Sumamed is a new antibiotic that is still being studied! Use of sumamed for children, instructions and important information

In this article you can read the instructions for use of the drug Sumamed. Feedback from site visitors - consumers - is presented of this medicine, as well as the opinions of specialist doctors on the use of Sumamed in their practice. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Sumamed in the presence of existing structural analogues. Use for the treatment of sore throat, bronchitis, pneumonia and other infectious diseases in adults, children, as well as during pregnancy and lactation. Methods for preparing the suspension. The effect of alcohol on concomitant use of the drug.

Sumamed- a broad-spectrum bacteriostatic antibiotic from the group of macrolides-azalides. The mechanism of action of azithromycin (the active ingredient of the drug Sumamed) 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.

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

In most cases, the drug Sumamed is active against aerobic gram-positive and gram-negative bacteria, anaerobic bacteria, other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Pharmacokinetics

After oral administration, azithromycin is well absorbed and quickly distributed in the body. 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. In the liver it is demethylated, losing activity. 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.

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 chronic bronchitis, pneumonia, incl. caused by atypical pathogens);
stomach diseases and duodenum, associated with Helicobacter pylori(for powder);
skin and soft tissue infections (acne moderate severity, erysipelas, impetigo, secondary infected dermatoses);
the initial stage of Lyme disease (borreliosis) - erythema migrans;
infections genitourinary tract caused by Chlamydia trachomatis (urethritis, cervicitis).

Release forms

Film-coated tablets 125 mg and 500 mg.

Capsules 250 mg.

Lyophilisate for the preparation of solution for infusion (injections) 500 mg.

Powder for the preparation of suspension for oral administration 100 mg/5 ml.

Instructions for use and dosage

The drug is prescribed orally 1 time per day, according to at least, 1 hour before or 2 hours after meals. The tablets are taken without chewing.

For adults (including the elderly) and children over 12 years of age weighing more than 45 kg, the drug is prescribed in the form of tablets and capsules.

For children aged 6 months and older, the drug should be prescribed in the form of an oral suspension; for children aged 3 years and older, the drug can also be prescribed in the form of 125 mg tablets. The drug in the form of 125 mg tablets is dosed taking into account the child’s body weight.

For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema) in adults and children over 12 years of age weighing more than 45 kg, the drug is prescribed in a dose of 500 mg 1 time per day for 3 days, course dose - 1.5 g. Children aged 6 months and older are prescribed at the rate of 10 mg/kg body weight once a day for 3 days, course dose - 30 mg/kg.

For diseases of the stomach and duodenum associated with Helicobacter pylori, the drug is prescribed in powder form at a dose of 1 g per day for 3 days in combination with antisecretory agents and other drugs.

For migrating erythema, the drug is prescribed once a day for 5 days. Adults and children over 12 years of age weighing more than 45 kg are prescribed on the 1st day - 1 g, then from days 2 to 5 - 500 mg; course dose - 3 g. Children aged 6 months and older are prescribed on the 1st day at a dose of 20 mg/kg body weight and then from days 2 to 5 - daily at a dose of 10 mg/kg body weight, course dose - 60 mg /kg.

At acne medium degree severity, the course dose is 6.0 g. Adults and children over 12 years of age weighing more than 45 kg are prescribed at a dose of 500 mg once a day for 3 days, then 500 mg once a week for 9 weeks. The first weekly dose should be taken 7 days after the first daily dose (8th day from the start of treatment), the subsequent 8 weekly doses should be taken at an interval of 7 days.

For sexually transmitted infections, for the treatment of uncomplicated urethritis/cervicitis caused by Chlamydia trachomatis, the drug is prescribed in a dose of 1 dose; for the treatment of complicated long-term urethritis/cervicitis caused by Chlamydia trachomatis, 1 g 3 times is prescribed with an interval of 7 days (days 1, 7, 14), the course dose is 3 g.

For patients with moderate renal impairment (creatinine clearance > 40 ml/min), no dose adjustment is required.

How to dilute and take the suspension

Add 12 ml of distilled or boiled water to a bottle containing 17 g of powder. The volume of the resulting suspension is 23 ml. The shelf life of the prepared suspension is 5 days. Before use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is given a few sips of tea 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 in a dry place along with the drug.

Sumamed forte (in the form of a suspension)

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) - a total dose of 30 mg/kg, i.e. 10 mg/kg once a day for three days.

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

For diseases of the stomach and duodenum associated with Helicobacter pylori: 20 mg/kg once a day in combination with an antisecretory agent and other drugs 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.

Method of preparing the suspension

To prepare 15 ml of suspension (nominal volume), add 8 ml of water to a vial containing 800 mg of azithromycin (actual volume - 20 ml of suspension).

To prepare 30 ml of suspension (nominal volume), add 14.5 ml of water to a vial containing 1400 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 1700 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 effect

thrombocytopenia, neutropenia, eosinophilia;
dizziness;
headache;
drowsiness;
convulsions;
insomnia;
hyperactivity, aggressiveness, anxiety, nervousness;
noise in ears;
reversible hearing loss up to deafness (when taken in high doses for a long time);
impaired perception of taste and smell;
heartbeat;
arrhythmia, including ventricular tachycardia;
nausea, vomiting;
diarrhea, constipation;
abdominal pain and cramps;
flatulence;
anorexia;
hepatitis;
itching, skin rashes;
angioedema;
hives;
anaphylactic reaction (in rare cases, fatal);
joint pain;
vaginitis;
candidiasis.

Contraindications

severe dysfunction of the liver and kidneys;
lactation period (breastfeeding);
simultaneous use with ergotamine and dihydroergotamine;
increased sensitivity to macrolide antibiotics;
childhood up to 12 years and body weight less than 45 kg (for capsules and tablets 500 mg);
children under 3 years of age (for tablets 125 mg).

Use during pregnancy and breastfeeding

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

If necessary, use the drug during lactation breast-feeding should be stopped.

special instructions

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

Just like with any antibiotic therapy, when treating with azithromycin, superinfection (including fungal) may occur.

In the treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes, as well as for the prevention of acute rheumatic fever Penicillin is usually the drug of choice. Azithromycin is also active against streptococcal infection in these cases, but is ineffective in preventing the development of acute rheumatic fever.

The patient should be warned to notify the doctor if any side effect occurs.

Noted bad influence combined use of Sumamed and alcohol (hepatotoxic effect).

Impact on the ability to drive vehicles and machinery

The drug does not affect the ability to drive vehicles and other activities that require high concentration and speed of psychomotor reactions.

Drug interactions

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.

With simultaneous use, azithromycin does not affect the concentration of carbamazepine, didanosine, rifabutin and methylprednisolone in the blood.

When used parenterally, Sumamed does not affect the plasma concentrations of cimetidine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole in the case of combination therapy, but the possibility of such an interaction should not be excluded when Sumamed is administered orally.

Azithromycin does not affect the pharmacokinetics of theophylline, however, when taken together with other macrolides, the concentration of theophylline in the blood plasma may increase.

If necessary joint use with cyclosporine, it is recommended to monitor the level of cyclosporine in the blood. Despite the fact that there is no data on the effect of azithromycin on changes in the concentration of cyclosporine in the blood, other representatives of the macrolide class are capable of changing its concentration in the blood plasma.

When taking digoxin and Sumamed together, it is necessary to monitor the concentration of digoxin in the blood, because many macrolides increase the absorption of digoxin from the intestine, thereby increasing its concentration in the blood plasma.

If co-administration with warfarin is necessary, careful monitoring of prothrombin time is recommended.

It was found that the simultaneous use of terfenadine and macrolide antibiotics causes arrhythmia and prolongation of the QT interval. Based on this, it is impossible to exclude the development of these complications when taking terfenadine and azithromycin together.

When azithromycin and zidovudine are taken together, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or the renal excretion of it and its glucuronide metabolite. However, the concentration of the active metabolite, phosphorylated zidovudine, increases in mononuclear cells peripheral vessels. Clinical significance this fact is not clear.

At simultaneous administration macrolides with ergotamine and dihydroergotamine may exhibit toxic effects.

Analogues of the drug Sumamed

Structural analogues of the active substance:

Azivok;
Azimicin;
Azitral;
Azitrox;
Azithromycin;
Azithromycin Forte;
Azithromycin dihydrate;
AzitRus;
AzitRus forte;
Azicide;
Vero-Azithromycin;
Zetamax retard;
ZI-Factor;
Zitnob;
Zitrolide;
Zitrolide forte;
Zithrocin;
Sumasid;
Sumaclid;
Sumamed forte;
Sumamecin;
Sumamecin forte;
Sumamox;
Sumatrolide solutab;
Tremak-Sanovel;
Chemomycin;
Ecomed.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Latin name: Sumamed forte
ATX code: J01FA10
Active substance: Azithromycin
Manufacturer: Pliva, Croatia
Conditions for dispensing from a pharmacy: On prescription

"Sumamed Forte" is an antibacterial drug, belongs to the group of macrolides, and has a bacteriostatic effect.

Indications for use

"Sumamed Forte" is indicated for use in infectious diseases that are accompanied by an inflammatory process:

Infections localized in upper sections respiratory system and in the middle ear (sinusitis, nasopharyngitis, tonsillitis and otitis media)
Infection of soft tissues and skin, which manifests itself as erysipelas, impetigo, and secondary dermatosis
Infections localized in the lower respiratory system (community-acquired pneumonia, acute course bronchitis)
Manifestation of erythema migrans.

Compound

1 gram of Sumamed Forte powder contains 47.79 mg of the main active ingredient - azithromycin dihydrate. In addition, it contains a number of excipients along with flavorings.

Medicinal properties

"Sumamed Forte" is characterized by bacteriostatic properties, and in elevated concentrations has a bactericidal effect. The mechanism of action of the drug is based on inhibition of the process of protein synthesis in pathogenic cells due to communication with their ribosomes, which disrupts metabolism, stops growth and completely blocks the reproduction of pathogenic flora, resulting in the death of microorganisms.

The drug exhibits high activity against a number of bacteria, both gram-positive and gram-negative. In addition, the antibiotic has Negative influence on the vital activity of anaerobes (represented by clostridia, peptostreptococci, and peptococci).

Compared to other types of antibacterial drugs, Sumamed Forte has the ability to penetrate cell membranes and have an effective effect on intracellular microorganisms, which are called atypical bacteria. In addition, the antibiotic has an anti-inflammatory effect, which is manifested by a decrease in the production of mucus inside the bronchi due to inhibition of neoplasm necrosis. It is this property of the drug that explains the high effectiveness of treating a disease such as cystic fibrosis. Thanks to complex treatment disease, it is possible to improve the circulation of oxygen in the respiratory tract.

Release form

Price: from 301 to 668 rubles.

Powder white with banana flavor, intended for cooking medicinal solution(suspension), by dissolving in liquid.

A 50 ml bottle contains 16.7 g or 15 ml of powder; a dosing spoon and syringe are placed in a cardboard package.

A 100 ml bottle can contain 30 ml or 37.5 ml of powder, which in terms of weight is 29.3 g and 35.6 g, respectively. Syringe and measuring spoon included.

Instructions for use of the drug "Sumamed Forte"

Sumamed Forte is usually recommended to be taken orally once a day for 60 minutes. before the intended meal or after 2 hours. Children are prescribed to drink the suspension along with a small volume of liquid to ensure that the drug enters the gastrointestinal tract in full.

Before taking the drug, the bottle with its contents must be shaken thoroughly until a homogeneous solution is obtained. Using a syringe or a special spoon, measure the required volume of the medicinal solution.

For diseases of the respiratory system of an infectious-inflammatory nature, for lesions of soft tissues, the daily dose of the drug is calculated from the ratio of 10 mg - 1 kg, this dosage is taken for the next 3 days. The total dose of antibiotic per course of treatment is calculated from the ratio of 30 mg - 1 kg of body weight.

From 10 to 14 kg of weight - dose per application - 2.5 ml (active ingredient content - 100 mg)
From 15 to 24 kg of weight - dose per dose - 5 ml (active ingredient content - 200 mg)
From 25 to 34 kg – dosage per application – 7.5 ml (active ingredient content – 300 mg)
From 35 to 44 kg – dose per dose – 10 ml (active ingredient content – 400 mg)
More than 45 kg - dosage per application - 12.5 ml (mass fraction of azithromycin - 500 mg).

For children whose weight does not exceed 10 kg, a suspension is usually prescribed at a dosage of 100 mg/5 ml.

In the case of treatment of rhinopharyngitis and tonsillitis, the daily dose is calculated taking into account the ratio of 20 mg - 1 kg of weight, the antibiotic is used for 3 days. The total dosage of the drug for the entire course of treatment is calculated in accordance with the norm of 60 mg - 1 kg of weight. Maximum dose antibiotic per day should not exceed 500 mg.

In the case of migratory erythema, the initial daily dose of the drug is calculated from the ratio of 20 mg - 1 kg of body weight, then the dosage is halved and taken over the next 2-5 days.

In the presence of impaired functioning of the kidneys and liver, additional adjustments daily dose not required.

Instructions for the preparation of a medicinal solution for oral administration

To properly prepare the suspension various dosages the following rules should be followed:

Using a syringe, powder at a dosage of 200 mg/5 ml is dispensed into 9.5 ml clean water(production of a suspension with a volume of 15 ml). After shaking, a composition homogeneous in consistency is obtained. The total volume of the medicinal mixture is 20 ml, which exceeds the calculated volume of the solution by 5 ml, thanks to this it will be possible to compensate for the loss of the drug when selecting the suspension for further administration.
Using a syringe, pour 16.5 ml of clean boiled water into the inside of the bottle (making a medicinal product with a volume of 30 ml). The mixture is shaken and a homogeneous consistency is obtained, ready for further use. The volume of the finished mixture is 30 + 5 ml.
Using a special syringe, the powder should be diluted in a bottle with 20 ml of clean water. The contents of the bottle are shaken to obtain a homogeneous suspension. The volume of the finished medicinal mixture is 42.5 ml, which is 5 ml more than the previously calculated volume.

During pregnancy and breastfeeding

The use of antibiotics during pregnancy is possible in individual cases when possible risks for the fetus is significantly lower than expected therapeutic effect for the mother. "Sumamed Forte" can only be taken as prescribed by a doctor if there are indications for its use.

The use of antibacterial agents for nursing mothers is contraindicated.

Contraindications

"Sumamed Forte" is not indicated for use in the presence of the following pathologies:

Serious disorders of the liver and kidneys
Excessive sensitivity to macrolide antibiotics.

Precautionary measures

If you miss a dose of an antibiotic once, it is recommended to take the drug as soon as possible. Further medication is taken after 24 hours.

If any adverse reaction develops, you should consult a doctor.

Cross-drug interactions

Antacid medications, alcohol and simultaneous food intake reduce the rate of absorption of the active substance, so it is recommended to take the medicine 60 minutes before. before meals or after 2 hours.

Azithromycin does not interact with isoenzymes of the cytochrome system.

Macrolides in combination with cycloserine, anticoagulant drugs, as well as methyprednazalone and felopine significantly slow down the process of removing azithromycin from the body, while increasing the concentration and toxicity of the components they contain. The use of azalides does not cause such an effect.

When taking wafarin together, there is a need for regular monitoring of blood clotting.

The combined use of macrolides with ergotamine and its derivatives can cause an increase in the toxicity of the latter, which is manifested by the development of vasospasm, as well as dysesthesia.

Lincosamines can reduce the therapeutic effectiveness of azithromycin, and chloramphenicol, on the contrary, increases its effect.

According to pharmaceutical indicators, heparin cannot be combined with Sumamed Forte.

Side effects

When treated with the antibiotic "Sumamed Forte", a number of reactions may be observed:

Gastrointestinal tract: melena, dysfunction of the stomach and intestines (nausea, gastritis, loss of appetite, abdominal pain, flatulence, diarrhea or constipation, high or moderate activity liver enzymes)
CVS: arrhythmia, chest pain
CNS: headaches, general weakness, vertigo, nervous tension, insomnia
Genitourinary system: fungal infections of the genital organs, nephritis
Allergic manifestations: rash on the skin, urticaria, Quincke syndrome, development of conjunctivitis, photosensitivity.

Pain in chest may be caused by other reasons, more details in the article:.

Overdose

Symptoms of an antibiotic overdose include nausea, vomiting and impaired bowel function.

Conditions and shelf life

The ready-to-use suspension (volume 15 mg) is stored under the following conditions: temperature regime(up to 20-25 C) for 5 days.

The suspension is stored for 10 days at a temperature not exceeding 20-25 C.

Analogs

Sandoz, Germany
Price from 452 to 601 rub.

"Azitro Sandoz" - antibacterial drug, the active ingredient of which is azithromycin. The medicine is produced in such dosage forms: tablets and powder for suspension. "Azitro Sandoz" is used to treat infectious diseases accompanied by an active inflammatory process.

Pros:

Easily tolerated by both adults and children
Can be taken simultaneously with probiotics
Rarely causes adverse reactions.

Minuses:

Available only by prescription
Allergic reactions are possible
The antibiotic is contraindicated in nursing mothers.

Kievmedpreparat, Ukraine
Price from 189 to 200 rub.

Azimed is a drug with a pronounced antimicrobial effect; the drug contains azithromycin dihydrate. "Azimed" is a complete analogue of "Sumamed Forte", which indicates the same characteristics and therapeutic effectiveness of these drugs. The medicine is available in 2 dosage forms: tablets, powder for suspension.

Pros:

Effectively treats infectious diseases of the ENT organs
Acceptable price
Can be used to treat children from 1 year of age.

Minuses:

Quite difficult to find in the pharmacy chain
Superinfection may develop while taking it
It is not recommended to combine antibiotics with alcohol.

Composition and release form

Sumamed® Capsules – 1 capsule:

active ingredients: azithromycin (in the form of dihydrate) - 250 mg;
excipients: MCC; sodium lauryl sulfate; magnesium stearate.

There are 6 pcs in a blister; 1 blister in a box.

Film-coated tablets - 1 tablet:

active ingredients: azithromycin (in the form of dihydrate) - 125 mg - 500 mg;
core: anhydrous calcium phosphate, hypromellose, corn starch, pregelatinized starch, MCC, sodium lauryl sulfate, magnesium stearate;
shell: hypromellose, dye similar to Indigotine (E132), polysorbate 80, titanium dioxide (E171), talc.

In a blister there are 3 (500 mg) or 6 (125 mg) pieces; 1 blister in a box.

Powder for the preparation of a suspension for oral administration (prepared suspension) - 5 ml:

active ingredients: azithromycin (in the form of dihydrate) - 100 mg;
excipients: sucrose, sodium carbonate anhydrous, sodium benzoate, tragacanth, titanium dioxide, glycine, colloidal silicon dioxide, strawberry, apple and mint flavors.

In 50 ml dark glass bottles - 17 g of powder (complete with dosing spoon, dosing syringe); 1 bottle in a box.

Lyophilisate for preparing solution for infusion - 1 vial:

active ingredients: azithromycin (in the form of dihydrate) - 500 mg;
excipients: citric acid, sodium hydroxide.

In bottles; There are 5 bottles in a cardboard pack.

Sumamed® forte Powder for the preparation of suspension for oral administration (prepared suspension) - 5 ml:

active ingredients: azithromycin (in the form of dihydrate) - 200 mg;
excipients: sucrose, trisodium phosphate anhydrous, hydroxypropylcellulose; xanthan gum, cherry flavor J7549, banana flavor 78701-31, vanillin flavor D-125Q38, colloidal silicon dioxide.

In bottles of 20, 35 or 42.5 ml (complete with dosing spoon or dosing syringe); 1 bottle in a box.

Description of the dosage form

Sumamed® Capsules: hard, gelatinous, opaque, size No. 1. The body color is blue, the lid is blue. Capsule contents: white to light yellow powder.

Film-coated tablets: blue color, round (125 mg) or oblong (500 mg) shape with biconvex surfaces and the designation “PLIVA” on one side and “125” or “500” on the other. The fractured appearance is white to almost white.

Powder for oral suspension 100 mg/5 ml: white or light yellow granular powder.

Lyophilisate for the preparation of solution for infusion: lyophilized powder or compacted white mass.

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

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 Cmax 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 h after eating.

The drug is rapidly distributed throughout the body, high concentrations, 50 times higher than the concentration of azithromycin in plasma, are observed in tissues. Depending on the organ/tissue, the drug concentration ranges from 1-9 mcg/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 MIC for infectious agents. Concentrations of azithromycin in infected tissues are higher compared to uninfected tissues. It has a long T1/2 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.

The pharmacokinetics of azithromycin in healthy volunteers after a single intravenous infusion lasting more than 2 hours at a dose of 1000-4000 mg (solution concentration 1 mg/ml) has a linear relationship and is proportional to the administered dose. T1/2 of the drug is 65-72 hours. High level The observed volume of distribution (33.3 l/kg) and plasma clearance (10.2 ml/min/kg) suggests that the long half-life of the drug is a consequence of the accumulation of the antibiotic in tissues followed by its slow release.

In healthy volunteers, with an intravenous infusion of azithromycin at a dose of 500 mg (solution concentration 1 mg/ml) for 3 hours, the Cmax of the drug in the blood serum was 1.14 μg/ml. The minimum serum level (0.18 μg/ml) was observed over 24 hours and the area under the concentration-time curve was 8.03 μg/ml/h.

Similar pharmacokinetic values were obtained in patients with community-acquired pneumonia, who were prescribed intravenous infusions (3-hourly) for 2 to 5 days. After daily administration of azithromycin at a dose of 500 mg (infusion duration - 1 hour) for 5 days, an average of 14% of the dose is excreted in the urine over a 24-hour dosing interval.

Pharmacodynamics

Has a wide spectrum of antimicrobial action. By binding to the 50S ribosomal subunit, it inhibits the biosynthesis of microorganism proteins. In high concentrations it has a bactericidal effect. It is active against gram-positive, gram-negative anaerobes, intracellular and other microorganisms.

Has no effect on gram-positive bacteria resistant to erythromycin.

Indications for use

infections of the upper respiratory tract and ENT organs;
lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens;;
skin and soft tissue infections;
genitourinary tract infections (urethritis, cervicitis).

Contraindications for use

severe dysfunction of the liver and kidneys;
lactation period;
simultaneous use with ergotamine and dihydroergotamine;
hypersensitivity to azithromycin and other components of the drug;
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).

Sumamed should be prescribed with caution when moderate violations liver and kidney function, patients with disorders or predisposition to arrhythmias and prolongation of the QT interval

Use during pregnancy and children

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

If it is necessary to use sumamed during lactation, breastfeeding should be stopped

Side effects

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

From the central nervous system and peripheral nervous system: sometimes - dizziness/vertigo, headache, drowsiness, convulsions; rarely - paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

From the outside digestive system: often - nausea, vomiting, diarrhea, abdominal pain and cramps; sometimes - diarrhea, flatulence, digestive disorders, anorexia; rarely - constipation, change in tongue color, pseudomembranous colitis, cholestatic jaundice, hepatitis, change in values laboratory parameters liver functions; very rarely - liver dysfunction and liver necrosis (possibly fatal).

Allergic reactions: sometimes - itching, skin rashes; rarely - angioedema, urticaria, photosensitivity, anaphylactic reaction, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Drug interactions

Sumamed® (capsules, film-coated tablets, powder for oral suspension)

Antacids (containing aluminum, magnesium, ethanol) and food intake significantly reduce the absorption of azithromycin (capsules and suspension), so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food. It does not bind to the enzymes of the cytochrome P-450 complex and, unlike macrolide antibiotics, to date there has been no interaction with theophylline, terfenadine, carbamazepine, methylprednisolone, cimetidine, triazolam, digoxin. Macrolides, when taken simultaneously with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs subject to microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents) slow down the elimination, increase the concentration and toxicity of these drugs, while with the use of azalides such an interaction has not been observed to date.

If it is necessary to take it together with warfarin, it is recommended to carefully monitor the PT (there may be an increase in PT and the incidence of hemorrhages). When macrolides are taken simultaneously with ergotamine and dihydroergotamine, their toxic effects (vasospasm, dysesthesia) may occur. Lincosamides weaken, and tetracycline and chloramphenicol enhance the effectiveness of azithromycin. Pharmaceutically incompatible with heparin.

Sumamed® (lyophilisate for the preparation of solution for infusion)

Although there is no data on interactions between azithromycin and ergot alkaloids, caution must be exercised as simultaneous administration can lead to an increase in the concentration of alkaloids in the blood and to the development of overdose symptoms (ergotism), which is observed when alkaloids are taken together with macrolides; Antibiotics of the macrolide group increase the blood concentration of theophylline, terfenadine, warfarin, carbamazepine, phenytoin, digoxin, cyclosporine, ergotamine, triazolam and midazolam, thereby enhancing their effect. Unlike macrolides, azithromycin does not inhibit cytochrome P450, therefore, when it is prescribed with the above drugs, similar interactions are not observed.

Dosage

Sumamed is prescribed orally 1 time, at least 1 hour before or 2 hours after meals. Sumamed is taken without chewing.

For adults and children over 12 years of age weighing more than 45 kg, sumamed is prescribed in the form of tablets and capsules.

For children aged 6 months and older, sumamed should be prescribed in the form of an oral suspension; for children aged 3 years and older, sumamed can also be prescribed in the form of 125 mg tablets.

Sumamed in the form of tablets 125 mg is dosed taking into account the child’s body weight, as presented in the table.

For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues in adults and children over 12 years of age weighing more than 45 kg, sumamed is prescribed at a dose of 500 mg 1 time per 3 days, course dose - 1.5 g.

For children aged 6 months and older, sumamed is prescribed at the rate of 10 mg/kg body weight 1 time/for 3 days, the course dose of sumamed is 30 mg/kg.

Overdose

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

Treatment: gastric lavage, symptomatic therapy.

The most effective antibiotic of the new generation is Sumamed for children, the instructions for use of which include information that the drug can be used to treat infectious diseases. The medicine is effective in the fight against respiratory infections. Children's Sumamed may affect great amount pathogenic microbes: staphylococcus, pneumococcus, streptococcus.

What is Sumamed

Medicine antibacterial spectrum effects of Sumamed with high concentration Azithromycin is widely used in various fields of medicine. Active substance strong medicine quickly penetrates to the site of the disease thanks to blood cells and suppresses the synthesis of microbes, slowing their growth and preventing further reproduction. In addition, the drug has a bactericidal effect on certain microorganisms, i.e. leads to the death of the main pathogens. The half-life of the antibiotic is 72 hours.

Compound

Active connection antibiotic Sumamed includes active substance- azithromycin and some auxiliary components that ensure rapid absorption of the drug into the body tissues. The substance acts at a deep cellular level, while destroying the structure of microbes. Concentration active component can range from 125 and 500 mg. Excipients medicinal product:

corn starch;
anhydrous calcium hydrogen phosphate;
talc;
hypromellose;
sodium lauryl sulfate;
microcrystalline cellulose;
polysorbate 80;
magnesium stearate;
indigo carmine dye.

Is it an antibiotic or not?

Sumamed is strong antibacterial agent, belonging to the category of macrolides. This non-toxic, safe group rarely causes side effects and effectively destroys pathogenic microorganisms. This antibiotic is prescribed by a doctor to children and adults for treatment. bacterial infections. You can buy it without a prescription at any pharmacy. The active ingredient azithromycin is active against many bacteria, but some of them are resistant to macrolides, so a sensitivity test must be done before use.

Release form of Sumamed for children

Medicine Available in several forms that are convenient for use:

Gelatin-coated capsules 250 mg. It can be found on sale with a dosage of 500 mg.
Powder with active ingredient 100 mg. Can be used to prepare a suspension. The syrup is sweet pleasant taste cherries, strawberries and bananas. A dispenser syringe (measuring spoon) comes with the bottle. Sumamed suspension is recommended for the treatment of young children.
Tablets with a hard film shell. They must be swallowed whole. Available in dosages of 500 and 125 mg.
Lyophilisate for injection and solution. Used only for patients over 16 years of age, when treating severe forms respiratory tract diseases and infectious and inflammatory diseases of the pelvic organs.

pharmachologic effect

A broad-spectrum antibiotic with a bacteriostatic effect and resistance to acidic environments, which helps it be distributed and quickly absorbed from the gastrointestinal tract. The substance is excreted from the body with bile and urine. Maintains active concentration in the affected area for one week after use. The use of macrolides is effective against gram-positive, anaerobic pathogens. The maximum level of Sumamed in the blood is reached after about 3 hours. A doctor can prescribe an antibacterial drug. The elimination period averages 4 days.

Indications for use

The antibacterial drug Sumamed is indicated for ailments caused by streptococci, gram-positive cocci and anaerobic organisms. The medication can be used in children from 6 months, but only if the baby weighs 10 kg or more. You cannot give Sumamed to a child yourself, because the drug is a strong antibiotic. It is necessary to contact a specialist who, after examination and tests, will choose a suitable treatment regimen. Children's diseases for which Sumamed may be prescribed:

duodenal and stomach ulcers caused by bacteria;
Lyme disease (on initial stage);
severe infections of the ENT organs: tonsillitis, scarlet fever, otitis media, tonsillitis, sinusitis, bronchitis (Sumamed is prescribed for pneumonia in children);
illnesses skin: erysipelas, streptoderma, impetigo, secondary dermatitis.

How to breed Sumamed

A powder for suspension has been developed especially for young patients, which can be easily prepared at home. You must add the amount of water indicated in the instructions to the bottle with the medicine (the dose of the powder is different, so a certain amount of liquid will be needed for dilution) and shake well until smooth. After preparation, the finished suspension in the bottle will be more than 5 ml. The solution is suitable for use for no more than five days. It is recommended to use this form of medication once a day.

Instructions for use

Taking capsules, suspensions and tablets depends on the weight, age of the patient, what stage of the disease and whether there are complications. The dosage of Sumamed for children should be calculated by the pediatrician for the course of treatment. Capsules are prescribed to children aged 12 years, tablets - to children from 4 years old, injections - after 16 years, and a suspension - from 6 months. It is recommended to drink the drug in any form one hour before meals. If you miss a dose of the medicine once, you should take the medicine as soon as possible.

For diseases of the respiratory tract, ailments of the ENT organs, skin diseases (excluding migratory chronic erythema) children who weigh 45 kg and over 12 years of age are prescribed a medicine in a dosage of 500 mg once a day. The course of administration is 3 days, the dose of the drug should not exceed 1.5 g. For six-month-old children and older, the medication is prescribed at the rate of 10 mg per kg of body weight, but not more than 30 mg. The course of treatment is 5 days.

Pills

Sumamed tablets for children are dosed based on body weight: for 18-30 kg, 2 tablets of 125 mg are prescribed; from 31 to 45 kg – 3 x 375 mg; more than 45 kg – adult doses are prescribed. The tablets should be taken orally, without chewing, preferably an hour before meals, once a day. Children under three years old need to use the medicine in the form of a powder of 100 mg/5 ml or 200 mg/5 ml.

Suspension

The most ideal form of treatment for schoolchildren and preschool age It is considered a suspension that is convenient to take. As a rule, the course of treatment is 3 or 5 days. The medication can be taken only 2 hours after meals. After dissolving the powder with water, you should get a homogeneous suspension of light yellow or white color with a pleasant strawberry smell.

The dose of medication for children from 6 months to 4 years should be calculated based on the baby’s weight, on average it should be 10 mg per kilogram - in the first two days from the onset of the disease, then it should be taken according to the regimen of 5 mg/kg. Before each use of the drug, the bottle with the prepared suspension must be shaken. The medicine must be stored in the refrigerator. The right dose measure using the included measuring spoon or use a syringe.

How often can you drink

Many parents are often interested in the question of how to take Sumamed for children. Based on the fact that the drug is a strong antibiotic, only a doctor should prescribe it, and he also prescribes the detailed dosage of the medication. There are certain rules that parents should follow if their child is prescribed Sumamed:

Antibacterial therapy can be administered to a newborn after his body weight is 10 kg (this is at least six months);
if a sick child has already received medicine within 6 months, then it cannot be given again;
the drug is taken for 5 days, if after this time there is no improvement, you must seek help from the hospital;
Infusions of the drug should not be given to children under 16 years of age;
like any modern antibacterial drug Sumamed can cause allergic reaction, so you need to carefully monitor the baby’s condition.

Drug interactions

For respiratory tract infections, the antibiotic cannot be combined with alcohol, because azithromycin enhances its effect and increases its concentration in the blood. Antacids containing magnesium and aluminum reduce the absorption of azithromycin, so the medicine must be taken two hours after using these drugs. If concomitant use with warfarin is necessary, the patient's condition should be monitored. Subject to a certain time interval, Sumamed for children can be taken simultaneously with other drugs:

lincosamines;
Dihydroergotamine: enhances its effect;
tetracyclines or Chloramphenicol: enhancing the effectiveness of Sumamed;
food or antacids (this only decreases);
Cycloserine or indirect anticoagulants;
valproic acid, carbamazepine, phenytoin, bromocriptine.

Side effects and overdose

Pediatricians prescribe Sumamed, as a rule, after undergoing sensitivity tests, but sometimes a specialist only conducts an external examination of a small patient and, based on this, decides to take Sumamed. Ideally, the doctor should find out in advance whether the baby has allergies and what antibiotics he was given over the past six months. Among adverse reactions When using a high dosage of medication in children, the following is often observed:

skin rash;
diarrhea;
drowsiness;
violation heart rate;
nausea;
high activity of liver enzymes;
neurological disorders;
vomit.

Modern antibiotic from the group of macrolides, according to reviews of many parents, generally has an effect on children's body the most gentle impact. Rarely side effect from Sumamed is a violation of the intestinal microflora. As a rule, dysbacteriosis appears against the background of antibiotic use, so bifidobacteria and lactobacilli, probiotics Acipol or Linex are often prescribed along with the medicine. After the main treatment, parents of babies need to undergo a recovery course.

Sumamed for children is one of effective means combating community-acquired respiratory infections. A modern antibiotic capable of affecting most pathogenic microbes: pneumococcus, streptococcus and other intracellular pathogens. Created on the basis of the erythromycin A molecule, the antibiotic Sumamed is resistant to the acidic gastric environment. Easily penetrating all tissues, it specifically targets the source of infection, destroying bacteria and accelerating the healing process.

The only substance that can block and destroy the development of all microorganisms is an antibiotic. Thanks to the developments of scientists of the last century, we have ceased to be mortally afraid dangerous diseases: pneumonia, gangrene, tuberculosis. The pharmaceutical industry produces more than two hundred forms based on antibiotics medicines with a wide range of prices.

For the convenience of patients, the antibiotic is released in various forms: powders, suspensions, tablets, syrups or solutions.

Only a specialist can determine the need to take antibiotic drugs. The doctor is responsible for the correctness of the prescription antibacterial treatment. After examining the child, the pediatrician will explain the need to prescribe Sumamed or its analogues. An antibiotic should only be used when infection cannot be cured without antibacterial drugs.

Due to the productive impact on a large number of pathogenic microorganisms Sumamed for children has an advantage over generics.

Accumulating in the body, the drug is localized at the site of development infectious inflammation. The mechanism of action is aimed at suppressing protein production by the infected cell. Convenient use of Sumamed is facilitated by the optimal dosage for children, which allows the medicine to be used once every 24 hours. The instructions for use recommend that you take the antibiotic for at least 5 days. The analogue usually shows its effectiveness only after two weeks.

In what forms is it produced?

The active substance of Sumamed is dihydrate. The antibiotic contained in the preparation in terms of dry matter in various types a medicine is determined by its form:

Tablets for oral administration 125 mg;
Capsules 250 mg;
Syrup suspension 100 and 200 mg/5 ml;
Parenteral powder.

Biconvex round tablets with a dosage of 125 mg are produced in a blue coating. Tablets of the same shade, but elongated, contain 500 mg of antibiotic. The block contains the required number of tablets for the course of treatment: 3 tablets. 500 mg each, 6 tablets. 250 mg and 125 mg. Sumamed 250 capsules are contained in a hard gelatin shell, tinted blue. Inside them there is a dry substance from white to yellow tint. The minimum dosage of a blister is 6 pieces. From share active substance The price of the drug also depends.

The liquid form of Sumamed 100 mg and 200 mg differs in the final volume of the drug. The dry substance for syrup has shades of white and light yellow. For improvement taste qualities the suspension is made with the addition of cherry, strawberry or banana flavors. The powder comes with a measuring spoon or a special dispenser. The instructions included with the medicine recommend diluting Sumamed 100 or 200 powder with freshly prepared boiled water, cooled to room temperature.

In hospitals, azithromycin is used in the form of a lyophilisate to prepare drip infections. It is used in the treatment of severe forms of the disease.

For what diseases is it prescribed?

A modern antibiotic based on erythromycin A is prescribed for infectious diseases of various etiologies:

Spicy and chronic infections respiratory tract: bronchitis, pneumonia.
Infections of the ENT and respiratory organs: otitis media, rhinosinusitis, streptococcal tonsillitis and pharyngitis.
Infections and inflammations of the genitourinary tract: cystitis, urethritis.
Diseases of soft tissues and skin: – pustular diseases of the dermis, folliculitis – purulent inflammation hair follicle, erysipelas skin, dermatoses.
Ulcer of the stomach and duodenum.
Infectious borreliosis caused by the bite of an infected ixodid tick.

Using an antibiotic to treat children with diseases from the above list, you can achieve symptom relief after one (maximum two) doses of Sumamed 125 mg tablet.

For tonsillitis, an antibiotic is prescribed even if the patient does not have high temperature, but there is soreness in the throat and weakness. The number of applications and dosage are determined by a specialist depending on the diagnosis, age and health of the child.

Nuances of treatment with sumamed

The attached instructions specify that capsules of 250 mg and suspensions of 100 and 200 mg should be taken once every 24 hours, one hour before meals or 2 hours after. When taking pills, you don’t have to rely on meal times. Azithromycin should be taken with plenty of liquid.

To prepare the liquid form of the medicine, the instructions recommend adding cool boiled water to the container with the dry substance and stirring vigorously. The prepared suspension is increased by 5 ml. This compensates for the possibility of losses during dosage. The syrup is stored in the room for no more than 5 days. After each use of the medicine, you must thoroughly wash the measuring spoon or dispenser.

In the treatment of children from six months to 3 years old, 100/200 mg syrup or tablets are used. The dosage of the drug is 10 mg/kg body weight. Duration therapeutic therapy is three days. For erythema, the following recommendations for use are available: 20 mg/kg on the first day of therapy; then 10 mg/kg. The course of treatment should not exceed 5 days.

If you miss a dose of medication, you should take your daily dose immediately and the next one a day later.

Side effects

Before prescribing Sumamed, the pediatrician must find out whether there is an allergy to the antibiotic or its analogue. In general, azithromycin-based medications are well tolerated. But in medicine there is none antibiotic drug, which does not cause adverse reactions. Be careful when using Sumamed, as activation of liver enzymes, disturbances in heart rate, and pain in the abdominal cavity, nausea, diarrhea, drowsiness. Vomiting and loss of appetite rarely occur. Sometimes there is an accumulation of gases. IN exceptional cases Joint pain, rash and Quincke's edema may occur.

Such an antibiotic has a depressing effect not only on pathogenic bacteria, but also kills living intestinal microflora. To avoid the development of dysbiosis or candidiasis during treatment, attention should be paid to the correct use of probiotics. If atypical manifestations occur in a child, immediately consult your doctor.

Contraindications

Children with chronic diseases kidney;
Children with exacerbation of liver diseases;
Children with allergies to azithromycin and its components.

The correct dosage of the medicine will allow the child to quickly cope with the disease. The prepared suspension is prescribed to infants from six months. Children over 3 years old – tablets. Patients under 12 years of age and weighing less than 45 kg are prohibited from taking Sumamed 500 tablets. Sumamed injections are not prescribed until they reach 16 years of age.

You should not use antibiotics without consulting a specialist. Do not exceed the dose recommended by your doctor. Use an antibiotic only when emergency!

Analogs

Sometimes doctors recommend using a more affordable analogue of Sumamed. For example, the price of Serbian does not affect the quality of the drug. It is actively used in the treatment of infectious diseases of various etiologies. The analogue of sumamed deservedly stands out - Zetamax retard. Thanks to specially created microspheres, the active substance gradually penetrates the body, maintaining healing effect during the day. The pharmacy price for Zetamax does not differ from the cost of similar generics and depends on the form of release and dosage of the drug.

Among the imported drugs based on azithromycin, the following positively proven analogue can be distinguished: Azicide, Azitral, Sumamox, Zimax, etc.

Russian generics of similar action include: Azitrox, Zitrolit, AzitRus, Ecomed. These medications have a more affordable price, but they do not always meet your needs modern medicine, because they have a wider range of contraindications.