active ingredients: 1 tablet contains azithromycin dihydrate equivalent to azithromycin 250mg or 500mg
Auxiliary substances: microcrystalline cellulose, crospovidone, ethyl cellulose, isopropyl alcohol, dichloromethane, silicon dioxide colloidal, talc, magnesium stearate, protectab HP - 1 (hydroxypropylmethyl cellulose, propylene glycol, castor oil, talc, titanium dioxide ( E171))), iron oxide yellow (E172).
Basic physical and chemical properties: tablets of 250 mg are light yellow, round, biconvex, film-coated, plain on both sides;
tablets of 500 mg-light yellow, biconvex, in the form of droplets, covered with a film shell, with a notch on the one hand and smooth on the other hand.
Antibacterial agents for systemic use. Macrolides, lincosamide and streptogramin. Azithromycin.
ATC code J01FA10.
Pharmacological. Azithromycin is a member of a new subgroup of macrolide antibiotics - azalidov. Binds to THE 50s ribosome 70S subunit of sensitive microorganisms, inhibiting RNA-dependent protein synthesis, slows the growth and reproduction of bacteria, at high concentrations, the bactericidal effect is possible.
It has a wide range of antimicrobial action. The drug is sensitive gram - positive cocci-Streptococcus pneumoniae, S. pyogenes, S. agalactiae, Streptococcus groups C, F and G, S. viridans; Staphylococcus aureus; gram-negative bacteria-Haemophilus influenzae, N. parainfluenzae, Moraxella catarrhalis, Bordatella pertussis, B. parapertussis, Legionella pneumophila, H. ducrei, Campylobacter jejuni, Neisseria gonorrhoeae, Gardnerella vaginalis ; some anaerobic microorganisms-Bacteroides bivius, Clostridium perfringens , Peptostreptococcus species, as well as Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi . Does not affect gram-positive microorganisms resistant to erythromycin.
Pharmacokinetics. After oral administration, azithromycin is rapidly absorbed from the digestive tract. Bioavailability is about 37% ("first pass"effect). The maximum concentration in plasma is reached after 2.5-3 h and is 0.4 mg/l when administered 500 mg azithromycin well into the respiratory tract, organs and tissues of the urogenital tract, in particular in the prostate, skin and soft tissue. The concentration in tissues and cells is 10-100 times higher than in serum. The stable level in plasma is reached in 5-7 days. The drug accumulates in large quantities in phagocytes, transporting it to the places of infection and inflammation, where it is gradually released in the process of phagocytosis.
The proteins are bound inversely in proportion to the blood concentration (7-50% of the drug). About 35% is metabolized in the liver by demethylation, losing activity.
More than 50% is excreted with bile in an unmodified form, about 4.5% - in the urine within 72 hours.
The half-life is 14-20 hours (in the range of 8-24 hours after taking the drug) and 41 hours (in the range of 24-72 hours). Food intake significantly alters the pharmacokinetics.
With age, the parameters of pharmacokinetics do not change in men (65-85 years), women increase the maximum concentration ( max ) by 30-50%; children aged 1-5 years decrease C max , T 1/2 , the area under the pharmacokinetic curve.
Infections caused by microorganisms sensitive to azithromycin:
ENT-organs (bacterial pharyngitis/tonsillitis, sinusitis, otitis media);
respiratory infections (bacterial bronchitis, community-acquired pneumonia);
infections of the skin and soft tissues migrating erythema (initial stage of Lyme disease), erysipelas, impetigo, secondary pyodermatosis, acne vulgaris (common acne) of moderate severity;
sexually transmitted infections: uncomplicated genital infections caused by Chlamydia trachomatis.
Hypersensitivity to azithromycin, erythromycin or any other macrolide antibiotics or Catalina and auxiliary substances of the drug. Through the theoretical possibility of ergotism, azithromycin should not be prescribed simultaneously with the derivatives of controversial.
Interaction with other drugs and other interactions.
Should be careful to prescribe azithromycin to patients with with other medications that can lengthen the QT interval.
Antacids: while the use of antacids as a whole, there are no changes in bioavailability, although plasma peak concentrations of azithromycin decrease by 30%. Azithromycin should be taken at least 1:00 before or 2:00 after taking antacids. Changes in the pharmacokinetics of azithromycin in the application of cimetidine 2:00 before the use of azithromycin absent.
Carbamazepine pharmacokinetic interaction of azithromycin does not significantly affect the plasma levels of carbamazepine or its active metabolites.
Cyclosporine: in Pharmacokinetic studies, after taking for 3 days azithromycin at a dose of 500 mg/day orally, and then taking a single dose of 10 mg/kg cyclosporine, there was a significant increase in the level of C max and AUC 0-5 cyclosporine. Therefore, be careful when considering the simultaneous administration of these drugs. If such simultaneous use is necessary, cyclosporine levels should be monitored and the dose adjusted accordingly.
Anticoagulants: it was reported about the increased tendency to bleeding in connection with the concurrent use of azithromycin and warfarin or kumarinovykh oral anticoagulants. Attention should be paid to the monitoring of PM.
Digoxin: the simultaneous use of macrolide antibiotics, including azithromycin with P-glycoprotein substrates such as digoxin, increases serum P-glycoprotein substrate levels. Therefore, the simultaneous use of azithromycin and digoxin should take into account the possibility of increasing the concentration of digoxin in serum.
Methylprednisolone: azithromycin has no significant effect on the pharmacokinetics of methylprednisolone.
Terfenadin: there is no reported interaction between azithromycin and terfenadin. As with other macrolide antibiotics, azithromycin should be administered with caution in combination with terfenadine.
Theophylline: azithromycin did not affect the pharmacokinetics of theophylline during concurrent use of azithromycin and theophylline. The combined use of theophylline and other macrolide antibiotics sometimes leads to an increase in serum levels of theophylline.
Zidovudine: concomitant use of azithromycin (single dose 1000 mg doses and multiple 1200 mg or 600 mg) had little impact on the plasma pharmacokinetics and renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin leads to an increase in the concentration of phosphorylated zidovudine, clinically active metabolite, in peripheral blood mononuclears.
Didanosine: with simultaneous use of daily doses of 1200 mg of azithromycin with didanosine, there is no effect on the pharmacokinetics of didanosine.
Efavirenz: concurrent use of a single dose of azithromycin 600 mg and 400 mg efavirenz daily for 7 days did not cause any clinically significant pharmacokinetic interaction.
Rifabutin: the simultaneous use of azithromycin and rifabutin does not affect the plasma concentrations of these drugs. Neutropenia was observed in subjects taking both azithromycin and rifabutin. Although neutropenia was associated with the use of rifabutin, a causal relationship with the simultaneous administration of azithromycin was not established.
Cetirizine: simultaneous use in a 5-day course of azithromycin with 20 mg of cetirizine in equilibrium does not lead to pharmacokinetic interaction and significant changes in THE Qt interval.
Ergot derivatives: due to the theoretical possibility of ergotism, should not be used azithromycin with ergot derivatives.
Azithromycin has no significant interaction with the liver system of cytochrome P450. It is believed that the drug has no pharmacokinetic interaction with erythromycin and other macrolides. Azithromycin does not cause induction or inactivation via cytochrome P450 cytochrome-metabolite complex.
Atorvastatin: simultaneous use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) does not cause changes in plasma concentrations of atorvastatin (based on the analysis of HMG SOA reductase inhibition).
Cimetidine: no changes in the pharmacokinetics of azithromycin are detected, provided the use of cimetidine 2:00 before taking azithromycin.
Fluconazole: the simultaneous use of a single dose of azithromycin 1200 mg does not change the pharmacokinetics of a single dose of 800 mg of fluconazole. Total exposure and half-life of azithromycin is not changed with coadministration of fluconazole, however, a decrease in C max of azithromycin (18%) that has no clinical significance.
Indinavir: the simultaneous use of a single dose of azithromycin 1200 mg does not cause a statistically significant effect on the pharmacokinetics of indinavir, which is used at 800 mg three times a day for 5 days.
Midazolam: simultaneous use of 500 mg of azithromycin for 3 days does not cause clinically significant changes in pharmacokinetics and pharmacodynamics of a single dose of 15 mg of midazolam.
Triazolam: simultaneous use of azithromycin 500 mg on the 1st day and 250 mg on the 2nd day with 0.125 mg triazolama does not cause a significant impact on the pharmacokinetic parameters of triazolam.
Nelfinavir: the use of nelfinavir leads to an increase in serum azithromycin concentrations. Although a dose adjustment of azithromycin during concomitant use with nelfinavir is not recommended, warranted a thorough monitoring of the known side effects of azithromycin.
Sildenafil: we received no evidence of the effect of azithromycin (500mg daily within 3 days) the value of AUC and max sildenafil or its main circulating metabolite in males.
Trimethoprim/sulfamethoxazole: concomitant use of trimethoprim/sulfamethoxazole (160 mg/800 mg) for 7 days with 1200 mg of azithromycin on the seventh day has no significant effect on maximum concentrations, total exposure or excretion in the urine of trimethoprim or sulfamethoxazole.
Doxorubicin: no clinical studies have been conducted on the interactions between azithromycin and doxorubicin. The clinical significance of preclinical studies is unknown.
Allergic reaction. Rarely was reported that azithromycin had severe allergic (rarely fatal) reactions such as angioedema and anaphylaxis. Some of these reactions caused the development of recurrent symptoms and required longer follow-up and treatment.
Elongated cardiac repolarization and Qt interval.
Elongation of cardiac repolarization and Qt interval, which were associated with the risk of cardiac arrhythmia and paroxysmal ventricular tachycardia "pirouette", was observed in the treatment of other macrolide antibiotics.
With caution, azithromycin should be prescribed to patients with an increased risk of prolonged cardiac repolarization:
or registered with congenital prolongation of the QT interval;
being treated with other active substances that prolong the QT interval, such as antiarrhythmic drugs class IA and III, cisapride and terfenadine;
in violation of electrolyte metabolism, especially in the case of hypokalemia and hypomagnesemia;
with clinically relevant bradycardia, arrhythmia or severe heart failure.
Streptococcal infection. Penicillin is the first choice drug in the treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes, as well as in the prevention of acute rheumatic polyarthritis. Azithromycin is generally effective in the treatment of Streptococcus in the oropharynx, but there is no evidence that demonstrates the effectiveness of azithromycin in the prevention of acute rheumatic polyarthritis.
Superinfections. As in the case of other antibacterial drugs, there is a possibility of superinfection (eg mycosis).
Since azithromycin is excreted primarily through the liver, the drug should not be used in patients with severe liver disease.
Impaired liver function. When signs of liver dysfunction, such as asthenia, develop rapidly, in combination with jaundice, dark urine, a tendency to bleeding or hepatic encephalopathy, it is necessary to conduct a study of liver function. Myasthenia gravis. Cases of myasthenic syndrome and increased symptoms of gravis myasthenia gravis were reported in patients receiving azithromycin. In patients receiving ergot derivatives, sometimes there is a phenomenon of ergotism due to the simultaneous application of some macrolide antibiotics. Data on the drug interaction between horns and azithromycin are not available, but because of the theoretical possibility of ergotism, azithromycin should not be administered simultaneously with the derivatives of sporynya.
Diarrhea. When using almost all antibacterial agents, including azithromycin, reported cases of diarrhea associated with Clostridium difficult, from mild diarrhea to colitis with a fatal outcome. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .
Strains of C. difficile that produce toxins A and b, increase morbidity and mortality, as these infections can be resistant to antimicrobial therapy and may cause colectomy.
The possibility of developing diarrhea associated with Clostridium difficult should be taken into account in all cases of diarrhea that has arisen after the use of antibiotics. It is necessary to carefully analyze the anamnesis of patients, as reported associated with Clostridium difficult diarrhea may develop 2 months after taking antibacterial drugs.
In patients with severe renal insufficiency (GFR
Use during pregnancy or breast-feeding.
Given the lack of data on the safety of the drug, it is not recommended to prescribe azithromycin during pregnancy and lactation, except when the expected positive effect for the mother exceeds the possible risk of the drug for the fetus or child.
Data on the penetration of the drug into breast milk is not available. Azithromycin can be used during breast-feeding only when absolutely necessary, when appropriate alternative treatment is not available.
The ability to influence the reaction rate when driving motor transport or operating other mechanisms
When driving vehicles or working with other mechanisms should take into account the possibility of adverse reactions from the nervous system, such as dizziness, drowsiness, convulsions.
Method of application and doses
Tablets 500mg should be used as a single daily dose with or without food. Tablets should be swallowed without chewing. In case of missing 1 dose of the drug missed dose should be taken as soon as possible, and the following - at intervals of 24 hours.
Adults and children weighing ?45 kg.
With infections of ENT organs, respiratory tract, skin and soft tissues (except chronic migrating erythema), the total dose of azithromycin is 1500 mg (500 mg once a day). The duration of treatment is 3 days.
When acne vulgaris recommended total dose of azithromycin is 6 g, which should be taken according to the following scheme: 1 tablet of 500 mg once a day for 3 days, after which - 1 tablet of 500 mg once a week for 9 weeks. The dose of the second week should be taken seven days after the first pill, and 8 subsequent doses should be taken at intervals of 7 days.
With migratory erythema, the total dose of azithromycin is 3 g, which should be taken according to the following scheme: 1 g (2 tablets of 500 mg) on the first day, after which - 500 mg 1 time per day for 5 days.
In sexually transmitted infections, the recommended dose of azithromycin is 1000 mg (2 tablets of 500 mg once).
Patients of advanced age.
For the elderly, there is no need to change the dosage.
Since elderly patients can be of high risk of violations of the electrical conductivity of the heart, we recommend caution in the use of azithromycin in connection with the risk of developing cardiac arrhythmia and torsade de pointes arrhythmia.
Patients with impaired renal function.
For patients with minor renal impairment (glomerular filtration rate 10-80 ml/min), the same dosage can be used for patients with normal renal function. Azithromycin should be administered with caution in patients with severe renal impairment (glomerular filtration rate
Patients with impaired liver function.
Since azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with severe liver dysfunction. There were no studies related to the treatment of such patients with azithromycin.
Tablets Zybax recommended for use in children weighing more than 45 kg.
Typical symptoms of overdose: reversible hearing impairment, severe nausea, abdominal pain, vomiting, diarrhea, increased manifestations of other adverse reactions.
Treatment: in case of overdose, it is necessary to take activated charcoal and conduct symptomatic therapy aimed at maintaining the vital functions of the body.
Groups on the frequency of manifestations were determined by means of a scale: very often (?1/10); often (?1/100 to 1/10) infrequently (?1/1000 to 1/100) rarely (?1/10000 to 1/1000), very rarely (<1/10000); unknown (cannot be determined from available data).
System organomegaly reaccessed
Infections on the invasion
Candidiasis, oral candidiasis, vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, impaired respiratory function, initdata
The blood and lymphatic sistemlerine, neutropenia, eosinophiluria
Thrombocytopenia, hemolytic reminiscence
The immune systemengineering edema, increased reaction chuvstvitelnosti
From the exchange westwingreport
From psychokinesist, bestonlinecasino
Aggression, anxiety, delirium, hallucinationsfalse
From the nervous Estemirova bolcato
Dizziness, drowsiness, paresthesia, disgustingest
Syncope, convulsion, psychomotor hyperactivity, anosmia, parosmia, ageusia, myasthenia gravis, hypertensiona
On the part of the visual disorders
The bodies of sluchaynosti hearing vertigineuse
Hearing impairment, including deafness and/or tinnitus
Torsade de pointes ventricular ( torsade de pointes ) arrhythmias, including ventricular tachycardia, elongation QT interval on Agreeswell
From the respiratory sistematina, bow krovotecheniyah
From the digestive tractarian often
Vomiting, abdominal pain, nausea often
Gastritis, constipation, flatulence, dyspepsia, dysphagia, dry mouth, burp, ulcers in the mouth, hypersecretion of saliva
Pancreatitis, color change is linguistically known
From the digestive system collapse of liver function, cholestatic jaundice
Hepatic failure (which has rarely resulted in a fatal outcome), fulminant hepatitis, necrotic hepatitises
The skin and subcutaneous kletchatkoj, itching, urticaria, dermatitis, dry skin, hyperhidrosis
Stevens-Johnson syndrome, toxic epidermal necrolysis, polymorphic arteminisin
The skeletal-muscle systemisation, myalgia, back pain, pain in cheesecake
From the urinary sistematizarea, pain in packagecase
Acute renal failure, interstitial nephritis is known
From the reproductive system and mammary julesmattsson bleeding, testicular narasannapeta
General disorders and local reactibole in the breast, swelling, malaise, asthenia, fatigue, swelling of the face, hyperthermia, pain, peripheral edema
laboratory pokazatelemvysokogo the number of white blood cells, increased eosinophils, increased levels of blood bicarbonate, increased levels of basophils, increased levels of monocytes, increased levels of neurofilament
Elevated levels of AST, increased Alt, increased level of bilirubin in the blood, elevated levels of urea in the blood, elevated creatinine in the blood, changes in the indices of potassium in the blood, increased alkaline phosphatase, increased levels of chloride, increased glucose levels, increased levels of platelets, lower hematocrit, increased levels of bicarbonate, the deviation of the level nitroanisole
Defeat and otrasleyekonomiki after proceduredata
Information about the side effects that may be associated with the prevention and treatment of Mycobacterium Avium Complex. These adverse reactions differ in type or frequency from those reported when using fast-acting dosage forms and dosage forms with prolonged action:
System organomegaly reaccessed
From the exchange westwarehouse
From psichologiniu, headache, paresthesia, discusiacute
The bodies of preneogene renecyto
From the hearing aid organs
Hearing impairment, tinnitus
From the digestive tract diarrhea, abdominal pain, nausea, flatulence, gastrointestinal discomfort often
From the digestive systemheadache
From the skin and subcutaneous tissue, itchy
Stevens-Johnson syndrome, photosensitivity
From the musculoskeletal systemarchitect
General disorders and local reactivity utomlemostew
Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of reach of children.
Tablets of 250 mg: 3 tablets in a blister, 1 blister in a carton;
6 tablets in a blister, 1 blister in a carton.
Tablets of 500 mg: 3 tablets in a blister, 1 blister in a carton.
6 tablets in a blister, 1 blister in a carton.
Category home away from home
Bafna Pharmaceuticals Ltd./Bafna Pharmaceuticals Ltd.
147, Madhavaram-Red hills road, Grantlee, village Vadakara Chennai IN Tamil Nadu 600052, India/147, Madhavaram - Red Hills Road Chennai Grantlyon Village Vadakarai IN Tamil Nadu 600052, India.
CAPSULES ANOMALONS 40G
Anomalons capsules 40 g No. 14 have antiulcer effect. The composition of the drug include esomeprazole, which begins to be active after 40-45 minutes after taking the medicine.
The drug is used for:
The medication is also used in complex General therapy during the treatment of gastric ulcer, duodenal ulcer, GERD. In addition, the capsules are assigned as the current preventive means for patients who have recovered from esophagitis.
When taking the drug in the stomach significantly reduces the activity of acid production (hydrochloric) as a result of complete inhibition of proton in the parietal cells of the gastrointestinal tract.
Dosage and method of administration
The tool is used inside after eating. The recommended dosage for symptomatic therapy of GERD is 20 mg of the drug (half a tablet) per day. The average course of treatment should be 4 weeks. In the treatment of esophagitis (erosive) you should drink 40 mg of the drug (1 tablet) per day, while with the duodenal ulcer – taking 20 mg. Before the use of Somelocal consult a doctor.