Chemomycin powder for the preparation of suspension for oral administration 200 mg/5 ml in Shchelkovo


Chemomycin 500 mg (tablets)

Antacids

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

Cetirizine

Concomitant use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction or a significant change in the QT interval.

Didanosine (dideoxyinosine)

The simultaneous use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6 HIV-infected patients did not reveal changes in the pharmacokinetic parameters of didanosine compared to the placebo group.

Digoxin (P-glycoprotein substrates)

Concomitant use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin, leads to increased concentrations of P-glycoprotein substrate in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.

Zidovudine

Concomitant use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has little effect on the pharmacokinetics, 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. Azithromycin has not been shown to participate in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or inducer of cytochrome P450 isoenzymes.

Ergot alkaloids

Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended. Pharmacokinetic studies were conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.

Atorvastatin

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on an HMC-CoA reductase inhibition assay). However, in the post-marketing period, isolated case reports of rhabdomyolysis have been received in patients receiving concomitant azithromycin and statins.

Carbamazepine

Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.

Cimetidine

In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected when cimetidine was used 2 hours before azithromycin.

Indirect anticoagulants (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Potentiation of the anticoagulant effect has been reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).

Cyclosporine

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days, followed by cyclosporine (10 mg/kg/day once), a significant increase in maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-5) of cyclosporine. Caution is advised when using these drugs together. If simultaneous use of these drugs is necessary, it is necessary to monitor the concentration of 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 the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance.

Indinavir

Concomitant use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg three times a day for 5 days).

Methylprednisolone

Azithromycin does not have a significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the equilibrium concentrations of azithromycin in the blood serum. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.

Rifabutin

The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood serum. Neutropenia has sometimes been observed with simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.

Sildenafil

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

Terfenadine

In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction occurred.

It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.

Theophylline

No interaction has been detected between azithromycin and theophylline.

Triazolam/midazolam

No significant changes in pharmacokinetic parameters were detected with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.

Trimethoprim/sulfamethoxazole

Concomitant use of trimethoprim/sulfamethoxazole with azithromycin did not show a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those found in other studies.

Hemomycin

The drug is taken orally 1 time/day 1 hour before meals or 2 hours after meals, because When taken simultaneously with food, the absorption of azithromycin is reduced.

If you miss one dose of the drug, it should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

Capsules

For adults

for
infections of the upper and lower respiratory tract,
Hemomycin is prescribed 500 mg (2 caps.) per day for 3 days; course dose - 1.5 g.

For skin and soft tissue infections

Prescribe 1 g (4 caps.) on the 1st day, then 500 mg (2 caps.) daily from 2 to 5 days; course dose - 3 g.

For acute uncomplicated urethritis or cervicitis

Prescribe 1 g (4 caps.) once.

For Lyme disease

(borreliosis) for the treatment of the initial stage (erythema migrans) is prescribed 1 g (4 caps.) on the 1st day and 500 mg (2 caps.) daily from 2 to 5 days (course dose - 3 g).

For diseases of the stomach and duodenum associated with Helicobacter pylori

, prescribed 1 g (4 caps.) per day for 3 days as part of combined anti-Helicobacter therapy.

Children over 12 years old

for
infections of the upper and lower respiratory tract, skin and soft tissues,
the drug is prescribed at a rate of 10 mg/kg 1 time/day for 3 days (course dose - 30 mg/kg) or on the first day - 10 mg/kg, then 4 day - 5-10 mg/kg/day.

In the treatment of erythema migrans

- 20 mg/kg on the first day and 10 mg/kg from days 2 to 5.

Pills

Adults and children over 12 years old

for
infections of the upper and lower respiratory tract,
500 mg/day is prescribed for 3 days; course dose - 1.5 g.

For skin and soft tissue infections

Prescribe 1 g/day on the first day, then 500 mg daily from days 2 to 5; course dose - 3 g.

For acute uncomplicated urethritis or cervicitis

prescribed once in a dose of 1 g.

For Lyme disease

(borreliosis) for the treatment of the initial stage (erythema migrans) the drug is prescribed in a dose of 1 g 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

, prescribed 1 g/day for 3 days as part of combined anti-Helicobacter therapy.

Suspension 200 mg/5 ml and 100 mg/5 ml

In children over 12 months

a suspension of 200 mg/5 ml is used, in
children over 6 months of age
- a suspension of 100 mg/5 ml.

For children

for
infections of the upper and lower respiratory tract, infections of the skin and soft tissues
(with the exception of chronic migratory erythema) Chemomycin in the form of a suspension is prescribed at the rate of 10 mg/kg body weight 1 time/day for 3 days (course dose - 30 mg/kg ).

Recommended dosage regimens for Hemomycin depending on the child’s body weight and suspension concentration are presented in the following table.

Body massDaily dose (suspension 200 mg/5ml)Daily dose (suspension 100 mg/5ml)
10-14 kg2.5 ml (100 mg) - 1/2 measure. spoons 5 ml (100 mg) - 1 measure. spoon
15-25 kg5 ml (200 mg) - 1 measure. spoon 10 ml (200 mg) - 2 measures. spoons
26-35 kg7.5 ml (300 mg) - 1.5 sc. spoons 15 ml (300 mg) - 3 mea. spoons
36-45 kg10 ml (400 mg) - 2 mea. spoons 20 ml (400 mg) – 4 mea. spoons
more than 45 kgprescribe doses for adultsprescribe doses for adults

For adults

for
infections of the upper and lower respiratory tract,
500 mg is prescribed 1 time / day for 3 days; course dose - 1.5 g.

For infections of the urogenital tract

the drug is prescribed
to adults
in a dose of 1 g once;
children under 8 years of age with a body weight of more than 45 kg
- 10 mg/kg once.

For chronic migratory erythema

prescribed 1 time/day for 5 days:
adults
— 1 g/day on the 1st day for 1 dose, then 500 mg/day daily from days 2 to 5, course dose — 3 g;
children
- on day 1 at a dose of 20 mg/kg body weight, then from days 2 to 5 - 10 mg/kg body weight.

Recommended dosage regimens for Chemomycin in the treatment of erythema migrans

in
children
, depending on body weight and concentration of the suspension, are presented in the following table.

1st day

Body massDaily dose (suspension 200 mg/5ml)Daily dose (suspension 100 mg/5ml)
< 8 kg5 ml (100 mg) - 1 measure. spoon
8-14 kg5 ml (200 mg) - 1 measure. spoons 10 ml (200 mg) - 2 measures. spoons
15-24 kg10 ml (400 mg) - 2 mea. spoons 20 ml (400 mg) – 4 mea. spoons
25-44 kg12.5 ml (500 mg) - 2.5 meg. spoons 25 ml (500 mg) - 5 measuring units. spoons

2-5th day

Body massDaily dose (suspension 200 mg/5ml)Daily dose (suspension 100 mg/5ml)
< 8 kg2.5 ml (50 mg) - 1/2 sc. spoons
8-14 kg2.5 ml (100 mg) - 1/2 measure. spoons 5 ml (100 mg) - 1 measure. spoons
15-24 kg5 ml (200 mg) - 1 measure. spoon 10 ml (200 mg) - 2 measures. spoons
25-44 kg6.5 ml (250 mg) - 1 and 1/4 scoop. spoons 12.5 ml (250 mg) - 2.5 measuring units. spoons

Rules for preparing the suspension

Water (distilled or boiled and cooled) is gradually added to the bottle containing the powder 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.

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 wash off and swallow the suspension remaining in the mouth.

Hemomycin powder for the preparation of suspension for oral administration 100 mg/5 ml bottle 1 pc. in Moscow

The drug is taken orally

1 time/day 1 hour before meals or 2 hours after meals.

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)

For children:

at the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose 30 mg/kg).

Depending on the child’s body weight, the following dosage regimen is recommended:

Patient's body weightDaily dose (suspension 100 mg/5ml)
< 8 kg2.5 ml (50 mg) - ½ spoon
8-14 kg5 ml (100 mg) – 1 spoon
15-24 kg10 ml (200 mg) – 2 spoons
25-34 kg12.5 ml (250 mg) - 2.5 spoons
35-45 kg17.5 ml (350 mg) - 3 ½ spoons
more than 45 kgprescribe doses for adults

For acne vulgaris of moderate severity (adults):

Adults: 500 mg (25 ml of 100 mg/5 ml suspension) 1 time per day for 3 days (course dose 1.5 g).

On days 1, 2 and 3 of treatment, take 500 mg (25 ml of a 100 mg/5 ml suspension) once a day, then take a break from the fourth to seventh days of treatment, from the eighth day of treatment take 500 mg (25 ml) 1 once a week (with an interval of 7 days) for 9 weeks. Course dose: 6 g.

For uncomplicated urethritis and/or cervicitis

cervicitis caused by
Chlamydia trachomatis
- the drug is prescribed to adults: 1 g (50 ml) once.

For Lyme disease (borreliosis)

for the treatment of the initial stage
( erythema migrans )
- 1 time per day for 5 days: on the 1st day at a dose of 20 mg/kg body weight, and then from the 2nd to the 5th day - 10 mg/kg body weight bodies.

The following dosage regimen for the drug suspension is recommended in children with e rythema migrans:

1st day

Body massDaily dose (suspension 100 mg/5 ml)
< 8 kg5 ml (100 mg) – 1 spoon
8-14 kg10 ml (200 mg) – 2 spoons
15-24 kg20 ml (400 mg) – 4 spoons
25-34 kg25 ml (500 mg) – 5 spoons
35-45 kg35 ml (700 mg) – 7 spoons

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

From 2nd to 5th day:

Body massDaily dose (suspension 100 mg/5 ml)
< 8 kg2.5 ml (50 mg) - ½ spoon
8-14 kg5 ml (100 mg) – 1 spoon
15-24 kg10 ml (200 mg) – 2 spoons
25-34 kg12.5 ml (250 mg) - 2.5 spoons
35-45 kg 17.5 ml (350 mg) - 3 ½ spoons

If a dose of the drug is missed, it should be taken immediately, if possible, and then subsequent doses should be taken at intervals of 24 hours. The suspension should be shaken before use.

Patients with impaired renal function

When used in patients with mild to moderate renal impairment (creatinine clearance > 40 ml/min), no dose adjustment is required.

Patients with liver dysfunction

When used in patients with mild to moderate liver dysfunction, no dose adjustment is required.

Elderly patients

In elderly patients, no dose adjustment is required.

1st day

Body massDaily dose (suspension 200 mg/5 ml)
10-14 kg5.0 ml (200 mg azithromycin) - 1 spoon
15-24 kg10.0 ml (400 mg azithromycin) - 2 spoons
25-34 kg15.0 ml (600 mg azithromycin) - 3 spoons
35-44 kg20.0 ml (800 mg azithromycin) - 4 spoons
not less than 45 kg25.0 ml (1 g azithromycin) - 5 spoons
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