Capsules

Inside, 1 time per day, at least 1 hour before or 2 hours after meals.

Adults (including the elderly) and children over 12 years of age weighing over 45 kg

Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: 500 mg (2 caps.) 1 time per day for 3 days (course dose - 1.5 g).

Lyme disease (initial stage of borreliosis) - erythema migrans (erythema migrans): 1 time per day for 5 days: 1st day - 1 g (4 caps.), Then from the 2nd to the 5th day - 500 mg (2 caps.); course dose - 3 g.

Urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): uncomplicated urethritis / cervicitis - 1 g (4 caps.) Once.

Special patient groups

Impaired renal function. When used in patients with CI creatinine from 10 ml / min to 80 ml / min, dose adjustment is not required.

Liver dysfunction. When used and in patients with mild to moderate liver dysfunction, dose adjustment is not required.

Elderly patients. No dose adjustment is required. Since the elderly may already have current proarrhythmic conditions, caution should be exercised when using Sumamed® due to the high risk of developing cardiac arrhythmias, incl. arrhythmias of the "pirouette" type.

Film-coated tablets

Inside, without chewing, at least 1 hour before or 2 hours after meals, 1 time per day.

Adults and children over 12 years old weighing more than 45 kg

Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: 1 tab. (500 mg) once a day for 3 days; course dose - 1.5 g.

Acne vulgaris of moderate severity: 1 tab. (500 mg) 1 time per day for 3 days, then 1 table. (500 mg) once a week for 9 weeks; course dose - 6 g. The first weekly tablet should be taken 7 days after taking the first daily tablet (8th day from the start of treatment), the next 8 weekly tablets - with an interval of 7 days.

Lyme disease (the initial stage of borreliosis) - erythema migrans (erythema migrans): once a day for 5 days: on the 1st day - 1 g (2 tablets, 500 mg each), then from the 2nd to the 5th day - 1 table. (500 mg); course dose - 3 g.

Infections of the genitourinary tract caused by Chlamydia trachomatis (urethritis, cervicitis): uncomplicated urethritis / cervicitis - 1 g (2 tablets, 500 mg each) once.

Children from 3 to 12 years old weighing less than 45 kg

Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: the drug is prescribed at the rate of 10 mg / kg 1 time per day for 3 days; course dose - 30 mg / kg. For ease of dosing, it is recommended to use the table below.

Calculation of the dose of Sumamed® for children weighing less than 45 kg

Body weight, kg:	Dose of azithromycin tablets 125 mg
18–30	2 tab. (250 mg azithromycin)
31–44	3 tab. (250 mg azithromycin)
not less than 45	Doses recommended for adults

In children under 3 years of age, it is recommended to use Sumamed®, powder for oral suspension, 100 mg / 5 ml and Sumamed® forte, powder for oral suspension, 200 mg / 5 ml.

For pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed® is used at a dose of 20 mg / kg / day for 3 days; course dose 60 mg / kg. The maximum daily dose is 500 mg.

Lyme disease (the initial stage of borreliosis) - erythema migrans (erythema migrans): 20 mg / kg once a day on the 1st day, then at the rate of 10 mg / kg once a day from the 2nd to the 5th day ... For ease of use in children of a course dose of 60 mg / kg, it is recommended to take the drug Sumamed®, powder for preparation of suspension for oral administration, 100 mg / 5 ml and Sumamed® forte, powder for preparation of suspension for oral administration, 200 mg / 5 ml.

Special patient groups:

Impaired renal function. When used in patients with mild to moderate renal impairment (Cl creatinine more than 40 ml / min), dose adjustment is not required.

Liver dysfunction. When used in patients with mild to moderate liver dysfunction, dose adjustment is not required.

Elderly patients. No dose adjustment is required. Since the elderly may already have current proarrhythmic conditions, caution should be exercised when using Sumamed® due to the high risk of developing cardiac arrhythmias, incl. arrhythmias of the "pirouette" type.

Application during pregnancy and lactation:

During pregnancy and during breastfeeding, it is used only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

If it is necessary to use the drug during breastfeeding, it is recommended to suspend breastfeeding.

Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug;

severe liver failure (Child-Pugh class C);

severe liver dysfunction (film-coated tablets, 125 and 500 mg);

severe renal impairment (Cl creatinine <40 ml / min);

children up to age 3 (film-coated tablets, 125 mg) or 12 years with a body weight of up to 45 kg (capsules and film-coated tablets, 500 mg);

simultaneous reception with ergotamine and dihydroergotamine.

With care: myasthenia gravis; mild to moderate liver dysfunction; mild to moderate renal impairment (Cl creatinine> 40 ml / min); the presence of proarrhythmogenic factors (especially in elderly patients): congenital or acquired prolongation of the QT interval, therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (antidepressants) ), fluoroquinolones (moxifloxacin and levofloxacin), imbalance in water and electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporin.

The incidence of side effects is classified in accordance with the WHO recommendations: very often (at least 10%); often (at least 1%, but less than 10%); infrequently (not less than 0.1%, but less than 1%); rarely (not less than 0.01%, but less than 0.1%); very rarely (less than 0.01%); frequency unknown - cannot be estimated from available data.

Infectious diseases: infrequently - candidiasis, incl. oral mucosa and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; frequency unknown - pseudomembranous colitis.

Blood and lymphatic system disorders: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

From the side of metabolism and nutrition: infrequently - anorexia.

Allergic reactions: infrequently - angioedema, hypersensitivity reactions; frequency unknown - anaphylactic reactions.

From the nervous system: often - headache; infrequently - dizziness, disturbance of taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; the frequency is unknown - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste, myasthenia gravis, delirium, hallucinations.

From the side of the organ of vision: infrequently - visual impairment.

On the part of the organ of hearing and labyrinth disorders: infrequently - hearing disorder, vertigo; frequency unknown - hearing impairment, incl. deafness and / or tinnitus.

From the CCC: infrequently - a feeling of palpitations, flushing of the face; the frequency is unknown - a decrease in blood pressure, an increase in the QT interval on the ECG, arrhythmia of the "pirouette" type, ventricular tachycardia.

From the respiratory system: infrequently - shortness of breath, epistaxis.

From the gastrointestinal tract: very often - diarrhea; often - nausea, vomiting, abdominal pain; infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - discoloration of the tongue, pancreatitis.

From the liver and biliary tract: infrequently - hepatitis; rarely - liver dysfunction, cholestatic jaundice; frequency unknown - liver failure (in rare cases with fatal outcome, mainly against the background of severe liver dysfunction); liver necrosis, fulminant hepatitis.

On the part of the skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity reaction; frequency unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

From the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; frequency unknown - arthralgia.

From the side of the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; frequency unknown - interstitial nephritis, acute renal failure.

From the genitals and mammary gland: infrequently - metrorrhagia, dysfunction of the testicles.

Others: infrequently - asthenia, malaise, fatigue, facial edema, chest pain, fever, peripheral edema.

Laboratory data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease in the concentration of bicarbonates in the blood plasma; infrequently - an increase in the activity of AST, ALT, an increase in the concentration of bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the content of potassium in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the content of chlorine in the blood plasma, an increase in the concentration of glucose in the blood, an increase in the number of platelets, an increase in hematocrit, an increase in the concentration of bicarbonates in the blood plasma, a change in the sodium content in the blood plasma.

Antacids

Antacids do not affect the bioavailability of azithromycin, but reduce the Cmax in the blood by 30%, so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food.

Cetirizine

Simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction and a significant change in the QT interval.

Didanosine (dideoxyinosine)

The simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected patients did not reveal any changes in the pharmacokinetic indications of didanosine compared with the placebo group.

Digoxin (P-glycoprotein substrates)

Simultaneous use of macrolide antibiotics, incl. azithromycin, with P-glycoprotein substrates such as digoxin, leads to an increase in the serum P-glycoprotein substrate concentration. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.

Zidovudine

The simultaneous use of azithromycin (a single dose of 1000 mg and multiple doses of 1200 or 600 mg) has little effect on pharmacokinetics, incl. renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear.

Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It has not been revealed that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes.

Ergot alkaloids

Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with derivatives of ergot alkaloids is not recommended.

Pharmacokinetic studies of the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system were carried out.

Atorvastatin

The simultaneous use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in plasma concentrations of atorvastatin (based on the analysis of HMG-CoA reductase inhibition). However, in the post-registration period, there were separate reports of cases of rhabdomyolysis in patients receiving both azithromycin and statins.

Carbamazepine

Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the concentration of carbamazepine and its active metabolite in the blood plasma in patients who received azithromycin at the same time.

Cimetidine

In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected, provided that cimetidine was used 2 hours before azithromycin.

Indirect anticoagulants (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin taken by healthy volunteers. It was reported about the potentiation of the anticoagulant effect after the simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, consideration should be given to the need for frequent PT monitoring when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).

Cyclosporine

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg / day once) and then cyclosporine (10 mg / kg / day once) orally for 3 days, a significant increase in Cmax in blood plasma and AUC0-5 of cyclosporine was found ... Caution should be exercised with the simultaneous use of these drugs. If it is necessary to simultaneously use these drugs, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.

Efavirenz

The simultaneous use of azithromycin (600 mg / day once) and efavirenz (400 mg / day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.

Fluconazole

The simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1 / 2 of azithromycin did not change with the simultaneous use of fluconazole, however, a decrease in the Cmax of azithromycin (by 18%) was observed, which had no clinical significance.

Indinavir

The simultaneous use of azithromycin (1200 mg once) did not have a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times a day for 5 days).

Methylprednisolone

Azithromycin does not significantly affect the pharmacokinetics of methylprednisolone.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the Css of azithromycin in the blood serum. No clinically significant side effects were observed, and dose adjustment of azithromycin when used simultaneously with nelfinavir is not required.

Rifabutin

The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the serum. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.

Sildenafil

When used in healthy volunteers, there was no evidence of the effect of azithromycin (500 mg / day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.

Terfenadine

In pharmacokinetic studies, there was no evidence of an interaction between azithromycin and terfenadine. Isolated cases were reported where the possibility of such an interaction could not be completely ruled out, however, there was no concrete evidence that such an interaction took place. It was found that the simultaneous use of terfenadine and macrolides can cause arrhythmias and prolongation of the QT interval.

Theophylline

There was no interaction between azithromycin and theophylline.

Triazolam / Midazolam

Significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses have not been identified.

Trimethoprim / sulfamethoxazole

The simultaneous use of trimethoprim / sulfamethoxazole with azithromycin did not reveal a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: symptomatic.