Azithromycin syrup instructions for use for children. Effective universal antibiotic Azithromycin (instructions for use)

Every mother tries to avoid the use of antibiotics during a child’s illness. When the pediatrician declares the need for such funds, most parents begin to panic. However, not everything is so scary. In some cases, antibacterial drugs can quickly cope with the infection and return the baby to good health. One of the frequently prescribed medications is Azithromycin. Instructions for use (the drug is used quite often for children) will be presented to your attention below. You can also find out about substitutes for this drug and reviews about it.

What is Azithromycin?

For a child, the choice of drug is very important. This medication is an antibiotic. It represents a group of macrolides. The medication has a bactericidal and bacteriostatic effect on the patient's body. The drug is available in dosages of 100, 125, 250 and 500 milligrams. The main active ingredient is azithromycin. Depending on the form of release, the medicine may have additional components. Thus, the medicine is available in the form of gelatin-coated capsules, hard tablets, suspension and powder for its preparation.

Azithromycin for a child is one of the most frequently prescribed drugs. It is very easy to use and can give a quick positive effect. This product is also quite safe for children's bodies.

When do children need the described antibiotic?

The drug "Azithromycin" for a child should be prescribed exclusively by a pediatrician. Self-use can lead to negative reactions and unpleasant consequences. Medicine is usually prescribed after analysis. An antibiotic is also indicated when other medications have not given a positive result within five days. The main indications for the use of Azithromycin for a child are the following situations:

diseases affecting the upper respiratory tract (tonsillitis, tonsillitis, sinusitis, laryngitis, nasopharyngitis, and so on);
infections affecting the lower respiratory tract (bronchitis, pneumonia, tuberculosis and others);
scarlet fever;
infections that cause damage to soft tissues and mucous membranes;
urinary tract infections.

This medicine may also be prescribed by doctors in other situations. In this case, each case is considered individually.

Contraindications to treatment

In what cases is it worth limiting the use of medication or completely abandoning treatment with Azithromycin? Instructions for use (for children it is especially important to take into account contraindications) informs about the following situations:

the child's age is less than 12 years (capsules, tablets) or less than 6 months (suspension);
renal failure in an advanced form;
liver diseases, including acquired ones;
hypersensitivity to azithromycin;
some diseases of the stomach and intestines.

Dosage of the drug

Doctors usually prescribe Azithromycin 250 mg for children. However, for children under three years of age it is preferable to give a suspension. The dosage of the medication depends on the age of the patient and the choice of dosage form.

For children under 16 years of age, the drug is prescribed at the rate of 10 milligrams of azithromycin per kilogram of body weight. Since it is preferable to choose a medicine for children under 12 years of age in the form of a suspension, the dose is calculated as follows. For example, your child weighs 10 kilograms. In this case, he needs to be given 100 milligrams of azithromycin. The syrup is available in two doses: 100 and 200 mg per 5 milliliters of the drug. This means that in the first case the baby needs to be given 5 ml of medicine, and in the second - 2.5.

Tablets at a dose of 250 mg are recommended for children over 12 years of age. In this case, you need to drink no more than one capsule or pill per day. It is worth noting that treatment with this medication lasts only three days. Only in particularly difficult situations this period can be extended to 4-5 days.

Features of the use of the drug

If Azithromycin 250 mg tablets are prescribed for children, they should not be chewed or crushed. The drug must enter the stomach unchanged. When using the suspension, shake it well each time before use. Also, the medicine should be taken with plenty of water. This is especially true

The medication is taken one hour before meals or two hours after meals. It is also worth remembering about the simultaneous use of other drugs. Many medications can suppress or enhance the effects of each other. That is why doctors recommend taking a break of two hours between various drugs and Azithromycin.

Side effects

What does the instructions say about the drug Azithromycin? For children, according to the abstract, antibiotics should only be prescribed by a doctor, because this drug can cause side effects. However, doctors assure that if the specified dosage is observed, the medication is well tolerated. Among the most common side effects, experts note weakness, malaise or anxiety, abdominal pain, abnormal bowel movements or nausea.

Antibacterial agents

Name

powder for the preparation of suspension for oral administration 100 mg/5 ml, 200 mg/5 ml; 50 mg, 100 mg, 200 mg

Pharmacotherapeutic group

Antibiotic - azalide

Trade name

AzitRus®

International nonproprietary name

azithromycin

Dosage form

Powder for the preparation of suspension for oral administration.

Compound

Active substance: azithromycin dihydrate in terms of azithromycin - 50 mg, 100 mg, 200 mg, 400 mg, 800 mg, 1200 mg Excipients: sodium citrate (sodium citrate trisubstituted), food orange flavor, sodium saccharinate (soluble saccharin), collidon CL-M (crospovidone), sugar (sucrose).

ATX Code

Pharmacological properties

Pharmacodynamics A broad-spectrum antibiotic, azalide, has a bacteriostatic effect. By binding to the 50S subunit of the ribosome, it inhibits protein synthesis, slows down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect. Acts on extra- and intracellular pathogens. Active against gram-positive microorganisms: Streptococcus spp. (groups C, F and G, except those resistant to erythromycin), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus epidermidis, Staphylococcus aureus; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Helicobacter pylori, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp.; as well as intracellular pathogens: Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium avium complex, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Inactive against gram-positive bacteria resistant to erythromycin. Pharmacokinetics Azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic environment and lipophilicity. It is quickly distributed throughout the body, while high concentrations of the antibiotic are achieved in the tissues. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is reached after 2.5 - 2.9 hours and is 0.4 mg/l. Bioavailability is 37.5%. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular, the prostate gland), skin and soft tissues. The high concentration in tissues (10-50 times higher than in blood plasma) and the long half-life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in the low pH environment surrounding lysosomes. This, in turn, determines the large apparent volume of distribution (31.1 l/kg) and high plasma clearance. The ability of azithromycin to accumulate predominantly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that phagocytes deliver azithromycin to sites of infection, where it is released during the process of phagocytosis. The concentration of azithromycin in foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which has made it possible to develop short (3-day and 5-day) courses of treatment. It is demethylated in the liver, the resulting metabolites are not active. The elimination of azithromycin from blood plasma occurs in 2 stages: the half-life is 14-20 hours in the range from 8 to 24 hours after taking the drug and 41 hours in the range from 24 to 72 hours, which allows the drug to be used once a day. The drug is excreted mainly in bile unchanged, a small part is excreted by the kidneys.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug; Infections of the upper respiratory tract and ENT organs (tonsillitis, sinusitis, tonsillitis, pharyngitis, otitis media); Scarlet fever; Infections of the lower respiratory tract (bacterial and atypical pneumonia, exacerbation of chronic pneumonia, bronchitis); Infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses); Urinary tract infections (gonorrheal and non-gonorrheal urethritis, cervicitis); Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans); Diseases of the stomach and duodenum associated with Helicobacter pylori (as part of combination therapy).

Contraindications

Hypersensitivity (including to other macrolides); liver and/or renal failure, lactation period, children under 6 months of age (efficacy and safety have not been established).

Use during pregnancy

Directions for use

Directions for use and doses

Orally 1 hour before or 2 hours after meals 1 time per day.
Adults: for infections of the upper and lower respiratory tract – 500 mg/day in one dose for 3 days (course dose – 1.5 g).
For infections of the skin and soft tissues - 1000 mg/day on the first day in 1 dose, then
500 mg/day daily from days 2 to 5 (course dose – 3 g).
For acute infections of the genitourinary organs (uncomplicated urethritis or cervicitis) – 1 g once.
For Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) - 1 g on the first day and 500 mg daily from days 2 to 5 (course dose - 3 g).
For gastric and duodenal ulcers associated with Helicobacter pylori – 1 g/day for 3 days as part of combination anti-Helicobacter pylori therapy.
Children with infections of the upper and lower respiratory tract, skin and soft tissues are prescribed at the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose - 30 mg/kg body weight) or for 5 days: on the first day – 10 mg/kg body weight, then 5-10 mg/kg body weight 1 time per day for 4 days.
Depending on the child’s body weight, the following dosage regimens are recommended:

Body weight
Release form

Average daily (single) dose

5 kg
6 kg
7 kg
8 kg
9 kg
10-14 kg

Powder for suspension 100 mg/5 ml

2.5 ml (50 mg)
3 ml (60 mg)
3.5 ml (70 mg)
4 ml (80 mg)
4.5 ml (90 mg)
5 ml (100 mg)

15-24 kg
25-34 kg
35-44 kg
>45 kg

Powder for suspension 200 mg/5 ml

5 ml (200 mg)
7.5 ml (300 mg)
10 ml (400 mg)
prescribed doses for adults (500-1000 mg)

When treating erythema migrans in children, the drug is prescribed once a day for 5 days: 20 mg/kg body weight on the first day and 10 mg/kg body weight from days 2 to 5.

Preparation of the suspension.
Single dose package. A small amount of boiled and cooled water is poured into a clean glass, then the contents of one packet are poured out and mixed until a homogeneous suspension is obtained.
After use, rinse the glass with water, dry and store in a dry and clean place.
Jar. Using a polymer compound dispenser, add 12 ml of boiled and cooled water or distilled water to a jar containing 400 mg or 800 mg of azithromycin; in a jar containing 1200 mg of azithromycin - 18 ml. The suspension is shaken before use.
Dispense the suspension with a double-sided spoon: a large spoon contains 5 ml of suspension, a small one - 2.5 ml; or a spoon with two marks: the lower one corresponds to 2.5 ml of suspension and the upper one - 5 ml; or a polymer compound dispenser.
After use, rinse the spoon and dispenser with water, dry and store in a dry and clean place.

Side effect

From the gastrointestinal tract: diarrhea (5%), nausea (3%), abdominal pain (3%), 1% or less – flatulence, vomiting, melena, cholestatic jaundice, increased activity of “liver” transaminases, in children – constipation, loss of appetite, gastritis; candidiasis of the oral mucosa, change in taste (1% or less).
From the cardiovascular system: palpitations, chest pain (1% or less).
From the nervous system: headache, dizziness, drowsiness; in children - headache (during treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disorders (1% or less). From the genitourinary system: vaginal candidiasis, nephritis (1% or less).
Allergic reactions: rash, urticaria, skin itching, angioedema; in children - conjunctivitis, itching, urticaria. Other: asthenia, photosensitivity.

Overdose

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

Use with other drugs

Antacids (aluminum- and magnesium-containing), ethanol and food slow down and reduce the absorption of azithromycin.
When warfarin and azithromycin were co-administered (in usual doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may enhance the anticoagulation effect, patients need careful monitoring of prothrombin time.
Increases the concentration of digoxin.
Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia).
Triazolam: decreased clearance and increased pharmacological action of triazolam.
Slows down the elimination and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs subject to microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocripine, phenytoin, oral hypoglycemic drugs agents, theophylline and other xanthine derivatives), due to the inhibition of microsomal oxidation in hepatocytes by azithromycin.
Lincosamines weaken, and tetracycline and chloramphenicol enhance the effectiveness of azithromycin.

Special instructions

Do not take with food.
If a dose is missed, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.
It is necessary to observe a break of 2 hours while using antacids.
After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy under medical supervision.

Release form

Suspensions, syrups

Release form

Powder for the preparation of suspension for oral administration 100 mg/5 ml and 200 mg/5 ml; powder for the preparation of suspension for oral administration 50 mg, 100 mg and 200 mg.
25 g (1200 mg of azithromycin to prepare 30 ml of suspension with a concentration of 200 mg/5 ml), 17 g (800 mg of azithromycin to prepare 20 ml of suspension with a concentration of
200 mg/5 ml) or 17 g (400 mg of azithromycin to prepare 20 ml of suspension with a concentration of 100 mg/5 ml) in orange glass jars with a plastic screw cap.
Each jar with instructions for use, a spoon for taking medicines or a pharmaceutical dosage spoon and a polymer compound dispenser is placed in a cardboard pack.
4.2 g (50 mg, 100 mg or 200 mg of azithromycin) in heat-sealed single-dose packages made of a combined multilayer material based on foil, buffalo or polyethylene-coated packaging paper.
3 or 6 packets (50 mg azithromycin), 3 or 6 packets (100 mg azithromycin), 3 or 6 packets (200 mg azithromycin) with instructions for use and a plastic cup are placed in a cardboard pack.
3 or 6 packets (50 mg azithromycin), 3 or 6 packets (100 mg azithromycin), 3 or 6 packets (200 mg azithromycin) with instructions for use are placed in a cardboard pack.

Storage conditions

List B. In a dry place, protected from light, at a temperature of 15 to 25°C. The aqueous suspension is stored at a temperature of 15 to 25°C for no more than 5 days or in the refrigerator for no more than 14 days. Keep out of the reach of children.

Best before date

2 years. Use the drug before the date indicated on the package.

Catad_pgroup Antibiotics macrolides and azalides

Azitrox - official instructions for use

INSTRUCTIONS
on the use of the drug
for medical use

Registration number:

Trade name:

Azitrox ®

International nonproprietary name:

azithromycin

Dosage form:

powder for the preparation of suspension for oral administration

Composition per bottle:

Dosage for prepared suspension	100 mg/5 ml	200 mg/5 ml
Azithromycin dihydrate in terms of azithromycin	419.3 mg 400 mg	838.6 mg 800 mg
Excipients:
Sucrose(sugar)	14948.7 mg	14529.4 mg
Sodium carbonate (sodium carbonate anhydrous)	238.5 mg	238.5 mg
Xanthan gum (xanthan gum)	21.7 mg	21.7 mg
Hyprolose (Klucel EF)	25.4 mg	25.4 mg
Flavor "Banana"	119.2 mg	119.2 mg
Flavor "Cherry"	71.5 mg	71.5 mg
Flavor "Vanilla"	55.7 mg	55.7 mg

Description: Crystalline or granular powder of white or white with a yellowish or creamy tint or light yellow color with a faint fruity odor.
Description of the prepared suspension. A homogeneous suspension from white or light gray with a yellowish or creamy tint to light yellow with a characteristic fruity odor.

Pharmacotherapeutic group:

antibiotic azalide

ATX Code:

Pharmacological properties

Azithromycin is a broad-spectrum bacteriostatic antibiotic from the macrolide-azalide group. Has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis in microbial cells. By binding to the SOS subunit of the ribosome, it inhibits peptide translocase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.
It is active against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.
Sensitive microorganisms: - Staphylococcus aureus(methicillin-sensitive strains), Streptococcus pneumonia(penicillin-sensitive strains), Streptococcus pyogenes, Streptococcus spp.(group C, F and G); 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 pneumonia(penicillin-resistant strains and strains with intermediate sensitivity to penicillin).
Microorganisms with natural resistance to azithromycin: aerobic gram-positive microorganisms - Enterococcus faecalis, Staphylococcus aureus(methicillin-resistant strains), Staphylococcus epidermidis(methicillin-resistant strains); anaerobic microorganisms - Bacteroides fragilis.
Cases of cross-resistance have been described in Streptococcus pneumoniae, Streptococcus pyogenes(beta-hemolytic streptococcus group A), Enterococcus faecalis And Staphylococcus aureus(including methicillin-resistant strains) to erythromycin, other macrolides, lincosamides and azithromycin.
Scale of sensitivity of microorganisms to azithromycin (Minimum inhibitory concentration (MIC), mg/l)
Pharmacokinetics. After oral administration, bioavailability is 37%, the maximum concentration in blood plasma (Cmax) is created after 2-3 hours, the volume of distribution is 31.1 l/kg. Binding to blood proteins is inversely proportional to the concentration in the blood and ranges from 7-50%. Penetrates through cell membranes (effective against infections caused by intracellular pathogens). 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 tissues. The concentration in tissues and cells is 50 times higher than in blood plasma, and at the site of infection it is 24-34% higher than in healthy tissues.
It has a long half-life of 2-4 days. The half-life from tissues is significantly longer. The therapeutic concentration of azithromycin lasts up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% by the intestines, 6% by the kidneys. In the liver it is demethylated, losing activity. In patients with severe renal failure (creatinine clearance (CC) less than 10 ml/min), the half-life of azithromycin increases by 33%.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin, including:

upper respiratory tract and ENT organs, including pharyngitis/tonsillitis, sinusitis, otitis media;

lower respiratory tract, including acute bronchitis, exacerbation of chronic bronchitis and community-acquired pneumonia;

urinary tract infections caused by Chlamydia trachomatis(urethritis, cervicitis);

infections of the skin and soft tissues (moderate acne, erysipelas, impetigo, secondary infected dermatoses);

Lyme disease - initial stage (erythema migrans);

Contraindications

Hypersensitivity to azithromycin, other macrolides or other components of the drug; severe liver dysfunction (no data on efficacy and safety); impaired renal function (creatinine clearance less than 40 ml/min (no data on efficacy and safety)); sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; children up to 6 months; breast-feeding; simultaneous use of ergotamine and dihydroergotamine.

With caution
With moderate liver dysfunction; impaired renal function (creatinine clearance more than 40 ml/min); predisposition to arrhythmia and prolongation of the QT interval, combined use with antiarrhythmic drugs of classes IA, III, cisapride, in the presence of hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia or severe heart failure; simultaneous use of terfenadine, warfarin, digoxin, pregnancy, myasthenia gravis, diabetes mellitus.

Use during pregnancy and breastfeeding

Animal studies have not revealed any harmful effects on the fetus; data on the effectiveness and safety of azithromycin in pregnant women are limited. Azithromycin is used during pregnancy only if the expected benefit to the mother outweighs the possible risk to the fetus. Breastfeeding should be suspended during treatment with azithromycin.

Directions for use and doses

Take orally, 1 hour before or 2 hours after meals, 1 time per day.
To prepare the suspension Add water (distilled or boiled and cooled) in the amount of 9.5 ml to the bottle with powder. Measure the water using the dosing pipette included with the bottle. Shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. The actual volume of the prepared suspension will be 20 ml.
Store the prepared suspension in its original packaging for no more than 5 days at a temperature not exceeding 25°C. Do not freeze.
The suspension must be shaken before each use. To dispense the finished suspension, use a dosing pipette or measuring spoon. Immediately after taking the suspension, you need to drink a few sips of water to rinse and swallow the drug remaining in the mouth. After use, a measuring spoon or pipette, which is previously disassembled, washed with running water, dried and stored with the drug.
Children over 6 months
at the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose 30 mg/kg). Children weighing up to 10 kg are recommended to take the drug in powder form to prepare an oral suspension with a concentration of 100 mg/5 ml.
When treating the initial stage of Lyme disease (erythema migrans): once a day: on the 1st day - at a dose of 20 mg/kg body weight, then from the 2nd to the 5th day at a dose of 10 mg/kg body weight. The course dose is 60 mg/kg body weight.

1st day
Patient's body weight	Required volume of suspension in ml (azithromycin dose in mg) per dose
Patient's body weight	Suspension 100 mg/5 ml	Suspension 200 mg/5 ml
5 kg	5 ml (100 mg)
6 kg	6 ml (120 mg)	3 ml (120 mg)
7 kg	7 ml (140 mg)	3.5 ml (140 mg)
8 kg	8 ml (160 mg)	4 ml (160 mg)
9 kg	9 ml (180 mg)	4.5 ml (180 mg)
10-14 kg	10 ml (200 mg)	5 ml (200 mg)
15-24 kg		10 ml (400 mg)
25-34 kg		15 ml (600 mg)
35-44 kg		20 ml (800 mg)
More than 45 kg		25 ml (1.0 g)
From 2nd to 5th day
	Suspension 100 mg/5 ml	Suspension 200 mg/5 ml
5 kg	2.5 ml (50 mg)
6 kg	3 ml (60 mg)	1.5 ml (60 mg)
7 kg	3.5 ml (70 mg)	1.8 ml (70 mg)
8 kg	4 ml (80 mg)	2 ml (80 mg)
9 kg	4.5 ml (90 mg)	2.3 ml (90 mg)
10-14 kg	5 ml (100 mg)	2.5 ml (100 mg)
15-24 kg		5 ml (200 mg)
25-34 kg		7.5 ml (300 mg)
35-44 kg		10 ml (400 mg)
More than 45 kg (prescribed doses for adults)		12.5 ml (500 mg)

Adults.
For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues (with the exception of erythema migrans):
500 mg 1 time per day for 3 days (course dose - 1.5 g).
In the treatment of the initial stage of Lyme disease (erythema migrans): For urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis):
For uncomplicated urethritis/cervicitis - once 1.0 g.
For the treatment of acne (acne vulgaris) of moderate severity.
On days 1, 2 and 3 of treatment, take 500 mg once a day, then take a break from the fourth to the seventh day, from the eighth day of treatment take 500 mg once a week for 9 weeks (course dose 6.0 g) .
Patients with impaired renal function. If renal function is impaired (creatinine clearance more than 40 ml/min), no dose adjustment is required.
Patients with impaired liver function. For moderate liver dysfunction, no dose adjustment is required.

Side effect

Classification of the frequency of side effects (WHO): very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (with a frequency of at least 1/1000, but less than 1 /100), rare (with a frequency of at least 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10000), including individual messages.
From the circulatory and lymphatic systems: often- lymphocytopenia, eosinophilia; uncommon - leukopenia, neutropenia; very rarely - thrombocytopenia, hemolytic anemia.
From the nervous system: often - dizziness, headache, paresthesia, anorexia; infrequently - nervousness, hyposthesia, insomnia, drowsiness; rarely - agitation; very rarely - fainting, convulsions, psychomotor hyperactivity, exacerbation of myasthenia gravis, anxiety, aggression.
From the senses: often - decreased hearing acuity, decreased visual acuity, impaired perception of taste; infrequently - tinnitus, deafness; rarely - vertigo; very rarely - anosmia, loss of taste, parosmia.
From the cardiovascular system: infrequently - palpitations; very rarely - arrhythmia, ventricular tachycardia, increased QT interval, pirouette-type arrhythmia, decreased blood pressure.
From the digestive system: very often - nausea, diarrhea, abdominal pain, flatulence; often - vomiting, dyspepsia; infrequently - gastritis, constipation; very rarely - discoloration of the tongue, pseudomembranous colitis, pancreatitis.
From the liver and biliary tract: uncommon - hepatitis, increased activity of liver transaminases, hyperbilirubinemia; rarely - liver dysfunction; very rarely - cholestatic jaundice, liver failure, fulminant hepatitis, liver necrosis.
Allergic reactions: often - skin itching, rash; uncommon - angioedema, hypersensitivity reactions, Stevens-Johnson syndrome, photosensitivity, urticaria; very rarely - anaphylactic reactions, toxic epidermal necrolysis, erythema multiforme.
From the musculoskeletal system: often - arthralgia.
From the urinary system: infrequently - increased concentrations of urea and creatinine in the blood plasma; very rarely - interstitial nephritis, acute renal failure.
Others: often - weakness; uncommon - chest pain, peripheral edema, soreness, asthenia, vaginitis, candidiasis of various localizations.

Overdose

When taking high doses of the drug, an increase in dose-dependent side effects may be observed: temporary hearing loss, severe nausea, vomiting, diarrhea. Treatment: administration of activated carbon, symptomatic therapy, monitoring of vital functions.

Interaction with other drugs

Antacids (aluminum and magnesium-containing) do not affect the bioavailability of azithromycin, but reduce its Cmax by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs. Azithromycin does not affect the blood concentrations of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin and methylprednisolone when used simultaneously.
If simultaneous use with cyclosporine is necessary, it is recommended to monitor the concentration of cyclosporine in the blood.
When taking digoxin and azithromycin simultaneously, it is necessary to monitor the concentration of digoxin in the blood, since many macrolides increase the absorption of digoxin in the intestine, thereby increasing its Cmax.
When used simultaneously with ergotamine and dihydroergotamine derivatives, the toxic effect (vasospasm, dysesthesia) of the latter may be enhanced. If it is necessary to take it simultaneously with indirect anticoagulants (warfarin and other coumarin-type anticoagulants), it is recommended to monitor the prothrombin time.
It has been established that the simultaneous use of terfenadine or cisapride and macrolide antibiotics causes arrhythmia and prolongation of the QT interval. Based on this, the above complications cannot be excluded when azithromycin and terfinadine are used 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, in monocytes increases.
When used simultaneously with nelfinavir, it is possible to increase the frequency of adverse reactions of azithromycin (decreased hearing, increased activity of liver transaminases).
The possibility of inhibition of the CYP3A4 isoenzyme by azithromycin should be taken into account when used simultaneously with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs whose metabolism occurs with the participation of this enzyme.

Special instructions

When prescribing to patients with diabetes mellitus, as well as on a low-calorie diet, it is necessary to take into account that the suspension contains sucrose (3.7 g/5 ml or 0.3 XE/5 ml). 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. It is necessary to follow the regimen and duration of taking the drug recommended in the instructions.
Azithromycin is contraindicated in patients with severe liver dysfunction. In patients with moderate hepatic impairment, azithromycin should be administered with caution due to the possibility of developing fulminant hepatitis and severe liver failure. If there are symptoms of liver dysfunction (rapidly increasing asthenia, jaundice, darkening of urine, bleeding tendency, hepatic encephalopathy), azithromycin therapy should be discontinued and a study of the functional state of the liver should be performed.
In case of moderate renal failure (creatinine clearance more than 40 ml/min), azithromycin should be taken under monitoring of renal function.
There is no data on a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism while taking macrolides with ergotamine and dihydroergotamine derivatives, this combination is contraindicated.
With long-term use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis, is possible. If diarrhea develops while taking azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. In case of delayed ventricular repolarization syndrome - long QT interval syndrome - while taking macrolides, including azithromycin, the risk of developing arrhythmia increases. Caution when prescribing azithromycin should be observed in patients with prolongation of the QT interval, receiving therapy with antiarrhythmic drugs of classes IA, III, cisapride, in the presence of hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia or severe heart failure.
The use of azithromycin may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.
Since 2010, azithromycin has been recommended by the International Union against Sexually Transmitted Infections, together with WHO Europe, as the first choice drug for the treatment of chlamydial infection during pregnancy.
As with the use of other antibacterial drugs, during therapy with azithromycin, patients should be regularly examined for the presence of non-susceptible microorganisms and signs of the development of superinfections, including fungal ones.

Influence on the ability to drive vehicles and machinery.
If adverse reactions from the central nervous system occur, patients are advised to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration, speed of psychomotor and motor reactions.

Release form

Powder for the preparation of suspension for oral administration 100 mg/5 ml or 200 mg/5 ml. 15.9 g in 50 ml bottles of dark (amber) glass. One bottle, along with instructions for use, a measuring spoon and a pipette for dosing, is placed in a cardboard pack.

Storage conditions

At a temperature not higher than 25 °C.
Store the prepared suspension at a temperature not exceeding 25 °C.
Do not freeze.
Keep out of the reach of children.

Best before date

2 years. Prepared suspension - no more than 5 days.
After the expiration date, do not use the drug.

Conditions for dispensing from pharmacies

According to the recipe.

Name and address of the manufacturer/organization accepting the claim:

OJSC Pharmstandard-Leksredstva, 305022, Russia, Kursk, st. 2nd Aggregatnaya, 1a/18.

Frequent colds are a problem faced by parents of preschool children. Insufficiently formed immune defense mechanisms lead to the development of various bacterial complications during ARVI. More than 80% of such cases are pathologies of the respiratory system and ENT organs. Therapy involves the prescription of antibacterial agents. Broad-spectrum antibiotics used in pediatric practice include Azithromycin for children, instructions for use of which are discussed below.

Azithromycin is the active ingredient of the drug of the same name, as well as the drugs Azitrox and Sumamed. It belongs to a special group of antibiotics - macrolides. Synthesized from the erythromycin molecule, developed more than 50 years ago. However, azithromycin has fundamental differences from its predecessors; it has greater antibacterial activity and better tolerability.

What is the drug

The mechanism of action of the drug is its effect on intracellular ribosomes. Due to this, the synthesis of bacterial proteins is disrupted and their growth stops.

At therapeutic concentrations, the drug has a bacteriostatic effect. When large doses and low concentrations of bacterial pathogens are administered, its bactericidal effect is manifested. This is especially noticeable in relation to streptococci and pneumococci. The spectrum of antibacterial activity of this drug is quite wide. It applies to:

gram-positive microorganisms (streptococci, pneumococci, staphylococci);
diphtheria bacillus;
Bordetella (the causative agent of whooping cough);
corynebacteria;
Moraxella;
intracellular microorganisms (chlamydia, mycoplasma, ureaplasma);
legionella;
listeria.

Azithromycin also acts on a number of gram-negative microorganisms (for example, Haemophilus influenzae). This medicine has also been proven effective against Borrelia, for infections after animal bites.

The drug acts on Helicobacter pylori, which provokes erosive and ulcerative lesions of the gastrointestinal tract. Therefore, Azithromycin has found wide use in gastroenterology.

Features of pharmacokinetics

For outpatient use, children are prescribed an oral form of the drug: a suspension, or less often tablets. A special feature of Azithromycin is its resistance to acidic gastric contents. It is well absorbed in the intestines, but simultaneous food intake can slow down this process. Also, bioavailability is reduced by the simultaneous use of antacid drugs.

Azithromycin can accumulate in high concentrations in body tissues, which significantly exceeds those in blood serum. At the same time, the active substance of the pharmaceutical drug retains its therapeutic concentration at the site of inflammation for a very long time: according to clinical studies, from three to five days.

Particularly high levels of the drug are observed in the middle ear, paranasal sinuses, bronchopulmonary system, soft tissues (skin, muscles), and organs of the urogenital system. Moreover, during inflammation there is an additional increase in the amount of the drug in the tissues.

The main metabolism of Azithromycin occurs in liver cells; the cytochrome P450 system is involved in this process. This point should be taken into account when simultaneously prescribing drugs with similar metabolism. The drug is excreted through the gastrointestinal tract with feces. Only a small part of it, only about 5%, is excreted through the urinary system.

Azithromycin is prescribed to children with bacterial infections. Indications for use are the following diseases:

diseases in otolaryngology: otitis media, sinusitis, nasopharyngitis;
pathologies of the oropharynx: tonsillitis, tonsillitis, tonsillopharyngitis;
bronchitis, tracheitis, laryngitis;
pneumonia;
damage to the skin and soft tissues;
intestinal infections caused by bacteria sensitive to this pharmaceutical.

Indications for the use of the drug are urinary tract infections caused by microflora sensitive to Azithromycin. Azithromycin is also used for a child with erythema migrans caused by Borrelia burgdorferi.

Treatment of peptic ulcers associated with Helicobacter pylori can also, in some cases, be carried out using Azithromycin. Other antibiotics can be used in the treatment of the above diseases. However, reviews of Azithromycin for a child indicate that it has a number of advantages over other antibacterial drugs.

High efficiency and wide spectrum of action. The drug acts on most pathogens that cause inflammation in the respiratory system and ENT organs.
Safety for children. The drug relatively rarely causes side effects, which is confirmed by clinical studies.
Good compliance. Azithromycin is convenient to use on an outpatient basis; it is taken in a short course, once a day.

Instructions for use of Azithromycin in children

Azithromycin preparations are available in two dosage forms:

pills;
powder for preparing a suspension.

For younger patients, the most convenient form is the suspension. There are several types of azithromycin in the form of a suspension on the pharmaceutical market:

"Sumamed";
"Azithromycin Ecomed";
Azithromycin Zentiva.

Azithromycin Ecomed is produced by a domestic pharmaceutical company, and therefore has a relatively low cost.

It is better to give Azithromycin to children under one year old and preschool age in the form of a suspension; for this purpose, bottles containing medicinal powder are produced. 5 ml of such a suspension will contain 0.1 g (or 0.2 g) of azithromycin. The package contains a measuring spoon and a dispenser syringe.

The medicine also contains additional substances: flavorings, sucrose, preservatives. Therefore, this point should be taken into account when treating a child with allergies.

Before using the drug, a suspension should be prepared from the existing powder. You can dilute and give Azithromycin to your child by following the following six-step instructions.

Boil and cool water.
Shake the bottle of powder.
Add 11 ml of prepared water to the bottle using a dispenser.
Thoroughly shake the contents of the bottle again until a homogeneous suspension is obtained.
Measure the required amount of syrup using a measuring spoon and give the medicine to the child.
Wash and dry the measuring spoon.

The prepared medicine can be stored in a cool place for no more than a week. After this period ends, the medicine is no longer suitable for use.

Azithromycin can be given to children starting from six months of age. Take the suspension between meals, an hour before or two to three hours after. This ensures maximum absorption of the drug in the gastrointestinal tract.

The dosage of Azithromycin for children is determined based on body weight, taking into account that 1 ml of the prepared suspension contains 0.01 or 0.02 g of the drug, depending on the form of release. For children over six months of age, the dosage is 0.01 g per kilogram of the child's weight. That is, if a child weighs 20 kg, then he needs to be given 0.2 g of medicine per day. The duration and treatment regimen for a particular disease is determined by the attending physician. You can also focus on the data in the table.

A similar dosage of 0.02 g per 1 kg of child weight is recommended for scarlet fever (sore throat or tonsillitis) caused by streptococcal infection. In this case, the course of treatment is three days.

Treatment of whooping cough with Azithromycin in a child is carried out according to a five-day regimen. For children over six months of age, the dosage is 0.01 g per 1 kg of child weight, in subsequent days 0.005 g per 1 kg of body weight.

The dosage, regimen, and duration of treatment are determined only by the attending physician. It is not recommended to change the dosage on your own, much less use the medicine to prevent complications from ARVI or influenza.

Side effects

Azithromycin relatively rarely provokes any side effects. According to reviews from doctors and parents, it is well tolerated by children. Rarely, the following negative effects may occur:

dyspeptic disorders- nausea, dry mouth, rarely vomiting, abdominal pain, loose stools, bloating;
exacerbation of gastrointestinal diseases- gastritis, pancreatitis.
pain syndrome – in muscles, joints, spine;
effect on the kidneys– difficulty urinating, lower back pain;
changes in blood tests– biochemical indicators of liver and kidney function;
neurological disorders– headache, vestibular disorders, drowsiness or, conversely, agitation, hearing impairment;
pathology of the cardiovascular system– increased heart rate, changes in the electrocardiogram;
other manifestations– exacerbation of myasthenia gravis, candidiasis infection, allergic reactions.

In rare situations, when taking very large doses of the drug, signs of overdose may develop:

vomiting, nausea;
sudden hearing loss;
diarrhea.

Contraindications

Contraindications for prescribing this drug are:

individual intolerance;
severe diseases of the hepatobiliary system;
simultaneous administration of drugs with ergotamine;
intolerance to the components of the suspension (impaired sugar metabolism).

Where to buy and what analogues are there

This medicine should be taken only as prescribed by a doctor. In most pharmacies, pharmacists do not require a doctor's prescription for Azithromycin. If a medicine is not available for sale, you can purchase its analogues:

"Sumamed";
"Azitrox";
"Hemomycin."

These medications contain azithromycin as the main active ingredient. They are also available in powder form for the preparation of a medicinal suspension, and therefore can be used to treat young children.

Azithromycin (suspension for children) is an effective drug that can be successfully used in outpatient practice. Its advantages are obvious: a wide spectrum of action, a convenient form of release, a short and understandable regimen for parents. However, before using it, it is necessary to show the child to the doctor and clarify the dosage. This will avoid unwanted side effects and shorten the path to recovery.

The question of treatment methods for their child is very important for parents. Therefore, they show great interest in the drugs prescribed by the pediatrician. In some cases, this interest even spills over into disputes with the pediatrician about the need to prescribe this or that medication. Basically, this attitude of parents may be caused by prejudice against antibiotics.

Choosing the appropriate treatment method and appropriate medications is a very serious and responsible process. Before prescribing any drug (especially if it is an antibiotic), a pediatrician analyzes a number of factors regarding the child’s health status and his or her tolerance to the drug. Despite parents' dislike of strong drugs, doctors are sometimes forced to prescribe them in order to avoid deterioration of the child's health. In this article we will look at an antibiotic for children such as azithromycin.

Azithromycin is the most widely used drug belonging to the macrolide group. It has a bactericidal effect and is prescribed in case of inflammation. Pathogens such as gram-negative bacteria, various streptococci, and some anaerobic microorganisms are sensitive to this drug. Azithromycin does not affect gram-positive bacteria, as they are resistant to erythromycin.

Can azithromycin be given to children?

Many years of experience in using this drug shows that azithromycin is well tolerated even by children under one year of age. And most importantly, it is safe and effective in treatment. Azithromycin has several forms of release: dry mixture, capsules and tablets. Azithromycin dry mixture is intended for preparing syrup for children. To prepare azithromycin syrup for your child, you need to shake the bottle with the dry mixture and add 12 ml of distilled water to it. After the child has drunk the syrup, you should give him a couple of sips of tea or other liquid to wash away any remaining syrup in his mouth.

When is azithromycin prescribed?

Azithromycin is prescribed mainly for infectious and inflammatory diseases caused by bacteria sensitive to azithromycin. These diseases include: pneumonia, bronchitis, skin and soft tissue infections, sinusitis, otitis media, tonsillitis, pharyngitis, urethritis and Lyme disease. If a child is suspected of having pneumonia, pediatricians immediately prescribe antibiotics, even before an X-ray examination. Because if you do not start timely treatment of this disease, the consequences can be sad. Antibiotics in this case are selected based on the symptoms, clinical picture and suspected pathogen. Moreover, when suggesting the causative agent of the disease, the age of the child is mainly taken into account. If he is from 1 to 6 months old, then most likely the cause of pneumonia is Staphylococcus aureus, and in children aged 1 to 6 years, in most cases, the cause of this disease is Streptococcus pneumoniae. Both are effectively destroyed by azithromycin.

Azithromycin dosage for children

It is best to consult with an experienced specialist about the need to take this drug and how to give azithromycin to children. The dosage and form of use of azithromycin largely depend on the type of disease and the age of the child. So, for example, when treating the upper and lower respiratory tract, on the first day of treatment, 500 mg (two capsules) of this drug is prescribed at a time. And from the second to the fifth day of treatment, it is recommended to give children 250 mg of azithromycin per day. On average, the course of treatment with this antibiotic is from 3 to 5 days.