Sumamed, 250 mg capsules 6 pcs

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Active ingredient

Composition

1 capsule contains:

the active ingredient azithromycin dihydrate 262.05 mg1), in terms of azithromycin – 250 mg;

excipients: microcrystalline cellulose 43.95 mg2), sodium lauryl sulfate 1.40 mg, magnesium stearate 12.60 mg.

Hard gelatin capsule #13) [capsule: indigocarmine (E-132) 0.1100%, titanium dioxide (E-171) 0.9000%, gelatin to 100%, capsule: indigo carmine (E-132) 0.0424%, titanium dioxide (E-171) 3.1237%, gelatin to 100%] 76.00 mg4).

1) – the amount is indicated based on the theoretical activity of azithromycin of 95.4%

2) – the amount of microcrystalline cellulose may vary depending on the actual activity of azithromycin

sup>The amount is given based on the theoretical activity of azithromycin/p>

3) – capsules contain sulfur dioxide 50 ppm as a preservative

4) – average weight of empty solid gelatin capsule #1

How to take, the dosage

Internal, once daily, at least 1 hour before or 2 hours after meals. Adults (including the elderly) and children over 12 years of age with body weight over 45 kg

.In infections of the upper and lower respiratory tract, ENT organs, skin and soft tissue

500 mg (2 capsules) once daily for 3 days (course dose of 1.5 g).

In Lyme disease (initial stage of borreliosis) – erythema migrans (.erythema migrans)

once daily for 5 days: Day 1, 1.0 g (4 capsules), then from day 2 to day 5, 500 mg (2 capsules) (3.0 g course dose).

Infections of the urogenital tract caused by Chlamydia .trachomatis (urethritis, cervicitis)

Uncomplicated urethritis/cervicitis – 1 g (4 capsules) once.

In renal dysfunction:In patients with a GFR of 10 – 80 ml/min, no dose adjustment is required.

In impaired hepatic function: No dose adjustment is required when used in patients with mild to moderate hepatic impairment.

Elderly patients:Dose adjustment is not required. Because the elderly may already have current proarrhythmogenic conditions, caution should be exercised when using Sumamed® due to the high risk of cardiac arrhythmias, including pirouette-type arrhythmias.

Interaction

Antacid drugs

The antacid drugs do not affect the bioavailability of azithromycin, but decrease 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 meals.

Cetirizine

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

Didanosine (didezoxynosine)

The concomitant use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6 HIV-infected patients showed no change in the pharmacokinetic readings of didanosine compared with the placebo group.

Digoxin(P-glycoprotein substrates)

. Concomitant use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates such as digoxin results in higher serum P-glycoprotein substrate concentrations. Thus, when concomitant use of azithromycin and digoxin is necessary to consider the possibility of increasing the concentration of digoxin in the blood serum.

Zidovudine

The concomitant use of azithromycin (single administration of 1000 mg and multiple administration of 1200 mg or 600 mg) has little effect on pharmacokinetics, including renal excretion of zidovudine or its glucuronide metabolite. However, azithromycin administration caused an increase in the concentration of phosphorylated zidovudine, the clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.

Azithromycin interacts weakly with cytochrome P450 isoenzymes. Azithromycin has not been found to be involved in pharmacokinetic interactions similar to those of erythromycin and other macrolides. Azithromycin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes.

Erthorine alkaloids

In view of the theoretical possibility of ergotism, concomitant use of azithromycin with derivatives of ergot alkaloids is not recommended.

Pharmacokinetic studies have been performed on the concomitant use of azithromycin and drugs metabolized by cytochrome P450 isoenzymes.

Atorvastatin

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in plasma concentrations of atorvastatin (based on HMK-CoA reductase inhibition analysis). However, in the post-registration period there were isolated reports of cases of rhabdomyolysis in patients receiving azithromycin and statins simultaneously.

Carbamazepine

Pharmacokinetic studies with healthy volunteers showed no significant effect on plasma concentrations of carbamazepine and its active metabolite in patients receiving azithromycin concomitantly.

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 found, provided that cimetidine was used 2 hours before azithromycin.

Indirect-acting anticoagulants (coumarin derivatives)

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

Cyclosporine

. In a pharmacokinetic study involving healthy volunteers who took oral azithromycin (500 mg/day once) for 3 days followed by cyclosporine (10 mg/kg/day once), a significant increase in the maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-5) of cyclosporine was found. Caution should be exercised when concomitant use of these drugs. If concomitant use of these drugs is necessary, plasma concentrations of cyclosporine should be monitored and the dose should be adjusted accordingly.

Efavirenz

The concomitant use of azithromycin (600 mg/day once daily) 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 daily) did not alter the pharmacokinetics of fluconazole (800 mg once daily). Total exposure and half-life of azithromycin were not altered by concomitant use of fluconazole, but there was a decrease in Cmax of azithromycin (by 18%), which had no clinical significance.

Indinavir

The concomitant use of azithromycin (1200 mg once) had no statistically significant effect on the pharmacokinetics of indinavir (800 mg three times daily for 5 days).

Methylprednisolone

Asithromycin has no significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times daily) causes increased equilibrium serum concentrations of azithromycin. No clinically significant adverse effects have been observed and no dose adjustment of azithromycin is required when used concomitantly with nelfinavir.

Rifabutin
Simultaneous use of azithromycin and rifabutin has no effect on the serum concentrations of either drug. Neutropenia has sometimes been observed with concomitant use of azithromycin and rifabutin. Although neutropenia has been 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 is no evidence of an effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite.

Terfenadine

In pharmacokinetic studies there has been no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported in which the possibility of such an interaction could not be ruled out completely, but there has not been any concrete evidence that such an interaction has occurred.

The concomitant use of terfenadine and macrolides has been found to cause arrhythmias and prolongation of the QT interval.

Theophylline

No interaction between azithromycin and theophylline has been identified.

Triazolam/midazolam

There are no significant changes in pharmacokinetic parameters when azithromycin is used simultaneously with triazolam or midazolam in therapeutic doses.

Trimethoprim/sulfamethoxazole

The concomitant use of trimethoprim/sulfamethoxazole with azithromycin showed no significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.

Special Instructions

In case of missing one dose of Sumamed® – the missed dose should be taken as soon as possible, and the next ones should be taken at 24-hour intervals.

Sumamed® should be taken at least one hour before or two hours after taking antacids.

Sumamed® should be used with caution in patients with mild to moderate hepatic impairment because of the possibility of fulminant hepatitis and severe hepatic impairment.

In patients with symptoms of hepatic impairment, such as rapidly increasing asthenia, jaundice, darkened urine, bleeding tendency, hepatic encephalopathy, therapy with Sumamed® should be discontinued and liver function testing should be performed.

In patients with renal dysfunction: no dose adjustment is required in patients with a GFR of 10 to 80 ml/min; therapy with Sumamed® should be performed with caution under renal function monitoring.

As with other antibacterials, therapy with Sumamed® should be regularly monitored for the presence of non-susceptible microorganisms and signs of superinfections, including fungal infections.

Sumamed® should not be used for longer courses than directed, because the pharmacokinetic properties of azithromycin recommend a short and simple dosing regimen.

There are no data on possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but because of the development of ergotism when using macrolides with ergotamine and dihydroergotamine derivatives simultaneously, this combination is not recommended.

Long-term use of Sumamed® may cause pseudomembranous colitis caused by Clostridium difficile, both as mild diarrhea and severe colitis. If antibiotic-associated diarrhea develops against the background of Sumamed® therapy, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit intestinal peristalsis.

Treatment with macrolides, including azithromycin, has been observed to prolong cardiac repolarization and the QT interval, increasing the risk of cardiac arrhythmias, including “pirouette” arrhythmias.

We should exercise caution when using Sumamed® in patients with the presence of proarrhythmogenic factors (especially in elderly patients): with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with electrolyte and water balance disorders, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia, or severe heart failure.

The use of Sumamed® may provoke myasthenic syndrome or worsen myasthenia gravis.

Influence on driving and operating ability

In case of adverse effects on the nervous system and eyesight, caution should be exercised when performing activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other drug components; severe hepatic impairment (Child-Pugh class C); children under 12 years of age with body weight less than 45 kg; simultaneous use with ergotamine and dihydroergotamine.

With caution

Myasthenia; mild to moderate hepatic impairment; terminal renal failure with a GFR (glomerular filtration rate) less than 10 ml/min; in patients with proarrhythmogenic factors (especially in older patients): with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with electrolyte balance disorders, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia, or severe heart failure; concomitant use of digoxin, warfarin, cyclosporine.

Side effects

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very common – at least 10%; common – at least 1%, but less than 10%; infrequent – at least 0.1%, but less than 1%; rare – at least 0.01%, but less than 0.1%; very rare – less than 0.01%; unknown frequency – can not be estimated based on available data.

Infectious diseases: infrequent – candidiasis, including oral mucosa, vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory disease, rhinitis; unknown frequency – pseudomembranous colitis.

With the blood and lymphatic system: infrequent – leukopenia, neutropenia, eosinophilia; very rare – thrombocytopenia, hemolytic anemia.

Metabolism and nutrition: infrequent – anorexia.

Allergic reactions: infrequent – angioedema, hypersensitivity reaction; unknown frequency – anaphylactic reaction.

Nervous system disorders: Frequent – headache; infrequent – dizziness, impaired sense of taste, paresthesias, somnolence, insomnia, nervousness; rare – agitation; unknown frequency – hypoesthesia, anxiety, aggression, fainting, seizures, psychomotor hyperactivity, loss of smell, perversion of smell, loss of sense of taste, myasthenia, delirium, hallucinations.

Visual organ: infrequent visual impairment.

Hearing organ and labyrinth disorders: infrequent – hearing disorder, vertigo; unknown frequency – hearing disorder, including deafness and/or tinnitus.

Cardiovascular system: infrequent – palpitations, “rushes” of blood to the face; unknown frequency – decreased blood pressure, increased QT interval in the electrocardiogram, arrhythmia type “pirouette”, ventricular tachycardia.

Respiratory system disorders: infrequent – shortness of breath, nasal bleeding.

From the gastrointestinal tract: very often – diarrhea; often – nausea, vomiting, abdominal pain; infrequently – flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, oral mucosa ulcers, increased salivary gland secretion; very rarely – color change of tongue, pancreatitis.

Hepatic and biliary tract: infrequent – hepatitis; rare – liver dysfunction, cholestatic jaundice; unknown frequency – liver failure (in rare cases – fatal, mostly with severe liver dysfunction); liver necrosis, fulminant hepatitis.

Skin and subcutaneous tissue: infrequent – skin rash, itching, urticaria, dermatitis, dry skin, sweating; rare – photosensitization reaction; unknown frequency – Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic manifestations (DRESS syndrome).

Musculoskeletal system: infrequent osteoarthritis, myalgia, back pain, neck pain; unknown frequency – arthralgia.

Kidney and urinary tract disorders: infrequent dysuria, renal pain; unknown frequency – interstitial nephritis, acute renal failure.

Gender and mammary gland disorders: infrequent – metrorrhagia, impaired testicular function.

Others: infrequent – edema, asthenia, malaise, feeling of fatigue, facial edema, chest pain, fever, peripheral edema.

Laboratory findings: often – decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased plasma bicarbonate concentration; infrequent – increased activity of aspartate aminotransferase, alanine aminotransferase, increased concentration of bilirubin in blood plasma, increased concentration of urea in blood plasma, increased concentration of creatinine in blood plasma, changes in plasma potassium, increased plasma alkaline phosphatase activity, increased plasma chloride concentration, increased blood glucose concentration, increased platelet count, decreased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium concentration.

Overdose

Pregnancy use

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