Release time:

This product main ingredient: azithromycin.
Chemical name:(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-nuclear-pyranosyl) oxygen] -2-ethyl-3, 4,10-trihydroxy -3,5,6,8,10,12,14-Hexamethyl -11-[[3,4, 6-trideoxy-3-(dimethylamino)-β-D-wood-hexapyranosyl] oxy] -1-oxa-6-azacyclopentadecan-15 one.
Molecular formula: C38H72N2O12
Molecular weight: 749.00

This product is white or white particles.

1. Streptococcus pyogenes caused by acute pharyngitis, acute tonsillitis.
2 sensitive bacteria caused by sinusitis, otitis media, acute bronchitis, acute attack of chronic bronchitis.
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.

0.1g (100000 unit).

Pour this product into a cup, add a proper amount of cold boiled water, dissolve and shake well and take it orally, 1 hour before meals or 2 hours after meals.
Adult Dosage:
1. For sexually transmitted diseases caused by Chlamydia trachomatis or sensitive Neisseria gonorrhoeae, only a single oral dose of 1.0g of this product is required;
2. Treatment of other infections: the total dose is 1.5g, divided into three times, and 0.5g of this product is taken once a day; Or the total dose is the same, still 1.5g, take 0.5g on the first day, and then take 0.25g orally once a day on the 2nd to 5th. Dosage for children: 1. For the treatment of otitis media and pneumonia, on the first day, a single oral administration of 10 mg/kg of body weight (the maximum amount per day is not more than 0.5g), and on the second to fifth days, a single oral administration of 5 mg/kg of body weight per day (the maximum amount per day is not more than 0.25g) or administration according to the following methods: body weight (kg) on the first day (once a day) and on the second-fifth day (once a day) 15-25 0.2g 0.1g 26-35 0.3g 0.15g 36-45 0.4g 0.2g 2. for the treatment of pharyngitis and tonsillitis in children, the body weight is 12 mg/kg per day (the maximum amount per day is not more than 0.5g) for 5 consecutive days. Or as directed.

This product is generally well tolerated, and 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 reactions: rash, itching, etc.; (3) other reactions: such as anorexia, vaginitis, dizziness or dyspnea.
2. The following <1% adverse reactions were also observed in the clinic. (1) Digestive system: dyspepsia, flatulence, mucositis, oral candidiasis, gastritis, etc.; (2) nervous system: headache, drowsiness, etc.; (3) allergic reaction: bronchospasm, etc.; (4) other reactions: abnormal taste, etc.
The following adverse reactions have also been observed with the marketed oral formulation, which are not known to be related to this product. (1) Allergic reactions: arthralgia, angioedema, urticaria, photosensitivity; (2) Cardiovascular system: arrhythmia, ventricular tachycardia; (3) Gastrointestinal tract: rare pseudomembranous enteritis and tongue staining; (4) Urogenital system: interstitial nephritis and acute renal failure; (5) Hematopoietic system: thrombocytopenia; (6) Hepatobiliary system: Azithromycin has occasionally caused hepatitis and cholic jaundice, but liver necrosis and liver failure, causality has not been determined; (7) Psychoneurosystem: aggressive reaction, nervousness, anxiety, anxiety, headache, drowsiness, dizziness, vertigo, convulsion, hyperactivity; (8) skin/accessory tissues: rare severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrosis have been reported; (9) sensory organs: macrolide antibiotics have been reported to damage the hearing of patients. Some people who take azithromycin have experienced hearing impairment including hearing loss, tinnitus, and/or deafness. According to the investigation and study, this phenomenon is related to the continuous high-dose use of this product in patients. Through the follow-up of these patients, it is found that the hearing of most patients can be restored. There are few reports of taste changes caused by azithromycin.
Abnormal laboratory tests: serum ALT, AST, creatinine, LDH, bilirubin and alkaline phosphatase increased, white blood cell, neutrophil and platelet count decreased.

It is contraindicated in people who are allergic to azithromycin, erythromycin, or any other macrolide.

1. Eating can affect the absorption of azithromycin, so it should be taken orally 1 hour before meals or 2 hours after meals.
2. Patients with mild renal insufficiency (creatinine clearance rate] 40 ml/min) do not need dose adjustment, but there is no data on the use of azithromycin in patients with more severe renal insufficiency. Azithromycin should be used with caution in these patients.
Since the hepatobiliary system is the main route of azithromycin excretion, it should be used with caution in patients with hepatic insufficiency and should not be used in patients with severe liver disease. Liver function was followed up regularly during medication.
4. If allergic reactions (such as angioedema, skin reaction, Stevens-Johnson syndrome and toxic epidermal necrosis, etc.) occur during medication, the drug should be stopped immediately and appropriate measures should be taken.
5. During treatment, if the patient has diarrhea symptoms, pseudomembranous enteritis should be considered. If the diagnosis is established, appropriate treatment should be taken, including maintaining water and electrolyte balance, and supplementing protein.
6. If any adverse events and/or adverse reactions occur during the use of this product, please consult your doctor.
7. At the same time use other drugs, please inform the doctor.
8. Please place in a place where children cannot reach.

Animal experiments have shown that this product has no effect on the fetus, but it is still lack of experience in the application of human pregnant women, so it is necessary to fully weigh the advantages and disadvantages in the application of pregnant women. There is no information on whether this product can be secreted into breast milk, so the application of lactating women should be carefully considered.

The recommended total dose of azithromycin in children is no more than 1500mg, regardless of infection. Azithromycin dry suspension is used for children weighing more than 45kg, and the usage and dosage are the same as adults. Efficacy and safety for the treatment of otitis media in children less than 6 months of age, community-acquired pneumonia, and pharyngitis or tonsillitis in children less than 2 years of age have not been established.

This experiment was not performed and there are no reliable references.

According to the introduction of drug interaction studies abroad, the following information about this product is obtained:
ANTACTS: In a pharmacokinetic study investigating the simultaneous administration of antacids and azithromycin, the peak concentration of azithromycin was reduced by approximately 25%, with no effect on total bioavailability. Patients taking azithromycin and antacids should not take these drugs at the same time. Cetirizine: In healthy volunteers, both azithromycin and cetirizine (20mg) were administered orally for 5 days. At steady-state concentrations, there was no pharmacokinetic interaction and no significant change in the QT interval was observed. Dedinosine (dideoxyhypoxanthine nucleoside): Concomitant daily doses of 1200mg of azithromycin and 400mg of didanosine did not affect the steady-state pharmacokinetics of didanosine compared with placebo in six HIV-positive patients. Digoxin: Some macrolide antibiotics have been reported to affect the intestinal metabolism of digoxin in some patients. Therefore, in patients who are taking azithromycin and digoxin at the same time, attention should be paid to the possibility of an increase in the blood concentration of digoxin. Zidovudine: single doses of 1000mg and multiple doses of 1200mg or 600mg of azithromycin have little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronic acid metabolite. However, oral azithromycin can increase the concentration of phosphorylated zidovudine, a clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of these findings is unclear, but may be beneficial for patients. Azithromycin had no significant effect on intrahepatic cytochrome P450 system. Unlike other macrolide antibiotics such as erythromycin, azithromycin does not affect the pharmacokinetics of other drugs and does not lose its activity by inducing cytochrome P450 in the liver or by forming cytochrome metabolic complexes. Ergot: due to the theoretical existence of the possibility of ergot poisoning, it is not recommended to use azithromycin and ergot derivatives at the same time. Pharmacokinetic studies have been performed between azithromycin and the following drugs metabolized primarily by the intrahepatic cytochrome P450 system. Atorvastatin: Concomitant administration of atorvastatin 10mg daily with azithromycin 500mg had no effect on atorvastatin plasma concentrations (HMG CoA-reductase inhibition assay)(3hydroxy-3-methyl-glutaryl coenzyme A reductase inhibition assay). Carbamazepine: Pharmacokinetic studies in healthy volunteers have shown that the concomitant use of carbamazepine and azithromycin has no significant effect on the plasma concentrations of carbamazepine and its active metabolite. Cimetidine: In a pharmacokinetic study of a single dose of cimetidine, no change in the pharmacokinetics of azithromycin was observed in the first two hours of azithromycin administration. Coumarin oral anticoagulants: In pharmacokinetic studies in healthy volunteers, azithromycin did not affect the anticoagulant effect of a single oral dose of 15mg of warfarin. After the marketing of azithromycin, it has been reported that the simultaneous application of azithromycin and coumarin oral anticoagulants can enhance the anticoagulant effect. Although a causal relationship has not been established, frequent monitoring of prothrombin time should be noted in patients concomitant with coumarin oral anticoagulants. Cyclosporine: In a pharmacokinetic study in healthy volunteers, with azithromycin 500mg orally daily followed by a single dose of cyclosporine 10 mg/kg orally for 3 consecutive days, the peak concentration of cyclosporine and the area under the curve at 5 hours were significantly increased. Therefore, the two must be used carefully at the same time. If concomitant use is necessary, the blood concentration of cyclosporine should be monitored so that the dose can be adjusted accordingly. Efavirenz: No clinically significant pharmacokinetic changes were found with the concomitant use of azithromycin (600mg single dose) and efavirenz (400mg daily for 7 days). Fluconazole: simultaneous application of single dose of fluconazole 800mg and single dose of azithromycin 1200mg, no significant change in the pharmacokinetics of fluconazole, the total exposure and half-life of azithromycin did not change, and the peak blood concentration was reduced by 18%, but there was no significant clinical significance. Indinavir: Concomitant application of a single dose of azithromycin 1200mg had no significant effect on the pharmacokinetics of indinavir (800mg 3 times daily for 5 consecutive days). Methylprednisolone: In drug interaction studies in healthy volunteers, azithromycin had no significant effect on the pharmacokinetic parameters of methylprednisolone. Midazolam: Concomitant use of azithromycin (500mg/day for 3 days) and midazolam (15mg single dose) in healthy volunteers did not significantly alter the pharmacokinetics and pharmacodynamics of the latter. Nelfinavir: simultaneous application of azithromycin 1200mg and nelfinavir (750mg, 3 times a day until the steady-state concentration of the blood drug is reached), no clinically significant drug interactions have occurred, so no dose adjustment is required. Rifabutin: The combination of this product and Rifabutin has no effect on the serum concentration of either. When azithromycin is combined with rifabutin, neutropenia occurs. Although neutropenia is associated with the use of rifabutin, the association with azithromycin is uncertain. Sildenafil: In studies conducted in healthy male volunteers, there is no evidence of an effect of azithromycin (500mg daily for 3 days) on the peak plasma concentration, area under the drug-time curve of sildenafil or its main N-ring metabolite. Terphenadine: Pharmacokinetic studies have shown no drug interaction between azithromycin and terphenadine. Although cases of interaction between the two are rarely reported, and the possibility of this effect cannot be completely ruled out, there is still no specific evidence that this interaction has occurred. Theophylline: Azithromycin does not interact with theophylline in healthy volunteers. Triazolam: Concomitant administration of azithromycin (500mg on day 1 and 250mg on day 2) and triazolam (0.125mg on day 2) in 14 healthy volunteers had no significant effect on the pharmacokinetics of triazolam compared with placebo. TMP/SMZ: TMP/SMZ160mg/800mg was taken daily for 7 days and 1200mg azithromycin was taken simultaneously on the 7th day. The blood concentration, total exposure and urine clearance of TMP/SMZ were not significantly changed. Blood concentrations of azithromycin were also similar to those in other studies.

This experiment was not performed and there are no reliable references.

Pharmacological action Azithromycin is an azalide antibiotic. Its mechanism of action is by binding to the subunits of the 50s ribosome of sensitive microorganisms, thereby interfering with their protein synthesis (without affecting the synthesis of nucleic acids).
In vitro tests and clinical studies have shown that azithromycin is effective against the following pathogens: Gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, and hemolytic streptococcus. Azithromycin is cross-resistant to erythromycin-resistant gram-positive bacteria. Most Streptococcus faecalis (Enterococcus) and methicillin-resistant Staphylococcus are resistant to this product. Gram-negative aerobic microorganisms: Haemophilus influenzae, Moraxella catarrhalis. Other microorganisms: Chlamydia trachomatis. In vitro tests and clinical studies suggest that this product can prevent diseases caused by avian intracellular Mycobacterium complex (composed of avian intracellular Mycobacterium and intracellular Mycobacterium). The β-lactamase produced by the bacteria did not affect the activity of azithromycin. The following microorganisms have been studied in vitro, but their clinical significance is unclear, including Streptococcus (C, F, G), Streptococcus viridans, Bordetella pertussis, Haemophilus ducchi, Legionella pneumophila, Bacteroides, Streptococcus peptidis, including Lexurium, Mycoplasma pneumoniae, Treponema pallidum, Ureaplasma urealyticum, etc. Toxicological effects Genotoxicity: Results of human lymphocyte test, mouse bone marrow micronucleus test and mouse in vitro lymphoma cell test Azithromycin showed no mutagenic effect. Reproductive toxicity: Reproductive toxicity tests in rats and mice show that when the dose of azithromycin (orally administered) reaches the dose level that produces moderate maternal toxicity (I .e. 200 mg/kg/day, calculated by body surface area, about 2-4 times of the human dose of 500 mg/kg/day), no teratogenic effect is found. No damage to fertility and the fetus has been found. There are no adequate and well-controlled clinical trials in pregnant women. Since the results of animal reproduction studies are not always predictive of human conditions, pregnant women should use this product only when it is really necessary. It is not known whether this product is secreted in human milk. Since many drugs are secreted by human milk, lactating women should pay attention to it when using it. Carcinogenicity: there is no long-term use of this product in animal carcinogenicity research data.

It is rapidly absorbed after oral administration and has a bioavailability of 37%. After a single oral dose of 0.5g, the peak time was 2.5-2.6 hours, and the peak blood concentration (Cmax) was 0.4-0.45mg/L. This product is widely distributed in the body, in the tissue concentration can reach the same period of blood concentration of 10~100 times, in macrophages and fibroblasts within the high concentration, the former can be azithromycin transported to the site of inflammation. The blood elimination half-life (t1/2β) of this product after single dose administration is 35-48 hours, more than 50% of the dose is excreted through the biliary tract in the original form, and about 4.5 within 72 hours after administration is excreted through the urine in the original form. The serum protein binding rate of this product decreases with the increase of blood concentration. When the blood concentration is 0.02 μg/ml, the serum protein binding rate is 15%; When the blood concentration is 2 μg/ml, the serum protein binding rate is 7%. Foreign data show that there is no significant change in the drug parameters of patients with mild to moderate renal insufficiency (glomerular filtration rate is 10-80 ml/min), while there is a significant difference between patients with severe renal insufficiency (glomerular filtration rate is less than 10 ml/min) and normal patients, and systemic exposure increases by 33%.

Seal and store in a dry place.

Broadcast paper aluminum composite film bag, 9 bags/box.

24 months.

Chinese Pharmacopoeia 2005 Edition II. ^[1]