Sumamed 250 mg capsules instructions for use for children. Dosage depending on age, acceptable regularity of intake. Composition and dosage forms

In this article, you can read the instructions for using the drug Sumamed. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Sumamed in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Sumamed in the presence of existing structural analogues. Use for the treatment of tonsillitis, bronchitis, pneumonia and other infectious diseases in adults, children, as well as during pregnancy and lactation. Suspension preparation methods. The effect of alcohol on the simultaneous administration of the drug.

Sumamed- a bacteriostatic broad-spectrum antibiotic from the group of azalide macrolides. The mechanism of action of azithromycin (the active substance of the drug Sumamed) is associated with the suppression of protein synthesis of the microbial cell. By binding to the 50S subunit of the ribosome, it inhibits the peptide translocase at the translation stage and inhibits 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 an antibiotic or may acquire resistance to it.

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

Pharmacokinetics

After oral administration, azithromycin is well absorbed and rapidly distributed in the body. It is transported by phagocytes to the site of infection, where it is released in the presence of bacteria. Easily penetrates through histohematic barriers and enters the tissues. The concentration in tissues and cells is 10-50 times higher than in plasma, and in the focus of infection it is 24-34% higher than in healthy tissues. Demethylated in the liver, losing activity. The therapeutic concentration of azithromycin is maintained up to 5-7 days after 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);
• infections of the lower respiratory tract (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 (acne of moderate severity, erysipelas, impetigo, secondarily infected dermatoses);
• the initial stage of Lyme disease (borreliosis) - migratory erythema (erythema migrans);
• urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Release form

Film-coated tablets 125mg and 500mg.

Capsules 250 mg.

Lyophilisate for solution for infusion (injections) 500 mg.

Powder for suspension for oral administration 100 mg/5 ml.

Instructions for use and dosage

The drug is administered orally 1 time per day, at least 1 hour before or 2 hours after a meal. Tablets are taken without chewing.

Adults (including the elderly) and children over 12 years of age weighing more than 45 kg are prescribed in the form of tablets and capsules.

For children aged 6 months and older, the drug should be administered in the form of a suspension for oral administration, 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 tablets of 125 mg is dosed taking into account the body weight of the child.

For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues (with the exception of chronic migratory erythema), adults and children over 12 years old with a body weight of more than 45 kg are prescribed at 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 of body weight 1 time per day for 3 days, the course dose is 30 mg / kg.

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

With migrating erythema, the drug is prescribed 1 time per 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 2 to 5 days - 500 mg each; course dose - 3 g. Children aged 6 months and older are prescribed on the 1st day at a dose of 20 mg / kg of body weight and then from 2 to 5 days - daily at a dose of 10 mg / kg of body weight, course dose - 60 mg /kg.

With acne of moderate severity, the course dose is 6.0 g. Adults and children over 12 years old weighing more than 45 kg are prescribed at a dose of 500 mg 1 time per day for 3 days, then 500 mg 1 time per week for 9 weeks. The first weekly dose should be taken 7 days after the first daily dose (day 8 from the start of treatment), the next 8 weekly doses should be taken at intervals of 7 days.

For sexually transmitted infections, for the treatment of uncomplicated urethritis / cervicitis caused by Chlamydia trachomatis, the drug is prescribed at a dose of 1 g once; 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 (1, 7, 14 days), the course dose is 3 g.

For patients with moderate renal impairment (CC> 40 ml / min), dose adjustment is not required.

How to dilute and take the suspension

In a vial containing 17 g of powder, add 12 ml of distilled or boiled water. The volume of the resulting suspension is 23 ml. The shelf life of the prepared suspension is 5 days. Before use, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is allowed to drink a few sips of tea in order to rinse 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 with the drug.

Sumamed forte (as a suspension)

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

For infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic erythema migrans) - a total dose of 30 mg / kg, i.e. 10 mg/kg once a day for three days.

In chronic migrating erythema, the total dose of the drug is 60 mg / kg: on the 1st day - once 20 mg / kg; on the following days (from the 2nd to the 5th) - 10 mg / kg.

In 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 physician.

In the event that a dose of the drug was missed, it should, if possible, be taken immediately, and then subsequent doses - with an interval of 24 hours.

For sexually transmitted infections

Uncomplicated urethritis / cervicitis - 1 g, once.

Suspension preparation method

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

To prepare 30 ml of suspension (nominal volume), it is necessary to add 14.5 ml of water to a vial containing 1400 mg of azithromycin (actual volume is 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 is 42.5 ml of suspension).

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

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

Using a dosing syringe, measure the required amount of water, add to the vial with the powder. Before use, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained.

For dosing the finished suspension, use a syringe or measuring spoon.

Immediately after taking the suspension, the child is allowed to drink 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 spasms;
• flatulence;
• anorexia;
• hepatitis;
• itching, skin rashes;
• angioedema;
• hives;
• anaphylactic reaction (in rare cases fatal);
• joint pain;
• vaginitis;
• candidiasis.

Contraindications

• severe violations of the liver and kidneys;
• lactation period (breastfeeding);
• simultaneous reception with ergotamine and dihydroergotamine;
• hypersensitivity to macrolide antibiotics;
• children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg);
• children's age up to 3 years (for tablets 125 mg).

Use during pregnancy and lactation

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, the use of the drug during lactation, breastfeeding should be discontinued.

special instructions

In case of missing 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.

As well as during any antibiotic therapy, in the treatment with azithromycin, superinfection (including fungal) may be added.

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 about the need to inform the doctor about the occurrence of any side effect.

A negative effect of the joint intake of Sumamed and alcohol (hepatotoxic effect) was noted.

Influence on the ability to drive vehicles and mechanisms

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

drug 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 eating.

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

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

Azithromycin does not affect the pharmacokinetics of theophylline, however, when co-administered with other macrolides, theophylline plasma concentration may increase.

If necessary, joint use with cyclosporine, it is recommended to control the content of cyclosporine in the blood. Despite the fact that there are no data on the effect of azithromycin on changes in the concentration of cyclosporine in the blood, other members of the macrolide class are able to change its concentration in blood plasma.

When taking digoxin and Sumamed together, it is necessary to control the concentration of digoxin in the blood, because. many macrolides increase the absorption of digoxin from the intestine, thereby increasing its concentration in 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 antibiotics of the macrolide class 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 excretion by the kidneys of it and its glucuronide metabolite. However, the concentration of the active metabolite, phosphorylated zidovudine, increases in mononuclear cells of peripheral vessels. The clinical significance of this fact is not clear.

With the simultaneous administration of macrolides with ergotamine and dihydroergotamine, their toxic effects may occur.

Analogues of the drug Sumamed

Structural analogues for 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;
• Zitrocin;
• Sumazid;
• Sumaclid;
• Sumamed forte;
• sumamecin;
• sumamecin forte;
• Sumamox;
• Sumatrolide solutab;
• Tremak-Sanovel;
• Hemomycin;
• Ecomed.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Infection with mutated viruses and prolonged illness complicate the recovery process: traditional medicines may not be able to cope with the disease. The immunity of a child is even more susceptible to infection, and the resistance of a fragile organism is much lower than that of an adult.

The use of antibiotics helps to defeat complex infectious diseases. One of the brightest representatives of the group is the drug Sumamed. While other drugs to suppress pathogenic microorganisms may be of low effectiveness, Sumamed in more than 90% of cases demonstrates the ability to destroy even the most insidious infections.

Composition, description, release form (125, 250 and 500 mg)

Sumamed refers to azalide antibiotics. This is a recently discovered new group of drugs with a pronounced bactericidal effect.

The main active ingredient is , excipients are sucrose, xanth gum, flavor, hyprolose and other components that bind the tablet structure.

The packaging has a protective valve to prevent outsiders from accessing the contents of the box until Sumamed is sold.

There are 3 forms for sale:

The capsule form is sold only in pills of 250 mg, tablets - 125 and 500 mg.

The tablets have a blue tint with the word PLIVA embossed, the powder has white-yellow color variations.

Tablets are also divided into 2 varieties - film-coated and dispersible.

The latter type is used in adults due to the high concentration of azithromycin (1 g) or in children with serious illnesses. In loose form, the release form of Sumamed Forte is realized, which is used to prepare a suspension (it has a raspberry, banana or cherry flavor). All varieties of the drug are manufactured by Teva (Croatia).

Azithromycin does not have a detrimental effect on gram-positive bacteria that are resistant to erythromycin.

Indications

Sumamed is a universal remedy that is prescribed for almost any progressive disease associated with the influence of an infectious factor. For children, the remedy is prescribed by pediatricians for complications caused by a cold or flu.

Positive effect on diseases:

The use of the drug in dermatology is also justified in the detection of other pathogenic microorganisms - mycoplasmas, borrelia.

In children, mycoplasmosis often affects the respiratory system, in adults it develops in the urogenital area.

A doctor can prescribe an antibiotic when diagnosing Lyme disease (transmitted by ticks), impetigo (expressed by a change in the skin with the appearance of scabs), inflammation of the cervix - cervicitis (a rare pathology diagnosed in childhood in girls).

Contraindications

With caution, you should take the medicine in the presence of diseases of the cardiovascular system (especially with the prolongation of the QT interval on the cardiogram), myasthenia gravis, and diabetes mellitus. There are completely prohibitive states of the body to the use of macrolide antibiotics.

Taboo on taking funds:

• individual intolerance;
• pathological changes in the liver and kidneys;
• allergic reaction to macrolide antibiotics.

Despite the sparing effect of Sumamed on the microflora (compared to non-macrolide type antibiotics), Croatian remedy is not recommended for children with dysbacteriosis, which only increases when exposed to an antibiotic drug.

How the drug works, after what time the effect is noticeable

After azithromycin enters the blood, the synthesis of microbial cells is suppressed, while growth and the process of its numerical increase slow down. Antibiotic components easily overcome the membrane barrier of cells, therefore Sumamed is effective in fighting infections related to intracellular pathogens.

The accumulation of azithromycin in the blood occurs after 3 hours - it is after such a period of time that the therapeutic effect begins to be observed.

Macrolide accumulation is a priority for cells and tissues in which the accumulation of azithromycin is up to 50 times higher than in blood plasma. After discontinuation of the drug, the therapeutic concentration of the active substance remains in the cells of the body for up to 1 week.

Dosage depending on age, acceptable regularity of intake

Regardless of the form taken and the age of the child, the antibiotic is always used once a day.

Method of application and special instructions

Sumamed is taken 1 time per day 2 hours after meals.

On the fourth day, the use of Sumamed is stopped, but there are some exceptions.

An extension of the treatment period is possible in the treatment of acne.

The drug is still taken in a concentration acceptable for the age of the child, and then only 1 tablet with the same content of azithromycin is drunk every week.

A similar frequency of administration is maintained for 9 weeks (the total course dosage is 6 g).

The dispersible tablet, which contains a concentration of 1000 mg of macrolide, is suitable for a single dose of an increased dose, which is necessary for diseases such as cervicitis, uncomplicated urethritis, and Lyme disease (take 1 g for the first day, then 500 mg for two -five days).

Warning. Food reduces the absorption of Sumamed, so the two-hour time interval for taking tablets after food intake must be observed.

Interactions with other drugs, with which it can and cannot be combined

Taking antacid (anti-heartburn) drugs, as well as alcoholic beverages, reduces the ability of the intestine to absorb the active substance. The combination of a macrolide antibiotic with antiplatelet agents (aspirin) is not recommended.

Combinations with different substances and observed effects:

• Lincosamides. The effect of the remedy is reduced.
• Tetracyclines. The impact is intensifying.
• Methylprednisolone and felopidin. Increased toxicity.
• Chloramphenicol. Efficiency is improved.
• Indirect anticoagulants, cycloserine. Carcinogenicity increases.

With the receipt of funds, including valproic acid, phenytoin, disopyramide, carbamazepine, theophylline, the risk of side effects (hepatotoxic effect) also increases.

The combination of macrolide antibiotics with heparin is strictly contraindicated.

Overdose and side effects

Negative reactions of the body appear both after an overdose and with the use of the permitted concentration of the substance. The most common disorders of the functioning of the digestive tract: flatulence, diarrhea, loss of appetite, nausea.

Other possible side effects:

• skin rashes and itching;
• dizziness;
• insomnia;
• increased anxiety;

Sumamed also changes the composition of the blood - after passing laboratory tests, a decrease in the concentration of lymphocytes and an increase in the content of eosinophils are revealed. In girls, the activation of Candida fungus is possible, which leads to a recurrence of vaginal thrush.

Price in Russia, conditions of release and storage, expiration date

Tablets and capsules are stored for no more than two years, provided they are in a place protected from moisture and sunlight.

Estimated cost:

• capsules: 250 mg (6 pcs) - 455-480 rubles.
• coated tablets: 125 mg (6 tablets) - 320–340 rubles.
• suspension: 20 ml (flask) - 218–230 rubles.

You can buy the drug in pharmacy chains only with a prescription.

Active substance

Azithromycin

Dosage form

Manufacturer

Pliva Hrvatska doo, Croatia

Compound

1 capsule contains azithromycin dihydrate 250 mg

pharmachologic effect

Pharmaceutical group: antibiotic-azalide.
Pharmaceutical action: Azithromycin is a broad-spectrum bacteriostatic antibiotic from the group of azalide macrolides. It has a wide spectrum of antimicrobial activity. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of microbial cells. By binding to the 50S subunit of the ribosome, it inhibits the peptide translocase at the translation stage and inhibits protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.
It has activity against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.
Susceptible microorganisms: aerobic gram-positive microorganisms - Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes; aerobic gram-negative microorganisms - Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic microorganisms - Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp.; other microorganisms - Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Microorganisms with acquired resistance to azithromycin: aerobic gram-positive microorganisms - Streptococcus pneumoniae (penicillin-resistant strains and strains with medium sensitivity to penicillin).
Microorganisms with natural resistance: aerobic gram-positive microorganisms - Enterococcus faecalis, Staphylococcus aureus (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains), anaerobic microorganisms - Bacteroides fragilis.
Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic streptococcus group A), Enterococcus faecalis and Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides have been described.
Microorganism susceptibility scale to azithromycin (minimum inhibitory concentration - MIC)

MicroorganismsMIC, mg/l*SusceptibleResistantStaphylococcus2Streptococcus A, B, C, G0.5Streptococcus pneumoniae0.5Haemophilus influenzae4Moraxella catarrhalis0.5Neisseria gonorrhoeae0.5

* Azithromycin has not been used to treat infectious diseases caused by Salmonella typhi (MIC ≤16 mg/l) and Shigella spp.
Pharmacokinetics: After oral administration, azithromycin is well absorbed and rapidly distributed in the body. After a single oral dose of 500 mg, bioavailability is 37% (first pass effect), Cmax (0.4 mg / ml) in blood plasma is created after 2–3 hours, apparent Vd is 31.1 l / kg. Plasma protein binding is inversely proportional to blood concentration and is 7-50%. Penetrates through cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria. Easily passes through histohematic barriers and enters the tissues. The concentration in tissues and cells is 50 times higher than in blood plasma, and in the focus of infection it is 24–34% higher than in healthy tissues.
Azithromycin has a long T1 / 2 - 35–50 hours. T1 / 2 from tissues is much larger. Therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is excreted mainly unchanged - 50% through the intestines, 6% by the kidneys. Demethylated in the liver, losing activity.
In patients with severe renal insufficiency (Cl creatinine) 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 the drug is 65-72 hours. The high level of observed Vd (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 the tissues, followed by a slow his 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 serum was 1.14 μg / ml. The minimum level in blood serum (0.18 µg/ml) was observed within 24 hours and the AUC was 8.03 µg·h/ml. Similar pharmacokinetic values ​​were obtained in patients with community-acquired pneumonia, who were given intravenous infusion (3-hour) 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 during the 24-hour dosing interval.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the lower respiratory tract (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis);
- infections of the upper respiratory tract and ear (bacterial pharyngitis, tonsillitis, sinusitis, otitis media);
- infections of the skin and soft tissues (chronic erythema migrans - the initial stage, Lyme disease, erysipelas, impetigo, secondary dermatoses);
- sexually transmitted infections (urethritis, cervicitis);
- diseases of the stomach and duodenum associated with Helicobacter pylori.

Use during pregnancy and lactation

During pregnancy, the drug should be administered only if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to administer Sumamed to women during lactation, it is necessary to resolve the issue of stopping breastfeeding.

Contraindications

- hypersensitivity to macrolide antibiotics;
- severe violations of the liver and kidneys;
With caution: during pregnancy and lactation, with impaired liver and kidney function, patients with disorders or predisposition to arrhythmias and prolongation of the QT interval.

Interaction

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 eating.
Azithromycin, unlike other macrolide antibiotics, does not bind to isoenzymes of the cytochrome P450 system. To date, there has been no interaction with theophylline, terfenadine, carbamazepine, triazolam, digoxin.
Macrolides, when taken simultaneously with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs that are subject to microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents), slow down the excretion, increase the concentration and toxicity of these drugs , while no such interaction has been noted with the use of azalides to date.
If co-administration with warfarin is necessary, careful monitoring of prothrombin time is recommended.
With the simultaneous administration of macrolides with ergotamine and dihydroergotamine, their toxic effects (vasospasm, dysesthesia) may occur.
Lincosamines reduce, and tetracycline and chloramphenicol increase the effectiveness of azithromycin.
Azithromycin is pharmaceutically incompatible with heparin.

How to take, course of administration and dosage

The drug is administered orally 1 time per day. Capsules are taken at least 1 hour before or 2 hours after meals.

For infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic migratory erythema), adults are prescribed the drug at a dose of 500 mg 1 time / day for 3 days, the course dose is 1.5 g.
Children are prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days, the course dose is 30 mg / kg.

For chronic erythema migrans:
for adults, the drug is prescribed 1 time / day for 5 days: 1 day - 1 g (2 tablets of 500 mg), then from 2 to 5 days - 500 mg each, a course dose of 3 g.
Children are prescribed on day 1 at a dose of 20 mg / kg of body weight and then from 2 to 5 days - daily at a dose of 10 mg / kg of body weight, a course dose of 60 mg / kg.

Sumamed is a new generation antibiotic for children. The main working component of the drug is azithromycin. Since the drug entered the pharmacology market recently, detailed information about its action and use will be important for parents. Antibiotics are serious drugs and require strict adherence to the rules for their administration, especially when used in the treatment of children.

How does the drug work?

The drug is included in the group of macrolides-azalides, fights microbes of various types. Penetrating into bacterial cells, Sumamed disrupts the process of protein synthesis in them, which leads to a decrease in their ability to reproduce and grow. At a high concentration of the active substance, the bactericidal effect of the drug is also manifested. Azithromycin is delivered to the lesion by blood and immune cells, which provides an immediate therapeutic effect.

Sumamed is especially attractive for children because it retains its therapeutic effect for a long time. It is enough for a child to give one tablet a day so that an intense detrimental effect on pathogenic microbes takes place in the body. The course of admission is also reduced and is 3-5 days. For children who do not like to be treated for a long time, such an effective antibiotic is ideal.

When is Sumamed prescribed?

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The drug Sumamed is often prescribed to children with pneumonia.

Indications for taking Sumamed are prescribed in the instructions attached to it. The antibiotic stops inflammatory manifestations and infectious processes of bacterial origin. We list the main ones:

• infection with microbes affecting the ENT organs and upper respiratory tract (tonsillitis, sinusitis, otitis media);
• bronchitis in acute and chronic form, pneumonia;
• acne vulgaris (pimples and blackheads), manifested by moderate severity;
• lesions of the epidermis and muscle tissues of an infectious nature (erysipelas, impetigo);
• Lyme disease in its initial stage;
• urinary tract infection caused by Chlamydia trachomatis.

Dosage forms

They produce a drug aimed at treating children in various dosage forms. Pharmacies offer:

1. Biconvex tablets of 125 mg, round, film-coated, blue. There are engraved designations - "125" or "PLIVA". Sold in a package: one blister - 6 tablets.
2. Tablets 500 mg oval. If you break it, inside it will be white. There are engravings "500" or "PLIVA". The blister contains 3 tablets.
3. Gelatin capsules containing a white or light yellow powder. The shell of the capsules is colored blue, the cap is blue. Blister for 6 capsules.
4. Powder in the form of the smallest granules to obtain a suspension (syrup), white or light yellow in color. The syrup obtained by dissolving the powder has a cherry or banana flavor. To measure the dose in the package there is a measuring spoon or syringe.

Sumamed in the form of a powder for the preparation of a suspension is convenient for accurately measuring the amount of the drug needed by the child

How to give medicine?

Babies from 6 months of age to 3 years of age are given the drug in the form of a suspension. When diluting the powder with water, you get a liquid with the consistency of jelly, which is very popular with many children. In addition, this choice is due to the following factors:

• pleasant taste of the suspension;
• the baby perceives liquid medicine more easily;
• simplifies the preparation of the required dose.

Tablets are prescribed for children from 3 years of age and older. They cannot be chewed, so parents should ensure that the child swallows the pill without biting it. If your baby chokes on pills, cannot swallow them normally, buy him a Sumamed suspension. The drug in capsules is not recommended for children under 12 years of age, because even at an older age they can hardly swallow them.

Treatment of a child older than three years can be carried out with the help of tablets that are washed down with water without chewing.

How is the course of treatment built?

The correct dose is calculated in the same way as any other children's medicine: 10 mg of the drug per 1 kg of weight. The heading dose of Sumamed is 30 mg / kg. Reception lasts 3 days. Since the remedy belongs to antibiotics, they drink it strictly according to the established daily dose. For a competent calculation of the medicine, consider the labeling indicated on the package of the medicine.

What do the numbers mean?

The content of azithromycin, the working substance of the drug, in one tablet or capsule is written in numbers - 100, 125, 200, 250, 500 milligrams. For a suspension, this indicator means the content of azithromycin in 5 ml of the finished drug. However, it is not worth doing independent calculations, the pediatrician observing the patient himself will select the correct dosage for him.

The importance of the full course

Despite the visible improvements that appeared in the child after the start of taking Sumamed, the course should not be stopped. Please note that only with the full course of the infection will be completely destroyed. If the treatment process is interrupted, the microbes will develop resistance to the drug and the disease will return. Be sure to correlate the dose of the drug with the weight of the child. Children may weigh more or less than the average for their age group.

When is the drug contraindicated?

Contraindications to the use of Sumamed are:

• high susceptibility of the organism to azithromycin, erythromycin, other antibiotics from a number of macrolides or ketolides, other components of the drug;
• simultaneous reception with ergotamine and dihydroergotamine;
• pathology of the liver and kidneys;
• sucrase deficiency, fructose intolerance, glucose-galactose malabsorption.

Patients under 12 years of age should not take Sumamed capsules or tablets, the dosage of which is 500 mg. The dosage of 125 mg is unacceptable for 3-year-olds and younger. Infants under 6 months are not given syrup (suspension).

In addition, the list of contraindications includes such diseases as arrhythmia, myasthenia gravis, bradycardia, heart failure, occurring in adult patients.

Instructions for use

Tablets

1. Traditionally, the calculation for children's drugs is as follows: 10 mg per 1 kg of weight. This dose is set for ENT infections, skin and muscle tissue lesions. The daily dose for a weight of 18-30 kg is 200-250 mg (2 tablets of 100-125 mg), given once a day. With a weight of 31-44 kg - three tablets (375 mg), once a day for 3 days.
2. With pharyngitis or tonsillitis - 20 mg per 1 kg, frequency of administration - 1 time per day, duration of administration - 3 days.
3. Some diseases require a special calculation for the dosage of the antibiotic. So, with Lyme disease, a small patient is expected to take medication based on 20 mg per 1 kg of weight on the first day from the start of treatment. Then they continue to take it for another 3 days, but already at the usual rate of 10 mg per kilogram of the child's weight. Parents should take into account all the nuances of taking an antibiotic and not resort to its help without consulting a doctor.

Only a doctor can prescribe the drug Sumamed and its dosage for a child, you cannot do it yourself

Suspension

For babies from 6 months to 3 years old, Sumamed is prescribed in the form of a powder, from which a liquid suspension is prepared. In order to correctly calculate the amount of the drug for a child weighing less than 15 kg, the suspension must be diluted with a syringe. If the baby weighs more than 15 kg, measure the dose with a measuring spoon:

• In case of bacterial damage to the organs of the upper respiratory tract and skin diseases, the suspension is taken at a dosage of 10 mg per 1 kg of weight.
• With tonsillitis or pharyngitis (with streptococcal infection), the ratio is 20 mg per 1 kg of weight with a frequency of administration 1 time per day for 3 days.
• To combat the initial stage of Lyme disease, the scheme changes: the first day - a daily dose of 20 mg / kg, then 4 days at 10 mg / kg, once a day.

In addition, parents of young patients should study in detail the rules for preparing the suspension.

How is the suspension prepared?

Sumamed powder is placed in a vial, and in order to obtain a suspension, it must be diluted with 12 ml of water, which is drawn into a syringe. Then the vial should be shaken thoroughly. The suspension obtained in this way is stored at room conditions, but make sure that the temperature is not higher than +25 degrees (it is allowed to store no more than 5 days). Shake the vial before using the drug. A syringe and a measuring spoon for dilution of the suspension are attached to the package.

For older children who have a bad attitude to drugs in solid form, you can buy Sumamed forte - this is a powder with a high content of azithromycin: 200 mg per 5 ml.

How is the suspension given?

The suspension, as well as tablets, is used at the same time, while the drug can be washed down with water

Many parents know how difficult it is to give medicine to six-month-old babies, they do not want to drink it, they spit it out and choke. Simple rules will help you do everything right:

• try to give the suspension at a certain time;
• Sumamed should be drunk one hour before meals or two hours after it;
• give the child the medicine to drink with a little water or unsweetened tea.

Dosage calculation rules

For parents of babies up to a year old, the dosage is calculated based on weight. Remember that you are giving your child an antibiotic - its amount must be strictly measured. To do this, a syringe is specially added to the package with the medicine, according to the divisions of which it will be easier for you to collect the required amount.

Correlating the weight of the patient and the amount of medication, we compiled a table of application:

Adverse reactions

Side effects from the drug Sumamed occur in very rare cases.

The likelihood of an adverse reaction to Sumamed in a small patient is very small. According to statistics, it manifests itself in only 1% of babies. The instruction indicates the following negative manifestations:

• diarrhea or constipation, decreased appetite, vomiting, nausea, signs of gastritis or cholesteric jaundice;
• nephritis in rare cases;
• vaginal candidiasis;
• pain in the chest, palpitations;
• sleep disturbance, weakness, headaches, unreasonable anxiety;
• allergy - manifestations of rash, itching, redness, conjunctivitis were noted;
• photosensitivity.

How to reduce side effects?

Initially, the properties sparing for the child's body, which were initially invested in the antibiotic, greatly reduced the risk of allergies and dysbacteriosis. However, to reduce this risk, doctors recommend taking Sumamed along with antihistamines (Suprastin, Zirtek) against allergic reactions. To prevent dysbacteriosis, you should drink probiotics (Linex, Acipol) (we recommend reading:). It is useful to take lacto- and bifidobacteria.

Suprastin will reduce the side effect of the antibiotic on the child's body

Consequences of an overdose of the drug

Is it possible to overdose the medicine if you know that it is an antibiotic and a child is being treated with it? Well, there are such cases. You can determine the excess dose by the following signs: vomiting, diarrhea, temporary hearing loss, nausea. With such reactions, you should immediately show the baby to the doctor, who will certainly prescribe symptomatic treatment to the patient to alleviate the condition.

Manufacturers of Sumamed and its analogues

The main manufacturers of the original Sumamed are Pliva Hrvatska, a Croatian pharmaceutical company, and Teva from Israel. The Russian analogue of the drug is called Azithromycin. In addition, domestic pharmacologists offer drugs such as:

• Zitrolide;
• Azitrox;
• Z-factor;
• Sumazid.

Foreign analogues are also sold: Yugoslav Hemomitsin, Indian Azitral, Sumamox and Azivok. As a rule, all analogues are cheaper than the original drug.

– the main active substance Sumamed ® , refers to a wide spectrum of antibacterial agents. Depending on the concentration in the infectious focus, the agent is able to exhibit both bacteriostatic and bactericidal mechanism of action. Azithromycin (Sumamed ®) is a representative of a subclass of azalides that are 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, inhibiting the 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 excreted from the body longer and has a prolonged effect, maintaining effective bactericidal concentrations in the affected organs and tissues for a long time.

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

Pharmacological group

Antibiotics azalides-macrolides.

Sumamed ® is an antibiotic or not?

Sumamed ® - release form and prices

Sumamed is produced by the Israeli pharmaceutical company Pliva Hrvatska d.o.o ® .

The price of an antibiotic in Russian pharmacies is about:

• 280 rubles for a bottle of a 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. for a vial with 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 manufacture of an infusion solution of 500 mg.

Recipe Sumamed ® in Latin

Rp: Summedi 0.25.
D.t. d. N. 5 in tab.
D.S. 1 tab. once a day one hour before meals.

The composition of the drug Sumamed ®

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

In capsules containing 0.25 grams of azithromycin, the content of gelatin, sulfur dioxide, indigo carmine, titanium dioxide, sodium lauryl sulfate and microcrystalline cellulose is indicated.

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

Lyophilisate vials contain 0.5 grams of azithromycin in the form of a dihydrate, citric acid in the form of a monohydrate, and sodium hydroxide.

What does the medicine Sumamed ® help with?

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

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

Azithromycin does not work against strains resistant to erythromycin preparations.

Pharmacodynamics

Azithromycin has a higher bioavailability and complete absorption in the gastrointestinal tract than erythromycin. Rapid and complete absorption after oral administration 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 pancreas. Good accumulation in tissues and a prolonged effect are due to the low binding of the macrolide to the plasma elements of the blood. Also, the specific features of azithromycin include its ability to penetrate into eukaryotic cells and accumulate in low pH environments surrounding lysosomes. This distribution of the drug determines its high efficiency in the fight against intracellular pathogens.

Azithromycin is delivered to the focus of the inflammatory process by phagocytes, then the antibiotic is released during 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 unutilized antibiotic residues are recaptured by phagocytes. 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 ones.

Sumamed ® indications for use

• Azithromycin is prescribed for the treatment of diseases caused by sensitive flora. It is effective in 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 to prevent rheumatic complications instead of bicillin, if the patient has, and the treatment of tonsillitis was carried out with another antibiotic.
• Used in prevention (post-exposure) and treatment.
• Azithromycin preparations are indicated for lesions of the skin and pancreas. May be used in 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 long-term use.
• In venereology, the antibiotic is used to treat STD infections, uncomplicated and complicated urethritis, and chlamydial and gonorrheal etiology.
• If necessary, it is prescribed in schemes - for the treatment of gastric ulcer and duodenal ulcer, when it is impossible to prescribe clarithromycin.
• It is used in stepwise therapy, that is, Sumamed ® can be administered parenterally, with a subsequent transition to tablet intake.

Dosage Sumamed ® for adults

The standard dosage of Sumamed ® for adults is 500 mg 1 time per day for a three-day course. Or 500 mg on day 1, followed by 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 for 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. In moderate and severe cases, the duration of treatment increases.

With an infectious lesion 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 each for four more days.

With the eradication of Helicobacter, the antibiotic is prescribed per gram, 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 disease, accompanied by its dysfunction;
• simultaneous use with ergotamine and dihydroergotamine preparations;
• malabsorption syndrome associated with deficiency of disaccharidases.

According to age restrictions, Sumamed ® :

• in the form of a suspension do not give babies up to 6 months;
• 125 mg tablets - for patients under three years of age;
• capsules Sumamed ® 250 mg for children under 12 years old;
• tab. 500 mg each - for children under 12 years old;
• parenteral administration (Sumamed ® in the form of a 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 the indications, after a comprehensive assessment by the doctor of the ratio of the expected benefit and the expected risk. It is important to remember that any antibiotics during pregnancy are always a risk, so their appointment should be strictly justified and balanced. Independent use of drugs, as well as changing the doses prescribed by the doctor and the duration of the course, is unacceptable.

Sumamed ® during breastfeeding is prescribed under the condition of a temporary cessation of breastfeeding

Also, with caution, the drug can be used in patients with myasthenia gravis, liver dysfunctions of moderate and mild severity, terminal kidney failure, diabetes mellitus, CCC pathologies accompanied by rhythm disturbances and a prolonged 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 upper respiratory tract and respiratory tract, for patients who are allergic to beta-lactam preparations.

Given the ability of the antibiotic to penetrate 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 may lead to drug-induced hepatitis.

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

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

Sumamed ® - side effects

The drug has low toxicity and is generally well tolerated by patients. Side effects of Sumamed ® can be manifested by feeling, stool disorders, abdominal pain, flatulence. Extremely rarely, antibiotic-associated diarrhea and pseudomembranous colitis develop.

Quite often observed and vaginitis.

Instructions for use Sumamed ® suspension for children

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

With erythema migrans, 20 mg per kg is prescribed on the first day, then 10 mg per kg for 4 days.

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

How to take Sumamed ®

Consider frequently asked questions to pharmacists and doctors on azithromycin.

Sumamed ® should be taken before meals or after?

Instructions for the use of Sumamed ® (including the children's form) indicate that the remedy should be taken 1 time per day 1 hour before or 2 hours after a meal.

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

It is necessary 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 vial)?

In a vial containing:

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

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

How to give the suspension to a child?

The finished suspension should be shaken thoroughly before use. The required amount of the drug is taken from the vial with a dosing syringe or poured into a special spoon (they are included). 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 part of the suspension remaining in the oral cavity.

Sumamed ® - reviews for adults and for children

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

Patients who took the remedy, in their reviews note a quick effect from its use. In the treatment of the respiratory tract, temperature stabilization and improvement in the general condition occurs on the second day of admission.

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 comorbidities that complicate the course of the disease, etc.).

It must be understood that each person is individual and one disease in any patient may have a different course, and accordingly, the reaction to the drug may 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 in a day.

However, with a moderate disease, it is advisable to apply a five-day course of therapy, and the improvement from taking Sumamed ® may be noticeable by the end of the second day. The treatment of respiratory chlamydia takes from two weeks, respectively, and the improvement will come more slowly than in previous cases.

A significant advantage over other drugs is the good tolerance 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).