Sumatrolide Solution Tablets, 125 mg 6 pcs

Azithromycin is a bacteriostatic broad-spectrum antibiotic of the macrolide-azolid group. Reversibly binding to 50S ribosome subunit of bacterial cells disrupts translocation of growing polypeptide chain from aminoacyl site to peptidyl site, which leads to suppression of protein synthesis in bacterial cells, slowing down growth and reproduction of bacteria. In high concentrations it has a bactericidal effect. It has activity against a number of Gram-positive, Gram-negative, anaerobic, intracellular and other microorganisms. Microorganisms may be resistant to antibiotic action initially or may acquire resistance to it.
Sensitive: aerobic gram-positive microorganisms -Staphylococcus aureus (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes, Streptococcus group A, B, C, G; 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. Microorganisms capable of developing resistance to azithromycin: Gram-positive aerobes Streptococcus pneumoniae (penicillin-resistant strains). Resistant: aerobic gram-positive microorganisms -Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant); anaerobes: Bacteroides fragilis group. Streptococcus pneumoniae, beta-haemolytic Streptococcus spp. group A, Enterococcus faecal is and Staphylococcus aureus (including methicillin-resistant strains), resistant to erythromycin and other macrolides, lincosamides resistant and to azithromycin.

Pharmacokinetics
After oral administration bioavailability is 37%, maximum concentration in plasma (Cmax) is reached after 2-3 hours, volume of distribution is 31 l/kg. Binding to plasma proteins is inversely proportional to the blood concentration and is 7-50%. It penetrates through cell membranes (effective in infections caused by intracellular pathogens). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria. It passes readily through histohematic barriers and enters tissues. The concentration in tissues and cells is 50 times higher than in blood plasma, and in the focus of infection it is 24-34% higher than in healthy tissues. It is slowly excreted from tissues and has a long half-life of 2-4 days. The therapeutic concentration of azithromycin is maintained for up to 5-7 days after the last dose. Azithromycin is mainly excreted unchanged – 50% by the intestine, 6% by the kidneys. It is demethylated in the liver, losing activity. In patients with renal insufficiency (creatin and on (CK) clearance less than 10 ml/min) the period of azithromycin excretion is increased by 33%.

Indications

Infectious inflammatory diseases caused by microorganisms sensitive to azithromycin:

Active ingredient

Composition

How to take, the dosage

Internal, once a day, at least 1 hour before or 2 hours after the meal.
Adults (including elderly people) and children over 12 years of age with body weight over 45 kg.

Interaction

Special Instructions

In case of missing one dose of the drug – the missed dose should be taken as soon as possible, and the next ones – with 24-hour intervals.
The drug should be taken at least 1 hour before or 2 hours after taking antacid drugs. The drug should be used with caution in patients with liver function disorders of mild to moderate degree of severity due to possible development of fulminant hepatitis and severe hepatic failure.
In case of symptoms of liver function abnormalities such as rapidly increasing asthenia, jaundice, darkened urine, susceptibility to bleeding, hepatic encephalopathy, the drug therapy should be discontinued and liver function tests should be conducted.
In mild to moderately severe renal impairment (CKD over 40 ml/min) the drug therapy should be used with caution while monitoring renal function. It should be remembered that for prophylaxis of pharyngitis/gonzillitis caused by Streptococcus rugensis and for prevention of acute rheumatic fever the drug of choice is usually penicillin.
As with other antibacterial drugs during therapy with the drug, patients should be regularly examined for the presence of immune microorganisms and signs of superinfections, including fungal.
The drug should not be used for longer courses than indicated in the instructions, since pharmacokinetic properties of azithromycin allow recommending a short and convenient dosing regimen.
There is no data on possible interaction 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.
With prolonged use of the drug, pseudomembranous colitis caused by Clostridium difficile may develop, both as mild diarrhea and severe colitis. If diarrhea develops against the background of azithromycin therapy, as well as 2 months after the end of therapy, Clostridium difficile pseudomembranous colitis should be excluded. In mild cases withdrawal of azithromycin and use of ion-exchange resins (colesteramine, colestipol) is sufficient, in severe cases compensation of loss of fluid, electrolytes and protein, prescription of vancomycin or metronidazole is indicated. Do not use drugs that inhibit intestinal peristalsis.
Ventricular repolarization syndrome – QT interval prolongation syndrome – increases the risk of arrhythmias, including “pirouette” arrhythmias during macrolide use, including azithromycin. Caution should be exercised when using azithromycin in patients with the presence of proarrhythmic factors (especially in elderly patients), including congenital or acquired prolongation of the QT interval: In patients receiving therapy with class IA (quinidine, procainamide), III (dofetidil, amiodarone, sotalol) antiarrhythmic agents, cisapride, terfenadine, antipsychotic p reparam (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin, levofloxacin), in patients with electrolyte balance disorders, especially in case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.
Administration of azithromycin may provoke development of myasthenic syndrome or cause exacerbation of myasthenia gravis.

In case of adverse reactions from the nervous system, patients are advised to refrain from driving and operating machinery, and to exercise caution when engaged in activities requiring high concentration and quick psychomotor reactions.

Contraindications

Side effects

Overdose

Similarities