How to take the antibiotic sumamed in the treatment of bacterial and viral diseases of various etiologies. Sumamed ® indications for use

Country of origin

Product group

Antibiotic of the macrolide group - azalide

Release forms

• 16.74 g - polyethylene bottle with a volume of 50 ml (1 piece) complete with a double-sided dosing spoon and/or dosage syringe - cardboard packs 17 g - dark glass bottles with a volume of 50 ml (1 piece) complete with a double-sided measuring spoon (for 2.5 and 5 ml) and/or dosage syringe (5 ml) - cardboard packs. 29.295 g (30 ml) - 100 ml high-density polyethylene bottle (1 pc) complete with a double-sided measuring spoon and dosing syringe - cardboard packs 29.295 g (30 ml) - 100 ml high-density polyethylene bottles (1 pc) complete with a double-sided measuring spoon and a dosing syringe - cardboard packs Capsules of 250 mg - 6 pcs per pack. Dispersible tablets, 1g - 1 piece per pack. Dispersible tablets, 1g - 3 pcs per pack. Film-coated tablets 125 mg - 6 pcs per pack. Film-coated tablets 500 mg - 3 pcs per pack. Colorless glass bottles (5) - cardboard packs. Colorless glass bottles (5) - cardboard packs.

Description of the dosage form

• Hard gelatin capsules, No. 1, with a blue body and a blue cap; the contents of the capsules are powder or compacted mass from white to light yellow, disintegrating when pressed. Lyophilisate for the preparation of a solution for infusion in the form of a powder or compacted white mass. Lyophilisate for the preparation of a solution for infusion in the form of a powder or compacted white mass. Powder for the preparation of a suspension for oral administration, granular, white or light yellow in color, with a characteristic odor of banana and cherry; the prepared aqueous suspension is homogeneous, light yellow in color, with a characteristic odor of banana and cherry. Powder for the preparation of a suspension for oral administration, granular, white or light yellow in color, with a characteristic strawberry odor; the prepared aqueous suspension is white or light yellow in color, homogeneous, with a characteristic strawberry odor. Powder for the preparation of a suspension for oral administration, granular, from white to light yellow in color, with a characteristic odor of cherry and banana; after dissolution in water - a homogeneous suspension from white to light yellow in color, with a characteristic odor of cherry and banana. Powder for the preparation of a suspension for oral administration, granular, from white to light yellow in color, with a characteristic odor of cherry and banana; after dissolution in water - a homogeneous suspension from white to light yellow in color, with a characteristic odor of cherry and banana. Dispersible tablets are white or almost white, round, flat, with beveled edges, with two perpendicular lines on one side and the inscription “TEVA 1000” embossed on the other side. Blue film-coated tablets, round, biconvex, engraved “PLIVA” on one side and “125” on the other; at the fracture - from white to almost white. Blue film-coated tablets, oval, biconvex, engraved with "PLIVA" on one side and "500" on the other; at the fracture - from white to almost white.

pharmachologic effect

Pharmacokinetics

Special conditions

Compound

• 1 g 5 ml ready-made suspension. azithromycin (in the form of dihydrate) 27.17 mg 100 mg Excipients: sucrose, sodium carbonate anhydrous, sodium benzoate, tragacanth, titanium dioxide, glycine, colloidal silicon dioxide, strawberry flavor, apple flavor, peppermint flavor. 1 g azithromycin dihydrate 50.094 mg, which corresponds to the content of azithromycin 47.79 mg Excipients: sucrose - 897.206 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, xanthan gum - 1.6 mg, cherry flavor J7549 - 4.5 mg, banana flavor 78 701- 31 - 7.5 mg, vanilla flavor D-125038 - 10.5 mg, colloidal silicon dioxide - 7 mg. 1 caps. azithromycin dihydrate 262.5 mg, which corresponds to the content of azithromycin 250 mg Excipients: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Composition of hard gelatin capsule No. 1: gelatin, titanium dioxide (E171), indigo carmine. 1 tab. Azithromycin dihydrate 131.027 mg, which corresponds to the content of azithromycin 125 mg Excipients: anhydrous calcium hydrogen phosphate, hypromellose, corn starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Shell composition: hypromellose, indigo carmine dye (E132), titanium dioxide (E171), polysorbate 80, talc 1 g azithromycin dihydrate 50.094 mg, which corresponds to the content of azithromycin 47.79 mg Excipients: sucrose - 897.206 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, xanthan gum - 1.6 mg, cherry flavor J7549 - 4.5 mg, banana flavor 78701-31 - 7.5 mg, vanilla flavor D-125038 - 10.5 mg, colloidal silicon dioxide - 7 mg. 1 tab. Azithromycin dihydrate 524.109 mg, which corresponds to the content of azithromycin 500 mg Excipients: anhydrous calcium hydrogen phosphate, hypromellose, corn starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Shell composition: hypromellose, indigo carmine dye (E132), titanium dioxide (E171), polysorbate 80, talc. 1 tab. azithromycin dihydrate 1048.218 mg, which corresponds to the content of azithromycin 1000 mg Excipients: sodium saccharinate dihydrate - 78 mg, microcrystalline cellulose (Avicel PH 101) - 39.782 mg, microcrystalline cellulose (Avicel PH 102) - 657.6 mg, crospovidone type A - 165.2 mg , povidone K30 - 44 mg, sodium lauryl sulfate - 6.4 mg, colloidal silicon dioxide - 8.8 mg, magnesium stearate - 22 mg, orange flavor - 52 mg, aspartame - 78 mg. azithromycin (in dihydrate form) 200 mg Excipients: sucrose, sodium phosphate anhydrous, hydroxypropylcellulose, xanthan gum, cherry flavor J7549, banana 78701-31, vanilla D-125038, colloidal silicon dioxide. Azithromycin dihydrate 524.1 mg, which corresponds to the content of azithromycin 500 mg Excipients: citric acid monohydrate, sodium hydroxide q.s.

Sumamed indications for use

• Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and ENT organs (pharyngitis/tonsillitis, sinusitis, otitis media); - lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens); - diseases of the stomach and duodenum associated with Helicobacter pylori (for powder); - infections of the skin and soft tissues (moderate acne, erysipelas, impetigo, secondary infected dermatoses); - the initial stage of Lyme disease (borreliosis) - erythema migrans; - urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Sumamed contraindications

• - severe dysfunction of the liver and kidneys; - lactation period (breastfeeding); - simultaneous use with ergotamine and dihydroergotamine; - increased sensitivity to macrolide antibiotics; - children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg); - children under 3 years of age (for tablets 125 mg). The drug should be prescribed with caution in case of moderate impairment of liver and kidney function, in patients with disorders or predisposition to arrhythmias and prolongation of the QT interval, together with terfenadine, warfarin, digoxin.

Sumamed dosage

• 100 mg/5 ml 125 mg 200 mg/5 ml 200 mg/5 ml 250 mg 500 mg

Sumamed side effects

• The incidence of side effects is classified according to WHO recommendations: very often (at least 10%); often (at least 1%, but less than 10%); infrequently (at least 0.1%, but less than 1%); rare (not less than 0.01%, but less than 0.1%); very rare (less than 0.01%, including isolated cases). Infectious diseases: uncommon - candidiasis, incl. mucous membrane of the oral cavity and genitals; very rarely - pseudomembranous colitis. Metabolism and nutrition: often - anorexia. Allergic reactions: often - skin itching, skin rash; uncommon - hypersensitivity reactions, photosensitivity reaction, urticaria, Stevens-Johnson syndrome, angioedema; very rarely - anaphylactic reaction, erythema multiforme, toxic epidermal necrolysis. From the blood and lymphatic system: often - eosinophilia, lymphopenia; uncommon - leukopenia, neutropenia; very rarely - thrombocytopenia, hemolytic anemia. From the nervous system: often - headache, dizziness, paresthesia, disturbance of taste; infrequently - hypoesthesia, drowsiness, insomnia; very rarely - anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell (or anosmia) and taste, myasthenia gravis, anxiety. From the side of the organ of vision: often - blurred vision. From the organ of hearing and labyrinthine disorders: often - deafness; infrequently - tinnitus; rarely - vertigo. From the cardiovascular system: infrequently - palpitations; very rarely - decreased blood pressure, increased QT interval, pirouette-type arrhythmia, ventricular tachycardia. From the gastrointestinal tract: very often - nausea, flatulence, abdominal pain, diarrhea; often - dyspepsia, vomiting; infrequently - constipation, gastritis; very rarely - change in tongue color, pancreatitis. From the liver and biliary tract: infrequently - increased activity of liver transaminases, increased bilirubin concentration, hepatitis; rarely - liver dysfunction; very rarely - cholestatic jaundice, liver failure (in rare cases with death, mainly due to severe liver dysfunction); liver necrosis, fulminant hepatitis. From the musculoskeletal system and connective tissue: often - arthralgia. From the kidneys and urinary tract: infrequently - increased concentrations of urea and creatinine in the blood plasma; very rarely - interstitial nephritis, acute renal failure. Other: often - weakness; uncommon - chest pain, peripheral edema, asthenia, malaise, changes in potassium concentration.

Drug interactions

Overdose

Storage conditions

• store in a dry place
• store at room temperature 15-25 degrees
• keep away from children

Synonyms

• Azithromycin, Zitrolide, Sumazid, Hemomycin

Sumamed (INN azithromycin) is an antibiotic that became the founder of the macrolide-azalide group. Losing to erythromycin in the severity of the effect on gram-positive microorganisms, it makes up for lost time in relation to other bacteria, primarily Mycoplasma pneumoniae. It is a bacteriostatic, and in high concentrations exhibits bactericidal properties. The mechanism of action is to suppress protein synthesis in bacterial cells determined by RNA. After administration, the drug is quickly absorbed from the digestive tract and accumulates in fibroblasts, which in this case act as reservoirs that release azithromycin for phagocytes. The latter are carriers of the antibiotic to the infectious focus. It has a wide therapeutic range, covering gram-positive and gram-negative anaerobic microorganisms. Resistance to azithromycin in bacteria may be present initially or developed over time. The pronounced antimicrobial effect of Sumamed is largely ensured by its ability to accumulate in tissues, where its content is an order of magnitude higher than the concentration in the blood. This feature of azithromycin allows you to reduce the frequency of its administration: it is enough to take the drug once a day for three days to effectively suppress the growth and development of most sensitive microorganisms. It is important that azithromycin acts directly in areas of greatest concentration of pathogens. Among the “targets” of the drug, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus parainfluenzae, Haemophilus influenzae, Moraxella catarrhalis, Legionella pneumophila, Pasteurella multocida, Fusobacterium spp. should be noted.

Clostridium perfringens, Porphyromonas spp., Prevotella spp, Chlamydia psittaci, Chlamydia pneumoniae, Chlamydia trachomatis, Neisseria gonorrhoeae, Borrelia burgdorferi. The already noted ease of administration and the breadth of the therapeutic range have made Sumamed one of the most popular antibacterial agents among doctors of various profiles. The drug is widely used for the treatment of ENT diseases of a bacterial nature (sinusitis, tonsillitis, pharyngitis). Sumamed is effective for pathologies of the respiratory tract - bronchitis and community-acquired pneumonia, since its spectrum of action covers both typical pathogens of respiratory tract infections (Haemophilus influenzae, pneumococcus) and atypical ones (mycoplasma, chlamydia). Sumamed is a reliable remedy for the treatment of skin diseases - secondary pyoderma, impetigo, erythema migrans. Due to sensitivity to azithromycin from chlamydia, neisseria and mycoplasma, the drug is used for the treatment of sexually transmitted diseases. Due to the availability of Sumamed in a variety of dosages and dosage forms (dispersible and regular tablets, powders, capsules, lyophilisates), the drug can be used in a wide range of age categories, incl. in pediatric practice.

Pharmacology

Bacteriostatic antibiotic of the macrolide-azalide group. Has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis in microbial cells. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.

It is active against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms.

Microorganisms may initially be resistant to the action of the antibiotic or may acquire resistance to it.

Scale of sensitivity of microorganisms to azithromycin (MIC, mg/l)

In most cases, the drug Sumamed ® is active against aerobic gram-positive bacteria: Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes; aerobic gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic bacteria: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp.; other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms that can develop resistance to azithromycin: gram-positive aerobes - Streptococcus pneumoniae (penicillin-resistant strains).

Initially resistant microorganisms: gram-positive aerobes - Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant strains of staphylococcus exhibit a very high degree of resistance to macrolides); gram-positive bacteria resistant to erythromycin; anaerobes - Bacteroides fragilis.

Pharmacokinetics

Suction

After oral administration, azithromycin is well absorbed and quickly distributed in the body. After a single dose of 500 mg, bioavailability is 37% due to the “first pass” effect through the liver. Cmax in blood plasma is reached after 2-3 hours and is 0.4 mg/l.

Distribution

Protein binding is inversely proportional to plasma concentration and ranges from 7-50%. The apparent Vd is 31.1 l/kg. Penetrates through cell membranes (effective against infections caused by intracellular pathogens). Transported by phagocytes to the site of infection, where it is released in the presence of bacteria. Easily penetrates histohematic barriers and enters tissues. The concentration in tissues and cells is 10-50 times higher than in plasma, and at the site of infection it is 24-34% higher than in healthy tissues.

Metabolism

In the liver it is demethylated, losing activity.

Removal

T 1/2 is long - 35-50 hours. T 1/2 from fabrics is much longer. The therapeutic concentration of azithromycin lasts up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% through the intestines, 6% by the kidneys.

Release form

Hard gelatin capsules, No. 1, with a blue body and a blue cap; the contents of the capsules are powder or compacted mass from white to light yellow, disintegrating when pressed.

Excipients: microcrystalline cellulose - 43.95 mg, sodium lauryl sulfate - 1.4 mg, magnesium stearate - 12.6 mg.

Composition of hard gelatin capsule No. 1*: (gelatin - q.s., titanium dioxide (E171) - q.s., indigo carmine - q.s.) - 75 mg.

* - capsules contain sulfur dioxide 200 ppm as a preservative.

6 pcs. - blisters (1) - cardboard packs.

Dosage

The drug is prescribed orally 1 time/day, at least 1 hour before or 2 hours after meals.

Tablets and capsules

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

For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at a dose of 500 mg 1 time / day for 3 days, course dose - 1.5 g.

For migratory erythema, the drug is prescribed 1 time/day for 5 days: on day 1 - 1 g, then from days 2 to 5 - 500 mg; course dose - 3 g.

Urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): for uncomplicated urethritis/cervicitis, the drug is prescribed in a dose of 1 g once.

For acne vulgaris of moderate severity, the drug is prescribed in tablets at a dose of 500 mg once a day for 3 days, then 500 mg once a week for 9 weeks. The course dose is 6 g. The first weekly dose should be taken 7 days after taking the first daily dose (8th day from the start of treatment), the next 8 weekly doses should be taken at intervals of 7 days.

Children aged 3 to 12 years with body weight<45 кг

For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at the rate of 10 mg/kg body weight 1 time/day for 3 days, course dose - 30 mg/kg. The drug in the form of 125 mg tablets is dosed taking into account the child’s body weight, as presented in Table 1.

Table 1.

In the initial stage of Lyme disease (borreliosis) - erythema migrans - prescribed on the 1st day at a dose of 20 mg/kg 1 time/day, then from days 2 to 5 - at a rate of 10 mg/kg 1 time/ days The course dose is 60 mg/kg.

The tablets should be taken without chewing.

For ease of use in children of a course dose of 60 mg/kg, it is recommended to use Sumamed ® in powder form for the preparation of an oral suspension of 100 mg/5 ml and Sumamed ® forte in powder form for the preparation of an oral suspension of 200 mg/5 ml.

Oral suspension

Prescribed to children aged 6 months to 3 years.

The required dose is measured using a syringe or measuring spoon included in the package with the drug: for children weighing up to 15 kg, a syringe is used, for children weighing more than 15 kg, a measuring spoon is used.

For 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/day for 3 days (course dose 30 mg/kg). The calculation scheme is presented in Table 2.

Table 2. Calculation of the required amount of the drug when prescribed at a dose of 10 mg/kg

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

In the initial stage of Lyme disease (borreliosis) - erythema migrans, the drug is prescribed on the 1st day at a dose of 20 mg/kg/day, then from the 2nd to the 5th day - daily at a dose of 10 mg/kg/day. The course dose is 60 mg/kg.

Rules for the preparation and dosage of suspension for oral administration

To the contents of the bottle intended for the preparation of 20 ml of suspension (nominal volume), add 12 ml of water using a dosing syringe and shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 25 ml, which exceeds the nominal volume by approximately 5 ml. This is provided to compensate for the inevitable losses of suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 5 days.

Before each dose of the drug, the contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained. If the required volume of suspension was not taken from the bottle within 20 minutes after shaking, the suspension should be shaken again, the required volume should be taken and given to the child. The required volume of suspension is taken from the bottle using a syringe or measuring spoon. Immediately after taking the suspension, the child is given a few sips of water to drink so that he can swallow the remaining amount of the suspension in the mouth.

After use, the syringe (after disassembling it) and the measuring spoon are washed with running water, dried and stored in a dry place until the next dose of the drug.

For adults and children with mild to moderate renal impairment (creatinine clearance >40 ml/min), no dose adjustment of Sumamed ® is required.

For adults and children with mild to moderate liver dysfunction, no dose adjustment of Sumamed ® is required.

In elderly patients, no dose adjustment of Sumamed ® is required. Since this category of patients may have proarrhythmogenic conditions, Sumamed ® should be used with caution due to the high risk of developing arrhythmias, incl. ventricular arrhythmia of the "pirouette" type.

Overdose

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

Treatment: symptomatic therapy.

Interaction

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

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

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

Simultaneous use of macrolide antibiotics, incl. azithromycin, with P-glycoprotein substrates such as digoxin, leads to increased concentrations of P-glycoprotein substrate in the blood serum. 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.

The simultaneous use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has a minor 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 fact is unclear.

Azithromycin interacts weakly with isoenzymes of the cytochrome P450 system. Azithromycin has not been shown to participate in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or inducer of cytochrome P450 isoenzymes.

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

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

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on an HMC-CoA reductase inhibition assay). However, in the post-marketing period, isolated case reports of rhabdomyolysis have been received in patients receiving concomitant azithromycin and statins.

Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.

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

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of warfarin when taken in a single dose of 15 mg in healthy volunteers. Potentiation of the anticoagulant effect has been reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days, and then cyclosporine (10 mg/kg/day once), a significant increase in plasma Cmax and AUC was detected. 5 cyclosporine. Caution is required with this combination. If concomitant use of these drugs is necessary, plasma concentrations of cyclosporine should be monitored and the dose adjusted accordingly.

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

Concomitant 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 simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance.

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

Azithromycin does not have a significant effect on the pharmacokinetics of methylprednisolone.

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in C ss of azithromycin in the blood plasma. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.

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

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.

In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction occurred. It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.

No interaction has been detected between azithromycin and theophylline.

No significant changes in pharmacokinetic parameters were detected with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.

When trimethoprim/sulfamethoxazole was co-administered with azithromycin, there was no significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those found in other studies.

Side effects

Tablets and capsules

Determination of the frequency of adverse reactions (according to WHO recommendations): very often (≥10%), often (≥1% -<10%), нечасто (≥0.1%-<1%), редко (≥0.01%-<0.1%), очень редко (<0.01%), частота неизвестна (невозможно оценить на основании имеющихся данных).

Infectious diseases: infrequently - candidiasis (including the mucous membrane of the oral cavity and genitals), pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; frequency unknown - pseudomembranous colitis.

From the hematopoietic system: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

From the side of metabolism: infrequently - anorexia.

Allergic reactions: uncommon - urticaria, angioedema, hypersensitivity reaction; frequency unknown - anaphylactic reaction.

From the nervous system: often - headache; infrequently - dizziness, disturbance of taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; frequency unknown - hypoesthesia, 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.

From the organ of hearing and labyrinthine disorders: infrequently - hearing loss, vertigo; frequency unknown - hearing impairment up to deafness and/or tinnitus.

From the cardiovascular system: infrequently - palpitations, flushing of the face; frequency unknown - decreased blood pressure, increased QT interval on ECG, pirouette-type arrhythmia, ventricular tachycardia.

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

From the digestive system: very often - diarrhea; often - nausea, vomiting, abdominal pain; uncommon - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - change in tongue color, pancreatitis.

From the liver and biliary tract: infrequently - hepatitis; rarely - impaired liver function, cholestatic jaundice; frequency unknown - liver failure (in rare cases with death, mainly due to severe liver dysfunction), liver necrosis, fulminant hepatitis.

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

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

From the urinary system: infrequently - dysuria, pain in the kidney area; frequency unknown - interstitial nephritis, acute renal failure.

From the reproductive system: infrequently - metrorrhagia, dysfunction of the testicles.

Other: infrequently - asthenia, malaise, feeling of fatigue, facial swelling, chest pain, fever, peripheral edema.

Laboratory data: often - lymphopenia, eosinophilia, basophilia, monocytophilia, neutrophilia, decrease or increase in the concentration of bicarbonates in the blood plasma; increased activity of AST, ALT, increased concentrations of bilirubin, urea and creatinine in the blood plasma, changes in the potassium content in the blood plasma, increased activity of alkaline phosphatase, increased chlorine content in the blood plasma, increased concentrations of glucose in the blood plasma, increased platelet count, increased hematocrit, change sodium content in the blood.

Powder for preparing suspension

Classification of adverse reactions by frequency of development (number of reported cases/number of patients): often (>1/100 and<1/10), нечасто (>1/1000 and<1/100), редко (>1/10,000 and<1/1000), очень редко (<1/10 000).

From the hematopoietic system: rarely - thrombocytopenia, neutropenia, eosinophilia.

From the side of the central nervous system: infrequently - dizziness/vertigo, headache, convulsions, drowsiness; rarely - paresthesia, asthenia, insomnia, increased excitability, aggressiveness, anxiety, nervousness.

From the senses: rarely - tinnitus, reversible hearing loss up to deafness (when taking high doses for a long time), impaired perception of taste and smell.

From the cardiovascular system: rarely - palpitations, arrhythmia, ventricular tachycardia, increased QT interval, bidirectional ventricular tachycardia.

From the digestive system: often - nausea, vomiting, diarrhea, abdominal pain/spasms; infrequently - loose stools, flatulence, indigestion, anorexia; rarely - constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function; very rarely - liver dysfunction, liver necrosis (possibly fatal).

Allergic reactions: infrequently - itching, skin rashes; rarely - urticaria, photosensitivity, angioedema, anaphylactic reaction (in rare cases fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the musculoskeletal system: infrequently - arthralgia.

From the urinary system: rarely - interstitial nephritis, acute renal failure.

Other: rarely - vaginitis, candidiasis.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infections of the upper respiratory tract and ENT organs (pharyngitis/tonsillitis, sinusitis, otitis media);
• lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);
• infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);
• moderate acne vulgaris (for tablets);
• the initial stage of Lyme disease (borreliosis) - erythema migrans;
• urinary tract infections (urethritis, cervicitis) caused by Chlamydia trachomatis (for tablets and capsules).

Contraindications

• hypersensitivity to the components of the drug;
• hypersensitivity to erythromycin, other macrolide antibiotics or ketolides;
• severe liver dysfunction (class C on the Child-Pugh scale);
• severe renal dysfunction (CK<40 мл/мин);
• simultaneous use with ergotamine and dihydroergotamine;
• children under 12 years of age with body weight<45 кг (для капсул и таблеток 500 мг);
• children under 3 years of age (for tablets 125 mg);
• children under 6 months of age (for powder for suspension preparation).

Carefully:

Myasthenia; mild to moderate liver dysfunction; mild to moderate renal dysfunction (creatinine clearance >40 ml/min); in patients with the presence of proarrhythmogenic factors (especially in old age) - with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with water and electrolyte imbalance, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, arrhythmia or severe heart failure; with simultaneous use of digoxin, warfarin, cyclosporine.

Features of application

Use during pregnancy and breastfeeding

During pregnancy, the use of the drug is possible only if the expected potential benefit of therapy for the mother outweighs the possible risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be suspended.

Use for liver dysfunction

Use for renal impairment

Use in children

Contraindicated: children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg); children up to 3 years of age (for tablets 125 mg; children up to 6 months (for powder for preparing a suspension).

special instructions

If you miss one dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

Sumamed ® should be used with caution in patients with impaired liver function due to the possibility of developing fulminant hepatitis and severe liver failure. If there are symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, darkening of urine, tendency to bleeding, hepatic encephalopathy, therapy with Sumamed ® should be stopped and a study of the functional state of the liver should be performed.

In case of moderate renal dysfunction (creatinine clearance > 40 ml/min), therapy with Sumamed ® should be carried out with caution under monitoring the state of renal function.

As with the use of other antibacterial drugs, during therapy with Sumamed ® patients should be regularly examined for the presence of non-susceptible microorganisms and signs of the development of superinfections, incl. fungal.

The drug Sumamed ® should not be used for longer courses than indicated in the instructions, because The pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.

There is no data on a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism with the simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is contraindicated.

With long-term use of the drug Sumamed ®, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis, is possible. If antibiotic-associated diarrhea develops while taking the drug Sumamed ® , as well as 2 months after the end of therapy, pseudomembranous colitis caused by Clostridium difficile should be excluded.

When treated with macrolides, incl. azithromycin, there was a prolongation of cardiac repolarization and QT interval, increasing the risk of developing cardiac arrhythmias, including torsade de pointes, which can lead to cardiac arrest.

The use of the drug Sumamed ® can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

When used in patients with diabetes mellitus, as well as in patients on a low-calorie diet, it is necessary to take into account that the powder for preparing the Sumamed ® suspension contains sucrose as an excipient (3.88 g in every 5 ml).

Impact on the ability to drive vehicles and operate machinery

With the development of undesirable effects on the nervous system and organ of vision, patients should be careful when performing actions that require increased concentration and speed of psychomotor reactions.

– the main active ingredient Sumamed ® is a broad-spectrum antibacterial agent. Depending on the concentration in the infectious focus, the drug can exhibit both bacteriostatic and bactericidal mechanisms of action. Azithromycin (Sumamed ®) is a representative of the azalide subclass, part of the group of macrolide antibiotics.

The effectiveness of the antimicrobial action is determined by its ability to bind 50-S ribosomal subunits, inhibiting bacterial peptide translocases and preventing protein synthesis, suppressing the processes of growth and division of microbes.

Sumamed ® has a high degree of tissue binding and low concentrations in blood plasma elements. Due to this, the antibiotic is removed from the body longer and has a prolonged effect, maintaining effective bactericidal concentrations in the affected organs and tissues for a long time.

Sumamed ® is excreted from the body unchanged in urine and bile for up to seven days.

Pharmacological group

Azalide-macrolide antibiotics.

Is Sumamed ® an antibiotic or not?

Sumamed ® - release form and prices

The manufacturer of sumamed is the Israeli pharmaceutical company Pliva Hrvatska d.o.o ®.

The price of an antibiotic in Russian pharmacies is about:

• 280 rubles per bottle of suspension of one hundred milligrams in 5 ml;
• 430 rub. for 6 tablets of 125 mg;
• 580 rubles per pack of 3 tablets. 500 mg or 6 caps. 250 mg each;
• 690 rub. per bottle of Forte suspension (200 mg in 5 ml);
• 1300 rubles – three tables. 1000 mg each (dispersible tablets);
• 1750 rubles for 5 bottles. With lyophilisate for the preparation of 500 mg infusion solution.

Sumamed ® recipe in Latin

Rp: Sumamedi 0.25.
D.t. d. N. 5 in tab.
D.S. 1 tablet each. once a day an hour before meals.

Composition of the drug Sumamed ®

In the table, in addition to the content of the main active component of azithromycin dihydrate in a dosage of 0.125 or 0.5 grams, the presence of additional ingredients is also indicated: anhydrous dibasic Ca phosphate, corn and modified starch, microcrystalline cellulose, sodium lauryl sulfate, Mg stearate, talc, polysorbate eighty, etc. d.

Capsules containing 0.25 grams of azithromycin indicate the content of gelatin, sulfur dioxide, indigo carmine, titanium dioxide, sodium lauryl sulfate and microcrystalline cellulose.

The instructions for use of children's Sumamed ® indicate that suspensions of 100 milligrams of antibiotic in five milliliters, as well as the Forte form (200 mg in 5 ml) additionally contain sucrose, xanthan copper, flavorings, etc.

Vials with lyophilisate contain 0.5 grams of azithromycin in the form of dihydrate, citric acid in the form of monohydrate, and sodium hydroxide.

What does the medicine Sumamed ® help with?

Azithromycin has a wide range of antimicrobial effects and is active against most intra- and extracellular pathogens. Its spectrum of action includes chlamydia, mycoplasma, legionella, streptococcus and staphylococcus, hemolytic bacillus, moraxella, bordetella, ureaplasma, treponema, etc.

When prescribing the drug, it is necessary to take into account the possibility of cross-resistance to the drug: -, - and enterococci.

Azithromycin does not work against strains that are resistant to erythromycin drugs.

Pharmacodynamics

Azithromycin has higher bioavailability and complete absorption in the gastrointestinal tract than erythromycin. Rapid and complete absorption when taken orally is due to the high lipophilicity of the antibiotic and its acid resistance. Plasma concentrations reach their maximum three hours after taking the drug.

The most effective indicators of azithromycin are observed in the respiratory tract, genitourinary system, skin and gastrointestinal tract. Good accumulation in tissues and a prolonged effect are due to the low binding of the macrolide to plasma elements of the blood. Also, the specific features of azithromycin include its ability to penetrate eukaryotic cells and accumulate in low pH environments surrounding lysosomes. This distribution of the drug determines its high effectiveness in the fight against intracellular pathogens.

Azithromycin is delivered to the site of the inflammatory process by phagocytes, then the antibiotic is released during the process of phagocytosis. An important feature of the drug is that after its release from phagocytes in the infectious focus, under the influence of bacterial stimuli, the phagocytes recapture unutilized antibiotic residues. However, it does not have a significant effect on the basic functions of phagocytes.

It should also be noted that the degree of accumulation of azithromycin in tissues is determined by the severity of the inflammatory process. In healthy tissues, the antibiotic accumulates almost 35% less than in inflamed tissues.

Sumamed ® indications for use

• Azithromycin is prescribed for the treatment of diseases caused by sensitive flora. It is effective for respiratory pathologies. systems and varying degrees of severity, that is, it is used for therapy, and. Highly effective for respiratory and...
• It can also be used for the prevention of rheumatic complications instead of bicillin if the patient has tonsillitis and was treated with another antibiotic.
• Used in prophylaxis (post-exposure) and treatment.
• Azithromycin preparations are indicated for lesions of the skin and pancreas. Can be prescribed for the early stages of Lyme disease.
• Sumamed ® is also used in dermatological practice for the treatment of varying degrees of severity. The low toxicity of the drug allows its use in long courses.
• In venereology, the antibiotic is used to treat STI infections, uncomplicated and complicated urethritis and chlamydial and gonorrheal etiology.
• If necessary, it is prescribed in regimens for the treatment of gastric and duodenal ulcers, when clarithromycin cannot be prescribed.
• It is used in step therapy, that is, Sumamed ® can be prescribed parenterally, followed by a transition to tablet administration.

Dosage of Sumamed ® for adults

The standard dosage of Sumamed ® for adults is 500 mg once a day for a three-day course. Or 500 mg on the 1st day, followed by a transition to 250 mg (0.25 g) for a five-day course.

In severe cases of the disease, the duration of treatment may be increased. The course of taking Sumamed ® for pneumonia is seven to ten days (five hundred mg each). Antibiotics for sinusitis in adults are also not recommended to be prescribed in short courses; it is preferable to take the drug for 5-7 days, 0.5 g each.

For uncomplicated, mild UTIs, a 3-day course of treatment of 0.5 g is sufficient. For moderate and severe cases, the duration of treatment increases.

In case of infectious lesions of the skin and pancreas, a five-day course of azithromycin is prescribed at a dose of 1 g on the first day and 0.5 g for another four days.

When eradicating Helicobacter, the antibiotic is prescribed one gram at a time for a three-day course.

Sumamed ® - contraindications for use

• Absolute contraindications to the use of this antibiotic are: individual intolerance to macrolide drugs and ketolides or auxiliary components of the drug;
• severe liver diseases accompanied by liver dysfunction;
• simultaneous use with ergotamine and dihydroergotamine drugs;
• malabsorption syndrome associated with disaccharidase deficiency.

According to age restrictions, Sumamed ®:

• in the form of a suspension is not given to babies under 6 months;
• 125 mg tablets – for patients under three years of age;
• Sumamed ® 250 mg capsules for children under 12 years of age;
• table 500 mg – children under 12 years of age;
• parenteral administration (Sumamed ® in the form of lyophilisate) – up to 16 years.

The instructions for use of Sumamed Forte ® for children (suspension) also indicate the age limit - 6 months.

Sumamed ® during pregnancy is used strictly according to indications, after a comprehensive assessment by the doctor of the relationship between the expected benefit and the expected risk. It is important to remember that any antibiotics during pregnancy are always a risk, so their prescription must be strictly justified and balanced. Independent use of medications, as well as changing the doses and course duration prescribed by the doctor, is unacceptable.

Sumamed ® during breastfeeding is prescribed subject to temporary cessation of breastfeeding

Also, with caution, the drug can be used in patients with myasthenia gravis, liver dysfunction of moderate and mild severity, end-stage renal failure, diabetes mellitus, cardiovascular pathologies accompanied by rhythm disturbances and an extended QT interval, patients receiving treatment with class 1A and 3 antiarrhythmics.

Sumamed ® during pregnancy and breastfeeding

Sumamed ® during pregnancy can only be used by the decision of the attending physician and under his supervision. Macrolides belong to the category of drugs that are used in such cases. However, it is important to remember that any antibiotics during pregnancy should be prescribed by the attending physician strictly according to indications.

Most often, Sumamed ® during pregnancy is used for infections of the genitourinary system, as well as for diseases of the ENT organs and respiratory tract, for patients who are allergic to beta-lactam drugs.

Given the ability of the antibiotic to pass into breast milk in small doses, breastfeeding should be temporarily stopped.

Sumamed ® and alcohol – compatibility

What happens if you take Sumamed ® with alcohol?

Firstly, given the mechanism of elimination of azithromycin (through the kidneys and liver), this combination will increase the toxic effect on the liver and can lead to drug-induced hepatitis.

Secondly, the combination with alcohol makes taking the medicine completely useless, leading to its inactivation.

That is, you cannot combine Sumamed ® with alcohol, as this not only neutralizes the effectiveness of treatment, but can also be life-threatening.

Sumamed ® - side effects

The drug is low-toxic and, as a rule, is well tolerated by patients. Side effects of Sumamed ® can be manifested by feeling, stool disorders, abdominal pain, flatulence. Antibiotic-associated diarrhea and pseudomembranous colitis develop extremely rarely.

Vaginitis is also observed quite often.

Instructions for use Sumamed ® suspension for children

For children, the drug is prescribed at the rate of ten mg per kilogram of body weight, for a three-day course and 10 mg/kg on the 1st day, followed by a transition to 5 mg/kg for a five-day course.

For erythema migrans, on the first day 20 mg per kg is prescribed, then 4 days at ten mg per kg.

For pneumonia, the course is from seven to ten days. For treatment of pelvic organ infections – seven days. The duration of taking medication for sinusitis depends on the severity of the disease. The minimum course is 5 days.

How to take Sumamed ®

Let's look at frequently asked questions to pharmacists and doctors about azithromycin.

Should Sumamed ® be taken before or after meals?

Instructions for use of Sumamed ® (including the children's form) indicate that the drug must be consumed 1 time per day, 1 hour before or 2 hours after meals.

How to prepare a suspension of 100 mg in 5 ml for children?

You need to add eleven ml of boiled water to the bottle and mix the resulting mixture well. The suspension can be stored for five days.

How to dilute Sumamed forte ® 200 milligrams in 5 ml (15 and 3 ml in a bottle)?

In a bottle containing:

• 600 mg of azithromycin must be added to 6 ml of boiled water.;
• 800 mg of antibiotic – 8 ml;
• 1400 mg -14.5 ml.

The resulting mixture must be shaken thoroughly. The shelf life of the prepared product is 5 days.

How to give the suspension to a child?

The prepared suspension should be shaken thoroughly before use. The required amount of the drug is taken from the bottle with a dosage syringe or poured into a special spoon (they are included in the kit). After use, they must be rinsed with water and dried. After the child drinks the drug, it is necessary to give him boiled water so that he swallows the remaining part of the suspension in the oral cavity.

Sumamed ® - reviews for adults and children

Patients who are prescribed this drug are often interested in: when does improvement occur when taking azithromycin?

Patients who took the drug noted in their reviews the rapid effect of its use. When treating the respiratory tract, stabilization of temperature and improvement in general condition occurs on the second day of treatment.

However, it is important to remember that the speed of recovery, as well as the duration of treatment, depends on many factors (the nature of the pathogen, the location of the infectious focus, the severity of the disease, the presence of complications and concomitant pathologies that complicate the course of the disease, etc.).

It is necessary to understand that each person is individual and one disease in any patient can have a different course, and accordingly, the reaction to the drug can also vary. For example, for the treatment of bacterial, uncomplicated bronchitis with a mild course, a three-day course is really enough, and the effect will be noticeable within a day.

However, for a moderately severe disease, it is advisable to use a five-day course of therapy, and improvement from taking Sumamed ® can be noticeable by the end of the second day. Treatment of respiratory chlamydia takes two weeks, respectively, and improvement will occur more slowly than in previous cases.

A significant advantage over other drugs is the good tolerability and low toxicity of Sumamed ®, which allows, if necessary, to prescribe it to children and pregnant women, as well as to use extended courses for the eradication of intracellular pathogens (chlamydia, mycoplasma, legionella).

Trade name of the drug: SUMAMED® FORTE

Reg.: P No. 011923/01 dated 09/22/2006

International nonproprietary name: Azithromycin

Dosage form:

Compound:

5 ml of prepared suspension contain
active substance azithromycin (in the form of dihydrate) - 200 mg and
auxiliary components:
sucrose, trisodium phosphate anhydrous, hydroxypropylcellulose, xanthan gum, cherry flavor J7549, banana 78701-31, vanilla D-125038, colloidal silicon dioxide.

Description:

granular powder of white or light yellow color with a characteristic odor of banana and cherry. After dissolution in water - a homogeneous suspension of white or light yellow color with a characteristic odor of banana and cherry.

Pharmacotherapeutic group: antibiotic – azalide.

ATX: J01FA10.

Pharmacological properties

Pharmacodynamics. Has a wide spectrum of antimicrobial action. By binding to the 50S subunit of the ribosome, it inhibits the biosynthesis of microorganism proteins. In high concentrations it has a bactericidal effect.

It is active against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms.

Pharmacokinetics . When taken orally, azithromycin is well absorbed and quickly redistributed from plasma to tissues and organs. After a single oral dose of 500 mg of azithromycin, 37% of the drug is absorbed and after 2-3 hours the maximum concentration of the drug is 0.41 mcg/ml in the plasma. It is known that food intake can reduce the absorption of azithromycin, however, due to the insufficiency of the manufacturer's own data on the effect of food on the pharmacokinetics of azithromycin when taking Sumamed in the form of a suspension, it should be taken at least 1 hour before or after 2 hours after meal.

The drug is fast distributed throughout the body, high concentrations of the drug, exceeding 50 times the concentration of azithromycin in plasma, are observed in tissues.

Depending on the location, the concentration of the drug ranges from 1-9 μg/ml. The volume of distribution averages 31 l/kg.

The therapeutic concentration of azithromycin in tissues is observed within 5-7 days after taking the last dose.

Penetrates into cells, including phagocytes, which migrate to the site of inflammation, helping to create therapeutic concentrations of the drug that exceed the minimum inhibitory concentration for infectious agents. Concentrations of azithromycin in infected tissues are higher compared to uninfected tissues.

The drug has high intracellular activity, because high concentrations of azithromycin are created in phagocytes.

It has a long half-life and is slowly eliminated from tissues (on average 2-4 days). Excretion of azithromycin into bile is the main route of elimination. On average, up to 50% is excreted in bile in unchanged form. The remaining 50% is excreted in the form of 10 metabolites formed during the process of N- and O-demethylation, hydroxylation of desosamine and aglycone ring and as a result of cleavage of the cladinose conjugate. Metabolites do not have antibacterial activity.

An average of 6% of the administered dose of the drug is excreted in the urine.

In elderly patients (over 65 years of age), the volume of distribution is slightly higher (30%) compared to patients under 45 years of age, which is not clinically significant and does not require dosage changes.

Indications for use

• Infections of the ENT organs (bacterial pharyngitis/tonsillitis, sinusitis, otitis media);
• Lower respiratory tract infections (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis);
• Infections of the skin and soft tissues (chronic migratory erythema - the initial stage of Lyme disease, erysipelas, impetigo, secondary pyodermatoses);
• Sexually transmitted infections (urethritis, cervicitis)
• Diseases of the stomach and duodenum associated with Helicobacter pylori.

Contraindications

• Hypersensitivity to macrolide antibiotics;
• Severe liver dysfunction.

With caution: in newborns (due to lack of sufficient clinical experience), during pregnancy and lactation, i.e. in cases where the expected benefit from its use exceeds the potential risk that exists when using any drug during these periods; In case of liver dysfunction, patients who have disorders or are predisposed to arrhythmias and prolongation of the QT interval (according to the literature, the occurrence is 0.001% of cases) also take the drug with caution.

Directions for use and doses

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

For infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema) total dose 30 mg/kg, i.e. 10 mg/kg body weight once a day for 3 days.

Children are dosed based on weight:

For chronic migratory erythema the total dose of the drug is 60 mg/kg: once a day, 20 mg/kg on day 1 and 10 mg/kg on subsequent days from days 2 to 5.

For diseases of the stomach and duodenum associated with Helicobacter pylori:

20 mg/kg body weight once a day in combination with an antisecretory agent and other medications as recommended by a doctor.

If a dose of the drug is missed, it should be taken immediately, if possible, and then subsequent doses should be taken at intervals of 24 hours.

For sexually transmitted infections

Uncomplicated urethritis/cervicitis– 1 g once.

Complicated, long-term urethritis/cervicitis, caused by Chlamydia trachomatis - 1 g three times with an interval of 7 days (1-7-14). Course dose 3 g.

Method of preparing the suspension

To prepare 15 ml of suspension (nominal volume), add 8 ml of water to a vial containing 600 mg of azithromycin (actual volume - 20 ml of suspension).

To prepare 30 ml of suspension (nominal volume), it is necessary to add 14.5 ml of water to a bottle containing 1200 mg of azithromycin (actual volume - 35 ml of suspension).

To prepare 37.5 ml of suspension (nominal volume), it is necessary to add 16.5 ml of water to a vial containing 1500 mg of azithromycin (actual volume - 42.5 ml of suspension).

Each bottle should contain a suspension 5 ml more than the course dose for more complete removal of the drug from the bottle.

The shelf life of the prepared suspension is 5 days at a temperature not exceeding 25°C.

Using a dosing syringe, measure out the required amount of water and add it to the bottle with the powder. Before use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained.

To dispense the finished suspension, use a syringe or measuring spoon. Immediately after taking the suspension, the child is given a few sips of tea or juice in order to wash off and swallow the remaining amount of the suspension in the mouth.

After use, the syringe is disassembled and washed with running water, dried and stored with the drug.

Side effects

Most of the observed adverse reactions are mild to moderately severe and are reversible after completion of the course of treatment or discontinuation of the drug.

From the gastrointestinal tract: nausea, vomiting, flatulence, constipation, abdominal pain, diarrhea, rarely cholestatic jaundice, decreased appetite, gastritis, very rarely - candidomycosis of the oral mucosa.

Allergic reactions: rash, itchy skin, urticaria; rarely angioedema and anaphylactic shock.

From the laboratory parameters:

reversible increase in the activity of liver transaminases, bilirubin, and the number of eosinophils; these indicators return to normal levels 2-3 weeks after the end of therapy.

In extremely rare cases, a transient decrease in the number of neutrophils may occur during azithromycin therapy, but no cause-and-effect relationship has been found.

From the cardiovascular system: palpitations, chest pain.

From the nervous system: dizziness, vertigo, headache, paresthesia, agitation, drowsiness, in children - headache (during treatment of otitis media), irritability, hyperkinesia, anxiety, neurosis, sleep disorders.

From the genitourinary system: vaginal candidiasis, nephritis.

Others: conjunctivitis, photosensitivity, increased fatigue,

If any side effect occurs, you should notify your doctor.

Overdose

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea
Treatment: symptomatic; gastric lavage.

Interaction with other drugs

• Antacids and food intake significantly reduce the absorption of azithromycin suspension, so the drug should be taken at least one hour before or two hours after taking these drugs and food.
• When taking macrolide antibiotics and ergot alkaloid preparations simultaneously, the development of ergotism is possible, but there is no data on the interaction of ergot alkaloid derivatives and azithromycin.
• Interactions of macrolide antibiotics with digoxin, cyclosporine, astemizole, triazolam, midazolam or alfentanil have been noted. Although there is no data on the interaction of azithromycin and the above drugs, it is recommended that azithromycin be taken concomitantly with these drugs under medical supervision.
• There was no effect of azithromycin on the blood concentrations of theophylline, terfenadine, carbamazepine, methylprednisolone and cimetidine, since, unlike most macrolides, azithromycin does not complex with cytochrome P-450.
• When taken together with warfarin, an increase in prothrombin time and the incidence of hemorrhages is possible.

special instructions

If you miss one dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

There is no need for longer courses of treatment than those recommended in the instructions for use.

Release form

16.740 g or 29.295 g or 35.573 g of powder are placed in a brown glass bottle of 50 ml or 100 ml with a resistant polypropylene cap.

1 bottle along with instructions for use, a double-sided measuring spoon and/or a dosing syringe is placed in a cardboard box.

Storage conditions
List B
Store at a temperature not exceeding 25°C.
Keep out of the reach of children .

Best before date
Powder for preparing a suspension - 2 years.
Prepared suspension – 5 days at a temperature not exceeding 25°C.
Do not use after the expiration date.

Conditions for dispensing from pharmacies
By doctor's prescription .

Manufacturer: