Azithromycin Ecomed, 200 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;
– infections of the lower respiratory tract: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including.Infections of lower respiratory tracts: acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia including those caused by atypical pathogens;
– skin and soft tissue infections: rye, impetigo, secondary infected dermatosis;
– 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 209.64 mg
(in terms of azithromycin) 100.00 mg 200.00 mg

Associates:

Lactitol 200.00 mg 400.00 mg
sodium carbonate anhydrous 83.00 mg 83.00 mg
crospovidone (collidone CL-M) 65.00 mg 65.00 mg strawberry flavoring 55.00 mg 55.00 mg
sodium benzoate 16.50 mg 16.50 mg
xanthan gum 15.00 mg 15.00 mg apple flavoring 13.75 mg 13.75 mg
cinnamon flavoring 13.75 mg 13.75 mg
titanium dioxide 10.00 mg 10.00 mg colloidal silica 5.50 mg 5.50 mg
mint flavoring 0.50 mg 0.50 mg
sucrose to weight 3.75 g 3.75 g

How to take, the dosage

Internal (the method of administration is determined by the form of release), once a day, 1 hour before or 2 hours after the meal.
After taking the drug the child should be offered to drink a few sips of water so that he can swallow the rest of the suspension.
Before each dose of the drug it should be thoroughly shaken to a homogeneous suspension. If the required volume of suspension was not taken within 20 minutes after shaking, the suspension should be shaken again, take the required volume and give to the child.
Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues
At the rate of 10 mg/kg body weight once daily for 3 days (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)

br> 15-24 kg 200 mg azithromycin (5.0 ml of suspension)
25-34 kg 300 mg azithromycin (7.5 ml of suspension)
35-44 kg 400 mg azithromycin (10.0 ml of suspension) at least 45 kg 500 mg azithromycin (12.5 ml of suspension) (corresponds to the dose for adult patients)

Children with a body weight less than 10 kg should take azithromycin in the form of powder for oral suspension preparation with the concentration of 100 mg/5 ml.
The table below should be used for precise dosing of azithromycin according to the body weight of the child.

Body weight, kg Dosage of azithromycin, mg (100 mg/5 ml suspension volume, ml) for 1 administration

5 50 mg azithromycin (2.5 ml of suspension)
6 60 mg azithromycin (3.0 ml of suspension)
7 70 mg azithromycin (3.5 ml of suspension)
8 80 mg azithromycin (4.0 ml of suspension)
9 90 mg azithromycin (4.5 ml of suspension)
10 100 mg azithromycin (5 ml of suspension)In 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.
In Lyme disease (initial stage of borreliosis) – erythema migrans
On the 1st day in dose 20 mg/kg/day, then from the 2nd to 5th day in dose 10 mg/kg/day (course dose 60 mg/kg).
In patients with impaired renal function
In patients with a GFR (glomerular filtration rate) of 10-80 ml/min, no dose adjustment is required.
Hepatic impairment
In patients with mild to moderate hepatic impairment 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 cardiac arrhythmia and pirouette arrhythmia.

Preparation of suspension
The suspension is prepared immediately before use.
The powder in the bottle is pre-shaken, 12 ml of boiled and cooled to room temperature water is added, using a syringe for dosing, stirred to obtain a homogeneous suspension.
For precise dosage of the suspension it is necessary to use a syringe that should be well rinsed with water after each use.
After dilution the suspension is ready to be kept in a refrigerator not more than 5 days, but not frozen.
In patients with renal dysfunction of mild to moderate degree of severity the dosage adjustment is not required; in patients with liver dysfunction of mild to moderate degree of severity, in elderly patients the dosage adjustment is not required.

Interaction

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

Concomitant use with ergotamine and dihydroergotamine derivatives may increase the toxic effects of the latter (vasospasm, dysesthesia).

When co-administration with coumarin-type indirect anticoagulants (warfarin) patients require close monitoring of prothrombin time.

Caution is required when terfenadine and azithromycin are coadministered, because it has been found that concomitant administration of terfenadine and macrolides causes arrhythmias and prolongation of the Q-T interval. Therefore, these complications cannot be excluded when terfenadine and azithromycin are taken together.

In concomitant use with cyclosporine it is necessary to monitor the blood concentration of cyclosporine. When concomitant use of azithromycin and cyclosporine, correction of the dose of cyclosporine is necessary.

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, azithromycin has not been found to be involved in pharmacokinetic interactions similar to those of erythromycin and other macrolides, azithromycin is not an inducer or inhibitor of cytochrome P450 isoenzyme.

In concomitant use of azithromycin and rifabutin, neutropenia has occasionally 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.

Asithromycin does not affect 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.
Azithromycin should be taken at least one hour before or two hours after taking antacids.
Azithromycin should be taken with caution in patients with mild to moderate hepatic impairment due to the possibility of fulminant hepatitis and severe hepatic failure.
In case of symptoms of liver function abnormality such as rapidly increasing asthenia, jaundice, darkened urine, bleeding tendency, hepatic encephalopathy, treatment with azithromycin should be discontinued and liver function tests should be conducted.
In patients with renal dysfunction: in patients with GFR (glomerular filtration rate) 10-80 ml/min the dose adjustment is not required, azithromycin therapy should be performed with caution under renal function monitoring.
As with other antibacterial agents during azithromycin therapy the patients should be regularly tested for the presence of immune microorganisms and signs of superinfections including fungal.
Azithromycin should not be used for longer courses than indicated, since the pharmacokinetic properties of azithromycin allow recommending a short and simple dosing regimen.
There are no data on possible interactions between azithromycin and ergotamine and dihydroergotamine derivatives, but because of the development of ergotism when using macrolides simultaneously with ergotamine and dihydroergotamine derivatives, this combination is contraindicated
The development of pseudomembranous colitis caused by Clostridium difficile, both as mild diarrhea and severe colitis, is possible with prolonged use of azithromycin. If antibiotic-associated diarrhea develops during 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.
During treatment with macrolides, including azithromycin, prolongation of cardiac repolarization and QT interval have been observed, increasing the risk of cardiac arrhythmias, including “pirouette” type arrhythmias that 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 electrolyte balance disorders, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure.
Use of azithromycin may provoke development of myasthenic syndrome or cause exacerbation of myasthenia gravis.

Influence on driving and operating machinery
During treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Side effects

Infectious and parasitic diseases
infrequent: 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
infrequent: leukopenia, neutropenia, eosinophilia
very rare: thrombocytopenia, hemolytic anemia
Disorders of the metabolism and nutrition
infrequent: anorexia
Disorders of the immune system
infrequent: Angioneurotic edema, hypersensitivity reaction
unknown frequency: anaphylactic reaction
Nervous system disorders
often: headache
infrequent: dizziness, taste disturbance, paresthesias, somnolence, insomnia, nervousness
rare: agitation
unknown frequency: hypoesthesia, anxiety, aggression, fainting, seizures, psychomotor hyperactivity, loss of smell, perverse sense of smell, loss of taste, myasthenia, delirium, hallucinations
Visual disturbances
often: visual disturbance
Hearing organ and labyrinth disturbances
infrequent: hearing disturbance, vertigo
unknown frequency: Hearing disturbances, including deafness and/or tinnitus
Cardiovascular disturbances
infrequent: palpitations
very rare: arrhythmia
unknown frequency: QT interval prolongation on electrocardiogram, pirouette type arrhythmia, ventricular tachycardia
Vascular disorders
infrequent: “flushes” of blood to the face
unknown frequency: decreased blood pressure
Disorders of the respiratory system, thoracic organs and mediastinum
infrequent: shortness of breath, nasal bleeding
Gastrointestinal tract disorders
very often: Diarrhea
frequent: nausea, vomiting, abdominal pain
infrequent: flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, oral mucosa ulcers, increased salivary gland secretion
very rare: discoloration of tongue, pancreatitis
Hepatic and biliary tract disorders
infrequent: hepatitis
rare: impaired liver function, cholestatic jaundice
unknown frequency: Liver failure (rarely fatal, mostly against the background of severe liver function impairment); liver necrosis, fulminant hepatitis
Skin and subcutaneous tissue disorders
infrequent: skin rash, itching, urticaria, dermatitis, dry skin, sweating
rare: photosensitization reaction
unknown frequency: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic manifestations (DRESS syndrome)
Muscular and connective tissue disorders
infrequent: osteoarthritis, myalgia, back pain, neck pain
unknown frequency: arthralgia
Kidney and urinary tract disorders
infrequent: dysuria, renal pain
unknown frequency: interstitial nephritis, acute renal failure
Renital and breast disorders
infrequent: Metrorrhagia, impaired testicular function
General disorders and disorders at the injection site
infrequently: edema, asthenia, malaise, feeling of fatigue, facial edema, chest pain, fever, peripheral edema
Effects on laboratory and instrumental findings
often: decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased plasma bicarbonate concentration
infrequent: 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.
Treatment: 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.

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