Pharmacy No. 84. Delivery of medicines to your home and office.

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SUMAMED FORTE

Interaction

Antacid drugs
Antacid drugs do not affect the bioavailability of azithromycin, but reduce the maximum concentration in the blood 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 indications 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 a minor 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 HMG-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 concentration of carbamazepine and its active metabolite in the blood plasma 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 and then 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 was not of 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.

Triazole

m/
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 reveal 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 100 mg/5 ml 20 ml por.d/susp. for oral administration

Instructions for medical use of the drug Sumamed® Trade name Sumamed® International nonproprietary name Azithromycin Dosage form Powder for the preparation of suspension for oral administration, 100 mg/5 ml. Composition One bottle contains the active substance - azithromycin (in the form of azithromycin dihydrate) - 0.500 g (0.5241 g). excipients: sucrose, anhydrous sodium phosphate, hydroxypropicellulose, xanthan gum, cherry (J7549), banana (78701-31) and vanilla (D125038) flavors, anhydrous colloidal silicon, purified water. Description Granular powder from white to light yellow color with a characteristic odor of banana and cherry. The prepared solution is a homogeneous suspension of white or light yellow color with a characteristic odor of banana and cherry. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Macrolides. ATC code J01FA10 Pharmacological properties Pharmacokinetics Azithromycin is rapidly absorbed when taken orally, due to its stability in an acidic environment and lipophilicity. After a single oral dose, 37% of azithromycin is absorbed, and peak plasma concentration (0.41 µg/ml) is recorded after 2-3 hours. Vd is approximately 31 l/kg. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract, prostate gland, skin and soft tissues, reaching from 1 to 9 µg/ml depending on the type of tissue. The high concentration in tissues (50 times higher than the concentration in plasma) and the long half-life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in the low pH environment surrounding lysosomes. The ability of azithromycin to accumulate in lysosomes is especially important for the elimination of intracellular pathogens. Phagocytes deliver azithromycin to sites of infection, where it is released through the process of phagocytosis. But despite the high concentration in phagocytes, azithromycin does not affect their function. The therapeutic concentration lasts 5-7 days after ingestion of the last dose. When taking azithromycin, a transient increase in the activity of liver enzymes is possible. The removal of half the dose from the plasma is reflected in a reduction of half the dose in the tissues within 2-4 days. After taking the drug in the interval from 8 to 24 hours, the half-life is 14-20 hours, and after taking the drug in the interval from 24 to 72 hours - 41 hours, which allows you to take Sumamed once a day. The main route of excretion is with bile. Approximately 50% is excreted unchanged, the other 50% is excreted in the form of 10 inactive metabolites. Approximately 6% of the dose taken is excreted by the kidneys. Pharmacodynamics Azithromycin is a broad-spectrum antibiotic, the first representative of a new subgroup of macrolide antibiotics - azalides. It has a bacteriostatic effect, but when high concentrations are created at the site of inflammation, it causes a bactericidal effect. Azithromycin suppresses protein synthesis in sensitive microorganisms, showing activity against most strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms: Mycoplasma pneumoniae, Haemophilus ducreyi, Moraxella catarrhalis, Propionibacterium acnes, Gardnerella vaginalis, Actinomyces species, Bordetella pertussis, Borrelia burgdorferi, Mobiluncus species; Haemophilus influenzae, Streptococcus pyogenes, Haemophilus parainfluenzae, Streptococcus pneumoniae, Legionella pneumophila, Streptococcus agalactiae, Neisseria meningitides, Streptococcus viridans, Neisseria gonorrhoeae, Streptococcus group C, F, G, Helicobacter pylori, Peptococcus species, Campylobacter jejun i, Peptostreptococcus, Pasteurella multocida, Fusobacterium necrophorum, Pasteurella haemolytica, Clostridium perfringens, Brucella melitensis, Bacteroides bivius, Bordetella parapertussis, Chlamydia trachomatis, Vibrio cholerae, Chlamydia pneumoniae, Vibrio parahaemolyticus, Ureaplasma urealyticum, Plesiomonas shigelloides, Listeria monocytogenes, Staphylococcus epidermidis , Staphylococcus aureus* (*erythromycin – sensitive strain ); Escherichia coli, Bacteroides fragilis, Salmonella enteritidis, Bacteroides oralis, Salmonella typhi, Clostridium difficile, Shigella sonnei, Eubacterium lentum, Yersinia enterocolitica, Fusobacterium nucleatum, Acinetobacter calcoaceticus, Aeromonas hydrophilia. Indications for use - upper respiratory tract infections (bacterial pharyngitis/tonsillitis, sinusitis, otitis media) - lower respiratory tract infections (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis) - skin and soft tissue infections (chronic migratory erythema - initial stage Lyme disease, erysipelas, impetigo, secondary pyodermatoses) - infections of the stomach and duodenum caused by Helicobacter pylori - infections of the urogenital tract (gonorrheal and non-gonorrheal urethritis and/or cervicitis) Method of administration and dosage Sumamed in the form of an oral suspension is taken 1 time per day for 1 an hour before or 2 hours after meals using a measuring spoon or dosage syringe. Infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic migratory erythema) The course dose is 30 mg/kg. Two treatment regimens are used: 1) 10 mg/kg body weight once a day for 3 days 2) 10 mg/kg body weight on the first day and 5 mg/kg body weight from the 2nd to the 5th day Children the drug is prescribed based on weight: Body weight Sumamed® powder for oral suspension 100 mg/5 ml 5 kg 2.5 ml (50 mg) 6 kg 3 ml (60 mg) 7 kg 3.5 ml (70 mg) 8 kg 4 ml (80 mg) 9 kg 4.5 ml (90 mg) 10-14 kg 5 ml (100 mg) For children weighing more than 14 kg, it is recommended to prescribe a prolonged form of the suspension. Chronic migratory erythema The course dose of the drug is 60 mg/kg: a single dose of 20 mg/kg on the 1st day and 10 mg/kg on the subsequent days, from 2 to 5. Diseases of the stomach and duodenum associated with Helicobacter pylori: 20 mg/kg body weight 1 time per day in combination with antisecretory agents and other drugs. If a dose of the drug is missed, it must be taken immediately, and then subsequent doses should be taken at intervals of 24 hours. Method of preparing the suspension To prepare 20 ml of suspension, add 12 ml of water to a bottle containing 100 mg of azithromycin using a dosage syringe. Before use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is given a few sips of liquid to rinse and swallow the remaining amount of the suspension in the mouth. Side effects - vomiting, diarrhea, abdominal pain, nausea, flatulence, constipation - a transient increase in the level of liver aminotransferases, bilirubin, eosinophils in the blood. Indicators return to normal 2-3 weeks after the end of therapy - cholestatic jaundice, hepatitis - hypersensitivity reactions (redness, skin rash, itching, angioedema, photosensitivity) Extremely rarely - erythema multiforme, Steven-Johnson syndrome and toxic epidermal necrolysis - fatigue, headache, dizziness, disorders of taste and smell, paresthesia, fainting, anxiety, nervousness, insomnia - palpitations, arrhythmias - arthralgia, interstitial nephritis, acute renal failure. Contraindications - hypersensitivity to macrolide antibiotics - severe impairment of liver and kidney function Drug interactions Antacids significantly reduce the absorption of Sumamed suspension, so the drug should be taken one hour before or two hours after taking these drugs. Macrolide antibiotics interact with digoxin, cyclosporine, astemizole, triazolam, midazolam, or alfentanil. Close monitoring is recommended if these drugs are used concomitantly. Azithromycin does not bind cytochrome P-450 and therefore does not interact with theophylline, terfenadine, warfarin, carbamazepine, methylprednisolone and cimetidine. Special instructions Sumamed 100 mg/5 ml is intended for use in children. The duration of use of the drug should not exceed the periods specified in the instructions. Sumamed should be prescribed with caution to patients with impaired liver function. Overdose There is no data on overdose of Sumamed. Overdose of macrolide antibiotics results in temporary hearing loss, severe nausea, vomiting and diarrhea. In this case, it is necessary to induce vomiting and immediately provide symptomatic treatment. Release form and packaging The granulated powder is placed in high-density polyethylene bottles with a child-resistant screw cap. 1 bottle with a measuring spoon and/or a syringe for dosing, along with instructions for use in the state and Russian languages, is placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 25 °C. Keep out of the reach of children! Shelf life: 2 years Prepared suspension: 5 days. Do not use after the expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer Pliva Hrvatska d.o.o. Prilaz Baruna Filippovicha 25, 10000 Zagreb, Croatia Name and country of the owner of the registration certificate Pliva Hrvatska d.o.o., Croatia Address of the organization that accepts claims from consumers on the quality of products (products) on the territory of the Republic of Kazakhstan: Representative office in the Republic of Kazakhstan 050000 Republic of Kazakhstan .Almaty, Al-Farabi Avenue 13, Business Center Nurly Tau 1b, office 305, 306 Telephone, fax; 311-10-68 E-mail teva @ teva.co.il

Description of the drug SUMAMED® for systemic use

Carbamazepine

In pharmacokinetic studies conducted in healthy volunteers, azithromycin did not have a significant effect on plasma levels of carbamazepine or its active metabolite.

Oral coumarin anticoagulants

In a pharmacokinetic interaction study, azithromycin never altered the anticoagulant effect of warfarin when administered as a single 15 mg dose in healthy patients. In the post-marketing period, an increase in the anticoagulant effect of coumarin derivatives was observed when used in combination with azithromycin. Although a cause-and-effect relationship has not been established, more frequent monitoring of prothrombin time should be considered when azithromycin is used in patients taking coumarin anticoagulants.

While taking cimetidine

two hours before taking azithromycin, no changes in the pharmacokinetics of azithromycin were observed.

Cyclosporine

In a pharmacokinetic study in healthy volunteers who received a daily dose of azithromycin 500 mg orally for 3 days and who subsequently took a single dose of 10 mg/kg cyclosporine orally, the Cmax and AUC0-5 values of cyclosporine were significantly increased. Therefore, these drugs should be used simultaneously with caution. If concomitant use of these drugs is necessary, monitor cyclosporine levels and adjust the dose accordingly.

Efavirenz

Co-administration of a single dose of azithromycin 600 mg and efavirenz 400 mg per day for 7 days did not result in a clinically significant pharmacokinetic interaction.

Fluconazole

The simultaneous use of a single dose of 1200 mg of azithromycin does not change the pharmacokinetics of a single dose of 800 mg of fluconazole. The total concentration and half-life of azithromycin did not change with concomitant use of fluconazole. However, a clinically insignificant decrease in Cmax (18%) of azithromycin was noted.

Indinavir

Concomitant use of a single dose of 1200 mg of azithromycin does not have a significant effect on the pharmacokinetics of indinavir when administered at a dose of 800 mg three times daily for 5 days.

Methylprednisolone

In a pharmacokinetic study of drug interactions in healthy patients, azithromycin did not have a significant effect on the pharmacokinetics of methylprednisolone.

Midazolam

In healthy patients, simultaneous administration of azithromycin 500 mg daily for 3 days does not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of midazolam when administered once 15 mg.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg three times a day) leads to an increase in the concentration of azithromycin at steady state. No clinically significant side effects were identified. There is no need to adjust the dose.

Rifabutin

Concomitant use of azithromycin and rifabutin did not affect the serum concentrations of either drug. With simultaneous use of azithromycin and rifabutin, neutropenia was observed in patients. Neutropenia is associated with the use of rifabutin; a causal relationship when taken in combination with azithromycin has not been established.

Sildenafil

There was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the blood AUC and Cmax values of sildenafil or its major metabolites.

Theophylline

Azithromycin did not affect the pharmacokinetics of theophylline in healthy volunteers. Concomitant use of theophylline and other macrolide antibiotics has sometimes resulted in increased serum theophylline concentrations.

Triazolam

Co-administration of azithromycin 500 mg on day 1 and 250 mg on day 2 and triazolam 0.125 mg on day 2 in 14 healthy patients did not have a significant effect on the pharmacokinetic parameters of triazolam compared with co-administration of triazolam and placebo.

Trimethoprim/sulfamethoxazole

Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days and 1200 mg azithromycin on day 7 had no significant effect on peak concentrations and urinary excretion of trimethoprim/sulfamethoxazole. Azithromycin serum concentrations were similar to those in other studies.

Cisapride

metabolized in the liver by the enzyme CYP3A4.
Because macrolides inhibit this enzyme, concomitant administration of cisapride may result in QT prolongation, ventricular arrhythmias, and torsades de pointes
.

Data on interactions with astemizole

and
alfentanil
are absent. Caution should be exercised when these drugs are used concomitantly with azithromycin, given the potential effects described with concomitant use of the macrolide antibiotic erythromycin.

Azithromycin should not be used concomitantly with other active substances that prolong the QT interval