Item nanme:Azithromycin tablets Item character:This product is white
Indication: This product is suitable for the following infections caused by sensitive bacteria:
Lower respiratory tract infections such as bronchitis and pneumonia; skin and soft tissue infections; acute otitis media; upper respiratory tract infections such as sinusitis, pharyngitis and tonsillitis (penicillin is a commonly used drug for the treatment of suppurative streptococcal pharyngitis and for the prevention of rheumatic fever). Azithromycin can effectively remove Streptococcus from oropharynx, but there is no data about the efficacy of azithromycin in the treatment and prevention of rheumatic fever.
Azithromycin can be used for simple genital infection caused by Chlamydia trachomatis in male and female sexually transmitted diseases. Azithromycin can also be used for simple genital infection caused by non multidrug resistant Neisseria gonorrhoeae and chancre caused by Haemophilus Duke (the co infection of Treponema pallidum should be excluded).
Item specifications: 0.25g*6tab/box
Usage and dosage:Azithromycin should be given orally once a day, swallow the whole tablet, and can be taken with food at the same time. Azithromycin tablets were used to treat various infectious diseases
For sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus duke or sensitive Neisseria gonorrhoeae, only a single oral dose of 1000mg is required.
Treatment for other infections: the total dose is 1500mg, 500mg once a day for three days. Or the total dose is the same, taking 500mg on the first day, taking 250mg once a day from the second day to the fifth day.
[u] Patients with renal insufficiency
Patients with mild or moderate renal insufficiency (glomerular filtration rate is 10-80 ml / min) do not need to adjust the dose, while patients with severe renal insufficiency (glomerular filtration rate < 10 ml / min) (see [precautions] and [pharmacokinetics]).
[u] Patients with liver dysfunction
For patients with mild to moderate liver dysfunction, the usage and dosage of this product are the same as those with normal liver function.
Adverse reactions Although it is not certain that all events were caused by azithromycin, we have reported all adverse events collected during clinical trials and in post market reports.
The patients had good tolerance to this product, and the incidence of adverse reactions was low.
The following adverse events were observed in clinical trials:
[u] Abnormal blood and lymph system: [/u] once seen neutropenia in clinical trials, but no data showed that azithromycin was related.
[u] Abnormal ear and labyrinthine: [/u] some patients had hearing impairment after azithromycin, including hearing loss, tinnitus and / or deafness. According to the investigation, this phenomenon is related to the continuous use of this product in large doses. Through the follow-up of these patients, it is found that hearing can be recovered in most patients.
[u] Gastrointestinal abnormalities: [/u] nausea, vomiting, diarrhea, diarrhea, diarrhea, abdominal discomfort (pain or spasm), gastrointestinal distention.
[u] Abnormal liver and gallbladder system: [/u] abnormal liver function.
[u] Abnormal skin and subcutaneous tissue: [/u] allergic reactions including rash and vascular edema.
After listing, other adverse events reported during the use of this product include:
[u] Infection and colonization [/u]: candidiasis and vaginitis.
[u] Abnormal blood and lymph system: [/u] thrombocytopenia.
[u] Immune system abnormality: [/u] allergic reaction (rarely fatal) (see [precautions].
[u] Metabolic and nutritional abnormalities: [/u] anorexia.
[u] Mental abnormality: [/u] aggressive response, neuroticism, anxiety, anxiety, anxiety.
[u] Nervous system abnormality: [/u] dizziness, convulsion (similar to other macrolides), headache, increased activity, abnormal sensation, sleepiness, fainting. There are rare reports of taste / olfactory fallback and / or missing. However, whether the drug use is related has not been clear.
[u] Abnormal ear and labyrinth: [/u] vertigo.
[u] Cardiac system abnormality: [/u] palpitation and arrhythmia, including ventricular tachycardia (as with other macrolides), and QT interval extension and tip torsion tachycardia are rarely reported. However, it has not been confirmed that it is related to azithromycin (see [precautions].
[u] Abnormal blood vessels: [/u] hypotension.
[u] Gastrointestinal abnormalities: [/u] vomiting / diarrhea (rare dehydrated), dyspepsia, constipation, pseudomembranous enteritis, pancreatitis, tongue discoloration rare (rare).
[u] Hepatobiliary system abnormality: [/u] azithromycin has been reported to cause hepatitis and cholestasis jaundice, occasionally causing liver necrosis and liver failure, but few of them have died, and the causal relationship has not been determined.
[u] Abnormal skin and subcutaneous tissue: [/u] allergic reactions such as pruritus, rash, photoallergy, edema, urticaria, vascular edema. Rare serious skin reactions such as erythema multiforme, Stevens Johnson syndrome and toxic epithelial lysis and necrosis have been reported.
[u] Musculoskeletal and joint tissue abnormality: [/u] joint pain.
[u] Renal and urogenital system abnormality: [/u] interstitial nephritis and acute failure.
[u] General abnormality and injection site abnormality: [/u] there is no general inability to report but it has not been confirmed to be related to this product, other fatigue and general discomfort.
Taboo: Patients allergic to azithromycin, erythromycin, other macrolide antibiotics or any excipient should not use this product.
Matters needing attention: Allergic reaction
Like erythromycin and other macrolides, there are rare reports of severe allergic reactions such as vascular edema and anaphylactic shock reactions (rare fatal), as well as skin reactions including Stevens Johnson syndrome and toxic epidermal necrolysis (rare fatal). Some of the reactions caused by azithromycin can be repeated, which need long time observation and treatment. If allergic reactions occur, the product should be stopped and treated properly. Doctors should understand that allergy symptoms may reappear after the treatment is stopped.
Hepatotoxicity
Because liver is the main way of azithromycin clearance, it should be cautious when it is used in patients with obvious liver disease. There have been reports of liver dysfunction, hepatitis, cholestasis jaundice, liver necrosis and liver failure, some of which may lead to death. If signs and symptoms of hepatitis occur, azithromycin should be stopped immediately.
Ergot derivatives
It has been reported that patients treated with ergot derivatives may suffer from ergot poisoning when they take some macrolides antibiotics at the same time. Although there is no data that ergot and azithromycin interact, azithromycin and ergot derivatives should not be given simultaneously because of the possibility of ergot poisoning in theory. Like other antibiotic agents, we should pay attention to the symptoms of secondary infection caused by non sensitive bacteria including fungi.
Clostridium difficile associated diarrhea
Almost all antimicrobial applications have been reported with Clostridium difficile associated diarrhea (CDAD), including azithromycin, which can be seen as mild diarrhea to fatal enteritis. The treatment of antimicrobial agents can cause the change of normal colic flora and the over growth of Clostridium difficile.
The toxin A and toxin B produced by Clostridium difficile are related to the pathogenesis of CDAD. High incidence rate of Clostridium difficile leads to increased morbidity and mortality. These infections may not be effective for antimicrobial therapy, and may require colectomy. For all patients with diarrhea after antibiotics, the possibility of CDAD must be considered. Since there have been reports of CDAD after more than 2 months of antimicrobial treatment, the medical history needs to be carefully asked.
In patients with severe renal dysfunction (glomerular filtration rate < 10ml / min), azithromycin increased overall exposure by 33%. (see [pharmacokinetics])
QT interval extension
It has been reported that the use of other macrolides, including azithromycin, can cause ventricular repolarization and QT interval extension, which may lead to the risk of arrhythmia and tip torsion ventricular tachycardia (see [adverse reactions]. Therefore, care should be taken when treating the following patients:
· Patients with congenital or known QT interval extension
· Other active substances known to extend QT intervals, such as type Ia and type III antiarrhythmic drugs, are being accepted; Antipsychotics; Antidepressants; And fluoroquinolones
· Electrolyte disorders, especially in patients with hypokalemia and hypomagnesemia
· A patient with clinical manifestations of bradycardia, arrhythmia, or cardiac dysfunction
· Elderly patients: older patients may be more sensitive to drug-related QT interval effects
There is no evidence that azithromycin has an impact on the ability of patients to drive and operate the machine.
Medication for pregnant and lactating women: The reproductive toxicity of animal was studied by using the highest concentration which could make the mother moderately poisoned. In these studies, there is no evidence that azithromycin can cause harm to the fetus. However, there are no adequate and well controlled clinical trials in pregnant women. Since animal reproductive tests can not only predict human responses, azithromycin can only be administered during pregnancy when the need for azithromycin is clear.
There is no data on the secretion of this product in breast milk. Since many drugs can be secreted in breast milk, doctors can only use this product in lactating women after weighing the potential benefits and risks of drugs for infants.
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Our Manufacture Factory Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.
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At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.
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