide antibiotics can damage the hearing of patients. Some patients taking azithromycin have experienced hearing impairment including hearing loss, ringing, and/or deafness. According to the investigation research shows that this phenomenon is related to the continuous use of large doses of this product in patients, through the follow-up of these loyal patients, it is found that the hearing of most patients can be restored. There are few reports of changes in taste index.
4. Abnormal laboratory examination: serum ALT, AST, creatinine, LDII, biliary cord and alkaline phosphatase increased, leukocyte, neutrophil and platelet count decreased.
Pharmacology and toxicology:
Pharmacological action
Azithromycin is an azalactone antibiotic that acts by binding to subunits of the 50s ribosomes of sensitive microorganisms, thereby interfering with their protein synthesis (without affecting nucleic acid synthesis).
In vitro and clinical studies have shown that azithromycin is effective against the following pathogens:
Gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, hemolytic streptococcus.
Azithromycin is cross-resistant to gram-positive bacteria that are resistant to rhodoxorph. Most streptococcus faecalis (enterococcus) and methicillin-resistant staphylococcus are resistant to this product.
Gram-negative aerobic microorganisms: Haemophilus influenzae, Moraxella catarrhal, Mycoplasma trachomatis.
In vitro and clinical studies suggest that this product can prevent disease caused by mycobacterium avium intracellular complex (composed of mycobacterium avium intracellular and mycobacterium avium intracellular).
Strains producing B-lactamase are ineffective to this product.
There have been in vitro studies on the following microorganisms, but their clinical significance is unclear, including Streptococcus (C, F, G), Streptococcus viriosa, Bacillus pertussis, Haemophilus duque, Legionella pneumophila, Bacterioid, Peptostreptococcus, spiral law, mycoplasma pneumoniae, spirochaeta syphilis, ureaplasma uyticum, etc.
Toxicological study
Genotoxicity: The results of human lymphocyte test, mouse bone marrow micronucleus test and mouse in vitro lymphatic cancer cell test all confirmed that this product has no mutagenic effect.
Reproductive toxicity: Reproductive toxicity tests in both rats and mice have shown that teratogenic effects are found when doses of the drug reach a dose level that produces moderate maternal toxicity (i.e. 200mg/kg/ day, about 2 to 4 times the human dose of 500mg/.kg/ goal based on body surface area). No damage to fertility or the fetus has been found.
Carcinogenicity; There are no carcinogenicity studies on long-term use of this product in animals.
Storage:
Seal and store in a dry place.
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