Description
Latin name
Azithromycin Ecomed
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.
Packaging
16.5 g each in dark glass bottles with a capacity of 60 ml with a screw-on plastic cap. 1 bottle with a syringe for dispensing and instructions for use are placed in a pack of cardboard.
Pharmacological action
Broad-spectrum antibacterial drug from the group of azrolide macrolides, has a bacteriostatic effect.
By binding to the 50S subunit of ribosomes, it inhibits the peptide translocase at the translation stage, inhibits protein synthesis, slows down the growth and reproduction of bacteria, and has a bactericidal effect in high concentrations.
Acts on extra- and intracellularly located pathogens.
Microorganisms may be initially resistant to the action of the antibiotic or may become resistant to it.
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, obesity including 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 (erythema migrans).
Contraindications
hypersensitivity to azithromycin (including other macrolides) or other components of the
preparation 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.
Use during pregnancy and lactation
Azithromycin during pregnancy is recommended only in cases where the expected benefits of taking it for the mother outweigh the potential risk to the fetus.
During treatment with azithromycin, breastfeeding is stopped.
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 (Collidone CL-M) – 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
Ekomed® as a suspension for oral administration is prescribed for children from 6 months.
3-day course: at the rate of 10 mg / kg 1 time per day (course dose of 30 mg / kg).
5 day course: in 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, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands , cholestatic jaundice, hepatitis, a change in laboratory parameters of liver function, liver failure, liver necrosis (possibly fatal), hyperbilirubinemia, 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 mucous membrane of the oral cavity and genitals, weakness, peripheral edema, malaise, nosebleeds, facial swelling, fever, chest pain, sweating.
Drug Interactions
Antacids (aluminum and magnesium containing) do not affect bioavailability, but reduce the concentration of azithromycin in the blood by 30%, so the interval between administration should be 1 h before or 2 h after administration of these drugs.
When used with ergotamine and dihydroergotamine derivatives, the toxic effects of the latter (vasospasm, dysesthesia) may be increased.
When combined with the anticoagulants of the indirect action of coumarin (warfarin), patients need careful monitoring of prothrombin time.
Caution should be exercised when co-administering terfenadine and azithromycin, as it has been found that concomitant administration of terfenadine and macrolides causes arrhythmia and QT prolongation. Based on this, the above complications with the co-administration of terfenadine and azithromycin cannot be ruled out.
When used with ciclosporin, it is necessary to control the concentration of ciclosporin in the blood. When azithromycin and cyclosporine are co-administered, a dose adjustment of cyclosporine is required. When co-administered with digoxin, control of the concentration of digoxin in the blood is required (increased absorption of digoxin in the intestine is possible). Concomitant use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times daily) causes an increase in the equilibrium concentration of azithromycin in blood plasma, no clinically relevant side effects were observed and no dose adjustment of azithromycin when used with nelfinavir is required.
When used with zidovudine, azithromycin has little effect on the pharmacokinetics, including renal excretion, zidovudine or its glucuronide metabolite. Azithromycin interacts poorly with cytochrome P450 isoenzymes, it is not revealed that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides, and azithromycin is not an inducer and inhibitor of cytochrome P450 isoenzyme.
Neutropenia has occasionally been observed with azithromycin and rifabutin co-administered, Although 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, atorvastatin, atorvastatin, atorvastatin
Separate reports of rhabdomyolysis have been reported in patients receiving both azithromycin and statins.
Overdose
Symptoms: temporary hearing loss, nausea, vomiting, diarrhea.
Treatment: symptomatic.
active substance
Azithromycin
Conditions of dispatch from
pharmacies Prescription by
lekarstvennaja form
suspensions for pryema inside
Prescription
For children prescribed by a doctor, For adults prescribed by a doctor, Children over 3 years old
Indications
Indications
Indications
Indications, Sickl3, Bruises, 62 diseases, pharyngitis, cystitis, respiratory infections, skin infections, urethritis, sinusitis, pneumonia, tonsillitis, bronchitis
