Description
Release form
Powder of white or yellowish-white color with a slight fruity odor. Ready suspension: from white to light yellow, homogeneous with a slight fruity odor.
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, incl. caused by atypical pathogens of
• infections of the skin and soft tissues: erysipelas, impetigo, secondarily infected dermatoses
• the initial stage of Lyme disease (borreliosis) – migratory erythema (erythema migrans).
Contraindications
hypersensitivity to azithromycin (including other macrolides) or other components of
severe renal failure (creatinine clearance (CC) less than 40 ml / min)
severe hepatic insufficiency (class C-point scale) breastfeeding
concomitant use with ergotamine and dihydroergotamine
children under 6 months of age
sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Caution:
renal failure (creatinine clearance (CC) over 40 ml / min)
liver failure (Child-Pugh class A and B)
for arrhythmias or a predisposition to arrhythmias and lengthening of the QT interval srdlfpin with warfarin digoxin
myasthenia gravis.
Special instructions
Indication for patients with diabetes mellitus: 5 ml of a suspension of 100 mg of azithromycin / 5 ml of a suspension contains 0.32 XE, 5 ml of a suspension of 200 mg of azithromycin / 5 ml of a suspension contains 0.29 XE.
In case of skipping a dose, the missed dose should be taken as soon as possible, and the next with an interval of 24 hours. Azithromycin should be taken 1 hour before or 2 hours after taking antacid drugs.
Use with caution in patients with impaired liver function of mild to moderate severity due to the possibility of developing fulminant hepatitis and severe liver failure. In the presence of symptoms of impaired liver function (rapidly increasing asthenia, jaundice, dark urine, a tendency to bleeding, hepatic encephalopathy) azithromycin therapy should be discontinued and a study of the functional state of the liver should be carried out. The drug should be used with caution in patients with impaired renal function of mild to moderate severity. In moderate renal failure (CC 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 on the background of taking it and 2-3 weeks after discontinuing treatment, the development of diarrhea caused by Clostridium difficile (pseudomembranous colitis) is possible. In mild cases, it is sufficient to cancel the treatment and use of ion-exchange resins (colestyramine, colestipol), in severe cases, compensation for fluid loss is indicated, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole.
Contraindicated drugs that inhibit intestinal motility.
Since prolongation of the QT interval in patients receiving macrolides is possible, caution should be exercised when using azithromycin in patients with known risk factors for prolonging the QT interval in patients with 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), anti epressantami (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), impaired with water and electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmias, or severe heart failure.
As with other antibacterial drugs, patients with azithromycin should be examined regularly for the presence of unresponsive microorganisms and signs of superinfection, including fungal infections.
When using azithromycin, the development of myasthenic syndrome or exacerbation of myasthenia is possible.
The drug should not be used for longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin make it possible to recommend a short and simple dosing regimen.
Effect on the ability to drive vehicles and mechanisms
During treatment, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Composition of
In 5 ml of suspension:
active substance: azithromycin dihydrate (in terms of azithromycin) – 100 mg
excipients: lactulose – 200.0 mg, xanthan gum – 15.0 mg, crospovidone (M Collidone CLIDON-CLIDON – 65.0 mg, colloidal silicon dioxide (Aerosil) – 5.5 mg, anhydrous sodium carbonate – 83.0 mg, sodium benzoate – 16.5 mg, titanium dioxide – 10.0 mg, strawberry flavor – 55.0 mg , mint flavor 0.5 mg, apple flavor 13.75 mg, cinnamon flavor 13.75 mg, sucrose to a weight of 3.75 g.
Dosage and administration of
EkomedВ® in the form of a suspension for oral administration is prescribed for children from 6 months.
3-day course: at the rate of 10 mg / kg once a day (course dose of 30 mg / kg).
5-day course: for Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) in children, the dose is 20 mg / kg on the first day and 10 mg / kg from the 2nd to 5th day of the disease, the course dose is 60 mg / kg.
Method for preparing a suspension
A suspension is prepared immediately before use.
The powder in the vial is pre-shaken, add 12 ml of boiled and cooled to room temperature water using a syringe for dosing, mix, obtaining a homogeneous suspension. For an accurate dosage of the suspension, use a double-sided dosage spoon or 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.
Side effects
From the respiratory system: pneumonia, pharyngitis, respiratory diseases, rhinitis, perversion of smell, shortness of breath.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, loose stools, flatulence, indigestion, anorexia, constipation, discoloration of the tongue, gastritis, pseudomembranous colitis, gastroenteritis, dysphagia, bloating, dry mucous membranes of the oral cavity, belching, ulcers of the oral mucosa, increased secretion of salivary glands, cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function, liver failure, liver necrosis (possibly fatal), hyperbilirubin mission pancreatitis, fulminant hepatitis.
Allergic reactions itching, skin rashes, dermatitis, hypersensitivity reactions, dry skin, angioedema, urticaria, photosensitivity, anaphylactic reaction (in rare cases with fatal outcome), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the cardiovascular system: palpitations, arrhythmia, ventricular tachycardia, increased QT interval, bidirectional ventricular tachycardia, decreased blood pressure, flushing of the face.
From the nervous system: dizziness / vertigo, headache, cramps, drowsiness, anxiety, paresthesia, feeling tired, asthenia, insomnia, hyperactivity, aggressiveness, nervousness, fainting, myasthenia gravis, agitation, delirium, hallucinations.
On the part of the sensory organs: tinnitus, hearing impairment reversible hearing loss up to deafness (when taking high doses for a long time), impaired perception of taste and smell, impaired vision, hypesthesia, loss of smell, loss of taste sensations.
From the hemopoietic organs: thrombocytopenia, leukopenia, neutropenia, eosinophilia, lymphopenia, hemolytic anemia.
In blood plasma: an increase in the number of basophils, monocytes, neutrophils, a decrease or increase in the concentration of bicarbonates, an increase in the activity of alkaline phosphatase, an increase in the activity of aspartate aminotransferase, alanine aminotransferase, a change in the potassium content in the blood plasma, an increase in the chlorine content, an increase in the glucose concentration, an increase in the platelet count, an increase hematocrit, a change in the sodium content in the blood plasma.
From the side of the musculoskeletal system: arthralgia, osteoarthritis, myalgia, back pain, neck pain.
From the genitourinary system: interstitial nephritis, acute renal failure, increased concentration of urea and creatinine in blood plasma, dysuria, pain in the kidneys, metrorrhagia, impaired testicular function.
Other: candidiasis, including oral and genital mucosa, weakness, peripheral edema, malaise, nosebleeds, facial swelling, fever, chest pain, sweating.
Drug interaction
Antacids (aluminum and magnesium containing) do not affect bioavailability, but reduce the concentration of azithromycin in the blood by 30%, therefore, the interval between their intake should be 1 hour before or 2 hours after taking these drugs.
With simultaneous use with ergotamine and dihydroergotamine derivatives, the toxic effects of the latter may be enhanced (vasospasm, dysesthesia).
When used together with indirect anticoagulants of the coumarin series (warfarin), patients need careful monitoring of prothrombin time.
Caution should be exercised when co-administering terfenadine and azithromycin, since it has been established that the simultaneous administration of terfenadine and macrolides causes arrhythmia and lengthening of the QT interval. Based on this, the above complications cannot be excluded with the combined use of terfenadine and azithromycin.
With simultaneous use with cyclosporine, it is necessary to control the concentration of cyclosporine in the blood. With the simultaneous use of azithromycin and cyclosporine, dose adjustment of cyclosporin is necessary. With simultaneous use with digoxin, it is necessary to control the concentration of digoxin in the blood (possibly increasing 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 blood plasma, there are no clinically significant side effects and dose adjustment of azithromycin when it is used simultaneously with nelfinavir is not required.
With simultaneous use with zidovudine, azithromycin has little effect on pharmacokinetics, including excretion by the kidneys, 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 and inhibitor of cytochrome P450 isoenzyme.
With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed, despite the fact that neutropenia was 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 concentration of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, cetirizine, sildenafil, atorvastatin and blood rifabredin.
Cases of rhabdomyolysis have been reported in patients simultaneously taking azithromycin and statins.
Overdose
Symptoms: temporary hearing loss, nausea, vomiting, diarrhea.
Symptomatic treatment.
Terms and conditions
Prescription
lekarstvennaja form
suspensions
Prescription
For children 6 months and older, For adults as prescribed by a doctor, Children on doctor’s prescription
Indications
Sinusitis, Skin infections, Angina, Cystitis, Bronchitis, Bronchitis, Bronchitis, m, d hatelyn h Putten infections, otitis, Infektsionn e ill, Urethritis
