Azithromycin Ecomed, 500 mg 3 pcs

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

Active ingredient

Composition

Composition per tablet:

Active ingredient, mg:

azithromycin dihydrate 524.06 (in terms of azithromycin) 500.00

Associates, mg:

Lactitol 600.00

croscarmellose sodium 70.00

Hyprolose 70.00

Pregelatinized starch 40.00

Magnesium stearate 28.00

sodium lauryl sulfate 7.00

silicon dioxide colloid 7.00

microcrystalline cellulose 102 to make a tablet without a shell mass:1400.00

Shell composition, mg: hypromellose 18.98, titanium dioxide 10.40, macrogol-4000 7.49, talc 2.24, povidone K-17 0.83, quinoline yellow dye 0.06.

How to take, the dosage

Azithromycin Ecomed® is taken orally, without chewing, once daily. The drug is taken at least 1 hour before or 2 hours after meals.

Adults (including elderly people) and children over 12 years of age with a body weight over 45 kg.

Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissue: 0.5 g a day for 3 days (course dose is 1.5 g).

In mild-to-moderate acne: 0.5 g per day for 3 days, then 0.5 g once a week for 9 weeks. The first weekly tablet should be taken 7 days after taking the first daily tablet (8th day from the start of treatment), the next 8 weekly tablets at 7-day intervals. The course dose is 6.0 g.

In erythema migrans: once daily for 5 days, 1 day 1.0 g, then from day 2 to day 5 to 0.5 g. The course dose is 3.0 g.

Infections of the urogenital tract caused by Chlamydia trachomatis (urethritis, cervicitis): 1.0 g once.

When used in patients with renal dysfunction of mild severity: no dose adjustment is required.

In use in patients with mild to moderate hepatic impairment, in elderly patients: no dose adjustment is required.

Elderly patients:Dose adjustment is not required. Caution should be exercised in elderly patients with persistent proarrhythmogenic factors due to the high risk of arrhythmias, including pirouette-type arrhythmias.

Interaction

Antacid drugs
Antacid drugs do not affect the bioavailability of azithromycin, but reduce its maximum blood concentration by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and meals.

Cetirizine
Simultaneous use for 5 days in healthy volunteers of azithromycin with cetirizine
(20 mg) did not result in a pharmacokinetic interaction or significant change in QT interval.

Didanosine (didezoxynosine)
. Concomitant use of azithromycin (1200 mg/day) and diddanosine (400 mg/day) in 6 HIV-infected patients showed no change in the pharmacokinetic indication of diddanosine compared with the placebo group.

Digoxin (P-glycoprotein substrates)
Concurrent use of macrolide antibiotics, including azithromycin with P-glycoprotein substrates, such as digoxin, leads to increased concentration of P-glycoprotein substrate in blood serum. Thus, when azithromycin and digoxin are used concomitantly, the possibility of increased serum concentrations of digoxin should be considered.

Zidovudine
Simultaneous use of azithromycin (single administration of 1000 mg and multiple administration of 1200 or 600 mg) has little effect on pharmacokinetics, including renal excretion of zidovudine.including renal excretion of zidovudine or its glucuronide metabolite. However, azithromycin administration caused an increase in the concentration of phosphorylated zidovudine, the clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.

Asithromycin interacts weakly with cytochrome P450 isoenzymes. Azithromycin has not been found to be involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes.

Sorgonum alkaloids
Given the theoretical possibility of ergotism, concomitant use of azithromycin with derivatives of ergot alkaloids is not recommended.

Pharmacokinetic studies have been performed on the concomitant use of azithromycin and drugs whose metabolism involves cytochrome P450 isoenzymes.

Atorvastatin

. Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in plasma concentrations of atorvastatin (based on HMG-CoA reductase inhibition assay). However, in the post-registration period there were isolated reports of cases of rhabdomyolysis in patients receiving azithromycin and statins simultaneously.

Carbamazepine
Pharmacokinetic studies with healthy volunteers showed no significant effect on plasma concentrations of carbamazepine and its active metabolite in patients receiving azithromycin concomitantly.

Cimetidine
. Pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin showed no change in the pharmacokinetics of azithromycin, provided cimetidine was used 2 h before azithromycin.

Indirect-acting anticoagulants (coumarin derivatives)
In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single dose of 15 mg warfarin taken by healthy volunteers. Potentiation of anticoagulant effect has been reported after concomitant use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, frequent PV monitoring should be considered when using azithromycin in patients who receive oral indirect anticoagulants (coumarin derivatives).

Cyclosporine
. In a pharmacokinetic study involving healthy volunteers who took oral azithromycin (500 mg/day once) for 3 days followed by cyclosporine (10 mg/kg/day once), a significant increase in plasma Cmax and AUC0-5 of cyclosporine was observed. Caution should be exercised when concomitant use of these drugs. If concomitant use of these drugs is necessary, plasma concentrations of cyclosporine should be monitored and the dose should be adjusted accordingly.

Efavirenz
The concomitant use of azithromycin (600 mg/day once) and efavirenz (400 mg/day) daily for 7 days has not caused any clinically significant pharmacokinetic interaction.

Fluconazole
Concurrent use of azithromycin (1200 mg once daily) did not alter the pharmacokinetics of fluconazole (800 mg once daily). Total exposure and T1/2 of azithromycin were not altered by concomitant use of fluconazole, but there was a decrease in Cmax of azithromycin (by 18%), which had no clinical significance.

Indinavir
Concurrent use of azithromycin (1200 mg once) had no statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times daily for 5 days).

Methylprednisolone
Azithromycin has no significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir
Simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times daily) causes increased serum Css of azithromycin. No clinically significant adverse effects have been observed, and no dose adjustment of azithromycin is required when used concomitantly with nelfinavir.

Rifabutin
Concomitant use of azithromycin and rifabutin has no effect on the serum concentrations of either drug. Neutropenia was sometimes observed when azithromycin and rifabutin were used concomitantly. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.

Sildenafil
When used in healthy volunteers, there is no evidence of an effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite.

Terfenadine
In pharmacokinetic studies there has been no evidence of interaction between azithromycin and terfenadine. Single cases have been reported in which the possibility of such an interaction could not be completely ruled out, but there has been no specific evidence that such an interaction has occurred. It has been found that concomitant use of terfenadine and macrolides can cause arrhythmias and prolongation of the QT interval.

Theophylline
No interaction between azithromycin and theophylline has been identified.

Triazolam/midazolam
No significant changes in pharmacokinetic parameters have been found when azithromycin is used simultaneously with triazolam or midazolam in therapeutic doses.

Trimethoprim/sulfamethoxazole
. Concomitant use of trimethoprim/sulfamethoxazole with azithromycin showed no significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.

Special Instructions

If one dose is missed, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.

The drug should be taken at least one hour before or two hours after taking antacids.

The drug should be used with caution in patients with mild to moderate hepatic impairment because of the possibility of fulminant hepatitis and severe hepatic failure.

In case of symptoms of hepatic impairment such as rapidly increasing asthenia, jaundice, darkened urine, bleeding tendency, hepatic encephalopathy the drug therapy should be discontinued and liver function tests should be performed.

In patients with mild to moderate renal impairment (creatinine clearance greater than 40 ml/min) azithromycin therapy should be used with caution while monitoring renal function.

As with other antibacterial drugs, during therapy with azithromycin patients should be regularly examined for the presence of non-susceptible microorganisms and signs of superinfections, including fungal infections.

The drug should not be used for longer courses than directed, because the pharmacokinetic properties of azithromycin recommend a short and simple dosing regimen.

There are no data on possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but because of the development of ergotism when using macrolides with ergotamine and dihydroergotamine derivatives simultaneously, this combination is not recommended.

The development of pseudomembranous colitis caused by Clostridium difficile, both as mild diarrhea and severe colitis, is possible with long-term administration of azithromycin. If antibiotic-associated diarrhea develops against the background of the drug, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.

When treating with macrolides including azithromycin, prolongation of cardiac repolarization and QT interval have been observed that increase the risk of cardiac arrhythmias including pirouette type arrhythmias.

Caution should be exercised when using the drug in patients with the presence of proarrhythmogenic factors (especially in elderly patients): with congenital or acquired prolongation of the QT interval, in patients taking antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disorders of fluid and electrolyte balance, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure.
Use of azithromycin may provoke development of myasthenic syndrome or cause exacerbation of myasthenia gravis.

Influence on driving and operating machinery.
In case of adverse effects on the nervous system and organs of vision, caution should be exercised when performing activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Cautions

– myasthenia;

– mild to moderate hepatic impairment;

– mild to moderate renal function impairment (creatinine clearance greater than 40 ml/min);

– 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) antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with electrolyte and water balance disorders, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure;

– concomitant use of terfenadine, warfarin, digoxin, cyclosporine.

Side effects

The incidence of side effects is classified according to WHO guidelines: very common – at least 10%; common – at least 1% but less than 10%; infrequent – at least 0.1% but less than 1%; rare – at least 0.01% but less than 0.1%; very rare – less than 0.01%; unknown frequency – cannot be estimated based on available data.

Metabolism and nutrition: infrequently – anorexia.

Allergic reactions: infrequent – angioedema, hypersensitivity reaction; unknown frequency – anaphylactic reaction.

Nervous system disorders:

Hearing organ and labyrinth disorders: infrequent – hearing disorder, vertigo; unknown frequency – hearing disorder, including deafness and/or tinnitus.

Cardiovascular disorders: infrequent – sensation of palpitations, flushes of blood to the face; unknown frequency – decreased BP, increased QT interval on ECG, “pirouette” type arrhythmia, ventricular tachycardia.

Respiratory system: infrequent – shortness of breath, nasal bleeding.

Gastrointestinal disorders: very frequently – diarrhea; frequently – nausea, vomiting, abdominal pain; infrequently – flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, oral mucosa ulcers, increased salivary gland secretion; very rarely – color change of tongue, pancreatitis.

Liver and biliary tract side: infrequent – hepatitis; rare – impaired liver function, cholestatic jaundice; unknown frequency – liver failure (in rare cases with fatal outcome, mainly in the background of severe liver impairment); liver necrosis, fulminant hepatitis.

Skin and subcutaneous tissue: infrequent – skin rash, itching, urticaria, dermatitis, dry skin, sweating; rare – photosensitization reaction; unknown frequency – Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

Musculoskeletal system: frequent – osteoarthritis, myalgia, back pain, neck pain; unknown frequency – arthralgia.

Kidney and urinary tract: infrequent – dysuria, renal pain; unknown frequency – interstitial nephritis, acute renal failure.

Gender and mammary gland: infrequent – metrorrhagia, testicular dysfunction.

Others: infrequent – asthenia, malaise, feeling of fatigue, facial edema, chest pain, fever, peripheral edema.

Laboratory findings:

often – decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased plasma bicarbonate concentration; infrequent – increase in AST activity, ALT, increased plasma bilirubin concentration, increased plasma urea concentration, increased plasma creatinine concentration, change in plasma potassium concentration, increased plasma ALT activity, increased plasma chloride concentration, increased blood glucose concentration, increased platelet count, increased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium concentration.

Overdose

Symptoms: temporary hearing loss, nausea, vomiting, diarrhea.

The treatment is symptomatic.

Pregnancy use

Similarities