Sumamed forte instructions for use 200 mg. Suspension "Sumamed" for children: instructions for use

Date: 04.07.2020

powder for suspension for oral administration

Owner/Registrar

PLIVA HRVATSKA, d.o.o.

International Classification of Diseases (ICD-10)

A46 Erysipelas A48.1 Legionnaires' disease A56.4 Chlamydial pharyngitis A69.2 Lyme disease H66 Suppurative and unspecified otitis media J01 Acute sinusitis J02 Acute pharyngitis J03 Acute tonsillitis J04 Acute laryngitis and tracheitis J15 Bacterial pneumonia, not elsewhere classified J15.7 Pneumonia , caused by mycoplasma pneumoniae J16.0 Pneumonia caused by chlamydia J20 Acute bronchitis J31 Chronic rhinitis, nasopharyngitis and pharyngitis J32 Chronic sinusitis J35.0 Chronic tonsillitis J37 Chronic laryngitis and laryngotracheitis J42 Chronic bronchitis, unspecified L01 Impetigo L02 Skin abscess, furuncle L08 .0 Pyoderma L30.3 Infectious dermatitis T79.3 Post-traumatic wound infection, not elsewhere classified

Pharmacological group

Macrolide antibiotic - azalide

pharmachologic effect

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

It has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms.

Sumamed ® forte active against aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes; aerobic Gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp.; other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

microorganisms, capable of developing resistance to azithromycin: gram-positive aerobes- Streptococcus pneumoniae (penicillin-resistant strains and strains with medium sensitivity to penicillin).

Microorganisms with natural resistance: gram-positive aerobes- Enterococcus faecalis, Staphylococcus aureus (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains); anaerobes- Bacteroides fragilis.

Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (group A beta-hemolytic streptococcus), Enterococcus faecalis and Staphylococcus aureus, including Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides have been described.

Microorganism susceptibility scale to azithromycin (MIC, mg/l)*

* - Azithromycin was used to treat infectious diseases caused by Salmonella typhi (MIC not more than 16 mg/l) and Shigella spp.

Pharmacokinetics

Suction

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

Distribution

Plasma protein binding is inversely proportional to blood concentration and is 12-52%. V d 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 through histohematic barriers and enters the tissues. The concentration in tissues and cells is 50 times higher than in plasma, and in the focus of infection it is 24-34% higher than in healthy tissues.

Metabolism

Demethylated in the liver, losing activity.

breeding

Slowly excreted from the tissues and has a long T 1/2 - 2-4 days. The therapeutic concentration of azithromycin is maintained up to 5-7 days after 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), T 1/2 increases by 33%.

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

Upper respiratory infections, including pharyngitis/tonsillitis, sinusitis, otitis media;

Infections of the lower respiratory tract, including acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia;

Infections of the skin and soft tissues, including erysipelas, impetigo, secondary infected dermatoses;

Lyme disease (initial stage of borreliosis) - migratory erythema (erythema migrans).

Severe liver dysfunction;

Simultaneous administration of ergotamine and dihydroergotamine;

Children's age up to 6 months;

Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;

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

WITH caution the drug should be prescribed for myasthenia gravis, mild to moderate hepatic impairment, end-stage renal disease with GFR less than 10 ml / min, patients with the presence of proarrhythmic factors (especially elderly patients): with congenital or acquired prolongation of the QT interval, patients receiving antiarrhythmic therapy Class IA drugs (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with water and electrolyte imbalance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia, or severe heart failure; with the simultaneous use of digoxin, warfarin, cyclosporine; with diabetes.

The frequency of side effects is classified according to WHO recommendations: very often (≥10%), often (≥1%-<10%), нечасто (≥0.1%-<1%), редко (≥0.01%-<0.1%), очень редко (<0.01%), неизвестная частота - не может быть оценена, исходя из имеющихся данных.

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

From 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, taste disturbance, 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 sensations, 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 loss, vertigo; unknown frequency - hearing impairment, incl. deafness and/or tinnitus.

From the side of the cardiovascular system: infrequently - a feeling of palpitations, "tides" 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, nosebleeds.

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 side of the liver and biliary tract: infrequently - hepatitis; rarely - impaired liver function, 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.

From the skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - a 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 side of the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.

From the genitals and mammary gland: infrequently - metrorrhagia, testicular dysfunction.

Others: infrequently - asthenia, malaise, fatigue, swelling of the face, 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, increase in the concentration of glucose in the blood, increase in the number of platelets, increase in hematocrit, increase in the concentration of bicarbonates in the blood plasma, changes in the sodium content in the blood plasma.

Overdose

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

Treatment: taking activated charcoal, conducting symptomatic therapy, monitoring vital functions.

special instructions

When using the drug Sumamed ® forte in patients with diabetes mellitus, as well as with a low-calorie diet, it must be taken into account that the suspension contains sucrose (0.32 XU / 5 ml). In case of missing one dose of Sumamed ® forte, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

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

The drug Sumamed ® 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.

If there are symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, dark urine, a tendency to bleeding, hepatic encephalopathy, therapy with Sumamed ® forte should be stopped 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 Sumamed ® 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 Sumamed ® forte, patients should be regularly examined for the presence of non-susceptible microorganisms and signs of the development of superinfections, incl. fungal.

The drug Sumamed ® forte should not be used for longer courses than indicated in the instructions, because. The pharmacokinetic properties of azithromycin allow a short and simple dosing regimen to be recommended.

There is no evidence of a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism while using macrolides with ergotamine and dihydroergotamine derivatives, this combination is not recommended.

With prolonged use of the drug Sumamed ® forte, pseudomembranous colitis caused by Clostridium difficile may develop, both in the form of mild diarrhea and severe colitis. With the development of antibiotic-associated diarrhea while taking the drug Sumamed ® 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, there was an increase in cardiac repolarization and the QT interval, which increase the risk of developing cardiac arrhythmias, incl. arrhythmias such as "pirouette", which can lead to cardiac arrest.

Caution should be exercised when using the drug Sumamed ® forte in patients with the presence of proarrhythmic factors (especially in elderly patients), incl. with congenital or acquired prolongation of the QT interval; in patients taking antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water and electrolyte balance, especially in the case of hypokalemia or hypomagnesaemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

The use of the drug Sumamed ® 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 an increased concentration of attention and speed of psychomotor reactions.

With kidney failure

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

In violation of the functions of the liver

In severe violations of liver function, the drug is contraindicated. WITH caution should be prescribed for mild to moderate hepatic impairment.

Use during pregnancy and lactation

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

During treatment with azithromycin, breastfeeding should be suspended.

drug interaction

Antacids

Antacids do not affect the bioavailability of azithromycin, but reduce C max in the blood by 30%, so Sumamed ® forte should be taken at least 1 hour before or 2 hours after taking these drugs and eating.

cetirizine

The simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to a 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)

Simultaneous use of macrolide antibiotics, incl. azithromycin, with substrates of P-glycoprotein, such as digoxin, leads to an increase in the concentration of substrate P-glycoprotein 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 mg or 600 mg) has little 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 weakly interacts with isoenzymes of the cytochrome P450 system. It has not been found 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

Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended.

Pharmacokinetic studies have been conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.

Atorvastatin

Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter plasma concentrations of atorvastatin (based on MMC-CoA reductase inhibition assay). However, in the post-registration period, there have been isolated reports of cases of rhabdomyolysis in patients receiving both azithromycin and statins.

Carbamazepine

In pharmacokinetic studies involving healthy volunteers, there was no significant effect on the concentration of carbamazepine and its active metabolite in plasma in patients who received azithromycin concomitantly.

Cimetidine

In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, there were no changes in the pharmacokinetics of azithromycin, provided that 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 given to healthy volunteers. Potentiation of the anticoagulant effect has been reported after the simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, consideration should be given to the need for frequent monitoring of prothrombin time when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).

Cyclosporine

In a pharmacokinetic study in healthy volunteers who took orally for 3 days
azithromycin (500 mg / day once), and then cyclosporine (10 mg / kg / day once), there was a significant increase in C max in blood plasma and AUC 0-5 of cyclosporine. Caution should be exercised when these drugs are used concomitantly. If it is necessary to use these drugs simultaneously, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.

Efavirenz

The 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

The simultaneous 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 the 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 significantly affect the pharmacokinetics of methylprednisolone.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / 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 co-administered with nelfinavir.

Rifabutin

The simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in the blood serum. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. 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 an 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 an interaction between azithromycin and terfenadine. Isolated cases have been reported where the possibility of such an interaction could not be completely ruled out, but there was no concrete evidence that such an interaction took place.

It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.

Theophylline

There was no interaction between azithromycin and theophylline.

Triazolam/midazolam

Significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses have not been identified.

Trimethoprim/sulfamethoxazole

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

The drug is administered orally 1 time / day, 1 hour before or 2 hours after a meal. After taking the drug Sumamed ® 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 was not 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 division value 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) inserted in a cardboard packaging along with the vial.

After use, the syringe (having previously disassembled it) and the measuring spoon are washed with running water, dried and stored in a dry place until the next dose of Sumamed ® forte.

At 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 accurate dosing of the drug Sumamed ® forte in accordance with the body weight of the child, use the table below.

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

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

At Lyme disease (initial stage of borreliosis) - migrating erythema (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 applied to patients with impaired renal function with GFR 10-80 ml/min dose adjustment is not required.

When applied to patients with impaired liver function mild and moderate severity dose adjustment is not required.

Elderly patients dose adjustment is not required. In elderly patients, when using the drug Sumamed ® forte, special care is recommended due to the possible presence of proarrhythmic factors that may increase the risk of developing cardiac arrhythmia and arrhythmia of the "pirouette" type.

Rules for the preparation and storage of the suspension

to prepare 15 ml suspension (nominal volume), using a dosing syringe add 9.5 ml of water. 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 provided to compensate for the inevitable losses of the suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 5 days.

To the contents of the vial intended to prepare 30 ml suspension (nominal volume), using a dosing syringe, add 16.5 ml of water. 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 provided to compensate for the inevitable losses of the suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 10 days.

To the contents of the vial intended for the preparation of 37.5 ml of suspension (nominal volume), using a dosing syringe, add 20 ml of water. 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 provided to compensate for the inevitable losses of the suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 10 days.

Storage conditions and shelf life

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 2 years.

Instructions for the medical use of the medicinal product

Sumamed ® forte

Tradename

Sumamed ® forte

International non-proprietary name

Azithromycin

Dosage form

Powder for suspension for oral administration, 200mg/5ml

Compound

One vial contains

active substance- azithromycin (in the form of azithromycin dihydrate) - 600 mg (for a volume of 15 ml), 1200 mg (for a volume of 30 ml), 1500 mg (for a volume of 37.5 ml).

Excipients: sucrose, sodium phosphate anhydrous, hydroxypropycellulose, xanthan gum, colloidal anhydrous silicon, cherry flavor, banana flavor and vanilla flavor.

Description

Granular powder from white to light yellow color with a characteristic smell of banana and cherry.

The prepared solution is a homogeneous suspension of white or light yellow color with a characteristic smell of banana and cherry.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Azithromycin.

ATX code J01FA10

Pharmacological properties

Pharmacokinetics

Azithromycin is rapidly absorbed when taken orally, due to its acid resistance and lipophilicity. After a single oral dose, 37% of azithromycin is absorbed, and the peak plasma concentration (0.41µg / ml) is recorded after 2-3 hours. The volume of distribution V d is approximately 31 l/kg. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract, the prostate gland, into the skin and soft tissues, reaching from 1 to 9 µg / ml, depending on the type of tissue. The high tissue concentration (50 times higher than the plasma concentration) and 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 the sites of infection, where it is released during phagocytosis. But, despite the high concentration in phagocytes, azithromycin does not affect their function. Therapeutic concentration remains 5-7 days after ingestion of the last dose. When taking azithromycin, a transient increase in the activity of liver enzymes is possible. Removal of half the dose from the blood plasma is reflected in a decrease in half the dose in the tissues within 2-4 days. After taking the drug in the range from 8 to 24 hours, the half-life is 14-20 hours, and after taking the drug in the range from 24 to 72 hours - 41 hours, which allows you to take Sumamed ® forte 1 time per day. The main route of excretion is with bile. Approximately 50% is excreted unchanged, the other 50% is in the form of 10 inactive metabolites. Approximately 6% of the dose taken is excreted by the kidneys.

Pharmacodynamics

Sumamed ® forte 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 in the focus of inflammation, it causes a bactericidal effect. Binding 50S ribosomal subunit, Sumamed ® forte inhibits protein synthesis in sensitive microorganisms, showing activity against most strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.

MIC 90 ≤ 0.01 µg/ml

Mycoplasma pneumoniae Haemophilus ducreyi

MIC 90 0.01 - 0.1 µg/ml

Moraxella catarrhalis Propionibacterium acnes

Gardnerella vaginalis Actinomyces species

Bordetella pertussis Borrelia burgdorferi

Mobiluncus species

MIC 90 0.1 - 2.0 µg/ml

Haemophilus influenzae Streptococcus pyogenes

Haemophilus parainfluenzae Streptococcus pneumoniae

Legionella pneumophila Streptococcus agalactiae

Neisseria meningitidis Streptococcus viridans

Neisseria gonorrhoeae Streptococcus group C, F, G

Helicobacter pylori Peptococcus sp.

Campylobacter jejuni 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)

MIC 90 2.0 - 8.0 µg/ml

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

respiratory tract infections, including pharyngitis/tonsillitis, sinusitis, otitis media

lower respiratory tract infections, including acute exacerbation of chronic bronchitis, community-acquired pneumonia

skin and soft tissue infections: erythema migrans (early Lyme disease), erysipelas, impetigo, secondary pyodermatoses

stomach and duodenal infections caused by Helicobacter pylori

Dosage and administration

Sumamed ® forte in the form of an oral suspension is taken 1 time per day 1 hour before or 2 hours after a meal using a measuring spoon or dosing syringe.

In the treatment of infections of the upper and lower respiratory tract, skin and soft tissues (except for erythema migrans) the total dose of azithromycin is 30 mg / kg, which must be taken for 3 days (10 mg / kg 1 time per day).:

Azithromycin has been shown to be effective in the treatment of streptococcal pharyngitis in children as a single dose of 10 mg/kg or 20 mg/kg for 3 days. However, it is usually the drug of choice in the prevention of pharyngitis caused by Sterptococcus pyogenes, and rheumatic polyarthritis,

developing as a secondary disease is penicillin.

During treatment migratory erythema the total dose of azithromycin is 60 mg/kg with the following dosing regimen: 20 mg/kg on the 1st day, then 10 mg/kg 1 time per day.

In the treatment of stomach ulcers and duodenal infections caused by Helicobacter pylori use a dose of 20 mg / kg per day in combination with antisecretory agents and other drugs at the discretion of the physician.

Renal failure.

In patients with mild renal dysfunction (GFR 10-80 ml/min) there is no need to change the dose. Patients with severely impaired renal function (GFR<10 мл/мин) необходимо с осторожностью применять азитромицин.

Liver failure.

Since azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with severe liver disease. Studies aimed at studying the effect of azithromycin on liver function have not been conducted.

Elderly patients

Elderly patients are prescribed the same dose as adults. Among elderly patients, proarrhythmogenic conditions are possible, so the drug is used with caution due to the risk of developing cardiac arrhythmia and bidirectional tachycardia.

Suspension preparation method

Each vial should contain a suspension of 5 ml more than the course dose.

To prepare 15 ml of suspension, add 9.5 ml of water (20 ml of suspension) to a vial containing 600 mg of azithromycin.

To prepare 30 ml of suspension, add 16.5 ml of water (35 ml of suspension) to a vial containing 1200 mg of azithromycin.

To prepare 37.5 ml of suspension, add 20 ml of water (42.5 ml of suspension) to a vial containing 1500 mg of azithromycin.

Before use, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is allowed to drink a few sips of liquid in order to rinse and swallow the remaining amount of the suspension in the mouth.

Side effects

Often

Headache

Nausea, vomiting, diarrhea, abdominal pain

Decrease in white blood cells, increase in eosinophils, decrease in blood bicarbonate, increase in basophils, increase in monocytes, increase in neutrophils

Infrequently

Constipation, flatulence, dyspepsia, gastritis, dysphagia, bloating,

dry mouth, belching, mouth ulcers, hypersecretion of salivary glands

Dizziness, drowsiness, taste perversion, paresthesia

Hearing impairment, dizziness

Cardiopalmus

Shortness of breath, nosebleeds

visual impairment

Anorexia

Osteoarthritis, myalgia, back pain, neck pain

Nervousness, insomnia

Leukopenia, neutropenia, eosinophilia

Candidiasis, vaginal infections, pneumonia, fungal infections, bacterial infection, pharyngitis, gastroenteritis, respiratory disorders, rhinitis, candidiasis

tides

Rash, pruritus, urticaria, dermatitis, dry skin, hyperhidrosis

Angioedema, hypersensitivity

Dysuria, kidney pain

Metrorrhagia, testicular involvement

Edema, asthenia, malaise, fatigue, facial edema, chest pain, fever, pain, peripheral edema

Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium abnormal, blood alkaline phosphatase increased, chloride increased, glucose increased, platelets increased, hematocrit decreased , increased bicarbonate, abnormal sodium levels

Rarely

Agitation

Abnormal liver function, cholestatic jaundice

photosensitivity reactions

unknown

Pseudomembranous colitis

Thrombocytopenia, hemolytic anemia

Anaphylactic reaction

Aggression, anxiety, delusions, hallucinations

Syncope, convulsions, paresthesia, psychomotor hyperactivity, anosmia, ageusia, parosomia, myasthenia gravis

Hearing impairment, including deafness and/or tinnitus

Bidirectional tachycardia and arrhythmia including ventricular tachycardia, QT prolongation on ECG

hypotension

- pancreatitis, tongue discoloration

Liver failure (rarely fatal) fulminant hepatitis, liver necrosis

Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme

Arthralgia

Acute renal failure, interstitial nephritis

Adverse reactions associated with the prevention and treatment of infections caused by the complex Mycobacterium Avium possible or probable based on clinical studies and post-marketing experience. These adverse reactions differ in type or frequency from those reported for immediate release or extended release formulations:

System-organ Class	Often	Often	Infrequently
Metabolic and nutritional disorders		anorexia
Violations by nervous system		dizziness, headache, paresthesia, disorders	hypoesthesia
Violations of the organ of vision		visual impairment
Violations by organ of hearing and balance			hearing loss, tinnitus
Violations by heart organ			rapid heartbeat
Violations by gastrointestinal	diarrhea, abdominal pain, nausea, constipation, stomach discomfort, a soft chair
Violations by biliary
Violations by skin and subcutaneous		rash, itching	Stevens-Johnson syndrome, reactions photosensitivity
Violations by musculoskeletal and connective tissue arthralgia		arthralgia
General violations and reactions in place introductions		fatigue	asthenia, malaise

Contraindications

Hypersensitivity to macrolide antibiotics

Severe liver and kidney dysfunction

lactation period

Medicinal interactions

Antacids: When studying the effect of the simultaneous use of antacids on the pharmacokinetics of azithromycin, no changes in bioavailability were noted, although the maximum concentration of azithromycin in the blood plasma decreased by 25%. Patients should not take azithromycin and antacids at the same time. Cetirizine: In healthy volunteers, co-administration of a 5-day course of azithromycin with cetirizine 20 mg at steady state did not lead to a pharmacokinetic interaction and a significant change in the QT interval.

Didanosine (dideoxyinosine): Co-administration of azithromycin 1200 mg/day with didanosine 400 mg/day in 6 HIV-positive patients did not affect the steady-state pharmacokinetics of didanosine compared with placebo.

Digoxin (substratesP- gp): Co-administration of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates such as digoxin results in increased serum levels of P-glycoprotein substrates. Therefore, with the simultaneous use of azithromycin and P-glycoprotein substrates, such as digoxin, the possibility of increasing the concentration of P-glycoprotein substrates in serum should be borne in mind.

Zidovudine: With a single application of 1000 mg and repeated use of 1200 mg or 600 mg of azithromycin, there was a slight effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, azithromycin increased the concentration of phosphorylated zidovudine (a clinically active metabolite) in peripheral blood mononuclear cells. . The clinical significance of these indicators remains uncertain, but they may be useful to patients.

Azithromycin does not interact with the liver cytochrome P450 system. It does not participate in pharmacokinetic drug interactions like erythromycin and other macrolides. Azithromycin does not induce or inactivate cytochrome P450 via the cytochrome-metabolite complex.

Ergotamine derivatives: Due to the theoretical possibility of developing ergotism, the simultaneous use of azithromycin with ergot derivatives is not recommended. Pharmacokinetic studies have been conducted with azithromycin and the following drugs with known cytochrome P450-mediated metabolism.

Atorvastatin: Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter plasma concentrations of atorvastatin (based on HMG CoA reductase analysis). However, post-marketing cases of rhabdomyolysis have been reported in patients receiving azithromycin with statins.

Carbamazepine: In a pharmacokinetic interaction study of azithromycin in healthy volunteers, the drug did not significantly affect plasma levels of carbamazepine or its active metabolites.

Cimetidine: No change in the pharmacokinetics of azithromycin was noted in a pharmacokinetic study investigating the effect of a single dose of cimetidine taken 2 hours before azithromycin on the pharmacokinetics of azithromycin.

Coumarin oral anticoagulants: In pharmacokinetic interaction studies, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. In the post-marketing period, there have been reports of increased anticoagulation after co-administration of azithromycin and oral coumarin anticoagulants. Although a causal relationship has not been established, the frequency of monitoring of prothrombin time should be considered when prescribing azithromycin to patients receiving oral anticoagulants such as coumarin.

Cyclosporine: In a pharmacokinetic study in healthy volunteers who received azithromycin 500 mg/day orally for 3 days and then once orally 10 mg/kg cyclosporine, Cmax and AUC 0-5 of cyclosporine were found to be significantly elevated. Therefore, caution should be exercised before concurrent administration of these drugs is considered. If co-administration of these drugs is necessary, ciclosporin levels should be monitored and the dose adjusted accordingly.

Efavirenz: Co-administration of a single dose of azithromycin 600 mg and efavirenz 400 mg daily for 7 days did not result in clinically significant pharmacokinetic interactions.

Fluconazole: Co-administration 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 exposure and half-life of azithromycin did not change when co-administered with fluconazole, however, there was a clinically insignificant decrease in C max (18%) of azithromycin.

Indinavir: Co-administration of a single dose of 1200 mg of azithromycin had no statistically significant effect on the pharmacokinetics of indinavir administered at a dosage of 800 mg three times a day for 5 days.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin showed no significant effect on the pharmacokinetics of methylprednisolone.

Midazolam: In healthy volunteers, co-administration with azithromycin 500 mg/day for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15 mg midazolam.

Nelfinavir: Co-administration of azithromycin (1200 mg) and steady-state nelfinavir (750 mg three times a day) resulted in an increase in azithromycin concentrations. No clinically significant side effects were observed and dose adjustment is not required.

Rifabutin: The simultaneous use of azithromycin and rifabutin did not affect the concentration of these drugs in the blood plasma.

Neutropenia was detected with the simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship with concomitant use of azithromycin has not been established.

Sildenafil: In normal healthy male volunteers, there is no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite.

Terfenadine: No interactions between azithromycin and terfenadine have been reported in pharmacokinetic studies. In some cases, it is not possible to completely eliminate the possibility of an interaction. However, there was no concrete evidence that such an interaction took place.

Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction between azithromycin and theophylline when administered concomitantly to healthy volunteers.

Triazolam: In 14 healthy volunteers, co-administration of azithromycin 500 mg on day 1 and 250 mg on day 2 with triazolam 0.125 mg on day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared with co-administration of triazolam and placebo.

Trimethoprim/sulfamethoxazole: Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with azithromycin 1200 mg on day 7 had no significant effect on peak concentration, total exposure, or elimination of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were similar to those observed in other studies.

special instructions

As with erythromycin and other macrolides, rare serious allergic reactions have been reported, including angioedema and anaphylaxis (rarely fatal). Some of these reactions to azithromycin lead to the development of recurrent symptoms and require a longer period of observation and treatment.

The liver is the main organ for the elimination of azithromycin, so azithromycin should be used with caution in patients with severe liver disease. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported.

Some patients may have had existing liver disease or were taking other hepatotoxic drugs.

If signs and symptoms of liver dysfunction occur, such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency, or hepatic encephalopathy, perform liver function tests/tests immediately.

With the development of liver dysfunction, stop taking azithromycin.

In patients receiving ergot derivatives, the appearance of ergotism is provoked by the simultaneous administration of certain macrolide antibiotics. There are no data on the possibility of an interaction between ergot and azithromycin. However, due to the theoretical possibility of ergotism, azithromycin and ergot derivatives are taken separately.

diarrhea caused by Clostridium difficile has been reported in all cases of use of antibacterial agents, including azithromycin, and can range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal intestinal flora, leading to overgrowth C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. A strain that produces hypertoxin C. difficile lead to increased morbidity and mortality as these infections may be resistant to antimicrobial therapy and may require treatment

colectomy. CDAD should be considered in all patients who complain of diarrhea after antibiotic use. A careful history is essential, as CDAD may develop up to two months after administration of antibacterial agents.

In patients with severe renal insufficiency (GFR<10 мл / мин) наблюдалось 33% увеличение системного воздействия азитромицина.

Prolonged cardiac repolarization and prolongation of the QT interval, leading to the risk of developing cardiac arrhythmias and bidirectional tachycardia, have been reported with other macrolides, including azithromycin. The following conditions increase the risk of developing ventricular arrhythmias (including bidirectional tachycardia), which can lead to cardiac arrest, so azithromycin should be used with caution in patients with current proarrhythmic conditions (especially women and elderly patients), for example:

With congenital or documented QT prolongation

Who are currently being treated with other active substances known to prolong the QT interval, such as class IA antiarrhythmics (quinidine and procainamide) and class III antiarrhythmics (dofetilide, amiodarone and sotalol), cisapride and terfenadine; antipsychotics such as pimozide; antidepressants such as citalopram; and fluoroquinolones such as moxifloxacin and levofloxacin

With electrolyte imbalance, especially in cases of hypokalemia and hypomagnesemia

With clinically significant bradycardia, cardiac arrhythmias, or severe heart failure.

Exacerbation of myasthenia symptoms and new onset of myasthenia gravis have been reported in patients receiving azithromycin.

Penicillin is generally the drug of choice for the treatment of laryngitis/tonsillitis caused by Streptococcus pyogenes and is used as prophylaxis in acute rheumatic fever. Azithromycin is generally effective against streptococcal pharyngitis, but there is no information regarding its effectiveness in preventing acute rheumatic fever.

The safety and efficacy of Mycobacterium Avium Complex for prophylaxis or treatment in children have not been established.

Sucrose.

The drug contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency should not take this medicine.

Pregnancy

The use of the drug during pregnancy is possible when the expected benefit outweighs the potential risk to the fetus.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Sumamed ® forte does not affect the reaction rate when driving vehicles and working with other mechanisms.

Overdose

There are no data on overdose of Sumamed ® forte. An overdose of macrolide antibiotics is manifested by nausea, vomiting and diarrhea. In case of an overdose, it is necessary to take activated charcoal and carry out symptomatic therapy aimed at maintaining the vital functions of the body.

Release form and packaging

16.7 g, 29.30 g or 35.6 g of powder of the drug are placed in high-density polyethylene bottles with a child-resistant screw cap.

Sumamed forte: instructions for use and reviews

Sumamed forte is an antibacterial drug, azalide.

Release form and composition

Dosage form Sumamed forte - powder for suspension for oral administration: from yellowish-white to white, with a characteristic aroma of banana, strawberry or raspberry; when dissolved in water, a suspension with a homogeneous structure is formed, from yellowish-white to white, with an aroma corresponding to the smell of the powder [in a polyethylene bottle with a polypropylene resistant cap: with banana flavor - 16.74 g (15 ml), in a cardboard box 1 vial of 50 ml complete with a syringe and / or measuring spoon for dosing; with strawberry flavor - 29.295 g (30 ml), with raspberry flavor - 35.573 g (37.5 ml), in a cardboard box 1 bottle of 100 ml, complete with a syringe and (or) measuring spoon for dosing].

1 g of powder contains:

active ingredient: azithromycin dihydrate - 50.094 mg (with a theoretical activity of the substance 95.4%), which is equivalent to the content of azithromycin 47.79 mg, respectively;
auxiliary components: xanthan gum, sodium phosphate, sucrose, hyprolose, colloidal silicon dioxide, titanium dioxide;
flavorings: banana flavor powder - banana flavor and vanilla flavor, strawberry flavor powder - strawberry flavor, raspberry flavor powder - raspberry flavor.

Pharmacological properties

Pharmacodynamics

Sumamed forte is an antibiotic of the azalide macrolide group, has the ability to suppress or slow down the growth and reproduction of a wide range of bacteria. The antimicrobial effect is due to the ability of azithromycin to inhibit protein synthesis of microbial cells. After binding to the 50S subunit of the ribosome at the translation stage, the antibiotic inhibits the peptide translocase and, by inhibiting protein synthesis, slows down the growth and reproduction of bacteria. The bactericidal effect is manifested at high concentrations of the drug.

Azithromycin is active against a number of intracellular, anaerobes, gram-positive, gram-negative and other microorganisms.

Sensitive to Sumamed forte are:

aerobic gram-positive microorganisms: strains of Staphylococcus aureus, Streptococcus pyogenes sensitive to methicillin, strains of Streptococcus pneumoniae sensitive to penicillin;
aerobic gram-negative microorganisms: Haemophilus parainfluenzae, Haemophilus influenzae, Legionella pneumophila, Neisseria gonorrhoeae, Pasteurella multocida, Moraxella catarrhalis;
anaerobic microorganisms: Clostridium perfringens, Porphyromonas speciales (spp.) Fusobacterium spp., Prevotella spp.;
other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia burgdorferi, Mycoplasma hominis.

Resistance to azithromycin can develop gram-positive aerobes - strains with medium sensitivity to penicillin and penicillin-resistant strains of Streptococcus pneumoniae.

The following microorganisms are naturally resistant to Sumamed forte:

gram-positive aerobes: methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Enterococcus faecalis;
anaerobes: Bacteroides fragilis.

Cases of cross-resistance between beta-hemolytic Streptococcus pyogenes group A, Enterococcus faecalis, Streptococcus pneumoniae and Staphylococcus aureus, including its methicillin-resistant strains, to azithromycin, erythromycin and other lincosamides and macrolides are known.

Pharmacokinetics

The bioavailability of the drug is 37%, after oral administration, its maximum concentration (Cmax) in the blood plasma occurs after 2-3 hours.

The binding of azithromycin to plasma proteins is 12–52%. Vd (volume of distribution) of the drug - 31.1 l / kg. The effectiveness of the drug in infections caused by intracellular pathogens is due to its ability to overcome cell membranes. Transportation of azithromycin to the site of infection is carried out by phagocytes, polymorphonuclear leukocytes and macrophages; there it is released in the presence of bacteria. It enters the tissue by easy penetration through the blood-tissue barriers. In tissues and cells, its concentration is 50 times higher than in blood plasma; in healthy tissues, the content of azithromycin is 24-34% less than in the focus of infection.

Demethylated in the liver, losing activity.

It is excreted from the tissues slowly, T1 / 2 (half-life) - 48-96 hours. After taking the last dose, the level of therapeutic concentration of azithromycin continues to be maintained for 168 hours. In unchanged form, 50% of the active substance is excreted by the intestines, 12% by the kidneys.

In severe renal failure, with creatinine clearance (CC) less than 10 ml / min, the T1 / 2 of the drug increases by 33%.

Indications for use

According to the instructions, Sumamed forte is indicated for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug, including:

pharyngitis or tonsillitis, otitis media, sinusitis and other infections of the upper respiratory tract;
exacerbation of chronic bronchitis, acute bronchitis, community-acquired pneumonia and other infections of the lower respiratory tract;
impetigo, erysipelas, secondary infected dermatoses and other infections of the skin and soft tissues;
migrating erythema (Erythema Migrans) - Lyme disease (the first stage of borreliosis).

Contraindications

severe degree of liver dysfunction;
severe renal dysfunction;
fructose intolerance, sucrase or isomaltase deficiency, glucose-galactose malabsorption syndrome;
simultaneous use of ergotamine and dihydroergotamine;
breast-feeding;
individual intolerance to erythromycin, macrolides or ketolides;
hypersensitivity to the components of the drug.

Children Sumamed forte are not prescribed under the age of 6 months.

Care must be taken when prescribing the drug to patients with myasthenia gravis, mild to moderate liver dysfunction, terminal renal failure (CC less than 10 ml / min), diabetes mellitus, while using digoxin, warfarin or cyclosporine; in the presence (especially in elderly patients) of the following proarrhythmic factors: simultaneous therapy with antiarrhythmic drugs of class IA (procainamide, quinidine), III (sotalol, dofetilide, amiodarone), terfenadine, cisapride, antipsychotics (pimozide), fluoroquinolones (levofloxacin, moxifloxacin), antidepressants (citalopram), congenital or acquired prolongation of the QT interval, impaired water and electrolyte balance, especially with hypokalemia or hypomagnesemia, cardiac arrhythmia, clinically significant bradycardia, severe heart failure.

During pregnancy, the use of Sumamed forte is indicated only in special cases, if the benefit of treatment for the mother outweighs the potential threat to the fetus and child.

Instructions for use Sumamed forte: method and dosage

The finished suspension is taken 1 hour before a meal or 2 hours after a meal, 1 time per day. After taking the drug, children should definitely be allowed to drink a small amount of water so that they can swallow the rest of the suspension.

To prepare a suspension, water should be added to the contents of the vial using a dosing syringe. When dissolving the powder, the following proportions must be strictly observed:

vial with 16.74 g of powder: to obtain 15 ml of suspension, add 9.5 ml of water to the vial. The resulting suspension volume will be approximately 20 ml. Shelf life - no more than 5 days;
vial with 29.295 g of powder: to obtain 30 ml of suspension, add 16.5 ml of water to the vial. The resulting suspension volume is about 35 ml. Shelf life - no more than 10 days;
vial with 35.573 g of powder: to obtain 37.5 ml of suspension, add 20 ml of water to the vial. The resulting volume is approximately 42.5 ml. Shelf life - no more than 10 days.

After mixing the drug with water, the vial is shaken to obtain a homogeneous suspension structure. The amount of suspension in each of the vials exceeds the nominal volume by about 5 ml. This is provided in order to compensate for the natural losses during dosing of the drug.

The suspension should be stored at temperatures up to 25 °C.

The contents of the vial must be thoroughly shaken before each intake of the next dose of the drug and taken immediately.

The prescribed dose of Sumamed forte is measured using the dosing syringe included in the packaging kit (scale division - 1 ml, nominal capacity - 5 ml of suspension, or 200 mg of azithromycin) or measuring spoon (nominal capacity - 2.5 or 5 ml of suspension, which corresponds to 100 mg and 200 mg azithromycin).

After use, the syringe (previously disassembled) and the measuring spoon must be washed with running water, dried and stored in a dry place until the next dose of the drug.

The dose of Sumamed forte is determined by the doctor based on clinical indications.

For the treatment of children weighing up to 10 kg, it is recommended to prescribe Sumamed powder for oral suspension containing 100 mg of azithromycin in 5 ml of suspension. When using a measuring spoon for the dosage of this form of the drug, it should be borne in mind that a measuring spoon with a capacity of 2.5 ml contains 50 mg, and 5 ml contains 100 mg of azithromycin.

For children, Sumamed forte 200 mg / 5 ml is indicated in the following way, taking into account the weight of the child:

10-14 kg: 2.5 ml (100 mg of azithromycin);
15-24 kg: 5 ml (200 mg);
25-34 kg: 7.5 ml (300 mg);
35-44 kg: 10 ml (400 mg);
45 kg and above: 12.5 ml (500 mg, which corresponds to a single dose for adult patients).

infectious and inflammatory diseases of the upper and lower respiratory tract, soft tissues and skin: at the rate of 10 mg per 1 kg of body weight, course duration - 3 days, course dose - 30 mg per 1 kg;
tonsillitis or pharyngitis caused by Streptococcus pyogenes: 20 mg per 1 kg, but not more than 500 mg per day. Duration of treatment - 3 days, dose for 1 course - 60 mg per 1 kg of body weight;
Lyme disease: on the 1st day - 20 mg per 1 kg, from the 2nd to the 5th day - 10 mg per 1 kg of weight. The maximum dose of one course is 60 mg per 1 kg.

In case of impaired liver function of mild to moderate severity and in the treatment of elderly patients, the recommended doses should not be reduced.

Side effects

from the nervous system: often - headache; infrequently - paresthesia, insomnia, impaired taste sensations, dizziness, nervousness, drowsiness; rarely - agitation; possible (frequency unknown) - psychomotor hyperactivity, hypesthesia, anxiety, fainting, convulsions, aggression, loss of taste sensations, loss of smell, myasthenia gravis, perverted sense of smell, hallucinations, delirium;
infectious diseases: infrequently - rhinitis, pneumonia, candidiasis (including the mucous membrane of the mouth, genitals), pharyngitis, respiratory diseases, gastroenteritis; very rarely - pseudomembranous colitis;
from the side of the cardiovascular system: infrequently - flushing of blood to the skin of the face, a feeling of palpitations; possibly - ventricular tachycardia, lowering blood pressure (BP), prolongation of the QT interval on electrocardiography, pirouette-type arrhythmia;
on the part of the blood and lymphatic system: infrequently - leukopenia, eosinophilia, neutropenia; very rarely - hemolytic anemia, thrombocytopenia;
allergic reactions: infrequently - hypersensitivity reaction, angioedema; possibly an anaphylactic reaction;
labyrinth disorders and hearing organs: infrequently - vertigo, hearing impairment; possibly - tinnitus, deafness;
on the part of the organ of vision: infrequently - visual impairment;
from the respiratory system: infrequently - epistaxis, shortness of breath;
from the gastrointestinal tract: very often - diarrhea; often - abdominal pain, nausea, vomiting; infrequently - constipation, dryness of the oral mucosa, increased secretion of the salivary glands, flatulence, dyspepsia, gastritis, dysphagia, belching, bloating, ulceration of the oral mucosa; very rarely - pancreatitis, discoloration of the tongue;
from the hepatobiliary system: infrequently - hepatitis; rarely - cholestatic jaundice, functional impairment of the liver; possibly - fulminant hepatitis, liver failure (including fatal), liver necrosis;
from the urinary system: infrequently - pain in the kidneys, dysuria; possibly - acute renal failure, interstitial nephritis;
on the part of the genital organs and the mammary gland: infrequently - impaired testicular function, metrorrhagia;
from the musculoskeletal system: infrequently - back pain, osteoarthritis, neck pain, myalgia; possibly arthralgia;
on the part of metabolism and nutrition: infrequently - anorexia;
dermatological reactions: infrequently - dry skin, itching, skin rash, dermatitis, sweating, urticaria; rarely - a photosensitivity reaction; possibly erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
laboratory parameters: often - a decrease in the level of bicarbonates in the blood plasma, a decrease in the number of lymphocytes, an increase in the number of basophils, eosinophils, monocytes and (or) neutrophils; infrequently - an increase in blood glucose, an increase in the activity of alanine aminotransferase and aspartate aminotransferase, an increase in the level of bilirubin, urea and (or) creatinine in the blood plasma, a violation of the level of potassium concentration in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the amount of chlorine and (or ) bicarbonates in blood plasma, increased hematocrit, impaired sodium levels in blood plasma, increased platelet levels;
other: infrequently - a feeling of fatigue, asthenia, peripheral edema, malaise, swelling of the face, fever, chest pain.

Overdose

Overdose symptoms coincide with some of the undesirable effects that occur while taking azithromycin in therapeutic doses: nausea, vomiting, diarrhea, temporary hearing loss.

Treatment: the appointment of activated charcoal, symptomatic therapy with monitoring of vital functions.

special instructions

Patients with diabetes mellitus and patients on a low-calorie diet should take into account that the carbohydrate content in 5 ml of suspension (200 mg per 5 ml) corresponds to 0.32 XE.

In case of accidental skipping of the next dose of the drug, the patient should take it as soon as he remembers; then continue the reception with interruptions of 24 hours.

With concomitant therapy with antacids, Sumamed forte should be taken 1 hour before or 2 hours after taking them.

With mild to moderate severity of liver dysfunction, there is a risk of developing fulminant hepatitis and severe liver failure. The drug should be discontinued in the presence of the following symptoms of liver dysfunction: dark urine, rapidly increasing asthenia, bleeding tendency, jaundice, hepatic encephalopathy - and conduct a study of liver function.

During the treatment period, patients need regular examination for the presence of non-susceptible microorganisms and signs of the development of superinfections, including fungal infections.

Long-term use of Sumamed forte may contribute to the development of mild diarrhea or severe pseudomembranous colitis caused by Clostridium difficile. Patients who have had antibiotic-associated diarrhea while taking the drug should be examined to exclude clostridial pseudomembranous colitis, including 2 months after discontinuation of therapy. Do not use drugs that inhibit intestinal motility.

Azithromycin has an effect on prolongation of cardiac repolarization and the QT interval, which increase the risk of developing cardiac arrhythmias (including torsades de pointes), up to cardiac arrest. In addition, the drug may contribute to the development of myasthenic syndrome or exacerbation of myasthenia gravis.

Influence on the ability to drive vehicles and complex mechanisms

Since Sumamed forte can cause the development of undesirable effects on the part of the organ of vision and the nervous system, it is recommended to be careful during the period of treatment when driving vehicles, mechanisms and other activities that require a high speed of psychomotor reactions and concentration.

Use during pregnancy and lactation

The appointment of Sumamed forte during the gestation period is possible only as a last resort, when, according to the doctor, the expected effect of therapy for the mother outweighs the possible threat to the fetus and child.

It is contraindicated to take an antibiotic while breastfeeding.

Application in childhood

For the treatment of children aged 6 months and older, the use of the drug in the form of a suspension for oral administration or tablets at a dose of 125 mg is indicated.

In case of impaired renal function

The appointment of Sumamed forte is contraindicated in severe renal dysfunction with CC less than 10 ml / min.

With mild to moderate renal dysfunction, the drug should be used with caution, dose adjustment is not required.

In violation of liver function

The drug is contraindicated in patients with severe hepatic impairment.

Use in the elderly

When using Sumamed forte in elderly patients, special care must be taken because of the possible presence of proarrhythmogenic factors in the patient, which increase the risk of developing cardiac arrhythmia, arrhythmia of the pirouette type.

drug interaction

With the simultaneous use of Sumamed forte:

antacids: reduce the maximum concentration of azithromycin in the blood by 30%;
cetirizine: does not cause pharmacokinetic interaction and a significant change in the QT interval;
didanosine (dideoxyinosine): does not change its pharmacokinetic indications;
substrates of P-glycoprotein, including digoxin: increase their concentration in blood serum;
zidovudine (isoenzyme of the cytochrome P450 system): does not cause clinically significant interaction;
ergot alkaloids: they should not be prescribed, as there is a risk of ergotism;
atorvastatin (statins): may cause rhabdomyolysis;
carbamazepine: does not significantly change its concentration and active metabolite in plasma;
cimetidine: the pharmacokinetics of azithromycin is not affected if it is taken 2 hours before the use of the drug;
warfarin and other oral anticoagulants of indirect action (coumarin derivatives): may increase their effect, therefore frequent monitoring of prothrombin time is required;
cyclosporine: increases its concentration in blood plasma;
efavirenz, fluconazole, indinavir, methylprednisolone, sildenafil, theophylline, triazolam, midazolam, trimethoprim, sulfamethoxazole: do not produce a clinically significant pharmacokinetic interaction when used at therapeutic doses;
nelfinavir: may increase the level of equilibrium concentrations of the drug in the blood serum, which does not cause clinically significant side effects and does not require dose adjustment of azithromycin;
rifabutin: may cause the development of neutropenia, although a causal relationship between the use of this combination and the appearance of neutropenia has not been established;
Terfenadine: May cause QT prolongation and arrhythmia.

Analogues

Analogues of Sumamed forte are Azivon, Azimycin, Azivok, Azitrox, Azitral, Azithromycin Zentiva, Azithromycin Sandoz, Azithromycin, Azitsid, AzitRus, Vero-Azithromycin, Zetamax retard, Zitnob, ZI-Factor, Zitrolid, Zitrocin, Sumazid, Sumaclide, Sumamed , Sumamox, Sumatrolide solutab, Azilid, Tremak-Sanovel, Azidrop, Hemomycin, Ecomed.

Terms and conditions of storage

Keep away from children.

Store below 25°C.

Shelf life - 2 years.