How Effective Is Azithromycin for Strep?

Azithromycin tablets, the indication is applicable to the following infections caused by sensitive bacteria: bronchitis, pneumonia and other lower respiratory tract infections; skin and soft tissue infections; acute otitis media; sinusitis, pharyngitis, tonsillitis and other upper respiratory tract infections (penicillin is a treatment The commonly used medicine for streptococcal pharyngitis is also a commonly used medicine to prevent rheumatic fever. Azithromycin can effectively remove streptococcus in the oropharynx, but there is no data on the efficacy of azithromycin in the treatment and prevention of rheumatic fever). Azithromycin can be used for simple genital infections caused by Chlamydia trachomatis in sexually transmitted diseases in men and women. Azithromycin can also be used for simple genital infections caused by non-multidrug resistant gonococci and soft chancrees caused by Haemophilus Duke (complication of Treponema pallidum should be excluded).

Drug Name: Azithromycin tablets

Drug type: Prescription medicines, essential medicines, medicines for medical workers' injuries
Use classification: Antibiotics

Azithromycin tablets ingredients

The main ingredient of this product is azithromycin.
Chemical name: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R) -13-[(2,6-dideoxy-3-C-methyl-3-O-methyl- -L-Nuclear-hexapyranosyl) oxy] -2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11- [ [3,4,6-Trideoxy-3- (dimethylamino) --D-xylopyranosyl] oxy] -1-oxo-6-azacyclopentadecan-15-one Chemical Structure:

Dihydrate molecular formula: C ₃₈ H ₇₂ N ₂ O ₁₂ · 2H ₂ O
Dihydrate molecular weight: 785.03
Anhydrous molecular formula: C ₃₈ H ₇₂ N ₂ O ₁₂
Anhydrous molecular weight: 749.00

Azithromycin Tablet Properties

This product is a white or off-white capsule film-coated tablet with "ZTM 250" or "ZTM 500" inscriptions on the tablet. This product contains azithromycin dihydrate, which is equivalent to 250mg or 500mg azithromycin.

Azithromycin tablets indications

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 Can effectively remove oropharyngeal streptococcus, but there is no data on the efficacy of azithromycin in the treatment and prevention of rheumatic fever).
Azithromycin can be used for simple genital infections caused by Chlamydia trachomatis in sexually transmitted diseases in men and women. Azithromycin can also be used for simple genital infections caused by non-multidrug resistant gonococci and soft chancrees caused by Haemophilus Duke (complication of Treponema pallidum should be excluded).

Azithromycin Tablet Specifications

(1) 0.25g; (2) 0.5g

Azithromycin tablets dosage

Azithromycin should be administered orally once daily, swallowed whole, and taken with food. Azithromycin tablets are used to treat various infectious diseases. The course of treatment and application methods are as follows:
For sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus duke or Gonorrhoeae, only a single oral dose of 1000 mg of this product is required.
Treatment of other infections: the total dose is 1500mg, and the product is 500mg once a day for three days. Or the total dose is the same. Take 500mgg on the first day and 250mg orally once a day on the second to fifth days.
[u] Patients with renal insufficiency [/ u]
Patients with mild to moderate renal insufficiency (glomerular filtration rate of 10-80ml / min) do not need to adjust the dose, and severe renal insufficiency (glomerular filtration rate of <10ml / min) (see [Precautions] And [Pharmacokinetics]).
[u] Patients with liver dysfunction [/ u]
Patients with mild to moderate liver dysfunction, the usage and dosage of this product are the same as those with normal liver function.

Azithromycin tablets adverse reactions

Although it is not certain that all events were caused by azithromycin, we are here to report all adverse events collected during clinical trials and after product marketing reports.
Patients are well tolerated by this product and the incidence of adverse reactions is low.
The following adverse events have been observed in clinical trials:
[u] Hematological and lymphatic abnormalities: [/ u] Transient neutropenia is occasionally seen in clinical trials, but there is no data suggesting an association with azithromycin.
[u] Ear and labyrinth abnormalities: [/ u] Some patients have experienced hearing loss after taking azithromycin, including hearing loss, tinnitus, and / or deafness. Investigations have shown that 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.
[u] Gastrointestinal disorders: [/ u] Nausea, vomiting, diarrhea, loose stools, abdominal discomfort (pain or cramps), flatulence.
[u] Hepatobiliary system abnormalities: [/ u] liver function abnormalities.
[u] Skin and subcutaneous abnormalities: [/ u] Allergic reactions including rash and angioedema.
After listing, other adverse events reported during the use of this product include:
[u] Infection and planting [/ u]: Candidiasis and vaginitis.
[u] Blood and lymphatic abnormalities: [/ u] Thrombocytopenia.
[u] Immune system abnormalities: [/ u] Allergic reactions (rarely fatal) (see [Precautions]).
[u] Metabolic and nutritional disorders: [/ u] Anorexia.
[u] Mental disorders: [/ u] Aggressive response, nervousness, anxiety, anxiety.
[u] Nervous system abnormalities: [/ u] Dizziness, convulsions (similar to other macrolides), headache, increased activity, paresthesia, lethargy, fainting. Rare reports of taste / olfactory inversion and / or absence. However, it is not clear whether the medication is relevant.
[u] Ear and labyrinth abnormalities: [/ u] Dizziness.
[u] Cardiac system abnormalities: [/ u] Palpitations and arrhythmias, including ventricular tachycardia (like other macrolides) have been reported; rare QT interval prolongation and apical torsional tachycardia have been reported. However, it has not been confirmed to be related to azithromycin (see [Notes]).
[u] Vascular abnormalities: [/ u] Hypotension.
[u] Gastrointestinal disorders: [/ u] Vomiting / diarrhea (rarely dehydrated), indigestion, constipation, pseudomembranous enteritis, pancreatitis, rare discoloration of the tongue (rare).
[u] Hepatobiliary system abnormalities: [/ u] Azithromycin has been reported to cause hepatitis and cholestatic jaundice, occasionally liver necrosis and liver failure, but rare deaths, the cause and effect relationship has not been determined.
[u] Skin and subcutaneous tissue abnormalities: [/ u] Allergic reactions such as pruritus, rash, photosensitivity, edema, urticaria, angioedema. Rare serious skin reactions such as erythema polymorpha, Stevens-Johnson syndrome, and toxic epithelial lytic necrosis have been reported.
[u] Musculoskeletal and joint abnormalities: [/ u] Joint pain.
[u] Renal and urogenital abnormalities: [/ u] Interstitial nephritis and acute failure.
[u] General abnormalities and infusion site abnormalities: [/ u] There are reports of general weakness but have not been confirmed to be related to this product, others have fatigue and general discomfort.

Azithromycin tablets contraindications

Patients who are allergic to azithromycin, erythromycin, other macrolide antibiotics, or any excipients are contraindicated.

Azithromycin tablets precautions

Allergic reactions < br Like erythromycin and other macrolides, rare severe allergic reactions such as angioedema and anaphylactic shock (rarely fatal), and include Stevens Johnson syndrome and toxic epidermis Skin reactions including necrolysis (rarely fatal). Some reactions caused by azithromycin can recur, requiring longer observation and treatment. If an allergic reaction occurs, this product should be discontinued and treated appropriately. Doctors should be aware that allergic symptoms may recur after stopping symptomatic treatment.
Hepatotoxicity < br As the liver is the main route of elimination of azithromycin, azithromycin should be used with caution in patients with significant liver disease. Hepatic dysfunction, hepatitis, cholestatic jaundice, liver necrosis, and liver failure have been reported, and some of these cases may cause death. If signs and symptoms of hepatitis appear, azithromycin should be stopped immediately.
Ergot ergot derivatives < br ergot poisoning has been reported in patients receiving ergot derivatives when taking certain macrolide antibiotics at the same time. Although there is no data indicating that ergot and azithromycin have interactions, due to the theoretical possibility of ergot poisoning, azithromycin and ergot derivatives should not be administered at the same time. As with other antibiotic preparations, attention should be paid to the symptoms of secondary infection caused by non-sensitive bacteria, including fungi.
Clostridium difficile-associated diarrhea < br Almost all antimicrobial applications have reported reports of Clostridium difficile-associated diarrhea (CDAD), including azithromycin, which can range in severity from mild diarrhea to fatal enteritis. Antibacterial treatment can cause changes in the normal colonic flora, leading to the overgrowth of Clostridium difficile.
Clostridium difficile toxin A and toxin B are involved in the pathogenesis of CDAD. Highly toxic Clostridium difficile causes increased morbidity and mortality. These infections may be ineffective against antimicrobial therapy and may require colectomy. For all patients with diarrhea following antibiotic use, the possibility of CDAD must be considered. Since there have been reports of CDAD occurring more than 2 months after antimicrobial treatment, a careful medical history is required.
In patients with severe renal insufficiency (glomerular filtration rate <10ml / min), the systemic exposure of azithromycin increased by 33%. (See [Pharmacokinetics])
Prolonged QT interval <br /> It has been reported that the application of other macrolide antibiotics, including azithromycin, can cause ventricular repolarization and prolonged QT interval, which may lead to the risk of arrhythmia and torsional ventricular tachycardia ( (See Adverse Reactions). Therefore care should be taken when treating the following patients:
Patients with congenital or known QT interval extensions are receiving other active substances known to extend the QT interval, such as type IA and III antiarrhythmic drugs; antipsychotics; antidepressants; and fluoroquinolones Patients treated with medication · Electrolyte disorders, especially those with hypokalemia and hypomagnesemia · Patients with clinical manifestations of bradycardia, arrhythmia or cardiac insufficiency · Elderly patients: elderly patients may have drug-related QT Interval effects are more sensitive. There is no evidence that azithromycin affects patients' ability to drive and operate machines.

Azithromycin tablets for pregnant and lactating women

Animal reproductive toxicity studies were performed using the highest measured concentrations of maternal moderate poisoning. In these studies, there is no evidence that azithromycin can cause harm to the fetus. However, no adequate and well-controlled clinical trials have been performed in pregnant women. Because animal reproduction tests do more than predict human response, azithromycin can only be administered during pregnancy if it is clearly needed.
There is no information on the secretion of this product in breast milk. Because many drugs can be secreted in breast milk, only doctors can use this product in nursing women after weighing the potential benefits and risks of the drug to the baby.

Azithromycin tablets for children

Regardless of the infection, it is recommended that the total dose of azithromycin in children does not exceed 1500 mg.
Azithromycin tablets are only suitable for children weighing more than 45 kg. The usage and dosage are the same as for adults.
Children's pharmacokinetic data suggest that 20mg / kg in children is equivalent to 1200mg in adults, but its Cmax value is higher.

Azithromycin tablets for elderly

The administration method and dosage are the same as for adults.

Azithromycin tablets drug interactions

[u] Antacids: [/ u] In exploring the pharmacokinetics of simultaneous administration of antacids and azithromycin, although the peak concentration of azithromycin was reduced by about 25%, no effect on total bioavailability was seen. Patients taking azithromycin and antacids should not take these drugs at the same time.
[u] Cetirizine: [/ u] Healthy volunteers take azithromycin and cetirizine (20mg) simultaneously for 5 days. There is no pharmacokinetic interaction between the two at steady state concentration, and no QT is observed. Significant changes in intervals.
[u] Inosine (dideoxyxanthine): [/ u] Compared to taking placebo, 6 HIV-positive patients taking 1200 mg of azithromycin and 400 mg of inosine daily did not Affects the steady-state pharmacokinetics of didanosine.
[u] Digoxin: [/ u] It has been reported that certain macrolide antibiotics affect the intestinal metabolism of digoxin in some patients. Therefore, in patients taking azithromycin and digoxin simultaneously, attention should be paid to the possibility that the blood concentration of digoxin is increased.
[u] Zidovudine: [/ u] Plasma pharmacokinetics or urinary excretion of a single dose of 1000 mg and multiple doses of 1200 mg or 600 mg of azithromycin zidovudine or its glutamic acid metabolite has little effect. However, oral azithromycin can increase the concentration of phosphorylated zidovudine in peripheral blood mononuclear cells, which is a clinically active metabolite. The clinical significance of these findings is unknown, but may be beneficial for patients.
Azithromycin has no significant effect on the cytochrome P450 system in the liver. Azithromycin, unlike other macrolide antibiotics such as erythromycin, does not affect the pharmacokinetics of other drugs, and will not lose its activity by inducing hepatic cytochrome P450 or by forming a cytochrome metabolism complex.
[u] Ergot: [/ u] Due to the theoretical possibility of ergot poisoning, azithromycin and ergot derivatives should not be used simultaneously.
Pharmacokinetic studies have been performed between azithromycin and the following drugs that are primarily metabolized by the intrahepatic cytochrome P450 system.
[u] Atorvastatin: [/ u] Taking atorvastatin 10mg and azithromycin 500mg at the same time each day has no effect on the blood concentration of atorvastatin (3hydroxy-3methyl-glutaryl-CoA reduction Enzyme inhibition analysis).
[u] Carbamazepine: [/ u] The pharmacokinetic study on healthy volunteers shows that the simultaneous application of carbamazepine and azithromycin has no significant effect on the blood concentration of carbamazepine and its active metabolites.
[u] Cimetidine: [/ u] In the pharmacokinetic study of single-dose cimetidine, two hours before taking azithromycin, there was no change in the pharmacokinetics of azithromycin.
[u] Coumarin oral anticoagulants: [/ u] In a pharmacokinetic study conducted by healthy volunteers, azithromycin did not affect the anticoagulant effect of a single oral dose of warfarin 15 mg. After the market of azithromycin, it has been reported that the simultaneous use of azithromycin and coumarin oral anticoagulants can enhance the anticoagulant effect. Although a causal relationship has not been determined, patients with concurrent coumarin oral anticoagulants should be monitored for prothrombin time.
[u] Cyclosporine: [/ u] Perform pharmacokinetic studies in healthy volunteers, take azithromycin 500 mg daily, and then take a single cyclosporine dose 10 mg / kg for 3 consecutive days. The peak concentration of cyclosporine and The area under the curve increased significantly at 5 hours. Therefore, care must be taken when using both. If simultaneous use is necessary, the plasma concentration of cyclosporine should be monitored to adjust the dose accordingly.
[u] Efavirenz: [/ u] Simultaneous application of azithromycin (600 mg single dose) and efavirenz (400 mg daily for 7 days), no significant clinically significant pharmacokinetic changes were found.
[u] Fluconazole: [/ u] Simultaneous application of a single dose of fluconazole 800mg and a single dose of azithromycin 1200mg, no significant change in the pharmacokinetics of fluconazole, nor the total exposure and half-life of azithromycin Changes, the peak plasma concentration was reduced by 18%, but there was no significant clinical significance.
[u] Indinavir: [/ u] Simultaneous application of a single dose of 1200 mg of azithromycin has no significant effect on the pharmacokinetics of indinavir (800 mg 3 times a day for 5 consecutive days).
[u] Methylprednisolone: [/ u] Azithromycin has no significant effect on the pharmacokinetic parameters of methylprednisolone in drug interaction studies in healthy volunteers.
[u] Midazolam: [/ u] Healthy volunteers use azithromycin (500mg / day for 3 days) and midazolam (single dose 15mg) at the same time, the latter has no pharmacokinetics and pharmacodynamic Significantly changed.
[u] nelfinavir: [/ u] At the steady state concentration of nelfinavir (750 mg administered 3 times a day), simultaneous application of azithromycin 1200 mg will cause an increase in azithromycin concentration. No clinically significant adverse events occurred and no dose adjustment was required.
[u] Rifabutin: [/ u] The combination of this product and Rifabutin has no effect on the serum concentration of both.
When azithromycin is used in combination with rifabutin, neutropenia occurs. Although neutropenia is related to the use of rifabutin, whether it is associated with azithromycin is inconclusive.
[u] Sildenafil: [/ u] In studies conducted in healthy male volunteers, there is no evidence that azithromycin (500 mg per day for 3 days) is a blood drug for sildenafil or its major circulating metabolites The peak concentration and the area under the curve have an effect.
[u] Terfenadine: [/ u] Pharmacokinetic studies have shown that there is no drug interaction between azithromycin and terfenadine. Although cases of interaction between the two are rarely reported, and the possibility of this effect cannot be completely ruled out, there is no specific evidence that this interaction has occurred.
[u] Theophylline: [/ u] Azithromycin has no interaction with theophylline in healthy volunteers, but the theophylline level in plasma should still be monitored.
[u] Triazolam: [/ u] Compared with taking placebo, 14 healthy volunteers took azithromycin (500mg on day 1, 250mg on day 2) and triazolam (0.125mg on day 2), There was no significant effect on the pharmacokinetics of triazolam.
[u] Trimethoprim / sulfamethoxazole: [/ u] Take trimethoprim / sulfamethoxazole 160mg / 800mg daily for 7 consecutive days, and take a single dose of azithromycin 1200mg on the 7th day. The peak plasma concentration, total exposure, and urine clearance of trimethoprim or sulfamethoxazole were not significantly changed. Azithromycin plasma concentrations were similar to those in other studies.

Azithromycin tablets overdose

The overdose is the same as the recommended dose. Once overdose is found, symptomatic and supportive treatment can be given according to the condition.

Azithromycin tablets pharmacology and toxicology

Pharmacological effects <br /> Azithromycin is one of the macrolide antibiotic subclasses, that is, the first drug of azalide antibiotics.
The mechanism of action of azithromycin is to inhibit the bacterial protein synthesis by binding to the 50s ribosomal subunits and hindering the bacterial transpeptide process.
In vitro tests have proven that azithromycin is effective against a variety of pathogenic bacteria. include:
[u] Gram-positive aerobic bacteria: [/ u] Staphylococcus aureus, Streptococcus pyogenes (group A b-hemolytic streptococcus), Streptococcus pneumoniae, a hemolytic streptococcus (streptococcus grass green group) , Other streptococci and corynebacterium diphtheria. Azithromycin is cross-resistant to erythromycin-resistant Gram-positive bacteria including Streptococcus faecalis (enterococcus) and most methicillin-resistant Staphylococcus strains.
[u] Gram-negative aerobic bacteria: [/ u] Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Acinetobacter, Yersinia, Legionella pneumophila, Pertussis, Parapertussis, Shigella, Pasteurella, Vibrio cholerae, Vibrio parahaemolyticus, Pseudomonas Shigella. The activities of E. coli, Salmonella enteritidis, Salmonella typhi, Enterobacter, Aeromonas hydrophila, and Klebsiella differ, and sensitivity tests are required. It is usually resistant to Proteus, Serratia, Morganella and Pseudomonas aeruginosa.
[u] Anaerobic bacteria: [/ u] Bacteroides fragile, Bacteroides, Perfringens, Pneumococcus and Peptostreptococcus, Clostridium necrosis, Propionibacterium acnes.
[u] Microorganisms for sexually transmitted diseases: [/ u] Chlamydia trachomatis, Treponema pallidum, Neisseria gonorrhoeae, Haemophilus Duke.
[u] Other microorganisms: [/ u] Treponema pallidum (Lyme pathogen), Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma human, Mycoplasma urealyticum, Campylobacter, Listeria monocytogenes
[u] Conditional pathogens associated with HIV infection: Mycobacterium avian, Pneumocystis carinii, and Toxoplasma gondii. [/ u]
Mechanisms of drug resistance <br There are two major drug resistance determinants in clinical isolates of Streptococcus pneumoniae and Streptococcus pyogenes: mef and erm. Mef-encoded discharge pumps only make bacteria resistant to 14- and 15-membered macrolide antibiotics. Mef has also been detected in a variety of other fungi. The erm gene encodes a 23S-rRNA methyltransferase and adds a methyl group to adenine 2058 of 23S rRNA (E. coli rRNA numbering system). The methylated nucleotides in the V region, in addition to macrolide antibiotics, can also interact with lincosamide antibiotics and streptomycin B to form an MLSB-resistant phenotype. erm (B) erm (A) genotypes have been detected in clinical isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
The AcrAB-TolC pump in Haemophilus influenzae causes an inherent increase in MIC values for macrolide antibiotics.
23S rRNA mutations, especially those at nucleotide positions 2057-2059 in the V region, or mutations in ribosomal proteins L4 or L22, are rare in clinical isolates.
Sensitive breakpoint < br The recommended MIC value of azithromycin (unit: g / ml) is the sensitive breakpoint (NCLCS recommended standard):
Haemophilus: S4, no recommendation for resistance turning points *
Streptococcus includes Streptococcus pneumoniae and Streptococcus pyogenes: S0.5, R2
* Given the lack of information on resistant strains, it is not possible to define other types than sensitive. If the MIC value of the strain is not within the sensitive range, it should be sent to a reference laboratory for further testing.
Bacterial sensitivity < br The prevalence of acquired resistance to specific strains may vary regionally and temporally. Information on local resistance is important, especially for the treatment of severe infections. If local resistance develops concerns about using the drug in at least some infections, expert advice should be sought in due course.
In vitro sensitivity data are not always consistent with clinical results.
Usually sensitive strains [u] Gram-positive aerobic bacteria: [/ u]
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus (groups C, F, and G) and Streptococcus grass green group.
[u] Gram negative aerobic bacteria: [/ u]
Pertussis, Haemophilus ducreyi, Haemophilus influenzae *, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis * and Neisseria gonorrhoeae.
[u] Other [/ u]
Chlamydia pneumoniae *, chlamydia trachomatis, mycoplasma pneumoniae *, and ureaplasma urealyticum.
Strains with acquired resistance have been reported:
Gram-positive aerobic bacteria:
Streptococcus pneumoniae *
Streptococcus pyogenes *
Note: Azithromycin is cross-resistant to erythromycin-resistant Gram-positive strains.
Inherently resistant strains:
Enterobacteriaceae Pseudomonas * has been proven to be effective for this strain in clinical experiments. $ Naturally mediated susceptible strains. <br /> Toxicological studies [u] Genetic toxicity [/ u]: human lymphocyte test, The results of mouse bone marrow micronucleus test and mouse in vitro lymphoma cell test confirmed that this product has no mutagenic effect.
[u] Reproductive toxicity [/ u]: Reproductive toxicity tests in rats and mice have shown that when the dosage reaches a dosage level that produces a moderate degree of maternal toxicity (ie, 200 mg / kg / day, calculated based on body surface area, about human When the dosage was 500 mg / kg / day (2-4 times), no teratogenic effect was found.
No damage to fertility and the fetus has been found.
[u] Carcinogenicity [/ u]: There is no research data on carcinogenicity of this product for long-term use.
High-dose drug tolerance tests in animals have found that when azithromycin is administered at a concentration 40 times the clinically used dose, it can cause reversible phospholipidosis, but usually does not produce the observed toxicological response. There is no evidence that similar events occur with normal doses of azithromycin in humans.
Preclinical safety data <br /> Microscopy of various tissues (such as eyes, spinal dorsal root ganglia, liver, gallbladder, kidney, spleen and / or pancreas) of mice, rats and dogs after multiple doses of azithromycin Examination can reveal phospholipid lesions (intracellular accumulation of phospholipids). Phospholipid lesions can also be seen in similar tissues in pups and puppies. This effect can be reversed after stopping azithromycin treatment. The significance of this discovery to animals and humans is unclear.

Azithromycin tablets pharmacokinetics

Absorption < br After taking this product orally, azithromycin is widely distributed throughout the body, with a bioavailability of about 37%, and the plasma drug concentration peaks in 2-3 hours.
Distribution < br Animal tests have shown that azithromycin is present at high concentrations in phagocytes. The experimental model found that activated phagocytes released higher concentrations of azithromycin than non-activated phagocytes. The results of this animal model indicate that high concentrations of azithromycin can be released to the infection site.
Human pharmacokinetic studies show that azithromycin tissue concentration is much higher than plasma concentration (50 times higher than the maximum plasma concentration). In a single administration of 500 mg, the concentration in target tissues such as lung, tonsil and prostate is higher than that of most common pathogens. MIC ₉₀ .
Daily oral azithromycin 600mg, the peak plasma concentrations on day 1 and 22 were 0.33 g / ml and 0.55 g / ml, respectively. The disseminated bird-type intracellular Mycobacterium complex mainly infects leukocytes. The average peak concentration of azithromycin in leukocytes is 252 g / ml (± 49%), and its concentration can be maintained at 146 g / ml (± 33) for 24 hours under steady state. %)the above.
Elimination < br Plasma elimination half-life is closely related to tissue elimination half-life at 2-4 days.
About 12% of the intravenously administered dose is excreted from the urine in its original form within 3 days, and the majority is excreted within the first 24 hours. Azithromycin is mainly excreted through the biliary tract after oral administration. High concentrations of azithromycin and 10 metabolites can be seen in human bile. Comparing the results of HPLC and microbial determination of tissues, it was found that the metabolites did not have antibacterial activity.
Pharmacokinetics of special populations [u] age [/ u]
Elderly healthy volunteers (] 65 years old) found that their AUC was slightly higher than young healthy volunteers ([40 years old) after taking the drug for 5 days, but the significant clinical significance of this difference was not clear, so it is not recommended to adjust the dose.
[u] Impaired kidney function [/ u]
Patients with mild to moderate renal insufficiency (glomerular filtration rate of 10-80ml / min) had no significant change in pharmacokinetics after taking 1 g of azithromycin as a single dose. Patients with severe renal insufficiency (glomerular filtration rate <10ml / min) have statistically significant differences in pharmacokinetic parameters compared with those with normal renal function. The area under the curve (0 to 120 hours) The peak concentrations were 8.8 g · h / ml and 11.7 g · h / ml, respectively, at 1.0 g / ml and 1.6 g / ml, and the renal clearance was 2.3 ml / min / kg and 0.2 ml / min / kg.
[u] Impaired liver function [/ u]
Patients with mild (grade A) and moderate (grade B) liver dysfunction have no significant difference in plasma pharmacokinetics from those with normal liver function, but these patients have significantly increased azithromycin recovery in urine, which may be related to compensation .

Azithromycin tablets storage

Sealed and stored in a dry place.

Azithromycin tablet packaging

Aluminum plastic blister pack. 4 pieces / box, 6 pieces / box.

Azithromycin tablets expiration date

0.25g: 60 months;
0.5g: 24 months.

Azithromycin Tablets

The second part of Chinese Pharmacopoeia 2010 edition. ^[1]