Sumamed Forte powder d / prig.susp.d / pr. Inside 200mg / 5ml, 35.573g

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

• infections of the upper respiratory tract and ENT organs (pharyngitis / tonsillitis, sinusitis, otitis media);

• lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia);

• infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);

• Lyme disease (the initial stage of borreliosis) - erythema migrans (erythema mygrans).

The drug is administered orally 1 time / day, 1 hour before or 2 hours after meals. After taking SumamedЃ forte, the child must be offered to drink a few sips of water so that he can swallow the rest of the suspension.

Before each use of the drug, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained, if the required volume of the suspension has not been taken from the vial within 20 minutes after shaking, the suspension should be shaken again, the required volume should be taken and given to the child. The required dose is measured using a dosing syringe with a graduation rate of 1 ml and a nominal suspension capacity of 5 ml (200 mg azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (100 mg azithromycin) or 5 ml (200 mg azithromycin), enclosed in a cardboard packaging together with a bottle. After use, the syringe (after disassembling it) and the measuring spoon are washed with running water, dried and stored in a dry place until the next dose of SumamedЃ Forte.

In case of infectious and inflammatory diseases of the upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days, the course dose is 30 mg / kg.

For pharyngitis / tonsillitis caused by Streptococcus pyogenes, SumamedЃ Forte is used at a dose of 20 mg / kg / day for 3 days (course dose of 60 mg / kg). The maximum daily dose is 500 mg.

Children weighing up to 10 kg should be prescribed SumamedЃ in the form of a powder for the preparation of a suspension for oral administration with a concentration of 100 mg / 5 ml.

In Lyme disease (the initial stage of borreliosis) - erythema migrans (erythema migrans), the drug is prescribed on the 1st day at a dose of 20 mg / kg / day, then from 2 to 5 days - at a dose of 10 mg / kg / day (course dose - 60 mg / kg).

When used in patients with impaired renal function with a GFR of 10-80 ml / min, dose adjustment is not required.

When used in patients with mild to moderate hepatic dysfunction, dose adjustment is not required.

Elderly patients do not need dose adjustment. In elderly patients, when using the drug SumamedЃ forte, it is recommended to be especially careful due to the possible presence of proarrhythmogenic factors that can increase the risk of developing cardiac arrhythmias and arrhythmias of the 'pirouette' type.

Rules for the preparation and storage of the suspension

To the contents of the vial intended for the preparation of 15 ml of suspension (nominal volume), 9.5 ml of water is added using a syringe for dosing.

Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 20 ml, which exceeds the nominal volume by about 5 ml. This is intended to compensate for the inevitable loss of the suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ? — for no more than 5 days.

To the contents of the vial intended for the preparation of 30 ml of suspension (nominal volume), 16.5 ml of water is added using a syringe for dispensing.

Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 35 ml, which exceeds the nominal volume by about 5 ml. This is intended to compensate for the inevitable loss of the suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ? — for no more than 10 days.

To the contents of the vial intended for the preparation of 37.5 ml of suspension (nominal volume), 20 ml of water is added using a syringe for dispensing.

Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 42.5 ml, which exceeds the nominal volume by about 5 ml. This is intended to compensate for the inevitable loss of the suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ? — for no more than 10 days.

Powder for preparation of suspension for oral administration from white to yellowish-white color

1 g

azithromycin

Excipients: sucrose, sodium phosphate, giprolazag, xanthan gum, flavoring agent, titanium dioxide, colloidal silicon dioxide.

• Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug;

• severe liver dysfunction;

• deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption;

• simultaneous intake of ergotamine and dihydroergotamine;

• children's age up to 6 months.

With care: myasthenia gravis; dysfunction of the liver of mild to moderate severity; end-stage renal failure with a GFR less than 10 ml / min; patients with the presence of proarrhythmogenic factors (especially elderly patients): with congenital or acquired prolongation of the QT interval, patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimosychotic drugs ), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disturbances in water and electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia, or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporin; diabetes.

pharmachologic effect

Bacteriostatic antibiotic of the macrolide-azalide group. Possesses a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of the microbial cell. By binding to the 50S-subunit of the ribosome, it inhibits peptide translocase at the stage of translation and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.

Pharmacokinetics

Suction

Cmax in blood plasma is achieved after 2-3 hours. Bioavailability is 37%.

Distribution

Plasma protein binding is inversely proportional to blood concentration and amounts to 12-52%. Vd is 31.1 l / kg. Penetrates through cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria. Easily penetrates histohematogenous barriers and enters tissues. Concentration in tissues and cells is 50 times higher than in plasma, and in the focus of infection - 24-34% higher than in healthy tissues.

Metabolism

In the liver, it is demethylated, losing activity.

Withdrawal

It is slowly excreted from tissues and has a long T1 / 2 - 2-4 days. The therapeutic concentration of azithromycin lasts up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% by the intestines, 12% - by the kidneys.

Pharmacokinetics in special clinical situations

In patients with severe renal insufficiency (CC less than 10 ml / min), T1 / 2 increases by 33%.

Side effect

Infectious diseases: infrequently - candidiasis, incl. oral mucosa and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; very rarely - pseudomembranous colitis.

On the part of the blood and lymphatic system: infrequently leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

From the side of metabolism and nutrition: infrequently - anorexia.

Allergic reactions: infrequently - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.

From the nervous system: often - headache; infrequently - dizziness, impaired taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste, myasthenia gravis, delirium, hallucinations.

From the side of the organ of vision: infrequently - visual impairment.

On the part of the organ of hearing and labyrinth disorders: infrequently - hearing disorder, vertigo; unknown frequency - hearing impairment, incl. deafness and / or tinnitus.

From the side of the cardiovascular system: infrequently - a feeling of palpitations, 'hot flushes' of blood to the face; unknown frequency - a decrease in blood pressure, an increase in the QT interval on the ECG, arrhythmia of the 'pirouette' type, ventricular tachycardia.

From the respiratory system: infrequently - shortness of breath, epistaxis.

From the gastrointestinal tract: very often - diarrhea; often - nausea, vomiting, abdominal pain: infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - discoloration of the tongue, pancreatitis.

From the liver and biliary tract: infrequently - hepatitis; rarely - liver dysfunction, cholestatic jaundice; unknown frequency - liver failure (in rare cases with a fatal outcome, mainly against the background of severe liver dysfunction), liver necrosis, fulminant hepatitis.

Skin and subcutaneous tissue disorders: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity reaction; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

From the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.

From the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.

On the part of the genitals and mammary gland: infrequently - metrorrhagia, dysfunction of the testicles.

Others: infrequently - asthenia, malaise, fatigue, facial edema, chest pain, fever, peripheral edema.

Laboratory data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease in the concentration of bicarbonates in the blood plasma; infrequently - an increase in the activity of AST, ALT, an increase in the concentration of bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the content of potassium in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the content of chlorine in the blood plasma, an increase in the concentration of glucose in the blood, an increase in the number of platelets, an increase in hematocrit, an increase in the concentration of bicarbonates in the blood plasma, a change in the sodium content in the blood plasma.

Application during pregnancy and lactation

During pregnancy, the use of the drug is possible only if the potential benefit of therapy to the mother outweighs the possible risk to the fetus and child.

During treatment with azithromycin, breastfeeding should be suspended.

Application for violations of liver function

In severe liver dysfunction, the drug is contraindicated. With caution should be prescribed for mild to moderate liver dysfunction.

Application for impaired renal function

In severe renal impairment, the drug is contraindicated. The drug should be prescribed with caution for mild and moderate renal impairment.

Application in children

Children aged 6 months and older are advised to prescribe the drug in the form of a suspension for oral administration or 125 mg tablets.

special instructions

When using SumamedЃ forte in patients with diabetes mellitus, as well as with a low-calorie diet, it is necessary to take into account that the suspension contains sucrose (0.32 XE / 5 ml). In case of missing a dose of one SumamedЃ forte drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.

SumamedЃ forte should be taken at least 1 hour before or 2 hours after taking antacids.

SumamedЃ forte should be taken with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe liver failure.

In the presence of symptoms of liver dysfunction, such as rapidly increasing asthenia, jaundice, dark urine, a tendency to bleeding, hepatic encephalopathy, therapy with SumamedЃ forte should be discontinued and a study of the functional state of the liver should be carried out.

In case of impaired renal function in patients with GFR 10-80 ml / min, dose adjustment is not required, therapy with SumamedЃ should be carried out with caution under the control of the state of renal function.

As with the use of other antibacterial drugs, during therapy with SumamedЃ Forte, patients should be regularly examined for the presence of refractory microorganisms and signs of the development of superinfections, incl. fungal.

The drug SumamedЃ forte should not be used for longer courses than indicated in the instructions, because the pharmacokinetic properties of azithromycin make it possible to recommend a short and simple dosing regimen.

There is no data on the possible interaction between azithromycin and derivatives of ergotamine and dihydroergotamine, but due to the development of ergotism with the simultaneous use of macrolides with derivatives of ergotamine and dihydroergotamine, this combination is not recommended.

With prolonged use of the drug SumamedЃ forte, it is possible to develop pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis. With the development of antibiotic-associated diarrhea while taking SumamedЃ Forte, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit intestinal motility.

When treating with macrolides, incl. azithromycin, lengthening of cardiac repolarization and QT interval was observed, increasing the risk of developing cardiac arrhythmias, incl. arrhythmias of the 'pirouette' type, which can lead to cardiac arrest.

Caution should be exercised when using SumamedЃ forte in patients with the presence of proarrhythmogenic factors (especially in elderly patients), incl. with congenital or acquired lengthening of the QT interval; in patients taking class IA antiarrhythmics (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with electrolyte disturbances balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmias or severe heart failure.

The use of SumamedЃ forte can provoke the development of myasthenic syndrome or exacerbate myasthenia gravis.

Influence on the ability to drive vehicles and mechanisms

With the development of undesirable effects on the part of the nervous system and the organ of vision, care should be taken when performing actions that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms (similar to the side effects that occur when taking the drug in recommended doses): severe nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: intake of activated carbon, symptomatic therapy, monitoring of vital functions.

Drug interactions

Antacids

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

Cetirizine

Simultaneous use for 5 days in healthy volunteers of azithromycin with cetirizine (20 mg) did not lead to pharmacokinetic interaction and 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 with the placebo group.

Digoxin (P-glycoprotein substrates)

The simultaneous use of macrolide antibiotics, incl. azithromycin, with P-glycoprotein substrates such as digoxin, leads to an increase in the serum P-glycoprotein substrate concentration. 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 repeated administration of 1200 mg or 600 mg) has a slight effect on pharmacokinetics, incl. excretion by the kidneys 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 finding is unclear. Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It was not revealed that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes.

Ergot alkaloids

”читыва¤ теоретическую возможность возникновени¤ эрготизма, одновременное применение азитромицина с производными алкалоидов спорыньи не рекомендуетс¤.

Ѕыли проведены фармакокинетические исследовани¤ одновременного применени¤ азитромицина и препаратов, метаболизм которых происходит с участием изоферментов системы цитохрома –450.

јторвастатин

ќдновременное применение аторвастатина (10 мг ежедневно) и азитромицина (500 мг ежедневно) не вызывало изменени¤ концентраций аторвастатина в плазме крови (на основе анализа ингибировани¤ vћ - ој-редуктазы). ќднако в пострегистрационном периоде были получены отдельные сообщени¤ о случа¤х рабдомиолиза у пациентов, получающих одновременно азитромицин и статины.

 арбамазепин

¬ фармакокинетических исследовани¤х с участием здоровых добровольцев не вы¤влено существенного вли¤ни¤ на концентрацию карбамазепина и его активного метаболита в плазме крови у пациентов, получавших одновременно азитромицин.

?иметидин

¬ фармакокинетических исследовани¤х вли¤ни¤ разовой дозы циметидина на фармакокинетику азитромицина не вы¤влено изменений фармакокинетики азитромицина, при условии применени¤ циметидина за 2 ч до азитромицина.

јнтикоагул¤нты непр¤мого действи¤ (производные кумарина)

¬ фармакокинетических исследовани¤х азитромицин не вли¤л на антикоагул¤нтный эффект однократной дозы 15 мг варфарина, принимаемого здоровыми добровольцами. —ообщалось о потенцировании антикоагул¤нтного эффекта после одновременного применени¤ азитромицина и антикоагул¤нтов непр¤мого действи¤ (производные кумарина). Ќесмотр¤ на то, что причинна¤ св¤зь не установлена, следует учитывать необходимость проведени¤ частого мониторинга протромбинового времени при применении азитромицина у пациентов, которые получают пероральные антикоагул¤нты непр¤мого действи¤ (производные кумарина).

?иклоспорин

¬ фармакокинетическом исследовании с участием здоровых добровольцев, которые в течение 3 дней принимали внутрь азитромицин (500 мг/сут однократно), а затем циклоспорин (10 мг/кг/сут однократно), было вы¤влено достоверное повышение Cmax в плазме крови и AUC0-5 циклоспорина. —ледует соблюдать осторожность при одновременном применении этих препаратов. ¬ случае необходимости одновременного применени¤ этих препаратов, необходимо проводить мониторинг концентрации циклоспорина в плазме крови и соответственно корректировать дозу.

Ёфавиренз

ќдновременное применение азитромицина (600 мг/сут однократно) и эфавиренза (400 мг/сут) ежедневно в течение 7 дней не вызывало какого-либо клинически значимого фармакокинетического взаимодействи¤.

‘луконазол

ќдновременное применение азитромицина (1200 мг однократно) не мен¤ло фармакокинетику флуконазола (800 мг однократно). ќбща¤ экспозици¤ и период полувыведени¤ азитромицина не измен¤лись при одновременном применении флуконазола, однако при этом наблюдали снижение Cmax азитромицина (на 18%), что не имело клинического значени¤.

»ндинавир

ќдновременное применение азитромицина (1200 мг однократно) не вызывало статистически достоверного вли¤ни¤ на фармакокинетику индинавира (по 800 мг 3 раза в сут в течение 5 дней).

ћетилпреднизолон

јзитромицин не оказывает существенного вли¤ни¤ на фармакокинетику метилпреднизолона.

Ќелфинавир

ќдновременное применение азитромицина (1200 мг) и нелфинавира (по 750 мг 3 раза/сут) вызывает повышение равновесных концентраций азитромицина в сыворотке крови.  линически значимых побочных эффектов не наблюдалось и коррекции дозы азитромицина при его одновременном применении с нелфинавиром не требуетс¤.

–ифабутин

ќдновременное применение азитромицина и рифабутина не вли¤ет на концентрацию каждого из препаратов в сыворотке крови. ѕри одновременном применении азитромицина и рифабутина иногда наблюдалась нейтропени¤. Ќесмотр¤ на то, что нейтропени¤ ассоциировалась с применением рифабутина, причинно-следственна¤ св¤зь между применением комбинации азитромицина и рифабутина и нейтропенией не установлена.

—илденафил

ѕри применении у здоровых добровольцев не получено доказательств вли¤ни¤ азитромицина (500 мг/сут ежедневно в течение 3 дней) на AUC и Cmax силденафила или его основного циркулирующего метаболита.

“ерфенадин

¬ фармакокинетических исследовани¤х не было получено доказательств взаимодействи¤ между азитромицином и терфенадином. —ообщалось о единичных случа¤х, когда возможность такого взаимодействи¤ нельз¤ было исключить полностью, однако не было ни одного конкретного доказательства, что такое взаимодействие имело место.

Ѕыло установлено, что одновременное применение терфенадина и макролидов может вызвать аритмию и удлинение интервала QT.

“еофиллин

Ќе вы¤влено взаимодействие между азитромицином и теофиллином.

“риазолам/мидазолам

There were no significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.

Trimethoprim / Sulfamethoxazole

The simultaneous use of trimethoprim / sulfamethoxazole with azithromycin did not reveal a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.