Main physicochemical properties: white or almost white powder.
Pharmacotherapeutic group
Antibacterials for systemic use. Macrolides. ATX code J01F A10.
Pharmacological properties
Pharmacodynamics.
Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is formed by the introduction of a nitrogen atom into the lactone ring of erythromycin A. The mechanism of action of azithromycin is to inhibit bacterial protein synthesis by binding to the 50S ribosomal subunit and inhibiting peptide translocation. This usually results in a bacteriostatic effect.
Efficacy significantly depends on the ratio of the area under the concentration-time curve (AUC) to the minimum inhibitory concentration (MIC) of the pathogen.
Mechanism of resistance
Resistance to azithromycin can be congenital or acquired and is associated with three main mechanisms: alteration of the target site, alteration of antibiotic transport, and modification of the antibiotic.
Complete cross-resistance exists among Streptococcus pneumoniae, group A beta-hemolytic streptococcus, Enterococcus faecalis, and Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA), to erythromycin, azithromycin, other macrolides, and lincosamides.
Sensitivity control parameters
The scale of susceptibility of microorganisms to azithromycin (MIC, mg/L), established by the European Committee on Antibiotic Susceptibility Testing (EUCAST) (Clinical breakpoint v.8.0, 01.01.2018), is as follows:
Pathogen
Sensitive
Resistant
Staphylococcus spp.
≤ 1a mg/l
> 2a mg/l
Streptococcus spp. (groups A, B, C, G)
≤ 0.25a mg/l
> 0.5a mg/l
Streptococcus pneumoniae
≤ 0.25a mg/l
> 0.5a mg/l
Haemophilus influenzae
≤ 0.12b mg/l
> 4b mg/l
Moraxella catarrhalis
≤ 0.25a mg/l
> 0.5a mg/l
Neisseria gonorrhoeae
≤ 0.25 mg/l
> 0.5 mg/l
Campylobacter jejuni and coli
Notec
Notec
Kingella kingae
0.25d
0.25d
Viridans group streptococci
IE
IE
PK-PD (non-species specific MIC values)
IE
IE
a Erythromycin can be used to determine susceptibility to azithromycin, clarithromycin, and roxithromycin.
b Clinical data on the efficacy of macrolides in respiratory infections caused by H. influenzae are conflicting due to the high spontaneous cure rate. If there is a need to investigate the efficacy of any macrolide in these infections, epidemiological data (ECOFF) should be used to identify strains with acquired resistance. The ECOFFs for each agent are: azithromycin 4 mg/L, clarithromycin 32 mg/L, erythromycin 16 mg/L, and telithromycin 8 mg/L. There are insufficient data to establish an ECOFF for roxithromycin.
c Erythromycin can be used to determine susceptibility to azithromycin, clarithromycin.
d Susceptibility can be determined from erythromycin susceptibility data.
IE indicates that there is insufficient evidence that the organism or group of organisms is susceptible to azithromycin. The MIC is given but without a corresponding susceptibility categorization as S (susceptible), I (intermediately susceptible), or R (resistant).
Resistance
The prevalence of acquired resistance may vary geographically and over time for individual species, so local information on resistance is necessary, especially when treating severe infections. Expert advice should be sought if the local prevalence of resistance is such that the benefit of azithromycin is questionable. In severe infections or when therapy fails, microbiological diagnosis should be performed to identify the pathogen and its susceptibility to azithromycin.
The spectrum of antimicrobial action of azithromycin:
⃰ Clinical efficacy is demonstrated in susceptible microorganisms when treated according to approved clinical indications.
Pharmacokinetics.
Absorption
The maximum concentration of the drug in the blood serum (Cmax) is reached 2-3 hours after its administration. The terminal plasma half-life fully reflects the half-life from tissues within 2-4 days. Elderly patients (> 65 years) after five days of treatment were observed a slightly higher AUC value than in individuals under 40 years of age. The clinical significance is so small that there is no need for dose adjustment.
In animal studies, high concentrations of azithromycin were observed in phagocytes, with higher concentrations being released during active phagocytosis in experimental studies than in unstimulated phagocytes. In animal models, this resulted in increased concentrations of azithromycin at the site of infection.
Nonlinearity
These studies indicate nonlinear pharmacokinetics of azithromycin in the therapeutic range.
Distribution
Azithromycin concentrations in tissues are significantly higher (50-fold) than in plasma, indicating strong tissue binding. In target tissues such as the lungs, tonsils, and prostate, concentrations above the MIC90 of the expected pathogens are observed after a single 500 mg dose.
Serum protein binding varies with plasma concentrations and ranges from 12% at 0.5 μg/ml to 52% at 0.05 μg/ml in serum. The mean volume of distribution at steady state (VVss) is 31.1 l/kg.
Breeding
About 12% of an intravenous dose of azithromycin is excreted unchanged in the urine over the next 3 days, mostly within the first 24 hours. After oral administration, azithromycin is excreted mainly in the bile in unchanged form. In human bile, particularly high concentrations of unchanged azithromycin have been found, as well as 10 metabolites formed by N- and O-demethylation, hydroxylation of the desosamine and aglycone rings, and cleavage of the cladinose conjugate. Relevant studies show that the metabolites of azithromycin are not microbiologically active.
Pharmacokinetic/pharmacodynamic relationship
Kidney dysfunction
In patients with glomerular filtration rates of 10 to 80 mL/min, the pharmacokinetic parameters after a single oral dose of 1 g of azithromycin were not changed. In patients with glomerular filtration rates <10 mL/min, statistically significant differences were observed in AUC0-120 (8.8 μg h/mL vs. 11.7 μg h/mL), Cmax (1.0 μg/mL vs. 1.6 μg/mL), and CLr (renal clearance) (2.3 mL/min/kg vs. 0.2 mL/min/kg) compared to patients with normal renal function.
Liver dysfunction
There is no evidence of altered serum pharmacokinetics of azithromycin in patients with mild to moderate hepatic impairment compared with patients with normal hepatic function. In these patients, urinary excretion of azithromycin is enhanced, possibly to compensate for reduced hepatic clearance.
Indication
For dosages 100 mg/5 ml and 200 mg/5 ml
Infections caused by microorganisms sensitive to azithromycin:
ENT infections (bacterial pharyngitis/tonsillitis, sinusitis, otitis media);
Skin and soft tissue infections: erythema migrans (initial stage of Lyme disease), erysipelas, impetigo, secondary pyodermatoses.
For dosage 200 mg/5 ml
sexually transmitted infections: uncomplicated urethritis/cervicitis caused by Chlamydia trachomatis.
Contraindication
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or any other component of the drug. Severe liver dysfunction. Due to the theoretical possibility of ergotism, azithromycin should not be administered concomitantly with ergot derivatives.
Interaction with other medicinal products and other types of interactions
Antacids: In a study of the effect of concomitant administration of antacids on the pharmacokinetics of azithromycin, there was generally no change in bioavailability, although peak plasma concentrations of azithromycin were decreased by 25%. Azithromycin and antacids should not be taken concurrently.
Cetirizine: Coadministration of azithromycin and 20 mg cetirizine for 5 days did not result in a pharmacokinetic interaction at steady state, but significantly altered the QT interval.
Didanosine: Coadministration of 1200 mg/day of azithromycin and 400 mg/day of didanosine in 6 HIV-positive patients had no effect on the steady-state pharmacokinetics of didanosine.
Zidovudine. A single dose of 1000 mg azithromycin and multiple doses of 600 mg or 1200 mg azithromycin did not affect the pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, azithromycin increased the concentration of phosphorylated zidovudine in peripheral blood mononuclear cells. The clinical significance of these findings is unclear, but may be useful for patients.
Azithromycin does not have a significant interaction with the hepatic cytochrome P450 system. It is believed that the drug does not have the pharmacokinetic drug interactions characteristic of erythromycin and other macrolides. Azithromycin does not induce or inactivate hepatic cytochrome P450 through the cytochrome-metabolite complex.
Ergot: Given the theoretical possibility of ergotism, the simultaneous administration of azithromycin with ergot derivatives is not recommended.
Pharmacokinetic studies have been conducted on the use of azithromycin and the following drugs, the metabolism of which occurs to a large extent with the participation of cytochrome P450.
Ergotamine derivatives: Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergotamine derivatives should be avoided.
Astemizole, alfentanil. There are no available data on their interaction with azithromycin. However, caution is required when using them together with azithromycin due to the known interaction: increased action of astemizole and alfentanil when used together with the macrolide antibiotic erythromycin.
Atorvastatin: Coadministration of 10 mg/day of atorvastatin and 500 mg/day of azithromycin had no effect on plasma concentrations of atorvastatin (based on an HMG CoA reductase inhibition assay). However, cases of rhabdomyolysis have been reported in postmarketing experience in patients receiving azithromycin with statins.
Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the plasma levels of carbamazepine or its active metabolites.
Cisapride. Cisapride is metabolized in the liver by the CYP 3A4 enzyme, and macrolides inhibit this enzyme, so concomitant use of cisapride may cause increased QT prolongation.
Cimetidine: In a pharmacokinetic study of the effect of a single dose of cimetidine, taken 2 hours before azithromycin, on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were observed.
Oral Coumarin Anticoagulants. In a pharmacokinetic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Postmarketing reports of potentiation of the anticoagulant effect following concomitant administration of azithromycin and oral coumarin anticoagulants have been received. Although a causal relationship has not been established, frequent monitoring of prothrombin time should be considered when prescribing azithromycin to patients receiving oral coumarin anticoagulants.
Cyclosporine: A pharmacokinetic study in healthy volunteers receiving oral doses of azithromycin 500 mg daily for 3 days followed by a single oral dose of cyclosporine 10 mg/kg demonstrated a significant increase in Cmax and AUC0-5 of cyclosporine. Therefore, caution should be exercised when these drugs are used concomitantly. If concomitant use of these drugs is necessary, cyclosporine levels should be monitored and the dose adjusted accordingly.
Efavirenz: Co-administration of a single dose of azithromycin 600 mg and efavirenz 400 mg daily for 7 days did not result in any clinically significant pharmacokinetic interaction.
Fluconazole: Coadministration of a single dose of 1200 mg azithromycin did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. The total exposure and half-life of azithromycin were not altered by coadministration of fluconazole, but a clinically insignificant decrease in Cmax (18%) of azithromycin was observed.
Indinavir: Coadministration of a single dose of azithromycin 1200 mg had no statistically significant effect on the pharmacokinetics of indinavir administered at a dose of 800 mg 3 times daily for 5 days.
Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin did not significantly affect the pharmacokinetics of methylprednisolone.
Midazolam: In healthy volunteers, co-administration of azithromycin 500 mg daily for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of midazolam administered as a single 15 mg dose.
Nelfinavir. Concomitant administration of azithromycin (1200 mg) and nelfinavir at steady-state concentrations (750 mg 3 times a day) resulted in increased azithromycin concentrations. No clinically significant adverse events were observed, and no dose adjustment is required.
Sildenafil: In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite.
Terfenadine: No pharmacokinetic interaction has been reported between azithromycin and terfenadine. In some cases, the possibility of such an interaction cannot be completely excluded, but there is no specific data on the existence of such an interaction.
Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction when azithromycin and theophylline are coadministered in healthy volunteers.
Triazolam: Coadministration of 500 mg of azithromycin on the first day and 250 mg on the second day with 0.125 mg of triazolam in 14 healthy volunteers had no significant effect on all pharmacokinetic parameters of triazolam compared to triazolam and placebo.
Trimethoprim/sulfamethoxazole: Coadministration of trimethoprim/sulfamethoxazole at a double strength (160 mg/800 mg) for 7 days with azithromycin 1200 mg on the seventh day had no significant effect on the maximum concentrations, total exposure, or urinary excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those observed in other studies.
No clinically significant pharmacokinetic interactions were identified when azithromycin was co-administered with doxorubicin.
Drugs that prolong the QT interval. Azithromycin should not be administered concomitantly with other drugs that prolong the QT interval (e.g. quinidine, cyclophosphamide, ketoconazole, terfenadine, haloperidol, lithium) (see section "Special warnings and precautions for use").
Application features
Hypersensitivity reactions
As with erythromycin and other macrolide antibiotics, rare serious allergic reactions have been reported, including angioedema and anaphylaxis (in isolated cases fatal), dermatological reactions including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome, toxic epidermal necrolysis (in isolated cases fatal), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Some of these reactions have resulted in relapses and required longer periods of observation and treatment.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be initiated. Physicians should be aware that allergic symptoms may recur upon discontinuation of symptomatic therapy.
The liver is the primary route of metabolism and elimination of azithromycin, and patients with severe liver disease should not use the drug. Cases of myasthenic syndrome and exacerbation of myasthenia gravis symptoms have been reported in patients receiving azithromycin therapy.
Azithromycin should be used with caution in patients with severe renal impairment (creatinine clearance < 10 ml/min), as a 33% increase in plasma concentrations has been observed in such patients. Cases of fulminant hepatitis, resulting in life-threatening liver failure, have been reported with azithromycin (see section 4.8). Some patients may have a history of liver disease or may be taking other hepatotoxic drugs.
Liver function tests should be performed if signs and symptoms of liver dysfunction develop, such as rapidly progressive asthenia accompanied by jaundice, dark urine, bleeding tendency, or hepatic encephalopathy.
If liver function impairment is detected, azithromycin should be discontinued.
In patients taking ergot derivatives, concomitant use of some macrolide antibiotics has been associated with the rapid development of ergotism. There is no data on the potential for an interaction between ergot and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin should not be administered concomitantly with ergot derivatives.
As with other antibiotics, monitoring for signs of superinfection caused by non-susceptible organisms, including fungi, should be performed.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis.
Antibacterial treatment alters the normal flora of the large intestine, leading to overgrowth of C. difficile.
C. difficile produces toxins A and B, which cause the development of C. difficile-associated diarrhea.
Hypertoxin-producing strains of C. difficile increase morbidity and mortality because these infections can be resistant to antibacterial therapy and may necessitate colectomy.
In patients with severe renal dysfunction (glomerular filtration rate <10 mL/min), a 33% increase in systemic exposure to azithromycin was observed (see Pharmacokinetics).
Cardiovascular disorders
Prolongation of cardiac repolarization and the QT interval, which increases the risk of cardiac arrhythmias and ventricular tachycardia (torsade de pointes), has been observed with other macrolide antibiotics, including azithromycin (see section "Adverse reactions"). Since conditions associated with an increased risk of ventricular arrhythmias (including torsade de pointes) can lead to cardiac arrest, azithromycin should be prescribed with caution in patients with existing proarrhythmic conditions (especially elderly patients and younger women), in particular in patients:
with congenital or registered prolongation of the QT interval;
who are currently being treated with other active substances known to prolong the QT interval, such as antiarrhythmics of classes IA (quinidine and procainamide) and III (dofetilide, amiodarone and sotalol), cisapride and terfenadine, neuroleptics such as pimozide; antidepressants such as citalopram, and fluoroquinolones such as moxifloxacin and levofloxacin;
with electrolyte imbalance, especially in the case of hypokalemia and hypomagnesemia;
with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
Epidemiological evidence on the risk of adverse cardiovascular events with macrolides is mixed. Some studies have shown that in rare cases there is a risk of short-term arrhythmia, myocardial infarction, and increased cardiovascular mortality associated with the use of macrolides, including azithromycin. Given these data, the benefit-risk ratio should be considered when prescribing azithromycin.
Exacerbation of symptoms of myasthenia gravis or new development of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
The safety and efficacy of the drug for the prevention or treatment of Mycobacterium Avium Complex in children have not been established.
When prescribing azithromycin, the following information should be taken into account:
Azithromycin in the form of powder for oral suspension is not intended for the treatment of severe infections where rapid achievement of high antibiotic concentrations in the blood is necessary.
Azithromycin is not the drug of first choice for empirical treatment of infections in areas where the prevalence of resistant isolates is ≥ 10% (see section "Pharmacological properties").
In areas with a high incidence of erythromycin A resistance, it is very important to consider changes in susceptibility to azithromycin and other antibiotics.
As with other macrolides, resistance rates of Streptococcus pneumoniae (> 30%) have been high in some European countries (see section 5.1). This should be taken into account when treating infections caused by Streptococcus pneumoniae.
Pharyngitis/tonsillitis
The drug of first choice for the treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes and for the prevention of rheumatic fever is penicillin.
Sinusitis
In general, azithromycin is not the first-choice drug for the treatment of sinusitis.
Acute otitis media
In general, azithromycin is not the drug of first choice for the treatment of acute otitis media.
Skin and soft tissue infections
The main causative agent of soft tissue infections, Staphylococcus aureus, is often resistant to azithromycin. Therefore, susceptibility testing should be performed before initiating treatment of soft tissue infections with azithromycin.
Infected burn wounds
Azithromycin is not indicated for the treatment of infected burn wounds.
Sexually transmitted diseases
In sexually transmitted diseases, concomitant infection caused by T. pallidum should be excluded.
Neurological or psychiatric diseases
Azithromycin should be used with caution in patients with neurological or psychiatric disorders.
Information on excipients
The drug contains sucrose, so it should not be prescribed to patients with rare hereditary forms of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption syndrome.
5 ml of the 100 mg/5 ml and 200 mg/5 ml suspensions contain 3.81 g and 3.7 g of sucrose, respectively. This should be taken into account when administering the drug to patients with diabetes mellitus.
Aspartame is a derivative of phenylalanine, which is dangerous for people with phenylketonuria.
This medicinal product contains 18.4 mg/5 ml of trisodium phosphate anhydrous. Caution should be exercised when administering the product to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Pregnancy
There are no adequate data on the use of azithromycin in pregnant women. In animal reproductive toxicity studies, azithromycin did not show teratogenic effects on the fetus, but the drug crossed the placenta. The safety of azithromycin during pregnancy has not been confirmed. Therefore, azithromycin should be prescribed during pregnancy only if the benefit outweighs the risk.
Azithromycin has been reported to pass into human milk, but adequate and well-controlled clinical studies to characterize the pharmacokinetics of azithromycin excretion into human milk have not been conducted. Therefore, it is recommended to discontinue breastfeeding during treatment and for 2 days after the end of treatment.
Fertility
Fertility studies have been performed in rats; pregnancy rates were reduced following administration of azithromycin. The relevance of these findings to humans is unknown.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no evidence that azithromycin can impair the ability to drive or operate other mechanisms, but the possibility of developing adverse reactions such as dizziness, drowsiness, and visual disturbances should be taken into account.
Method of administration and doses
Dosage and duration of treatment are determined by the doctor. Take the suspension once a day 1 hour before or 2 hours after a meal, as simultaneous administration may impair the absorption of azithromycin.
The taste sensation after taking the suspension can be improved if you drink it with fruit juice. If one dose of the drug is missed, the next dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.
Adult patients (use azithromycin 200 mg/5 ml)
For infections of the ENT organs and respiratory tract, skin and soft tissues (except chronic migratory erythema), the total dose of azithromycin is 1500 mg: 500 mg once a day. The duration of treatment is 3 days.
For sexually transmitted infections caused by Chlamydia trachomatis, the dose is 1000 mg orally once.
In erythema migrans, the total dose of azithromycin is 3 g: on the 1st day, 1 g should be taken, then 500 mg 1 time per day from the 2nd to the 5th day. The duration of treatment is 5 days. Elderly patients.
There is no need to change the dosage for elderly people.
Since elderly patients may be at risk for cardiac conduction disorders, caution is recommended when using azithromycin due to the risk of developing cardiac arrhythmias and torsade de pointes.
Children
For infections of the ENT organs and respiratory tract, skin and soft tissues (except chronic migratory erythema), the total dose of azithromycin is 30 mg/kg body weight (10 mg/kg body weight 1 time per day). The duration of treatment is 3 days.
In erythema migrans, the total dose of azithromycin is 60 mg/kg: on the 1st day, 20 mg/kg of body weight should be taken, then 10 mg/kg of body weight 1 time per day from the 2nd to the 5th day. The duration of treatment is 5 days.
Azithromycin has been shown to be effective in the treatment of streptococcal pharyngitis in children at a single dose of 10 mg/kg or 20 mg/kg for 3 days. When these two doses were compared in clinical trials, similar clinical efficacy was found, although bacterial eradication was greater with the daily dose of 20 mg/kg. However, penicillin is usually the drug of choice for the prevention of pharyngitis caused by Streptococcus pyogenes and secondary rheumatoid arthritis.
Body weight from 5 to 15 kg (use azithromycin 100 mg/5 ml)
Depending on the child's body weight, the following dosage regimen is recommended.
Body weight
Daily dose of suspension
100 mg/5 ml
Azithromycin content in the daily dose of suspension
5 kg
2.5 ml
50 mg
6 kg
3 ml
60 mg
7 kg
3.5 ml
70 mg
8 kg
4 ml
80 mg
9 kg
4.5 ml
90 mg
10-14 kg
5 ml
100 mg
Body weight more than 15 kg (use azithromycin 200 mg/5 ml)
Depending on the child's body weight, the following dosage regimen is recommended.
Body weight
Daily dose of suspension
200 mg/5 ml
Azithromycin content in
daily dose of suspension
15-24 kg
5 ml
200 mg
25-34 kg
7.5 ml
300 mg
35-44 kg
10 ml
400 mg
≥ 45 kg
12.5 ml
500 mg
Kidney failure.
In patients with mild renal impairment (glomerular filtration rate 10-80 ml/min), the same dosage can be used as in patients with normal renal function. Azithromycin should be administered with caution to patients with severe renal impairment (glomerular filtration rate < 10 ml/min).
Liver failure.
Since azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with severe liver disease.
To prepare 20 ml of suspension (100 mg/5 ml or 200 mg/5 ml) you will need:
Shake the bottle thoroughly to separate the powder from the walls and bottom;
open the bottle cap and place the adapter into the bottle neck;
draw 10.5 ml of drinking water into a syringe (10 ml volume with 0.25 ml markings);
place the tip of the syringe into the adapter;
Add 10.5 ml of water from the syringe to the vial with the powder, shaking until a homogeneous suspension is obtained.
To prepare 30 ml of suspension (200 mg/5 ml) using the method described above, add 15 ml of drinking water to the vial.
SHAKE WELL BEFORE EACH USE.
shake the suspension;
place the tip of the syringe into the adapter;
turn the bottle upside down;
draw the required amount of suspension into the syringe;
Turn the bottle over to the correct position, remove the syringe and close the bottle with the cap.
Children.
The drug in a dosage of 100 mg/5 ml should be used in children weighing 5 to 15 kg.
The drug in a dosage of 200 mg/5 ml should be used in children weighing more than 15 kg and adult patients.
Overdose
Symptoms: reversible hearing loss, severe nausea, vomiting, diarrhea.
Treatment: gastric lavage, symptomatic and supportive therapy.
Side effects
The table below lists adverse reactions identified from clinical trials and post-marketing surveillance with all dosage forms of azithromycin, by system organ class and frequency.
Adverse reactions are classified according to the frequency of occurrence: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), including isolated cases, frequency unknown (cannot be estimated from the available data).
Adverse reactions possibly or probably related to azithromycin based on data obtained during clinical trials and during post-marketing surveillance.
