Hemomycin powder for the preparation of suspension for oral administration 200 mg/5 ml

1st day

Chemomycin, 1 piece, 10 g, 200 mg/5 ml, powder for oral suspension

Capsules, film-coated tablets

Orally, 1 hour before or 2 hours after meals, 1 time per day.

For infections of the upper and lower respiratory tract, 500 mg/day is prescribed for 3 days (course dose: 1.5 g).

For infections of the skin and soft tissues - 1 g / day on the first day for 1 dose, then - 0.5 g / day daily, from the 2nd to the 5th day (course dose - 3 g).

For uncomplicated urethritis and/or cervicitis, 1 g is prescribed once.

For Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g is prescribed on the 1st day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g).

For diseases of the stomach and duodenum associated with Helicobacter pylori, 1 g per day is prescribed for 3 days as part of combination therapy.

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.

Powder for suspension for oral administration

Orally, 1 hour before or 2 hours after meals, 1 time per day.

Water (distilled or boiled and cooled) is gradually added to the bottle to the mark. The contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained. If the level of the prepared suspension is below the mark on the bottle label, add water again to the mark and shake.

The prepared suspension is stable at room temperature for 5 days.

For infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema): children - at the rate of 10 mg/kg once a day for 3 days (course dose - 30 mg/kg). A suspension of 100 mg/5 ml is recommended for use in children over 6 months, 200 mg/5 ml - over 12 months. Recommended dosage regimens depending on the child’s body weight are presented in Table 1.

Table 1

Adults with upper and lower respiratory tract infections - 500 mg once a day for 3 days (course dose - 1.5 g); for infections of the skin, soft tissues, as well as Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans) - 1 g per day on the 1st day for 1 dose, then 0.5 g per day daily from the 2nd to Day 5 (course dose - 3 g).

For chronic migratory erythema - once a day for 5 days: on the 1st day at a dose of 20 mg/kg, and then from the 2nd to the 5th day - 10 mg/kg.

Recommendations for taking Hemomycin suspension 100 mg/5 ml in children with erythema migrans are presented in Table 2.

table 2

The suspension should be shaken before use.

Immediately after taking the suspension, the child should be given a few sips of liquid (water, tea) to drink in order to wash off and swallow the suspension remaining in the mouth.

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.

Lyophilisate for the preparation of solution for infusion

The drug should be used only in a hospital setting.

IV. Recommended doses for intravenous administration in the treatment of adults and children over 16 years of age with the following diseases

Community-acquired pneumonia. 500 mg/day, once for at least 2 days. IV administration should be followed by oral azithromycin at a dose of 500 mg/day once until the 7-10-day total course of treatment is completed.

Infectious and inflammatory diseases of the pelvic organs. 500 mg/day, once for at least 2 days. IV administration should be followed by oral azithromycin at a dose of 250 mg/day once until the 7-day total course of treatment is completed. The timing of transition to oral treatment is determined in accordance with clinical examination data.

Patients with liver and kidney failure. For patients with moderate impairment of liver and kidney function (Cl creatinine >40 ml/min), no dose adjustment is necessary.

The solution for infusion is prepared in 2 stages

Stage 1 - preparation of the reconstituted solution. Add 4.8 ml of sterile water for injection to a bottle with 500 mg of the drug and shake thoroughly until the powder is completely dissolved. 1 ml of the resulting solution contains 100 mg of azithromycin. The prepared solution remains stable for 24 hours at room temperature.

Stage 2 - dilution of the reconstituted solution (100 mg/ml). It is carried out immediately before administration in accordance with the data presented below:

To obtain a concentration of azithromycin in an infusion solution of 1 mg/ml, 500 ml of solvent is required; to obtain a concentration of azithromycin in an infusion solution of 2 mg/ml - 250 ml.

The reconstituted solution is added to a vial with a solvent (0.9% sodium chloride solution; 5% dextrose solution; Ringer's solution) to obtain a final concentration of azithromycin of 1-2 mg per 1 ml of infusion solution.

Hemomycin solution cannot be administered intravenously or intramuscularly. It is recommended to administer the prepared solution dropwise for at least 1 hour.

Before administration, the solution is subjected to visual inspection. If the prepared solution contains particles of the substance, it should not be used.

The prepared solution is stable at room temperature for 24 hours.

Chemomycin Powder, 20 ml, 200/5 mg/ml, for suspension

Interaction with other drugs

Antacid drugs
Antacid drugs do not affect the bioavailability of azithromycin, but reduce

the maximum concentration in the blood is 30%, so the drug should be taken according to

at least one hour before or two hours after taking these medications and eating.

Cetirizine

Concomitant use of azithromycin for 5 days in healthy volunteers with

cetirizine (20 mg) did not lead to pharmacokinetic interaction and

significant change in the QT interval.

Didanosine (dideoxyinosine)

Simultaneous use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6

HIV-infected patients showed no changes in pharmacokinetic

didanosine compared to the placebo group.

Digoxin and colchicine (P-glycoprotein substrates)

Concomitant use of macrolide antibiotics, including azithromycin, with

P-glycoprotein substrates, such as digoxin and colchicine, lead to increased

serum concentrations of P-glycoprotein substrate. Thus, when

simultaneous use of azithromycin and digoxin must be taken into account

the possibility of increasing digoxin in the blood serum.

Zidovudine

Simultaneous use of azithromycin (single dose 1000 mg and repeated

administration of 1200 mg or 600 mg) has a minor effect on pharmacokinetics, including

including renal excretion of zidovudine or its glucuronide metabolite. However

the use of azithromycin caused an increase in the concentration of phosphorylated

zidovudine, a clinically active metabolite in peripheral blood mononuclear cells.

The clinical significance of this fact is unclear.

Azithromycin interacts weakly with isoenzymes of the cytochrome P450 system. Not

Azithromycin has been found to be involved in pharmacokinetic interactions

similar to erythromycin and other macrolides. Azithromycin is not an inhibitor

and an inducer of cytochrome P450 isoenzymes.

Ergot alkaloids

Considering the theoretical possibility of the occurrence of ergotism, simultaneous

the use of azithromycin with ergot alkaloid derivatives is not recommended.

Pharmacokinetic studies have been conducted with concomitant use

azithromycin and drugs whose metabolism occurs with the participation of isoenzymes

cytochrome P450 system.

Atorvastatin

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg

daily) did not cause changes in plasma concentrations of atorvastatin (per

based on the HMC-CoA reductase inhibition assay). However, in post-registration

period, isolated reports of cases of rhabdomyolysis in patients

receiving azithromycin and statins simultaneously.

Carbamazepine

Pharmacokinetic studies involving healthy volunteers did not reveal

significant effect on the concentration of carbamazepine and its active metabolite in

blood plasma in patients receiving concomitant azithromycin.

Cimetidine

In pharmacokinetic studies of the effect of a single dose of cimetidine on

pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected,

provided that cimetidine is used 2 hours before azithromycin.

Indirect anticoagulants (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant

effect of a single dose of 15 mg warfarin given to healthy volunteers.

Potentiation of the anticoagulant effect has been reported following concomitant

the use of azithromycin and indirect anticoagulants (derivatives

coumarin). Although a causal relationship has not been established, it should be considered

the need for frequent monitoring of prothrombin time during

use of azithromycin in patients receiving oral anticoagulants

indirect action (coumarin derivatives).

Cyclosporine

In a pharmacokinetic study involving healthy volunteers who

Azithromycin was taken orally for 3 days (500 mg/day once), and then

cyclosporine (10 mg/kg/day once), a significant increase was detected

maximum plasma concentration (Cmax) and area under the curve

"concentration-time" (AUC0-5) of cyclosporine. Care should be taken when

simultaneous use of these drugs. If necessary, simultaneous

the use of these drugs, it is necessary to monitor the concentration

cyclosporine in the blood plasma and adjust the dose accordingly.

Efavirenz

Concomitant use of azithromycin (600 mg/day once) and efavirenz

(400 mg/day) daily for 7 days did not cause any clinically significant

pharmacokinetic interaction.

Fluconazole

Concomitant use of azithromycin (1200 mg once) did not change

pharmacokinetics of fluconazole (800 mg once). General exposure and period

the half-life of azithromycin did not change with simultaneous use

fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which is not

had clinical significance.

Indinavir

Concomitant use of azithromycin (1200 mg once) did not cause

statistically significant effect on the pharmacokinetics of indinavir (800 mg three times

per day for 5 days).

Methylprednisolone

Azithromycin does not have a significant effect on pharmacokinetics

methylprednisolone.

Nelfinavir

Simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day)

day) causes an increase in the equilibrium concentrations of azithromycin in the blood serum.

There were no clinically significant side effects and no dose adjustments were observed.

Azithromycin is not required when used concomitantly with nelfinavir.

Rifabutin

The simultaneous use of azithromycin and rifabutin does not affect the concentration

of each drug in blood serum. With simultaneous use of azithromycin

and rifabutin, neutropenia was sometimes observed. Although neutropenia

was 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 was no evidence of an effect

azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or

its main circulating metabolite.

Terfenadine

There was no evidence of interaction in pharmacokinetic studies

between azithromycin and terfenadine. Isolated cases have been reported where

the possibility of such an interaction could not be completely excluded, but there was no

no concrete evidence that such an interaction took place.

It has been found that the simultaneous use of terfenadine and macrolides may

cause arrhythmia and prolongation of the QT interval.

Theophylline

No interaction has been detected between azithromycin and theophylline.

Triazolam/midazolam

Significant changes in pharmacokinetic parameters with simultaneous

the use of azithromycin with triazolam or midazolam in therapeutic doses is not

revealed.

Trimethoprim/sulfamethoxazole

Concomitant use of trimethoprim/sulfamethoxazole with azithromycin is not

showed no significant effect on Cmax, total exposure or renal excretion

trimethoprim or sulfamethoxazole. Serum concentrations of azithromycin

were consistent with those found in other studies.