Azithromycin Ecomed, 100 mg/5 ml 16.5g

Indications

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, including.

– infections of the skin and soft tissues: rye, impetigo, secondary infectious dermatosis;

– the initial stage of Lyme disease (borreliosis) – erythema migrans.

Active ingredient

Composition

Component composition in 5 ml of suspension:

Active substance:

azithromycin dihydrate 104.82 mg (in terms of azithromycin) 100.00 mg

Associates:

Lactitol 200.00 mg

Sodium carbonate anhydrous 83.00 mg

Crospovidone (collidon CL-M) 65.00 mg

/p>

strawberry flavoring 55.00 mg

sodium benzoate 16.50 mg

xanthan gum 15.00 mg/p>

apple flavoring 13.75 mg

cinnamon flavoring 13.75 mg

titanium dioxide 10.00 mg

colloidal silicon dioxide 5.50 mg

mint flavoring 0.50 mg

sucrose to 3.75 g weight

How to take, the dosage

Orally (the method of administration is determined by the formulation), once a day, 1 hour before or 2 hours after meals.

After taking the drug it is necessary to offer the child to drink a few sips of water so that he can swallow the rest of the suspension.

Before each administration of the drug it is necessary to shake it thoroughly until a homogeneous suspension is obtained. If the desired volume of suspension is not taken within 20 minutes of shaking, the suspension should be shaken again, the desired volume taken away and given to the child.

Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissue

At the rate of 10 mg/kg body weight once daily for 3 days (a course dose of 30 mg/kg).

The table below should be used for precise dosing of azithromycin according to the child’s body weight.

Body weight, kg Dosage of azithromycin, mg (200 mg/5 ml suspension volume, ml) for 1 administration 10-14 kg 100 mg azithromycin (2.5 ml suspension)

Interaction

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

The concomitant use with ergotamine and dihydroergotamine derivatives may increase the toxic effect of the latter (vasospasm, dysesthesia).

In concomitant use with coumarin-type indirect anticoagulants (warfarin) patients need careful control of prothrombin time.

Caution should be exercised when coadministering terfenadine and azithromycin, because it was found that concomitant administration of terfenadine and macrolides causes arrhythmias and prolongation of the Q-T interval. Therefore, the above complications cannot be excluded when concomitant use of terfenadine and azithromycin.

In concomitant use with cyclosporine it is necessary to monitor the blood concentration of cyclosporine. In concomitant use of azithromycin and cyclosporine it is necessary to adjust the dose of cyclosporine. Concomitant use with digoxin requires control of digoxin concentration in blood (digoxin absorption in the intestine may increase). Concomitant use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes increase of equilibrium concentration of azithromycin in blood plasma, clinically significant adverse effects were not observed and azithromycin dose adjustment is not required in concurrent use with nelfinavir.

In concomitant use with zidovudine azithromycin has little effect on the pharmacokinetics, including renal excretion, of zidovudine or its glucuronide metabolite. Azithromycin interacts weakly with cytochrome P450 isoenzymes, no pharmacokinetic interactions similar to those of erythromycin and other macrolides have been found, and azithromycin is neither an inducer nor an inhibitor of cytochrome P450 isoenzyme.

In concomitant use of azithromycin and rifabutin, neutropenia has sometimes been observed; although neutropenia has been associated with rifabutin use, a causal relationship between use of a 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.

In isolated cases of rhabdomyolysis have been reported in patients taking azithromycin and statins concomitantly.

Special Instructions

If one dose of azithromycin is missed, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.

Asithromycin 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 because of the possibility of fulminant hepatitis and severe hepatic failure.

In the presence of symptoms of hepatic impairment, such as rapidly increasing asthenia, jaundice, darkened urine, bleeding tendency, hepatic encephalopathy, treatment with azithromycin should be discontinued and liver function tests should be performed.

In patients with impaired renal function: In patients with a GFR (glomerular filtration rate) of 10-80 mL/min, no dose adjustment is necessary; therapy with azithromycin should be given with caution under monitoring of renal function

As with other antibacterial agents, patients should be regularly screened during therapy with azithromycin for non-susceptible microorganisms and signs of superinfections, including fungal ones.

Azithromycin should not be used for longer courses than directed, since the pharmacokinetic properties of azithromycin recommend a short and simple dosing regimen.

There are no data on possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but because of the development of ergotism when using macrolides with ergotamine and dihydroergotamine derivatives simultaneously, this combination is contraindicated./p>

The development of pseudomembranous colitis caused by Clostridium difficile, both as mild diarrhea and severe colitis, is possible with long-term administration of azithromycin. If antibiotic-associated diarrhea develops against the background of azithromycin therapy, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit intestinal peristalsis.

In treatment with macrolides, including azithromycin, prolongation of cardiac repolarization and QT interval were observed, increasing the risk of cardiac arrhythmias, including “pirouette” arrhythmias, which may 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, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with the disorders of fluid and electrolyte balance, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

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

Influence on driving and operating ability

At the time of treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Side effects

Infectious and parasitic diseases

Blood and lymphatic system disorders

Disorders of metabolism and nutrition: infrequent: anorexia

Disorders of the immune system

Nervous system disorders

Visual disorders: often: visual disturbances

Hearing organ and labyrinth disturbances

cardiovascular disorders

vascular disorders

Disorders of the respiratory system, thoracic organs cage and mediastinum: infrequently: shortness of breath, nasal bleeding

Gastrointestinal tract disorders

Liver and biliary tract disorders

Skin and subcutaneous tissue disorders

Muscle and connective tissue disorders

Kidney and urinary tract disorders

Genital and mammary disorders: infrequent: metrorrhagia, testicular function disorders

General disorders and disorders of the injection site: infrequent: edema, asthenia, malaise, feeling of fatigue, facial edema, chest pain, fever, peripheral edema

Effects on laboratory and instrumental test results
often: decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased plasma bicarbonate concentration

infrequently: increased aspartate aminotransferase activity, alanine aminotransferase activity, increased plasma bilirubin concentration, increased plasma urea concentration, increased plasma creatinine concentration, changes in plasma potassium content, increased plasma alkaline phosphatase activity, increased plasma chloride concentration, increased plasma glucose concentration, increased platelet count, decreased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium concentration

Overdose

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

The treatment is symptomatic.

Pregnancy use

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

Breastfeeding
During breastfeeding, use azithromycin only if the expected benefit to the mother exceeds the potential risk to the baby. If azithromycin needs to be used during breastfeeding, it is recommended that breastfeeding be suspended.

Similarities