Azithromycin Ecomed, 3 pcs., 500 mg, film-coated tablets

Azithromycin Ecomed, 3 pcs., 500 mg, film-coated tablets

Antacids

Antacids do not affect the bioavailability of azithromycin, but reduce the maximum blood concentration by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and eating.

Cetirizine

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

Didanosine (dideoxyinosine)

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

Digoxin (P-glycoprotein substrates)

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

Zidovudine

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

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

Ergot alkaloids

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

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

Atorvastatin

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

Carbamazepine

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

Cimetidine

Pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin did not reveal changes in the pharmacokinetics of azithromycin, provided that cimetidine was used 2 hours before azithromycin.

Indirect anticoagulants (coumarin derivatives)

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

Cyclosporine

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

Efavirenz

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

Fluconazole

Concomitant use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1/2 of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which did not have clinical significance.

Indinavir

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

Methylprednisolone

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

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the Css of azithromycin in the blood serum. No clinically significant side effects were observed, and no dose adjustment of azithromycin is required when used concomitantly with nelfinavir.

Rifabutin

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

Sildenafil

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

Terfenadine

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

Theophylline

No interaction has been detected between azithromycin and theophylline.

Triazolam/midazolam

Significant changes in pharmacokinetic parameters with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses were not detected.

Trimethoprim/sulfamethoxazole

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

Buy Azithromycin Ecomed powder for oral suspension 200mg/5ml 16.5g in pharmacies

Dosage form:

powder for the preparation of suspension for oral administration

Composition of components in 5 ml suspension:

Description

White or yellowish-white powder with a faint fruity odor. Ready suspension: white to light yellow, homogeneous with a faint fruity odor.

Pharmacological group antibiotic – azalide.

Pharmacological properties

Pharmacodynamics

A broad-spectrum antibacterial drug from the group of macrolides-azalides, has a bacteriostatic effect. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage, suppresses protein synthesis, slows down the growth and reproduction of bacteria, and in high concentrations has a bactericidal effect. Acts on extra- and intracellularly located pathogens.

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

Scale of sensitivity of microorganisms to azithromycin (Minimum inhibitory concentration, mg/l):

Sensitive:

aerobic gram-positive microorganisms:

Staphylococcus aureus (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), 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., Porphyromonas spp.;

others:

Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Moderately sensitive or insensitive:

aerobic gram-positive microorganisms:

Streptococcus pneumoniae (moderately sensitive or resistant to penicillin).

Resistant: aerobic gram-positive microorganisms:

Enterococcus faecalis, Methicillin-resistant strains of Staphylococcus aureus.

Anaerobes: Bacteroides fragilis group.

Streptococcus pneumoniae, beta-hemolytic Streptococcus spp. group A, Enterococcus faecalis and Staphylococcus aureus (including methicillin-sensitive strains), resistant to erythromycin and other macrolides, lincosamides, and resistant to azithromycin.

Pharmacokinetics

After oral administration, azithromycin is well absorbed and quickly distributed in the body. Bioavailability after a single dose of 0.5 g is 37% (the “first pass” effect through the liver), maximum concentration (Cmax) after oral administration of 0.5 g is 0.4 mg/l, time to reach maximum concentration (TCmax) is 2 -3 hours. Concentration in tissues and cells is 10-50 times higher than in serum. The volume of distribution is 31.1 l/kg, binding to plasma proteins is inversely proportional to the concentration in the blood and amounts to 7-50%. Azithromycin is acid-stable and lipophilic. Easily passes through histohematic barriers, penetrates well into the respiratory tract, internal organs and tissues, including the prostate gland, skin and soft tissues. It is also transported to the site of infection by phagocytes, polymorphonuclear leukocytes and macrophages, where it is released in the presence of bacteria. Penetrates through cell membranes and creates high concentrations in them, which is especially important for the eradication of intracellular pathogens.

In foci of infection, the concentration is 24-34% higher than in healthy tissues and correlates with the severity of the inflammatory process. Remains in effective concentrations for 5-7 days after taking the last dose.

It is demethylated in the liver, the resulting metabolites are not active. The metabolism of the drug involves isoenzymes CYP3A4, CYP3A5, CYP3A7, of which it is an inhibitor. Plasma clearance - 630 ml/min: half-life between 8 and 24 hours after administration - 14-20 hours, half-life in the range from 24 to 72 hours - 41 hours. More than 50% of the drug is excreted through the intestines unchanged, 6% - kidneys.

Food intake significantly changes pharmacokinetics: Cmax increases (by 31%), the area under the concentration-time curve (AUC) does not change.

In elderly men (65-85 years old), the pharmacokinetic parameters do not change; in women, Cmax increases (by 30-50%).

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

infections of the upper respiratory tract and ENT organs: pharyngitis, tonsillitis, sinusitis, otitis media; lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens; infections of the skin and soft tissues: erysipelas, impetigo, secondary infected dermatoses; the initial stage of Lyme disease (borreliosis) – erythema migrans;

Contraindications

hypersensitivity to azithromycin (including other macrolides) or other components of the drug; severe renal failure (creatinine clearance (CC) less than 40 ml/min); severe liver failure (class C on the Child-Pugh scale); breast-feeding; simultaneous use with ergotamine and dihydroergotamine; children up to 6 months; sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; hypersensitivity to erythromycin; ketolides.

Carefully

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

Use during pregnancy and breastfeeding

Pregnancy

During pregnancy, azithromycin is used only if the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

During breastfeeding, it is used only if the expected benefit to the mother outweighs the potential risk to the child. If it is necessary to use azithromycin during breastfeeding, it is recommended to stop breastfeeding.

Directions for use and doses

Orally (the method of administration is determined by the release form), 1 time per day, 1 hour before or 2 hours after meals.

After taking the drug, the child must be offered to drink a few sips of water so that he can swallow the remainder of the suspension.

Before each dose of the drug, it must be shaken thoroughly until a homogeneous suspension is obtained. If the required volume of suspension has not been taken within 20 minutes after shaking, the suspension should be shaken again, the required volume taken and given to the child.

For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues

At the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose 30 mg/kg).

To accurately dose azithromycin according to your child's body weight, use the table below.

Children weighing up to 10 kg should take azithromycin in powder form to prepare an oral suspension with a concentration of 100 mg/5 ml.

To accurately dose azithromycin according to your child's body weight, use the table below.

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

For Lyme disease (the initial stage of borreliosis) - erythema migrans

On the 1st day at a dose of 20 mg/kg/day, then from the 2nd to the 5th day at a dose of 10 mg/kg/day (course dose 60 mg/kg).

If kidney function is impaired

In patients with GFR (glomerular filtration rate) 10-80 ml/min, no dose adjustment is required.

In case of liver dysfunction

When used in patients with mild to moderate liver dysfunction, no dose adjustment is required.

Elderly patients

No dose adjustment is required. In elderly patients, special caution is recommended when using azithromycin due to the possible presence of proarrhythmogenic factors that may increase the risk of developing cardiac arrhythmia and arrhythmias.

Method of preparing the suspension

The suspension is prepared immediately before use.

The powder in the bottle is first shaken, 12 ml of boiled and cooled to room temperature water is added using a dosing syringe, mixed to obtain a homogeneous suspension.

To accurately dose the suspension, you should use a syringe, which should be rinsed well with water after each use. After dilution, the prepared suspension should be stored for no more than 5 days in the refrigerator, but not frozen.

When used in patients with mild to moderate renal impairment, no dose adjustment is required; When used in patients with mild to moderate liver dysfunction, no dose adjustment is required in elderly patients.

Side effects

Infectious and parasitic diseases

uncommon: candidiasis, including oral mucosa, vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory diseases, rhinitis unknown frequency: pseudomembranous colitis

Blood and lymphatic system disorders

uncommon: leukopenia, neutropenia, eosinophilia very rare: thrombocytopenia, hemolytic anemia

Metabolic and nutritional disorders

uncommon: anorexia

Immune system disorders

uncommon: angioedema, hypersensitivity reaction unknown frequency: anaphylactic reaction

Nervous system disorders

often: headache uncommon: dizziness, disturbance of taste, paresthesia, drowsiness, insomnia, nervousness rare: agitation unknown frequency: hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste, myasthenia gravis, delusions, hallucinations

Visual disorders

common: visual impairment

Hearing and labyrinth disorders

Uncommon: Hearing impairment, vertigo Unknown Frequency: Hearing impairment, including deafness and/or tinnitus

Cardiovascular disorders

uncommon: palpitations very rare: arrhythmia unknown frequency: increased QT interval on the electrocardiogram, arrhythmia, ventricular tachycardia

Vascular disorders

uncommon: flushing of the face unknown frequency: decreased blood pressure

Respiratory, thoracic and mediastinal disorders

uncommon: shortness of breath, nosebleeds

Gastrointestinal disorders

very common: diarrhea common: nausea, vomiting, abdominal pain uncommon: flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands very rare: change tongue colors, pancreatitis

Disorders of the liver and biliary tract

uncommon: hepatitis rare: liver dysfunction, cholestatic jaundice unknown frequency: liver failure (in rare cases, fatal, mainly due to severe liver dysfunction); liver necrosis, fulminant hepatitis

Skin and subcutaneous tissue disorders

uncommon: skin rash, itching, urticaria, dermatitis, dry skin, sweating rare: photosensitivity reaction unknown frequency: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic manifestations (DRESS syndrome)

Musculoskeletal and connective tissue disorders

uncommon: osteoarthritis, myalgia, back pain, neck pain unknown frequency: arthralgia

Renal and urinary tract disorders

uncommon: dysuria, pain in the kidney area unknown frequency: interstitial nephritis, acute renal failure

Genital and breast disorders

uncommon: metrorrhagia, testicular dysfunction

General and administration site disorders

uncommon: edema, asthenia, malaise, feeling tired, facial swelling, chest pain, fever, peripheral edema

Influence on the results of laboratory and instrumental studies

often: decreased number of lymphocytes, increased number of eosinophils, increased number of basophils, increased number of monocytes, increased number of neutrophils, decreased concentration of bicarbonates in the blood plasma; infrequently: increased activity of aspartate aminotransferase, alanine aminotransferase, increased concentration of bilirubin in the blood plasma, increased concentration of urea in the blood plasma, increase in plasma creatinine concentration, change in plasma potassium content, increase in plasma alkaline phosphatase activity, increase in plasma chloride content, increase in blood glucose concentration, increase in platelet count, decrease in hematocrit, increase in plasma bicarbonate concentration, change sodium content in blood plasma

Overdose

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

Treatment is symptomatic.

Interaction with other drugs

Antacids (aluminum and magnesium containing) do not affect bioavailability, but reduce the concentration of azithromycin in the blood by 30%, so the interval between their administration should be 1 hour before or 2 hours after taking these drugs.

When used simultaneously with ergotamine and dihydroergotamine derivatives, the toxic effect of the latter may be enhanced (vasospasm, dysesthesia).

When used together with indirect coumarin anticoagulants (warfarin), patients need careful monitoring of prothrombin time.

Caution must be exercised when co-prescribing terfenadine and azithromycin, since it has been found that the simultaneous use of terfenadine and macrolides causes arrhythmia and prolongation of the QT interval. Based on this, the above complications cannot be excluded when taking terfenadine and azithromycin together.

When used simultaneously with cyclosporine, it is necessary to monitor the concentration of cyclosporine in the blood. When azithromycin and cyclosporine are used simultaneously, a dose adjustment of cyclosporine is necessary. When used simultaneously with digoxin, it is necessary to control the concentration of digoxin in the blood (it is possible to increase the absorption of digoxin in the intestine). The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the equilibrium concentration of azithromycin in the blood plasma; no clinically significant side effects were observed and no dose adjustment of azithromycin is required when used simultaneously with nefinavir.

When used concomitantly with zidovudine, azithromycin has little effect on the pharmacokinetics, including renal excretion, of zidovudine or its glucuronide metabolite.

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

Neutropenia has occasionally been observed with concomitant use of azithromycin and rifabutin, although neutropenia has been associated with the use of rifabutin; a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.

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.

There have been isolated case reports of rhabdomyolysis in patients taking azithromycin and statins concomitantly.

special instructions

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

Azithromycin should be taken at least one hour before or two hours after taking antacids.

Azithromycin should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe hepatic failure.

If there are symptoms of liver dysfunction, such as rapidly increasing asthenia, jaundice, dark 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 impaired renal function: in patients with GFR (glomerular filtration rate) 10-80 ml/min, no dose adjustment is required, azithromycin therapy should be carried out with caution under monitoring the state of renal function

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.

Azithromycin should not be used in longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.

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

With long-term use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis, is possible. If antibiotic-associated diarrhea develops while taking azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit intestinal motility.

When treated with macrolides, including azithromycin, prolongation of cardiac repolarization and QT interval was observed, increasing the risk of developing cardiac arrhythmias, including arrhythmias, which can lead to cardiac arrest.

Caution should be exercised when using azithromycin in patients with the presence of proarrhythmogenic factors (especially in elderly patients), including congenital or acquired prolongation of the QT interval, in patients taking antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with fluid and electrolyte imbalance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure .

The use of azithromycin may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

Impact on the ability to drive vehicles and machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form

Powder for the preparation of suspension for oral administration 100 mg/5 ml, 200 mg/5 ml.

16.5 g in 60 ml dark glass bottles with a screw-on plastic cap with a silica gel insert.

1 bottle along with a syringe for dosing and instructions for use is placed in a cardboard pack.

Best before date

2 years.

Ready suspension – 5 days.

Do not use after expiration date.

Storage conditions

In a place protected from moisture and light at a temperature not exceeding 25 ° C.

The prepared suspension is stored at a temperature from 2 ºС to 8 ºС in a tightly closed bottle.

Keep out of the reach of children.

Vacation conditions

On prescription.

Contraindications

• hypersensitivity to azithromycin (including other macrolides) or other components of the drug; severe renal failure (creatinine clearance (CC) less than 40 ml/min);
• severe liver failure (class C on the Child-Pugh scale);
• breast-feeding;
• simultaneous use with ergotamine and dihydroergotamine;
• children up to 6 months;
• sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

• infections of the upper respiratory tract and ENT organs: pharyngitis, tonsillitis, sinusitis, otitis media;
• lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens;
• infections of the skin and soft tissues: erysipelas, impetigo, secondary infected dermatoses;
• the initial stage of Lyme disease (borreliosis) is erythema migrans.

Compound

Composition of components in 5 ml of suspension: 5 ml of the finished suspension (one dosage spoon) contains: active substances azithromycin dihydrate (in terms of azithromycin) 100 mg 200 mg excipients lactulose 200.0 mg 400.0 mg xanthan gum 15.0 mg 15 .0 mg crospovidone (Kollidon CL-M) 65.0 mg 65.0 mg colloidal silicon dioxide (Aerosil) 5.5 mg 5.5 mg sodium carbonate anhydrous 83.0 mg 83.0 mg sodium benzoate 16.5 mg 16 .5 mg titanium dioxide 10.0 mg 10.0 mg mint flavor 0.5 mg 0.5 mg strawberry flavor 55.0 mg 55.0 mg apple flavor 13.75 mg 13.75 mg cinnamon flavor 13.75 mg 13 .75 mg sucrose to weight 3.75 g 3.75 g

special instructions

If a dose is missed, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart. Azithromycin should be taken 1 hour before or 2 hours after taking antacid medications. Use with caution in patients with moderate hepatic impairment 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, tendency to bleeding, 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), the use of azithromycin should be carried out under the control of renal function.

Concomitant use of azithromycin with ergotamine and dihydroergotamine derivatives is contraindicated due to the possible development of ergotism. When using the drug, both while taking it and 2-3 weeks after stopping treatment, diarrhea caused by Clostridium difficile (pseudomembranous colitis) may develop. In mild cases, it is sufficient to discontinue treatment and use ion-exchange resins (colestyramine, colestipol); in severe cases, replacement of loss of fluid, electrolytes and protein, and the appointment of vancomycin, bacitracin or metronidazole are indicated. Do not use medications that inhibit intestinal motility.

Since QT interval prolongation is possible in patients receiving macrolides, caution should be exercised when using azithromycin in patients with known risk factors for QT interval prolongation: advanced age; electrolyte imbalance (hypokalemia, hypomagnesemia); congenital long QT syndrome; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous use of drugs that can prolong the QT interval (including antiarrhythmic drugs of classes IA and III, tricyclic and tetracyclic antidepressants, antipsychotics, fluoroquinolones).

When using azithromycin, myasthenic syndrome or exacerbation of myasthenia may develop.