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Instructions for use SUMAMOX

Suction

After taking the drug orally, azithromycin is quickly absorbed from the gastrointestinal tract, which is due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg of azithromycin, Cmax in blood plasma is reached after 2.5-2.96 hours and is 0.4 mg/l. The bioavailability of the drug is 37%.

Eating food and alcohol reduces the speed and completeness of absorption. When using the drug shortly after a meal, Cmax in the blood decreases by approximately 50%.

Distribution

Azithromycin easily passes through histohematic barriers and enters tissues; it penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular, the prostate gland), skin and soft tissues. Penetrates through cell membranes (effective against infections caused by intracellular pathogens).

Stable plasma levels are achieved after 5-7 days. High concentration in tissues (10-50 times higher than in blood plasma) and long T1/2 are due to low binding of azithromycin to plasma proteins (7-50% inversely proportional to blood concentration), as well as its ability to penetrate eukaryotic cells and concentrate in the low pH environment surrounding the lysosomes. This, in turn, determines the large apparent Vd (31.1 l/kg) and high plasma clearance.

The ability of azithromycin to accumulate predominantly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that azithromycin is also transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria during the process of phagocytosis. The concentration of azithromycin in foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the severity of inflammatory edema.

Despite its high concentration in phagocytes, azithromycin does not have a significant effect on their function. Preservation of azithromycin in bactericidal concentrations at the site of inflammation for 5-7 days after taking the last dose allowed the development of short (3-day and 5-day) courses of treatment.

Metabolism and excretion

A small amount of the drug is metabolized in the liver. The resulting metabolites are inactive.

The removal of azithromycin from blood plasma occurs in two stages:

T1/2 is 14-20 hours in the interval from 8 to 24 hours after taking the drug and 41 hours in the interval from 24 to 72 hours, which allows the drug to be used once a day.

About 50% of the administered dose of azithromycin is excreted in the bile unchanged and in the form of metabolites in the bile, about 6% in the urine.

Pharmacokinetics in special clinical situations

In elderly (65-85 years old) male patients, the pharmacokinetic parameters do not change; in female patients, Cmax in blood plasma increases by 30-50%.

In patients aged 1 to 5 years, Cmax in the blood and T1/2 are reduced compared to those in adult patients.

Sumamox 500 mg No. 3 tablet p.o.

Sumamox Trade name Sumamox International nonproprietary name Azithromycin Dosage form Film-coated tablets 500 mg Composition One tablet contains the active substance - azithromycin dihydrate (equivalent to azithromycin base) 500.00 mg, excipients: starch, starch paste, calcium phosphate, talc, magnesium stearate, sodium starch glycolate, sodium crosscarmellose, polyvinylpyrrolidone K-30, shell composition: white tabcoate, hydroxypropyl methylcellulose, polyethylene glycol, talc, titanium dioxide. Description Tablets, coated, white or almost white, capsule-shaped (caplets), with a break line on both sides. At the break there is a white or almost white tablet core. Pharmacotherapeutic group Systemic antibacterial drugs, Macrolides ATC code J01FA10 Pharmacological action Pharmacokinetics After oral administration, Azithromycin is well absorbed and quickly distributed in the body. After a single dose of 500 mg, bioavailability is 37% (the “first pass” effect), the maximum concentration (0.4 mg/l) in the blood is created after 2 - 3 hours, the apparent volume of distribution is 31.1 l/kg, protein binding is inversely proportional to the concentration in the blood and ranges from 7 to 50%. Penetrates through cell membranes (effective against infections caused by intracellular pathogens). Transported by phagocytes to the site of infection, where it is released in the presence of bacteria. Easily passes histohematic barriers and enters tissues. The concentration in tissues and cells is 10–50 times higher than in plasma, and at the site of infection it is 24–34% higher than in healthy tissues. The elimination of azithromycin from blood plasma occurs in 2 stages: the half-life is 14-20 hours in the range from 8 to 24 hours after taking the drug and 41 hours in the range from 24 to 72 hours, which allows the drug to be used once a day. The half-life from tissues is significantly longer. The therapeutic concentration of azithromycin lasts up to 5 to 7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% by the intestines, 6% by the kidneys. In the liver it is demethylated, losing activity. Pharmacodynamics Sumamox is a broad-spectrum bacteriostatic antibiotic from the group of macrolides - azalides. Has a wide spectrum of antimicrobial action. The mechanism of action of Sumamox is associated with the suppression of protein synthesis in microbial cells. By binding to the 5OS subunit of the ribosome, it inhibits peptide translocase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect. Sumamox has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms. Microorganisms may be initially resistant to the action of Sumamox or may acquire resistance to it. In most cases, sensitive microorganisms 1. Gram-positive aerobes Staphylococcus aureus Methicillin - sensitive Streptococcus pneumoniae Penicillin - sensitive Streptococcus pyogenes 2. Gram-negative aerobes Haemophilus influenzae Haemophilus parainfluenzae Legionlla pneumophila Moraxella catarrhalis Pasteurella multocida Neisseria gonorrhoeae 3. Anaer oby Clostridium perfringens Fusobacerium spp. Prevotella spp. Porphyriomonas spp. 4. Other microorganisms Chlamydia trachomatis Chlamydia pneumonie Chlamydia psittaci Mycoplasma pneumoniae Mycoplasma hominis Borrelia burgdorferi Microorganisms that can develop resistance to azithromycinin Gram-positive aerobes Streptococcus pneumoniae Penicillin-resistant Initially resistant microorganisms Gram-positive aerobes Enterococcus faeclis Staphylococci (methicillin-resistant bacteria) phylococci exhibit a very high degree of resistance to macrolides ) Gram-positive bacteria resistant to erythromycin. Anaerobes Bacteroides fragilis. Indications - 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 - infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses) - the initial stage of Lyme disease (borreliosis) - erythema migrans (eruthema migrans) - genitourinary tract infections caused by Chlamidia trachomatis (urethritis, cervicitis) - diseases of the stomach and duodenum associated with Helicobacter pylori Method of administration and dosage Sumamox should be taken orally, 1 time per day, at least 1 hour before or 2 hours after meals. Adults (including elderly people) and children over 16 years of age weighing over 45 kg. For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: 500 mg (1 tablet) once a day for 3 days (course dose 1.5 g). For migratory erythema, once a day for 5 days: day 1 - 1.0 g (2 tablets), then from days 2 to 5 - 500 mg (1 tablet) (course dose 3.0 g). For urinary tract infections caused by Chlamidia trachomatis (urethritis, cervicitis) Uncomplicated urethritis/cervicitis - 1 g (2 tablets) once. For diseases of the stomach and duodenum associated with Helicobacter pylori, 1 g (2 tablets) per day is prescribed for 3 days as part of combination therapy. Prescription for patients with impaired renal function For patients with moderate impaired renal function (creatinine clearance > 40 ml/min), no dose adjustment is necessary. If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart. Side effects Common: nausea, vomiting, diarrhea, abdominal pain/cramps Uncommon: dizziness/vertigo, headache, convulsions, drowsiness - loose stools, flatulence, indigestion, anorexia - itching, skin rashes - arthralgia. Rarely - thrombocytopenia, neutropenia - paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness - tinnitus, reversible hearing loss up to deafness (when taking high doses for a long time), impaired perception of taste and smell - palpitations, arrhythmia , ventricular tachycardia, increased QT interval, bidirectional ventricular tachycardia - constipation, tongue discoloration, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory tests of liver function - angioedema, urticaria, photosensitivity, anaphylactic reaction, including edema (in rare cases fatal outcome), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis - nephritis, acute renal failure - vaginitis, candidiasis Very rare - liver failure, liver necrosis (possibly fatal) Contraindications - hypersensitivity to macrolide antibiotics - severe dysfunction liver and kidneys - pregnancy and lactation - children under 16 years of age Drug interactions Antacids (containing aluminum, magnesium) and food intake significantly reduce the absorption of azithromycin, so the drug should be taken 1 hour before or 2 hours after meals and antacids. It does not affect the activity of enzymes of the cytochrome P-450 complex and, unlike other macrolides, there is currently no interaction with theophylline, carbamazepine, triazolam. When warfarin and azithromycin were co-administered (in usual doses), no change in prothrombin time was detected, however, given that the interaction of macrolides and warfarin may enhance the anticoagulant effect, patients need careful monitoring of prothrombin time. Increases the concentration of digoxin by reducing its inactivation by intestinal flora. Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia). Special instructions It is necessary to observe a break of 2 hours while using antacids. Use in pediatrics The safety of prescribing Sumamox in children and adolescents under 16 years of age has not been fully established. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Considering the possibility of developing side effects from the central nervous system, caution should be exercised. Overdose Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: symptomatic. Release form and packaging 3 tablets in a blister pack made of polyvinyl chloride film and aluminum foil. 1 contour package along with instructions for medical use in the state and Russian languages is placed in a cardboard pack. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 25ºС. Keep out of the reach of children! Shelf life: 2 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription Name and country of the manufacturing organization Oxford Laboratories Pvt. Ltd, B306, Crystal Plaza, New Link Road, Andheri (West), Mumbai, India Name and Country of Marketing Authorization Holder Oxford Laboratories Pvt. Ltd., India Name and country of packaging organization Oxford Laboratories Pvt. Ltd., India Address of the organization that accepts claims from consumers on the quality of products (products) on the territory of the Republic of Kazakhstan Representative office of Oxford Laboratories Pvt., Ltd. Almaty, st. Auezova 3 Tel./fax + E-mail

Sumamox 200 mg/5 ml 13 g gran.d/susp. for oral administration

APPROVED by the Order of the Chairman of the Committee for Pharmaceutical and Medical Control of the Ministry of Health and Social Development of the Republic of Kazakhstan ____________________ Instructions for the medical use of the drug Sumamox Trade name Sumamox International nonproprietary name Azithromycin Dosage form Granules for the preparation of suspension for oral administration, 100 mg/5 ml and 200 mg/5 ml Composition 5 ml of suspension contains 100 mg / 5 ml 200 mg / 5 ml active substance - azithromycin dihydrate 104.82 mg 209.625 mg (equivalent to azithromycin) (100.0 mg) (200.0 mg) excipients: sucrose, sodium carboxymethylcellulose, xanthan gum, sodium phosphate tribasic dodecahydrate, sodium lauryl sulfate, sodium benzoate, sodium chloride, Ponceau 4R, cherry flavor, colloidal silicon dioxide. Description Granular powder of light pink color with a characteristic cherry odor. Reconstituted suspension of pink color with a characteristic cherry odor. Pharmacotherapeutic group Antibacterial drugs for systemic use. Macrolides, lincosamines and streptogramins. Macrolides. Azithromycin. ATC code J01FA10 Pharmacological properties Pharmacokinetics Absorption After oral administration, azithromycin is rapidly absorbed. The binding of azithromycin to plasma proteins varies depending on the concentration and decreases from 51% at 0.02 μg/ml to 7% at 2 μg/ml. Distribution Azithromycin is widely distributed throughout the body. The rapid distribution of azithromycin in tissues and high intracellular concentrations provide higher concentrations of the drug in tissues than in plasma or serum. Metabolism and elimination Removal of azithromycin from blood plasma occurs in 2 stages: the half-life (T1/2) is 14-20 hours in the range from 8 hours to 24 hours after taking the drug and 41 hours in the range from 24 hours to 72 hours, which allows you to use the drug 1 time/day. The drug is excreted mainly in bile unchanged, a small part is excreted by the kidneys. Pharmacodynamics The active substance of the drug Sumamox - azithromycin is a broad-spectrum antibiotic, the first representative of a new subgroup of macrolide antibiotics - azalides. Sumamox has a bacteriostatic effect, but when high concentrations are created at the site of inflammation, it causes a bactericidal effect. Sumamox inhibits protein synthesis in sensitive microorganisms, showing activity against most strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms: Mycoplasma pneumoniae, Haemophilus ducreyi, Moraxella catarrhalis, Propionibacterium acnes, Gardnerella vaginalis, Actinomyces species, Bordetella pertussis, Borrelia burgdorferi, Mobiluncus species; Haemophilus influenzae, Streptococcus pyogenes, Haemophilus parainfluenzae, Streptococcus pneumoniae, Legionella pneumophila, Streptococcus agalactiae, Neisseria meningitides, Streptococcus viridans, Neisseria gonorrhoeae, Streptococcus group C, F, G, Helicobacter pylori, Peptococcus species, Campylobacter jejun i, Peptostreptococcus, Pasteurella multocida, Fusobacterium necrophorum, Pasteurella haemolytica, Clostridium perfringens, Brucella melitensis, Bacteroides bivius, Bordetella parapertussis, Chlamydia trachomatis, Vibrio cholerae, Chlamydia pneumoniae, Vibrio parahaemolyticus, Ureaplasma urealyticum, Plesiomonas shigelloides, Listeria monocytogenes, Staphylococcus epidermidis , Staphylococcus aureus* (*erythromycin – sensitive strain ); Escherichia coli, Bacteroides fragilis, Salmonella enteritidis, Bacteroides oralis, Salmonella typhi, Clostridium difficile, Shigella sonnei, Eubacterium lentum, Yersinia enterocolitica, Fusobacterium nucleatum, Acinetobacter calcoaceticus, Aeromonas hydrophilia. Indications for use - upper respiratory tract infections (bacterial pharyngitis/tonsillitis, otitis media) - lower respiratory tract infections (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis) - skin and soft tissue infections (chronic migratory erythema - the initial stage of Lyme disease , erysipelas, impetigo, secondary pyodermatoses) - infections of the urogenital tract (gonorrheal and non-gonorrheal urethritis and/or cervicitis) Method of administration and dose Instructions for the preparation of the suspension. First, loosen the powder by shaking the bottle well, then add freshly boiled cooled water to the mark (20 ml) of the bottle to obtain 4 doses of a suspension containing 100 mg and 200 mg of azithromycin in 5 ml of suspension. Shake the contents of the bottle thoroughly until a homogeneous suspension is formed. After preparation, a pink suspension will be obtained. Sumamox suspension should be shaken before use. Take the suspension orally with a 2.5/5.0 ml dosing spoon. After taking the suspension, drink a small amount of water to rinse and swallow the remaining amount of the suspension in the mouth. Use Sumamox suspension within 5 days after preparation. Sumamox suspension should be taken 1 hour before meals or 2 hours after meals. Sumamox should not be taken with food. Adults (including elderly people), children over 12 years old and weighing over 45 kg. Treatment of mild to moderate exacerbations of chronic obstructive pulmonary disease, community-acquired pneumonia, pharyngitis and tonsillitis (as second-line therapy), and uncomplicated skin and soft tissue infections caused by susceptible microorganisms 500 mg (25 ml 100 mg/5 ml dosage or 12.5 ml of 200 mg/5 ml dosage) 1 time on the first day, then 250 mg (12.5 ml of 100 mg/5 ml dosage or 6.25 ml of 200 mg/5 ml dosage) from 2 to 5th day. Treatment of genital ulcers in men (chancroid) caused by Haemophilus ducreyi, non-gonococcal urethritis and cervicitis caused by C. trachomatis: single dose of 1 g (50 ml 100 mg/5 ml dosage, 25 ml 200 mg/5 ml dosage). Treatment of urethritis and cervicitis caused by Neisseria gonorrhoeae: single dose of 2 g (100 ml 100 mg/5 ml dosage, 50 ml 200 mg/5 ml dosage). Maximum single dose for adults: 2 g (100 ml 100 mg/5 ml dosage, 50 ml 200 mg/5 ml dosage). Maximum daily dose for adults: 2 g (100 ml 100 mg/5 ml dosage, 50 ml 200 mg/5 ml dosage). Children over 12 years of age for the treatment of pharyngitis or tonsillitis: 12 mg/kg once daily for 5 days. Maximum single dose for children over 12 years of age: 1.5 g (75 ml 100 mg/5 ml dosage, 37.5 ml 200 mg/5 ml dosage). Maximum daily dose for children over 12 years of age: 1.5 g (100 ml 100 mg/5 ml dosage, 37.5 ml 200 mg/5 ml dosage). Children weighing up to 45 kg. For children who weigh more than 15 kg, azithromycin suspension should be taken using a spoon dispenser that provides 2.5 or 5 ml doses, respectively 100 or 200 mg of azithromycin, according to the following dosage regimen: *Separate dosage recommendations for Sumamox for streptococcal pharyngitis are described below. For the treatment of streptococcal pharyngitis in children aged 2 years and older, azithromycin is used in a single dose of 10 mg / kg or 20 mg / kg for three days, without exceeding the maximum daily dose of 500 mg (25 ml of 100 mg / 5 ml dosage, 12.5 ml 200 mg/5 ml dosage). . However, penicillin remains the first choice for the treatment of streptococcal pharyngitis as a prophylaxis for acute rheumatism. Selected patient groups Elderly No dose adjustment is required for elderly patients. Patients with renal insufficiency No dose adjustment is necessary in patients with mild to moderate renal insufficiency (creatinine clearance 10 - 80 ml/min) Patients with hepatic insufficiency No dose adjustment is required in patients with mild to moderate hepatic impairment (class A or B). Side effects Often - nausea, vomiting, diarrhea, abdominal pain/cramps Uncommon - dizziness/vertigo, headache, convulsions, drowsiness, asthenia, malaise - loose stools, flatulence, indigestion, anorexia - itching, skin rashes, swelling - pain in chest, arthralgia Rarely - thrombocytopenia, neutropenia, hemolytic anemia, leukopenia, eosinophilia - paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, restlessness, nervousness, in the elderly depersonalization, disorders of consciousness, anxiety - tinnitus, reversible hearing loss up to deafness ( when taking high doses for a long time), impaired perception of taste and smell, visual impairment, tooth discoloration - palpitations, arrhythmia, ventricular tachycardia, increased QT interval, torsade de pointes, hypotension, hyperkalemia - constipation, tongue discoloration, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory parameters (increased ALT, AST, bilirubin levels) of liver function, pancreatitis, gastritis - angioedema, urticaria, photosensitivity, anaphylactic reaction, including edema (in rare cases fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis - nephritis, acute renal failure, increased levels of urea, creatinine - vaginitis, candidiasis Very rare - liver failure, fulminant liver necrosis (possibly fatal) Contraindications - hypersensitivity to azithromycin, erythromycin and any others macrolide antibiotics or any other components of the drug - severe impairment of liver and kidney function - patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrose deficiency - isomaltose - pregnancy - lactation Drug interactions Sumamox affects the activity of enzymes of the cytochrome P-450 complex and unlike other macrolides, there is currently no interaction with theophylline, carbamazepine, triazolam. When warfarin and azithromycin were co-administered (in usual doses), no change in prothrombin time was detected, however, given that the interaction of macrolides and warfarin may enhance the anticoagulant effect, patients need careful monitoring of prothrombin time. Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia). Antacids When studying the pharmacokinetics of the combined use of an antacid with azithromycin, no overall change in bioavailability was observed, although when measuring the maximum plasma concentration of azithromycin, a decrease in concentration by 25% was observed. Sumamox should be taken at least 1 hour before or 2 hours after antacids. Cetirizine In healthy volunteers, coadministration of azithromycin with cetirizine 20 mg did not result in pharmacokinetic interactions and no significant changes in the QT interval. Digoxin In some patients, the use of macrolides with digoxin has led to disruption of the metabolism of digoxin in the intestine. Therefore, the combined use of azithromycin and digoxin may lead to an increase in digoxin concentrations by reducing its inactivation by intestinal flora. Zidovudine 1000 mg and 1200 mg single dose or 600 mg multiple doses of azithromycin have little effect on the pharmacokinetics of zidovudine or its glucuronide metabolite in plasma or urinary excretion. Didanosine (dideoxyinosine) Concomitant use of azithromycin and didanosine does not affect the pharmacokinetics of didanosine. Cyclosporine When azithromycin and cyclosporine are used together, an increase in the concentration of cyclosporine and PPFK-5 is observed. If co-administration is necessary, dose adjustment of cyclosporine is necessary. Nelfinavir When azithromycin and nelfinavir are used together, an increase in the concentration of nelfinavir is observed. No clinically significant side effects were observed and no dose adjustment is required. Cisapride Cisapride is metabolized in the liver by the enzyme CYP3A4. Macrolides inhibit this enzyme, so coadministration of cisapride and azithromycin may cause QT prolongation, ventricular arrhythmia, and torsade de pointes (TdP). Substances that prolong the QT interval Azithromycin should not be used in combination with other active substances that prolong the QT interval. Special instructions Elderly patients and patients with heart disease may be more susceptible to the arrhythmogenic effects of the antibiotic. If signs of hepatitis appear, Sumamox should be discontinued immediately. If allergic reactions occur, Sumamox should be discontinued immediately and appropriate therapy should be initiated. Sumamox is prescribed with caution to patients with cardiovascular pathology. High-risk patients with a history of prolonged QT interval, hypokalemia, hypomagnesemia and bradycardia should be carefully consulted by a physician. Sumamox contains sucrose. The sucrose content should be taken into account in patients with diabetes mellitus. Allergic reactions In rare cases, azithromycin may cause serious allergic reactions such as angioedema and anaphylaxis. Renal failure In patients with mild to moderate renal failure (GFR 10 -80 ml/min), dose adjustment is not necessary. Caution is recommended when administered to patients with severe renal impairment (GFR <10 ml/min). Hepatic Impairment Because the liver is the primary route of elimination of azithromycin, use of Sumamox should be used with caution in patients with significant liver disease. If signs and symptoms of liver dysfunction appear, such as rapid development of asthenia associated with jaundice, dark urine, bleeding tendency, or hepatic encephalopathy, laboratory tests of liver function should be performed immediately. If liver dysfunction occurs, azithromycin should be discontinued immediately. It should be taken into account before prescribing Sumamox: Sumamox in oral suspension is not suitable for the treatment of severe infections where a rapid increase in the concentration of the antibiotic in the blood is necessary. When prescribing azithromycin and other antibiotics, it is important to take into account diseases caused by pathogens resistant to erythromycin. As for other macrolides, high levels of resistance to Streptococcus pneumoniae (> 30%) have been obtained for azithromycin. This should be taken into account when treating infections caused by Streptococcus pneumoniae. The main causative agent of soft tissue infections, Staphylococcus aureus, is often resistant to azithromycin. Therefore, azithromycin sensitivity testing is considered a prerequisite for the treatment of soft tissue infections. Pharyngitis/tonsillitis Sumamox is not the first choice substance for the treatment of pharyngitis and tonsillitis caused by Streptococcus pneumoniae. For this and for the prevention of acute rheumatic fever, penicillin is the first drug of choice. Sinusitis Sumamox is not the first choice substance for the treatment of sinusitis, acute otitis media. Superinfections Pay attention to possible symptoms of superinfections caused by non-susceptible pathogens such as fungi. Superinfection may require discontinuation of azithromycin treatment and appropriate measures are taken. Neurological or psychiatric diseases Sumamox should be prescribed with caution to patients suffering from neurological or psychiatric diseases. Myasthenia gravis There have been cases of the appearance of myasthenia gravis symptoms and exacerbation of myasthenia gravis symptoms in patients receiving azithromycin. Clostridium difficile associated diarrhea Clostridium difficile associated diarrhea (DAAD) occurs in almost all cases of use of antibacterial agents, including Sumamox, and can vary in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and leads to overgrowth of Clostridium difficile Long-term use The safety and effectiveness of long-term use of azithromycin for these indications is not known. In cases of rapid recurrent infection, treatment with other antibiotics should be considered. The safety of azithromycin in children under 6 months of age has not been established. The safety and effectiveness of azithromycin for the prevention or treatment of Yellow Bacillus Complex (YBC) in children has not been established. Features: the effect of the drug on the ability to drive vehicles or potentially dangerous mechanisms. Considering the side effects of the drug, care must be taken when driving vehicles and other potentially dangerous mechanisms. Overdose Symptoms. Reversible hearing loss, severe nausea, vomiting and diarrhea. Treatment. In case of overdose, activated charcoal is prescribed or the stomach is washed and general symptomatic treatment is prescribed if necessary. Release form and packaging 8.0 g (for 100 mg/5 ml dosage) and 13.0 g (for 200 mg/5 ml dosage) of the drug in 40 ml brown glass bottles with a 20 ml mark, sealed with a rubber stopper, crimped with an aluminum cap and polypropylene cover. A label is attached to each bottle. 1 bottle, together with a 2.5/5.0 ml dispenser spoon and instructions for medical use in the state and Russian languages, is placed in a cardboard pack. Storage conditions: In a dry place, protected from light, at a temperature not exceeding 25 0C. The prepared suspension is stored at a temperature from 15 ° C to 25 ° C for no more than 5 days. Keep out of the reach of children! Shelf life: 2 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription Manufacturer Oxford Laboratories Pvt. Ltd, B306, Crystal Plaza, New Link Road, Andheri (West), Mumbai, India Marketing Authorization Holder Oxford Laboratories Pvt. Ltd., India Address of the organization that accepts claims from consumers on the quality of products (products) on the territory of the Republic of Kazakhstan Representative office of Oxford Laboratories Pvt., Ltd. Almaty, st. Auezova 3 Tel./fax + E-mail