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Sumamed, 250 mg, dispersible tablets, 6 pcs.

Antacid drugs.

They do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food.

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 indications of didanosine compared to the placebo group.

Digoxin (P-glycoprotein substrates).

Simultaneous use of macrolide antibiotics, incl. 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.

The simultaneous use of azithromycin (single dose of 1000 mg and multiple doses of 1200 or 600 mg) has a minor effect on pharmacokinetics, incl. 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 administered 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 PT 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 plasma Cmax and AUC0–5 h was detected. 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 T1/2 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.

The simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 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 Css 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.

Sumamed and Sumamed forte

Sumamed ®

and
Sumamed ® forte
(lat.
Sumamed ®
and
Sumamed ® forte
) are antibiotics of the macrolide class.
The active ingredient is azithromycin. In gastroenterology, Sumamed is known as one of the antibiotic drugs used as part of complex therapy for the eradication of Helicobacter pylori
.

Dosage forms of Sumamed and Sumamed forte

Sumamed
in Russia is presented in the following forms:

film-coated tablets
having a round (125 mg) or oblong (500 mg) shape with biconvex surfaces and the designation “PLIVA” on one side and “125” or “500” on the other. The shell is blue, the fractured appearance is from white to almost white
gelatin capsules
: hard, opaque, partly blue, partly blue, containing white to light yellow powder
granular powder for the preparation of suspension for oral administration,
white or light yellow, 100 mg/5 ml
lyophilisate for the preparation of a
white solution for infusion.

Sumamed forte
has a single dosage form: granulated
powder for the preparation of a suspension for oral administration,
white or light yellow in color with the smell of banana and cherry.
The medicinal properties of Sumamed are determined by the active substance and are described in the article azithromycin.

Microorganisms against which Sumamed is active or inactive

Sumamed is active against many microorganisms, including bacteria:

gram-negative: Helicobacter pylori, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Neisseria gonorrhoeae, Prevotella bivia, Treponema pallidum, Borrelia burgdorferi, Campylobacter jejuni
, as well as intracellular parasites:
Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum, Mycoplasma pneumoniae
gram-positive Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans
, streptococci of groups C, F, G,
Listeria monocytogenes, Corynebacterium spp.
, as well as anaerobes:
Peptococcus spp., Clostridium perfringens, Peptostreptococcus spp.
and mycobacteria
Mycobacterium avium complex
gram-variable Gardnerella vaginalis.

Sumamed is not active against gram-positive bacteria resistant to erythromycin.

Professional medical publications regarding the use of Sumamed

Grigoriev P.Ya., Yakovenko E.P., Soluyanova I.P. and others. Modern methods of therapy for peptic ulcer disease, their effectiveness and cost // Experimental and clinical gastroenterology. – 2003. – No. 3. – p. 21–25.

On the website gastroscan.ru in the literature catalog there is a section “Antibiotics used in the treatment of gastrointestinal diseases”, containing articles on the use of antimicrobial agents in the treatment of diseases of the digestive tract.

Other medicines containing the active ingredient azithromycin

In addition to Sumamed and Sumamed forte, the following drugs with the active ingredient azithromycin are (have been) registered in Russia: Azibiot, Azivok, Azidrop, Azimicin, Azitral, Azithromycin-BI, Azitrox, Azithromycin, Azithromycin-J, Azithromycin Zentiva, Azithromycin-Lexwm, Azithromycin McLeods , Azithromycin Sandoz, Azithromycin Forte, Azithromycin Forte-OBL, Azithromycin-OBL, Azithromycin Ecomed, AzitRus, AzitRus forte, Azicide, Zetamax retard, Z-factor, Zitnob, Zitrolide, Zitrolide forte, Zithrocin, Safocid, Sweetrox, Sumaclide, Sumaclide 1000 , Sumamecin, Sumamox, Sumatrolide solutab, Sumatrolide Solution Tablets, Tremak-Sanovel, Ecomed, Hemomycin.
Azithromycin brands sold in the West: Sumamed, Pfizer Zithromax, Zentiva Azitrox, AzaSite.

general information

According to the pharmacological index, Sumamed and Sumamed forte belong to the group “Macrolides and azalides”.
According to ATC, Sumamed is included in the group “J01 Antibacterial drugs for systemic use” and has the code “J01FA10 Azithromycin”. The manufacturer of Sumamed and Sumamed forte is Pliva Hrvatska doo, Croatia.

Official instructions from the manufacturer (pdf):

Instructions for medical use of the drug Sumamed (film-coated tablets)
Instructions for medical use of the drug Sumamed (lyophilisate for the preparation of solution for infusion)
Instructions for medical use of the drug Sumamed (powder for the preparation of suspension for oral administration)
Instructions for medical use of the drug Sumamed Forte (powder for the preparation of suspension for oral administration)

The FDA, in its March 12, 2013 communique, warns that azithromycin may cause QT prolongation and, as a result, arrhythmia.
It was found that the number of deaths from cardiovascular events in patients who underwent a five-day course of azithromycin therapy was greater than in those who took amoxicillin, ciprofloxacin, or did not take antibiotics at all. In comparison with those taking levofloxacin, the difference was not established. Sumamed and Sumamed forte have contraindications, side effects and application features; consultation with a specialist is necessary.

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