Sumatrolide Solution Tablets, 125 mg, dispersible tablets, 6 pcs.
Antacids
do not affect the bioavailability of azithromycin, but reduce the maximum concentration of azithromycin by 30%, so azithromycin should be taken 1 hour before or 2 hours after taking antacids.
Cetirizine:
simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction and a significant change in the QT interval.
Didanosine:
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:
simultaneous use of macrolide antibacterial drugs, including azithromycin, with
P-glycoprotein substrates
, such as digoxin, leads to an increase in the concentration of P-glycoprotein substrate in the blood plasma. Thus, with the simultaneous use of digoxin and azithromycin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood plasma.
Zidovudine:
simultaneous use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has a minor effect on the pharmacokinetics, including renal excretion, of zidovudine or its glucuronide metabolite. However, the concentration of the active metabolite, phosphorylated zidovudine, in peripheral blood mononuclear cells increases. 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 developing ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives (ergotamine, dihydroergotamine) 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 plasma concentrations of atorvastatin (based on an HMC-CoA reductase inhibition assay). However, cases of rhabdomyolysis have been reported in patients receiving concomitant azithromycin and statins.
Carbamazepine:
Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the concentration of carbamazepine and its active metabolite in the blood plasma when used simultaneously with 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, provided that cimetidine was used 2 hours before azithromycin.
Indirect anticoagulants (coumarin derivatives):
In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of warfarin in a single dose of 15 mg taken by 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, careful monitoring of prothrombin time in patients is recommended when azithromycin and indirect anticoagulants (coumarin derivatives) are used simultaneously.
Cyclosporine:
in pharmacokinetic studies involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days, and then cyclosporine (10 mg/kg/day once), a significant increase in the maximum plasma concentration and area under the curve was detected “concentration-time” 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:
simultaneous 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:
simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life did not change with simultaneous use of fluconazole, however, a decrease in the maximum concentration of azithromycin by 18% was noted, which had no clinical significance.
Indinavir:
simultaneous 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:
simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg three times a day) causes an increase in the equilibrium concentrations of azithromycin in the blood plasma. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.
Rifabutin:
simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood plasma. 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 maximum plasma concentration and the area under the concentration-time curve of sildenafil and its main metabolite.
Terfenadine:
In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. Isolated cases have been reported in which the possibility of such an interaction could not be completely excluded, but no concrete evidence was identified that such an interaction occurred. The simultaneous use of terfenadine and macrolide antibiotics has been found to cause arrhythmia and prolongation of the QT interval.
Theophylline:
no interaction was detected between azithromycin and theophylline.
Triazolam/midazolam:
There were no significant changes in pharmacokinetic parameters 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 the maximum concentration, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin plasma concentrations were consistent with those found in other studies.
Sumatrolide solutab
Manufacturer: OZONE LLC (Russia)
tab. dispersible 250 mg: 3, 6, 18, 24, 30, 36, 48, 60 or 100 pcs. Reg. No.: LP-001161
Clinical and pharmacological group:
Antibiotic of the macrolide group - azalide
Release form, composition and packaging
Dispersible tablets
Flat-cylindrical in shape from white to white with a slightly yellowish tint, with the smell of vanillin and black currant, with a chamfer on both sides and a notch on one side.
| 1 tab. | |
| azithromycin (dihydrate) | 250 mg |
Excipients:
microcrystalline cellulose 225.9 mg, crospovidone 60.3 mg, pregelatinized starch 67.0 mg, blackcurrant flavor 5.0 mg, magnesium stearate 6.0 mg, sodium saccharinate 15.0 mg, vanillin 1.5 mg, colloidal silicon dioxide 24.0 mg.
3 pcs. — cellular contour packages (1) — cardboard packs. 6 pcs. — cellular contour packages (1) — cardboard packs. 3 pcs. — contour cell packaging (2) — cardboard packs. 3 pcs. — cellular contour packages (3) — cardboard packs. 3 pcs. — contour cell packaging (4) — cardboard packs. 3 pcs. — contour cell packaging (5) — cardboard packs. 3 pcs. — contour cell packaging (6) — cardboard packs. 3 pcs. — contour cell packaging (7) — cardboard packs. 3 pcs. — contour cell packaging (8) — cardboard packs. 3 pcs. — contour cell packaging (9) — cardboard packs. 3 pcs. — contour cell packaging (10) — cardboard packs. 6 pcs. — contour cell packaging (2) — cardboard packs. 6 pcs. — cellular contour packages (3) — cardboard packs. 6 pcs. — contour cell packaging (4) — cardboard packs. 6 pcs. — contour cell packaging (5) — cardboard packs. 6 pcs. — contour cell packaging (6) — cardboard packs. 6 pcs. — contour cell packaging (7) — cardboard packs. 6 pcs. — contour cell packaging (8) — cardboard packs. 6 pcs. — contour cell packaging (9) — cardboard packs. 6 pcs. — contour cell packaging (10) — cardboard packs. 6 pcs. — cans (1) made of polyethylene terephthalate — cardboard packs. 18 pcs. — cans (1) made of polyethylene terephthalate — cardboard packs. 24 pcs. — cans (1) made of polyethylene terephthalate — cardboard packs. 30 pcs. — cans (1) made of polyethylene terephthalate — cardboard packs. 36 pcs. — cans (1) made of polyethylene terephthalate — cardboard packs. 48 pcs. — cans (1) made of polyethylene terephthalate — cardboard packs. 60 pcs. — cans (1) made of polyethylene terephthalate — cardboard packs.
Description of the active components of the drug "Azithromycin"
pharmachologic effect
An antibiotic of the macrolide group, a representative of the azalides. Suppresses RNA-dependent protein synthesis of sensitive microorganisms.
Active against gram-positive bacteria: Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes /group A/); gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Moraxella catarrhalis, Escherichia coli, Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi, Neisseria gonorrhoeae, Campylobacter spp., Legionella pneumophila; anaerobic bacteria: Bacteroides fragilis.
Azithromycin is also active against Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis, Treponema pallidum.
Also active against Toxoplasma gondii.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin, incl. bronchitis, pneumonia, skin and soft tissue infections, otitis media, sinusitis, pharyngitis, tonsillitis, gonorrheal and non-gonorrheal urethritis and/or cervicitis, Lyme disease (borreliosis).
Dosage regimen
They are established individually, taking into account the nosological form, the severity of the disease and the sensitivity of the pathogen.
Adults orally - 0.25-1 g 1 time / day; children - 5-10 mg/kg 1 time/day. Duration of treatment is 2-5 days.
Side effect
From the digestive system:
nausea, vomiting, flatulence, diarrhea, abdominal pain, transient increase in the activity of liver enzymes; rarely - cholestatic jaundice.
Allergic reactions:
rarely - skin rash, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Dermatological reactions:
rarely - photosensitivity.
From the side of the central nervous system:
dizziness, headache; rarely - drowsiness, weakness.
From the hematopoietic system:
rarely - leukopenia, neutropenia, thrombocytopenia.
From the cardiovascular system:
rarely - chest pain.
From the genitourinary system:
vaginitis; rarely - candidiasis, nephritis, increased residual urea nitrogen.
Other:
rarely - hyperglycemia, arthralgia.
Contraindications
Hypersensitivity to azithromycin and other macrolide antibiotics.
Pregnancy and lactation
Azithromycin penetrates the placental barrier. Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to use azithromycin during lactation, the issue of stopping breastfeeding should be decided.
Use for liver dysfunction
Not recommended for use in patients with impaired liver function.
Use for renal impairment
Use with caution in case of impaired renal function.
Application for children
Application is possible according to the dosage regimen.
special instructions
Not recommended for use in patients with impaired liver function.
Use with caution in case of impaired renal function.
Azithromycin should be taken at least 1 hour before or 2 hours after meals or antacids.
Drug interactions
When used simultaneously with ergot alkaloids, the risk of developing ergotism cannot be excluded.
With simultaneous use of azithromycin with warfarin, cases of increased effects of the latter have been described.
With the simultaneous use of digoxin or digitoxin with azithromycin, a significant increase in the concentration of cardiac glycosides in the blood plasma and the risk of developing glycoside intoxication are possible.
When used simultaneously with disopyramide, a case of the development of ventricular fibrillation has been described.
When used simultaneously with lovastatin, cases of rhabdomyolysis have been described.
When used simultaneously with rifabutin, the risk of developing neutropenia and leukopenia increases.
With simultaneous use, the metabolism of cyclosporine is disrupted, which increases the risk of developing side and toxic reactions caused by cyclosporine.
Drug interactions
When used simultaneously with ergot alkaloids, the risk of developing ergotism cannot be excluded.
With simultaneous use of azithromycin with warfarin, cases of increased effects of the latter have been described.
With the simultaneous use of digoxin or digitoxin with azithromycin, a significant increase in the concentration of cardiac glycosides in the blood plasma and the risk of developing glycoside intoxication are possible.
When used simultaneously with disopyramide, a case of the development of ventricular fibrillation has been described.
When used simultaneously with lovastatin, cases of rhabdomyolysis have been described.
When used simultaneously with rifabutin, the risk of developing neutropenia and leukopenia increases.
With simultaneous use, the metabolism of cyclosporine is disrupted, which increases the risk of developing side and toxic reactions caused by cyclosporine.
