Sumamed - instructions for use. Antibiotic Sumamed - “☆ Angina, sinusitis, bronchitis? This antibiotic is up to the task! ☆ Sumamed in capsules and tablets: composition, full instructions, price, dosage ☆ Cheap analogue of Sumamed ☆ Azithromycin for breastfeeding

International non-proprietary name

Azithromycin

Dosage form

Film-coated tablets

Compound

active substance - azithromycin (as azithromycin dihydrate) - 125 mg,

Excipients: calcium hydrogen phosphate anhydrous, hypromellose (methylhydroxypropylcellulose 15 mPas), corn starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

shell composition: hypromellose (methylhydroxypropylcellulose 3 mPas), indigotine lacquer dye (E132), titanium dioxide (E171), polysorbate 80, talc.

Description

Light blue film-coated tablets, round, biconvex, marked "PLIVA" on one side and "125" on the other side.

Pharmacotherapeutic group

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

ATX code J01FA10

Pharmacological properties

Pharmacokinetics

Azithromycin is rapidly absorbed after oral administration, due to its stability in acidic environment and lipophilicity. After a single oral dose, 37% of azithromycin is absorbed, and the peak plasma concentration (0.41 µg / ml) is recorded after 2-3 hours. Vd is approximately 31 l/kg. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract, 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 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 plasma is reflected in a decrease in half the dose in 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 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 is a broad-spectrum antibiotic, the first representative of a new subgroup macrolide antibiotics- azalides. It has a bacteriostatic effect, but when high concentrations are created in the focus of inflammation, it causes a bactericidal effect. By binding the 50S ribosomal subunit, Sumamed inhibits protein synthesis in sensitive microorganisms, showing activity against most strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.

MIC90 ≤ 0.01 µg/mL

Mycoplasma pneumoniae Haemophilus ducreyi

MIC90 0.01 - 0.1 µg/ml

Moraxella catarrhalis Propionibacterium acnes

Gardnerella vaginalis Actinomyces species

Bordetella pertussis Borrelia burgdorferi

Mobiluncus species

MIC900.1 - 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)

MIC902.0 - 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

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

Lower respiratory 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 infections and duodenum caused by Helicobacter pylori

Dosage and administration

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).

In the treatment of erythema migrans, 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 H. pylori apply a dose of 20 mg / kg per day in combination with antisecretory agents and other medicines doctor's choice.

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.

Mode of application

Sumamed 125 mg tablets are taken once a day one hour before or

two hours after eating. Tablets should be swallowed whole.

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

Increase in aspartate aminotransferase, increase in alanine

aminotransferase, increased bilirubin in the blood, increased urea in

blood, increased blood creatinine, abnormal blood potassium, increased blood alkaline phosphatase, increased chloride, increased glucose, increased platelets, decreased hematocrit, increased bicarbonate, abnormal sodium

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 dosage forms immediate release or sustained release:

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

Children under 18 years of age (due to the presence of dye indigotine lacquer (E132)

Drug 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 (P-gp substrates): Co-administration of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates such as digoxin results in increased serum levels of P-glycoprotein substrates. Therefore, when used simultaneously

azithromycin and P-glycoprotein substrates such as digoxin, the possibility of elevated serum P-glycoprotein substrate concentrations should be considered.

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 performed 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.

Oral coumarin 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 followed by a single oral dose of 10 mg/kg ciclosporin, Cmax and AUC0-5 of ciclosporin were 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 Cmax (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 to co-administration

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 medical conditions

liver or they 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, immediately perform liver function tests/tests. With the development of liver dysfunction, stop taking azithromycin.

In patients receiving ergotamine 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 leads to increased morbidity and mortality as these infections may be resistant to antimicrobial therapy and may require 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, bradycardia, cardiac arrhythmia or severe cardiac

insufficiency.

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.

Safety and efficiency of the complex Mycobacterium Avium have not been established for prevention or treatment in children.

The duration of the drug should not exceed the time specified in the instructions.

Pregnancy and lactation

Azithromycin should be used during pregnancy and lactation only if the benefit outweighs the risk.

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

There are no data on the effect of Sumamed on the ability to drive a vehicle or potentially dangerous mechanisms.

Overdose

Sumamed is an antibacterial agent based on azithromycin, belongs to the group of macrolides, lincosamides and streptogramins. By its effect on the bacterial cell, it has a pronounced bacteriostatic effect, preventing the division of the bacterial flora. Due to the large variety of forms of release, the drug is widely used both for the treatment of adults and in pediatrics. This is an antibiotic for systemic use with strict indications for use and dosage features.

Release form and composition

500 mg film-coated tablets; 3 blisters in a box. Each tablet contains the active ingredient azithromycin dihydrate - 500 mg; excipients: disubstituted anhydrous calcium phosphate, hypromellose, corn starch, modified starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, indigotin (E 132), titanium dioxide (E 171), polysorbate 80, talc.

Powder for suspension for oral administration 100 mg / 5 ml in a 20.925 g polyethylene bottle with a dosing spoon and / or dosing syringe. 5 milliliters of suspension contain the active ingredient azithromycin dihydrate - 100 mg; excipients: sucrose, sodium phosphate, hypromellose, xanthan gum, anhydrous colloidal silicon dioxide, titanium dioxide (E 171); flavors: banana, strawberry, vanilla, cherry.

Tablets 125, 250, 500, 1000 mg dispersible; 1 blister in a cardboard box. Each tablet contains the active ingredient azithromycin dihydrate - 125, 250, 500, 1000 mg, respectively; excipients: sodium saccharin dihydrate, microcrystalline cellulose, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, aspartame (E 951); flavorings: in tablets of 125 mg - banana, in tablets of 250 mg, 500 mg, 1000 mg - orange.

Capsules 250 mg; 6 blisters in a box. Each capsule contains the active ingredient azithromycin dihydrate - 250 mg; excipients: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, gelatin, titanium dioxide (E 171), indigo (E 132), sulfur dioxide (E 220).

Lyophilisate for solution for infusion 500 mg in a vial. Each vial contains the active ingredient azithromycin citrate - 500 mg; excipients: citric acid monohydrate, sodium hydroxide.

pharmachologic effect

Pharmacodynamics

Sumamed refers to broad-spectrum antibiotics. The mechanism of action of azithromycin on a bacterial cell is chemical binding to the 50S subunit of the ribosome. This element of the ribosome combines with a small subunit and is involved in protein synthesis inside the bacterial cell. When the ribosome is blocked, elongation does not occur, thus, the bacterial cell loses the ability to divide effectively, which provides a pronounced bacteriostatic effect of Sumamed.

The spectrum of action of this drug includes the following types of bacteria, both gram-positive and gram-negative: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Clostridium perfringens, Fusobacterium spp., Prevotella s pp. , Porphyromonas spp., Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae.

Resistant to macrolides, in particular to azithromycin, are some strains of Streptococcus pneumoniae, group A β-hemolytic streptococcus, Enterococcus faecalis and Staphylococcus aureus and MRSA (methicillin-resistant streptococcus). When bacteria are resistant to an antibacterial agent, it is recommended to reconsider the need to take a macrolide, a reserve line antibiotic should be used to suppress the resistant flora.

Pharmacokinetics

When administered orally, the absorption of the drug occurs in the intestine with a relatively low bioavailability - 37%, and the maximum concentration of the drug in the blood accumulates by 3 hours after taking Sumamed. The drug has a high tropism for tissues: in clinical studies it was found that the drug accumulates in tissues and its concentration in them is 50 times higher than in the blood.

The volume of binding to albumin and blood proteins ranges from 12-52% and depends on the concentration of the drug in the blood - the higher the maximum concentration, the lower the binding coefficient.

The half-life of azithromycin and its metabolites is 2 to 4 days. Approximately 12% of the dose taken is excreted in the urine, up to 50% - unchanged in the stool. In tissues, the therapeutic content of the active substance can be stored for up to 7 days. Biological binding occurs in the liver - due to demethylation, azithromycin loses its activity.

Infusion forms of the drug Sumamed have a slightly higher bioavailability and bypass the absorption phase, entering the systemic circulation immediately. Features of their pharmacodynamics and pharmacokinetics are the same as those of dosage forms for oral administration.

Indications for use Sumamed

A bacterial infection caused by a flora of bacteria sensitive to azithromycin, as well as bacterial complications of a viral infection, are indications for the use of Sumamed.

For the treatment of pathological conditions of mild and moderate severity, tablet forms (tablets, capsules) can be used.

With a cough caused by infections of the ENT organs and lower respiratory tract - tracheitis, laryngitis, sinusitis, scarlet fever - the total dose of azithromycin for the course of treatment is 1500 mg (500 mg 1 time per day for 3 days). For infections of the skin and soft tissues, the same dose is used.

For acne vulgaris, the recommended total dose of azithromycin is 6000 mg, which should be taken as follows: 1 tablet 500 mg 1 time per day for 3 days, then 1 tablet 500 mg 1 time per week for 9 weeks to maintain an effective therapeutic dose .

With migrating erythema, the total dose of azithromycin for the course of treatment is 3000 mg, it is recommended to take it according to the following scheme: 1000 mg (2 tablets of 500 mg once) on the first day, then 1 tablet of 500 mg 1 time per day for 4 days

Sexually transmitted infections can be treated with both tablet and injectable forms of the drug. The oral dose for ureaplasma, chlamydia, mycoplasmosis, cystitis and infectious prostatitis is 1000 mg (2 tablets of 500 mg once).

Before use, you need to prepare an infusion solution. To do this, 4.8 ml of water for injection should be injected into a vial with Sumamed and shaken thoroughly until a homogeneous milky solution is formed, which is a concentrate and is not suitable for injection.

After that, it is necessary to prepare the final solution by diluting the concentrate with a solvent. To prepare a solution with an active ingredient concentration of 1 mg / ml, the contents of the vial must be diluted in 500 ml of a solvent, for example, 0.9% NaCl. To prepare a solution with an active substance concentration of 2 mg / ml, add the contents of the vial to 250 ml of the solvent. In addition to saline, a 5% glucose solution or Ringer's solution, standard solutions of crystalloids can act as a solvent. Before the introduction of the drug, it is necessary to confirm the complete dissolution of the lyophilisate. The presence of macroparticles, which should not be, is visually assessed. If they are present, the solution is not suitable for intravenous administration.

In community-acquired pneumonia, the use of Sumamed in the form of a solution for infusion at a concentration of 1 mg / ml, 500 mg intravenously 1 time per day for 2 days is indicated, further treatment is carried out after monitoring the curability, oral forms of release of 500 mg of Sumamed as a single daily dose . The total duration of the course of treatment is 7-10 days.

In inflammatory diseases of the genitourinary system with severe course, including endometritis and salpingitis: 500 mg of a 1 mg / ml solution intravenously 1 time per day, then treatment continues orally at 250 mg azithromycin 1 time per day as a single daily dose. The course of treatment is a week.

For the treatment of children over the age of 6 months and weighing less than 12.5 kg, it is recommended to use the drug Sumamed in the form of a suspension for oral use due to the best organoleptic qualities. For the treatment of children from 3 years of age and weighing up to 45 kg, it is possible to use the tablet form of the drug Sumamed at a dose of 125 mg, if the child can swallow the tablet. For the treatment of children from 12 years of age or with a body weight of more than 45 kg, an adult dosage (500 mg of active substance) can be used if there are appropriate medical indications for this. Doses for specific nosologies correspond to adult doses and are indicated above.

Elderly patients do not need dose adjustment. Sumamed should be used with caution in patients with renal insufficiency, with a glomerular filtration rate of less than 10 ml / minute, the dose of azithromycin should be recalculated or the drug should be discontinued. In patients with impaired liver function, one should make sure that Sumamed is necessary, since the metabolism of the drug occurs with the participation of liver enzymes, which in the terminal stages of insufficiency can cause dangerous complications.

Contraindications

The multicomponent composition of the drug increases the list of conditions that are contraindications for use, including:

1. Hypersensitivity or sensitization to the active substance or to any other component of the drug Sumamed, a history of anaphylactic reactions, including other drugs of the macrolide group, azalides. This can cause an immediate type of allergic reaction and lead to a terminal condition.
2. Severe liver failure. Taking Sumamed only increases the chemical load on the liver, reducing its function and worsening the general condition of the patient.
3. Renal failure. At a glomerular filtration rate of less than 40 ml/minute, the drug cannot be eliminated without harm to the renal barrier.
4. Congenital fermentopathy, phenylketonuria.
5. Age up to 3 years when taking tablet forms and up to 6 months when taking oral suspension. Use in children should be justified in terms of therapeutic effect and possible side effects on the child's body.
6. Reception simultaneously with ergotamine, dihydroergotamine.

With extreme caution, Sumamed should be prescribed to patients with moderate renal and hepatic insufficiency, cardiac disorders (rhythm, conduction disturbances, with a prolonged QT interval); it is recommended to refrain from using azithromycin in patients who are taking class IA, III antiarrhythmic drugs, antidepressants, digoxin, warfarin, cyclosporine; people with severe disorders of water and electrolyte parameters, heart failure.

Side effects

Side effects are classified depending on the affected organs and systems, as well as the frequency of occurrence based on reports of adverse reactions and reviews received in the post-marketing period as follows: very frequent (1 case out of 10), frequent (1 case out of 100); infrequent (1 in 1000), rare (1 in 10,000), very rare (less than 1 in 10,000), unknown (no exact frequency data available):

1. From the blood and lymphatic system: infrequently - inhibition of bone marrow activity, leukopenia, neutropenia, eosinophilia; unknown - thrombocytopenia, hemolysis and hemolytic anemia.
2. Metabolic changes: infrequently - acceleration of general metabolism, weight loss, anorexia.
3. Infections and invasions: infrequently - oral, vaginal and systemic candidiasis, fungal infection associated with other pathogens, bacterial infection: bacterial rhinitis, pharyngitis, gastroenteritis, impaired respiratory function; unknown - pseudomembranous colitis.
4. On the part of the psyche: infrequently - sleep disturbances, rarely - agitation; unknown - anxiety, restlessness, aggressiveness towards others, delirium, hallucinations.
5. From the nervous system: often - headache; infrequently - drowsiness, paresthesia, dizziness; unknown - hypesthesia, loss of consciousness, convulsions or contractures, increased psychomotor activity, myasthenia gravis.
6. From the senses: infrequently - a decrease in the function of the visual and olfactory analyzers, vertigo; unknown - tinnitus, deafness.
7. From the immune system: infrequently - urticaria, angioedema, allergic laryngospasm; unknown - anaphylactic reaction.
8. From the side of the cardiovascular system: infrequently - discomfort in the region of the heart, palpitation, swims; unknown - prolongation of the QT interval, ventricular arrhythmia, ventricular fibrillation, tachycardia, arterial hypotension.
9. From the respiratory system: infrequently - shortness of breath, dyspnea, epistaxis.
10. From the skin and subcutaneous tissue: infrequently - urticaria, dermatitis, dryness and peeling of the skin, itching, swelling, hyperhidrosis; rarely - photosensitivity; unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme.
11. From the hepatobiliary system: rarely - liver failure, cholestasis and associated jaundice; unknown - hepatitis.
12. From the genitourinary system: infrequently - pain in the projection of the kidneys, dysuric manifestations, uterine bleeding, hormonal disorders; unknown - acute renal failure, interstitial nephritis.
13. Changes in laboratory parameters: often - a decrease in the level of lymphocytes, blood bicarbonate, an increase in the level of eosinophils, basophils, monocytes, neutrophils; infrequently - an increase in the levels of ALT, AST, bilirubin, urea, alkaline phosphatase, glucose, chlorides in the blood, a decrease in hematocrit, changes in the level of electrolytes - calcium, sodium, potassium.
14. General disorders: infrequently - swelling, weakness, drowsiness, fever, pain.
15. Poisoning is rare.

Overdose

If the permissible therapeutic dosages of azithromycin are exceeded, the risk of developing adverse reactions increases significantly. Clinical experience with Sumamed over many years, as well as the reported side effects base, indicate that overdose of this medicinal product may develop effects characteristic of its side effects. These include nausea, vomiting, weakness, swelling, pain, changes in laboratory parameters, dizziness, drowsiness, reversible hearing loss.

If an overdose is suspected, moderate hydration of the body should be prescribed, sorbents should be taken to reduce the absorption of that part of the drug that has not yet been absorbed. Depending on the symptoms that occur during an overdose in a particular patient, symptomatic therapy should be prescribed and the general condition of the patient should be maintained.

There is no specific antidote for azithromycin overdose.

Interaction

The complex mechanisms of the biological transformation of azithromycin and excipients of the drug in the body lead to interaction features at the stages of pharmacodynamics and pharmacokinetics. It is worth considering this and prescribing the drug with caution to patients taking any other groups of drugs that can interact with the components of Sumamed.

Simultaneous administration of Sumamed with paracetamol can be highly effective in combating inflammatory diseases of bacterial origin, as well as in relieving pain accompanied by some nosologies. But a moderate effect on the blood system, an immunosuppressive effect and a load on the liver enzyme systems in some patients can cause complications, so these two drugs should be prescribed with caution.

ACC (acetylcysteine) is a mucolytic, which is indicated for diseases of the respiratory system. Its simultaneous use with Sumamed is possible if the interval between taking ACC and antibiotic is more than 2 hours.

The simultaneous use of antiviral drugs, such as Kagocel, together with Sumamed is possible. This is justified in the case of a combined bacterial and viral infection or bacterial complications of SARS. Most often, these drugs are prescribed for severe forms of pharyngitis, bronchitis, tonsillitis. The duration of the course should be calculated individually, but these drugs are compatible.

Sumamed and Theraflu can be administered simultaneously, because the main active ingredient of Theraflu is paracetamol, which is used to relieve the symptoms of inflammation, hyperthermia, and Sumamed at this time acts etiotropically and destroys bacterial cells, which lead to this inflammation. It is necessary to combine these drugs with caution in patients with impaired liver function.

Ibuklin also contains paracetamol, but it also contains ibuprofen. This indicates an even higher efficacy of this drug, but in combination with azithromycin it should be used with caution. The hepatotoxic effect and inhibition of the protective inflammatory response make this combination of drugs more of a reserve than a first line in the treatment of bacterial infection.

Sumamed does not have a significant effect on the metabolism and pharmacological action of glucocorticoids and preparations based on them. Thus, the use of azithromycin together with Polydex is possible if there are strict medical indications for this. It is possible to develop side effects in case of individual intolerance to one or more components of these drugs.

Sumamed and Ceftriaxone can be successfully used for the treatment of pneumonia in the form of injections. At the stage of pharmacodynamics and pharmacokinetics, these drugs do not interact, but by their antibacterial effect they affect different types and strains of bacteria. Therefore, their use may provide protection against the formation of resistant strains, but due to the extensive list of side effects of each of the drugs, they should be prescribed only under the supervision of a physician.

Trichopol contains metronidazole, which is well combined with azithromycin to achieve a complex therapeutic effect - relief of symptoms of inflammation and elimination of its main cause, that is, a bacterial pathogen.

Sumamed's analogs

Similar drugs differ not only in composition and price, but also in indications for use, so they are not always interchangeable in terms of treating a specific nosology.

Which is better: Sumamed or Azithromycin?

The active substance of Sumamed is precisely azithromycin, so these drugs are complete analogues. But they differ in the forms of release, which Sumamed has much more, which means that the range of application of this drug is wider. Sumamed can be prescribed to children in the form of a suspension, which cannot be done with the relatively cheaper Azithromycin. Despite the same active substance, the auxiliary components provide Sumamed with better absorption and the best therapeutic effect.

Which is better: Sumamed or Amoxiclav?

Amoxiclav belongs to the group of protected penicillins in combination with clavulanic acid. The active substance - amoxicillin - affects the transpeptidase in the bacterial cell and disrupts the synthesis of peptidoglycan, thereby causing the lysis of the bacterium. Clavulanic acid protects amoxicillin from bacterial enzymes that can break it down. Amoxiclav is a broad-spectrum antibiotic that fights most microorganisms. But the advantages of Sumamed are the low resistance of strains to it (resistance to amoxicillin is much higher), as well as the duration of stay in the systemic circulation, which lasts up to 7 days after the end of the course and maintains a bacteriostatic effect.

Which is better: Sumamed or Suprax?

The active substance of Suprax is cefixime, which belongs to the group of III generation cephalosporins. The pronounced bactericidal effect of the drug and the lack of resistance to it by many of the main pathogens make it a first-line drug for diseases of the ENT organs, respiratory tract or genitourinary system. However, this drug has a large number of side effects, so its long-term use is not recommended, only a short course lasting 10-14 days.

Which is better: Sumamed or Flemoxin?

Amoxicillin-based Flemoxin is used to treat bacterial infections of the respiratory and genitourinary systems, but bacterial resistance makes itself felt. A convenient form of release - soluble tablets - allows the patient to easily cope with the dosing of the drug. However, Sumamed acts on a larger number of species and its effectiveness is much higher. Just like any other amoxicillin preparations, Flemoxin should not be used during lactation, because this can cause sensitization to the components of the drug in a child.

Which is better: Sumamed or Augmentin?

Augmentin also contains amoxicillin and clavulanic acid, which together have an antibacterial effect. This drug is suitable for the outpatient treatment of pathological conditions with a mild course, and in a hospital setting, Sumamed is a more effective remedy. The form of Augmentin tablets is convenient for dosing, so the patient can easily take it according to the scheme.

Which is better: Sumamed or Klacid?

Klacid is based on the substance clarithromycin, which belongs to the same class of antibacterial agents as azithromycin, which is part of Sumamed. It also binds to the 50S subunit of the ribosome and provides a bacteriostatic effect. The spectrum of action of clarithromycin corresponds to that of azithromycin, but the minimum active dose of clarithromycin is on average two times lower, which means its low toxicity. Most microorganisms are not resistant to the action of clarithromycin. The drug differs from Sumamed in pharmacodynamics, therefore, it requires special control.

Which is better: Sumamed or Hemomycin?

These two drugs have the same active ingredient - azithromycin. Therefore, their effect and spectrum of sensitive microorganisms are the same. However, Sumamed has more forms of release and the possibility of precise dose regulation, this drug is also absorbed better, food intake does not affect its pharmacokinetics so much, unlike Hemomycin. Sumamed is preserved and acts longer, therefore, if a long course of treatment is necessary, it is the drug of choice.

Which is better: Sumamed or Amoxicillin?

Amoxicillin has an even wider range of pathogens that can be affected by it than azithromycin. But there is a very important factor that makes Sumamed many times more effective - this is the resistance of bacteria, which has developed over the years of using antibacterial agents, often from their improper use. Therefore, amoxicillin in its pure form is not effective for the treatment of a bacterial infection, unlike Sumamed.

Which is better: Sumamed or Azitrox?

The method of application, doses, indications and contraindications, the spectrum of sensitive species and strains of microorganisms of these two drugs are completely similar, since the active substance here is azithromycin in the same dosages.

Which is better: Sumamed or Vilprafen?

Vilprafen is developed on the basis of josamycin, which belongs to the group of macrolides. It has excellent efficiency and a wide spectrum of action, it is used to treat the pathology of the respiratory, genitourinary systems, tonsillitis, skin infections, as a reserve drug for massive antibiotic therapy. Josamycin inhibits liver enzymes much more strongly, in particular P450, the main enzyme for the biotransformation of drugs. Hence the large number of side effects that Vilprafen "pays" for its effectiveness. Sumamed is more balanced in this regard.

Which is better: Sumamed or Zinnat?

Cefuroxime-based Zinnat has the same variety of release forms as Sumamed, which allows it to be used quite widely. It disrupts cell wall synthesis even in bacteria that are resistant to penicillins. The drug differs from Sumamed in the speed of all stages of distribution in the body: the concentration reaches its maximum value already in 3 hours, and half of the drug is excreted in a period of up to 12 hours. Zinnat also compares favorably with Sumamed by the possibility of using it for the treatment of pathologies of the musculoskeletal system, such as osteomyelitis.

Which is better: Sumamed or Ceftriaxone?

Ceftriaxone belongs to the III generation cephalosporins and is one of the most common antibiotics. It is good for low bacterial resistance to it (which, however, has greatly increased in recent years), ease of dosage and a small number of side effects. But it cannot be used in the practice of a pediatrician to treat children, unlike Sumamed.

Which is better: Sumamed or Macropen?

Macropen is developed on the basis of midecamycin, which also belongs to the group of macrolides, but has some important differences. It is effective against almost every existing type of pathogenic microorganisms, but is completely contraindicated for use during pregnancy or lactation. Also, Macropen, with prolonged use, can cause changes in the biochemical parameters of the liver, which should be monitored throughout the course of treatment. This suggests its potential hepatotoxicity. However, its high efficacy and the absence of resistant strains justify its use when indicated.

Which is better: Sumamed or Tavanik?

Tavanic contains levofloxacin, therefore, it can be prescribed for the treatment of pathologies that were provoked by strains sensitive to it. It is used in the treatment of infections of the urinary system (pyelonephritis), chronic bacterial prostatitis, skin infections. The drug should be used quickly, immediately after unpacking. Tavanic is also contraindicated under 18 years of age, during pregnancy and lactation. At this time, Sumamed can be used to treat the same diseases, albeit with less efficiency.

Which is better: Sumamed or Azitral?

The method of application, doses, indications and contraindications, the spectrum of sensitive species and strains of microorganisms of these two drugs is completely similar, since the active substance here is azithromycin in the same dosages.

Sumamed for children

Up to 6 months, the use of drugs based on azithromycin for the treatment of a bacterial infection is contraindicated, up to 3 years, tablet forms of the drug are contraindicated. The benefits of using Sumamed in children should exceed the potential risks of development adverse reactions from this drug.

For the treatment of children over the age of 6 months and weighing less than 12.5 kg, it is recommended to use the drug Sumamed in the form of a suspension for oral use due to the best organoleptic qualities. For the treatment of children from 3 years of age and weighing up to 45 kg, it is possible to use the tablet form of the drug Sumamed at a dose of 125 mg.

For the treatment of children from 12 years of age or with a body weight of more than 45 kg, an adult dosage of 500 mg of the active substance can be used if there are appropriate medical indications for this.

Sumamed and alcohol

It is not recommended to take the antibiotic Sumamed simultaneously with alcohol due to a multiple increase in the toxicity of the drug in relation to the liver. Biotransformation and elimination of Sumamed metabolites occurs mostly with the help of liver enzymes. Ethanol intake competitively inhibits these enzymes, in particular cytochrome P450 with subfamilies, which leads to the accumulation of toxic products of alcohol metabolism, acetaldehyde, in the systemic circulation. This leads to an increased chance of adverse reactions, toxic hepatitis. The toxic effect persists regardless of the dose of alcohol.

The interaction of these substances at the pharmacodynamic level can lead to the development of a teturam-like effect after taking Sumamed - inhibition of liver enzymes leads to the accumulation of ethanol aldehyde, which adversely affects organs and systems, in particular the central nervous system. As a result, dizziness, nausea, vomiting, abdominal pain, tremors may develop.

Sumamed during pregnancy and lactation

In isolated studies, no teratogenic effect of Sumamed on the fetus was determined. The drug penetrates the hematoplacental barrier, so use during pregnancy, regardless of the timing, is not recommended. It is possible to prescribe a drug only when the potential therapeutic effect is higher than the risk of developing problems with the fetus, or it is necessary to stabilize the somatic condition of the mother.

There is evidence that azithromycin and some of its metabolites penetrate into breast milk and are found in it throughout the course of treatment and for a long time after its completion. However, there are no exact reports on the toxic effect of azithromycin on the child's body, as well as the pharmacokinetic properties of the penetration of the active substance into breast milk.

In the experiment, after the introduction of azithromycin into the body of laboratory rats, they observed a pronounced decrease in fertility. This may indicate a violation of fertility in women while taking Sumamed.

Terms of sale

In pharmacies, Sumamed is dispensed by prescription.

Storage conditions

Keep out of the reach of children at a temperature not exceeding +25°C. Avoid direct sunlight.

Best before date

The drug is usable for 2 years. Do not use after the expiration date!

Manufacturer

Pliva Hrvatska d.o.o. Barun Filipović 25, 10000, Zagreb, (Croatia)

Bibliography:

1. Anatomical Therapeutic Chemical Classification (ATX);
2. Nosological classification (ICD-10);
3. Official instructions from the manufacturer.

The instructions for use of Sumamed indicate in detail the dosages depending on age, type of disease, form of release. The antibacterial agent is well tolerated, has a low percentage of side effects. The high concentration of the active substance and the peculiarity of its excretion from the tissues make it possible to use the antibiotic for a short time, with the achievement of the necessary therapeutic result.

The active pharmaceutical substance (API) is azithromycin.

In medical practice, it is used in the form of tablets, capsules, suspensions, powder for injection.

The tablet dose contains 125 mg, 500 mg of API. Appearance: blue round or oblong, white inside, imprinted with the name of the pharmaceutical company. Packing in blisters of 6 pieces, for a lower concentration, 3 pieces for a larger one.

Capsule version: dosage form of blue-blue gelatin with yellow, white powder. The blister contains 6 pieces containing azithromycin 250 mg.

A bottle with a capacity of 50 milliliters contains a crushed substance to obtain a suspension. The concentration of the active substance is 100 mg. Sumamed Forte is a powder for the preparation of a suspension containing 200 mg / 5 milliliters. Together with the vial, a measuring spoon or syringe is required.

Injection form: vial with 500 milligrams of lyophilized powder. Packing - a cardboard box for 5 bottles.

Pharmacological action of the drug

APS Sumamed is an azalide, one of the varieties of macrolides, antibacterial agents of the latest generation.

The drugs of this group do not cause severe side effects from:

• brain and spinal cord;
• hematopoietic function;
• joints and muscles;

The difference between azalides and other macrolides is the presence of a nitrogen atom in the molecule, which affected:

• resistance to enzymes of the digestive system;
• increased antimicrobial action;
• increase in insight.

Thanks to these properties, Sumamed is an effective, low-toxic antibacterial agent.

Pharmacokinetics and pharmacodynamics of the drug

The drug has good absorption, penetrates into the cells. Delivery of the drug to the site of infection is provided by phagocytic cells, which creates a concentration that is detrimental to pathogenic microorganisms. The time to create a bactericidal focus is from 12 to 72 hours.

The drug is excreted mainly with bile within 4-5 days. A long period of preservation of therapeutic properties makes it possible to use the medicine once every 24 hours for 3 days.

The mechanism of action is to limit the synthesis of protein molecules, which leads to the death of pathogens.

Microorganisms susceptible to the active pharmaceutical substance:

Indications for the use of the drug

Sumamed is prescribed for bacterial infection of the respiratory tract, hearing organs, skin, genitourinary system.

Purpose of the drug:

• acute tonsillitis;
• throat inflammation;
• mucous membranes of the nose;
• middle ear;
• bronchi (acute and chronic form);
• lungs;
• urethra;
• cervix;
• erysipelas;
• pustular skin lesions;
• infected dermatoses;
• acne.

The medicine is used to treat the effects of a tick bite (Lyme disease).

Instructions for use

The dosage of Sumamed depends on the form of release, the age of the patient, the type of disease. In order to avoid overdose in children, the dosage rate is calculated from the weight.

Sumamed tablets and capsules

Time of taking the tablet: in the interval between meals (an hour before, two after).

Therapeutic amount and course duration for persons after 12 years (from 12 to 14, weighing at least 45 kilograms):

• Nasal, oropharyngeal, inner ear, lower respiratory tract infections, skin infections: 500 milligrams/24 hours three times.
• Inflammation of the hair follicles and sebaceous glands on the face (moderate): 500 milligrams / 24 hours for 72 hours; continuation of the course of treatment - 9 times 500 milligrams / week.

• For the first symptoms of Lyme disease: 1,000 milligrams first dose/24 hours; subsequent 4 doses - 500 milligrams / day.
• Chlamydial lesions of the urethra, cervix without complications - a single dose of 1000 milligrams; complicated form - 1000 milligrams in 3 days, 7 times.
• Diseases of the stomach and duodenum caused by Helicobacter pylori: as part of complex therapy, 1000 milligrams / day, for 3 days.

Therapeutic amount of antibiotic for children 3-12 years old (if the body weight does not exceed 45 kilograms):

1. Angina, inflammation of the nasal passages, bronchi, lungs, otitis media, erysipelas: once, at the rate of 10 milligrams / kilogram, 3 times, after 24 hours.
2. Infection of the pharynx, palatine tonsils with pyogenic streptococcus: 1 time / 24 hours, 20 milligrams per kilogram of body weight for 3 days.
3. Lyme disease: on the first day, 20 milligrams/kilogram/day; in the next 4 days - 10 milligrams / kilogram / day.

Capsules have indications and dosage similar to the tablet form.

Orally dispersible tablets are pre-dissolved in ¼ cup of liquid.

injection form

Intravenous jet, intramuscular administration of the drug is contraindicated.

Infusions are prescribed for community-acquired pneumonia, endometritis, salpingitis, occurring in severe form due to the characteristics of pathogens: chlamydia, mycoplasma, staphylococci, legionella.

Preparation of the injection occurs in 2 stages:

1. Obtaining an active solution: 4.8 ml of water for injection is poured into a vial with 500 milligrams of API. The resulting mixture is shaken, mixing well. In the presence of visually determined undissolved particles, the solution is not used. 1 milliliter contains 100 milligrams of azithromycin. The solution is not stored. It is used immediately to obtain the required concentration.
2. Method for obtaining an injection solution:

• to obtain ratios of 1 milligram/milliliter use 500 milliliters of solvent;
• for a concentration of 2 milligrams / milliliter - 250 milliliters.

As a diluent use:

• saline sodium chloride 0.9%;
• glucose 5%;
• Ringer's saline.

The resulting injection is kept for 24 hours at a temperature of 25 degrees, 7 days - up to 5 degrees.

Therapy for community-acquired pneumonia: 500 milligrams in the first 2 days (maximum 5), then for 5-7 days daily 500 milligrams in the form of tablets.

Infectious and inflammatory process in the uterus, fallopian tubes: once - 500 milligrams for 2-5 days; continuation of the course of treatment - 5-7 days, 250 milligrams of azithromycin orally.

Sumamed suspensions for children

How to prepare medicinal syrup:

• the powder in the vial is diluted with 12 milliliters of distilled / boiled water;
• the mixture is thoroughly stirred;
• the finished medicine can be used within 5 days.

The children's version of Sumamed is intended for children from six months to three years of age. At a dose of less than 5 milliliters, a syringe is used, in other cases, a measuring spoon.

Use in elderly patients

For elderly patients, the dose is not adjusted. Appointment with caution in the presence of a rapid heart rate: ventricular tachycardia of the "pirouette" type may occur.

Features of the use of the drug during pregnancy and lactation

Appointment during childbearing is carried out under the condition that the benefit of the drug exceeds the risk to the life of the fetus. When a child receives breast milk, the drug is not prescribed.

Specifics of use for violations of the liver and kidneys

Overdose

Exceeding the recommended dose is accompanied by a violation in the digestive system. There is nausea, turning into vomiting, loose stools. The auditory function is weakened. Measures for relief of symptoms: gastric lavage, intake of sorbents.

Side effect

Side effects are classified according to the reported cases.

Very often or in more than 10% of patients treated with Sumamed, frequent defecation is observed.

Recurrence of side effects is often possible in 1-10% of all patients:

• headache;
• nausea;
• vomit;
• stomach ache;
• pain at the injection site.

Uncommon or in less than 1% of patients:

• fungal infection of the oral cavity, vagina;
• a decrease in the blood level of leukocytes, neutrophilic granulocytes, an increase in the number of eosinophils;
• loss of appetite, nausea, vomiting;
• allergic puffiness;
• dizziness;
• taste change;
• violations of skin sensitivity in the form of goosebumps, burning;

• drowsiness or insomnia;
• decreased visual acuity;
• hearing;
• tachycardia;
• the appearance of shortness of breath during physical exertion;
• nosebleeds;
• disturbances in the work of the alimentary tract;
• medicinal hepatitis;
• changes in the skin;
• pain in the back, neck, muscles, joints;
• decrease in the amount of urine, pain in the kidney area;
• uterine bleeding in the intermenstrual period;
• weight loss;
• fast fatiguability;
• swelling of the limbs;
• chest pain.

The effect on the digestive system is expressed in the difficulty of digesting food, which causes bloating, belching, inflammation of the mucous membrane of the stomach, oral cavity (up to the appearance of sores in the mouth), constipation.

Skin manifestations can be in the form of dryness or sweating, itching, rash, urticaria, development of dermatitis.

Rare disorders are considered to be the frequency of not more than 0.1% of side effects, which manifested themselves as:

• liver damage;
• yellowness of the skin;
• increased skin reaction to ultraviolet radiation.

More rare manifestations do not have statistical data.

Contraindications for use

Sumamed is not prescribed for the following indications:

• hypersensitivity to azithromycin, excipients;
• functional disorders of the liver, kidneys in a severe stage;
• allergies to drugs from ergot;
• narrowing of the arteries.

For children it is contraindicated:

• Sumamed in any form - up to six months;
• up to 3 years - tablets of any concentration;
• up to 12 years, with a weight of up to 45 kilograms - a tablet-capsule form containing 500 milligrams;
• up to 18 years - intravenously.

When appointing Sumamed, the following are taken into account:

• mild and moderate degree of functional disorder of the liver and kidneys;
• heart rate less than 60 beats per minute;
• rapid heartbeat, which is reflected on the electrocardiogram in the form of a "pirouette";
• therapy with antidepressants, fluoroquinolones, antiarrhythmic drugs;
• simultaneous reception of Cyclosporine, Digoxin.

The use of the injection is contraindicated in diabetes mellitus (glucose solvent), arterial hypertension (sodium chloride solvent).

special instructions

Stop taking the drug and consult a doctor if side effects take a form that threatens the health of the patient, for example:

1. Rapid weight loss, yellowness of the skin, dark urine, nosebleeds - a combination of symptoms indicates abnormalities in the liver.
2. Persistent or recurrent abdominal pain, flatulence, diarrhea, weakness may be due to pseudomembranous colitis caused by Clostridium difficile.

It is necessary to observe the intervals between taking the drug. When skipping up to 12 hours, Sumamed is taken in the usual way. A time interval over 12 hours means a transfer to the next day.

Children are prescribed capsules and suspension.

During therapy with azithromycin, driving a vehicle, driving dangerous machinery should be avoided due to possible violations of the nervous regulation, organs of vision and hearing.

The therapeutic doses of Sumamed should not be exceeded.

drug interaction

The dosage form is not compatible with the simultaneous use of heparin.

Reduce the therapeutic activity of azithromycin:

• preparations containing magnesium, aluminum;
• alcohol;
• food intake (for capsule form and suspension);
• lincomycins (bactericidal antibiotics).

Enhance the effectiveness of Sumamed: Tetracycline, Chloramphenicol.

Interaction with alcohol

Alcohol is contraindicated while taking Sumamed.

Reasons for incompatibility:

• the bactericidal effect is reduced due to the effect on arithromycin in the digestive tract;
• the liver and kidneys receive an additional toxic load;
• inflammatory symptoms intensify.

Ethanol slows down the absorption of the drug, thereby reducing the therapeutic dose. Alcohol has a negative effect on liver cells and nephrons. The intake of ethanol causes the expansion of blood vessels, a rush of blood, which contributes to the activation of bacteria.

Terms and conditions of storage

The temperature regime for the preservation of medicinal properties is not higher than 25, not lower than 15 degrees.

Shelf life:

• tablets - 36 months;
• capsules - 36 months;
• powder for suspension - 24 months;
• powder for injection - 24 months;
• ready solution - 5 days.

Keep away from children.

Terms of dispensing from pharmacies and the cost of the drug

Price for the drug (rubles):

• Sumamed 500 - 500/550 for 3 pieces;
• Sumamed 125 - 350/470 for 6 pieces;
• capsules - 500/560 for 6 pieces;
• suspension - 250 per bottle.

The drug is dispensed by medical prescription.

Drug analogues

Analogues of Sumamed are medicines that are identical in active substance, mechanism of action, therapeutic indications.

The drug is a complete analogue of Sumamed. Available in the form of tablets and capsules. The content of the active substance is 500 and 250 milligrams.

Suprax

The active substance, cefixime, belongs to the cephalosporin group of antibiotics. bactericidal properties. Similar in mechanism of action to Sumamed. Release form: granules for suspension preparation, tablets, including instant ones. Side effects and contraindications are similar to those of azithromycin.

Augmentin

Combined drug, which includes two active ingredients: amoxicillin and clavulanic acid. It is used for intravenous and intramuscular administration. Indications for therapy - diseases of the respiratory tract, genitourinary system, skin.

Zee Factor

The active substance is azithromycin. Release form: tablets of 500 milligrams of the active substance, capsules of 250 milligrams.

Excipients:

Shell composition:

6 pcs. - blisters (1) - packs of cardboard.

Capsules hard gelatin, No. 1, with a blue body and a blue cap; the contents of the capsules are a powder or compacted mass from white to light yellow in color, disintegrating when pressed.

Excipients: anhydrous calcium hydrogen phosphate, hypromellose, corn starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Shell composition: hypromellose, dye indigo carmine (E132), titanium dioxide (E171), polysorbate 80, talc.

3 pcs. - blisters (1) - packs of cardboard.

Powder for suspension for oral administration granular, white or light yellow in color, with a characteristic strawberry odor; prepared aqueous suspension of white or light yellow color, homogeneous, with a characteristic smell of strawberries.

Excipients: sucrose, anhydrous sodium carbonate, sodium benzoate, tragacanth, titanium dioxide, glycine, colloidal silicon dioxide, strawberry flavor, apple flavor, peppermint flavor.

17 g - dark glass bottles with a volume of 50 ml (1) complete with a double-sided measuring spoon (for 2.5 and 5 ml) and / or dosing syringe (for 5 ml) - packs of cardboard.

Clinical and pharmacological group

Macrolide antibiotic - azalide

pharmachologic effect

Bacteriostatic broad-spectrum antibiotic from the group of azalide macrolides. 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.

Microorganisms may initially be resistant to the action of an antibiotic or may acquire resistance to it.

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

Microorganisms	MIC (mg/l)
sensitive	sustainable
Staphylococcus spp.	≤1	>2
Streptococcus A, B, C, G	≤0.25	>0.5
S. pneumoniae	≤0.25	>0.5
H. influenzae	≤0.12	>4
M. catarrhalis	≤0.5	>0.5
N. gonorrhoeae	≤0.25	>0.5

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

microorganisms, able to develop resistance to azithromycin: gram-positive aerobes- Streptococcus pneumoniae (penicillin-resistant strains).

Initially sustainable microorganisms: Gram-positive aerobes Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant strains of staphylococcus show a very high degree of resistance to macrolides), Gram-positive bacteria resistant to erythromycin; anaerobes- Bacteroides fragilis.

Pharmacokinetics

Suction

After oral administration, azithromycin is well absorbed and rapidly distributed in the body. After a single dose of 500 mg, bioavailability is 37% due to the first pass effect through the liver. C max in blood plasma is reached after 2-3 hours and is 0.4 mg / l.

Distribution

Protein binding is inversely proportional to plasma concentration and is 7-50%. The apparent V d is 31.1 l/kg. Penetrates through cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes 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 10-50 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

T 1/2 long - 35-50 hours. T 1/2 of the tissues is much larger. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is excreted mainly unchanged - 50% through the intestines, 6% by the kidneys.

Indications for the use of the drug

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, pneumonia, incl. caused by atypical pathogens);

- diseases of the stomach and duodenum associated with Helicobacter pylori (for powder);

- infections of the skin and soft tissues (acne of moderate severity, erysipelas, impetigo, secondarily infected dermatoses);

- the initial stage of Lyme disease (borreliosis) - migrating erythema (erythema migrans);

- urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Dosing regimen

The drug is administered orally 1 time / day, at least 1 hour before or 2 hours after a meal. Tablets are taken without chewing.

Adults (including the elderly) and children over 12 years of age weighing more than 45 kg the drug is prescribed in the form of tablets and capsules.

Children aged 6 months and older the drug should be prescribed in the form of a suspension for oral administration, children aged 3 years and older the drug can also be prescribed in the form of tablets of 125 mg. The drug in the form of tablets of 125 mg is dosed taking into account the body weight of the child, as shown in the table.

At infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues (with the exception of chronic erythema migrans) adults and children over 12 years of age weighing more than 45 kg the drug is prescribed at a dose of 500 mg 1 time / day for 3 days, the course dose is 1.5 g. Children aged 6 months and older appoint at the rate of 10 mg / kg of body weight 1 time / day for 3 days, the course dose is 30 mg / kg.

At diseases of the stomach and duodenum associated with Helicobacter pylori the drug is prescribed in the form of a powder at a dose of 1 g / day for 3 days in combination with antisecretory agents and other drugs.

At erythema migrans the drug is prescribed 1 time / day for 5 days. Adults and children over 12 years of age weighing more than 45 kg are prescribed on the 1st day - 1 g, then from 2 to 5 days - 500 mg each; course dose - 3 g. Children aged 6 months and older appoint on the 1st day at a dose of 20 mg / kg of body weight and then from 2 to 5 days - daily at a dose of 10 mg / kg of body weight, course dose - 60 mg / kg.

At moderate acne to the urs dose is 6.0 g. Adults and children over 12 years of age weighing more than 45 kg Assign a dose of 500 mg 1 time / day for 3 days, then 500 mg 1 time per week for 9 weeks. The first weekly dose should be taken 7 days after the first daily dose (day 8 from the start of treatment), the next 8 weekly doses should be taken at intervals of 7 days.

At sexually transmitted infections, for treatment uncomplicated urethritis/cervicitis, caused by Chlamydia trachomatis, the drug is prescribed in a dose of 1 g once; for treatment complicated long-term urethritis/cervicitis caused by Chlamydia trachomatis, appoint 1 g 3 times with an interval of 7 days (days 1, 7, 14), course dose - 3 g.

For patients with moderate renal impairment (CC> 40 ml / min) dose adjustment is not required.

Rules for the preparation and administration of the suspension

In a vial containing 17 g of powder, add 12 ml of distilled or boiled water. The volume of the resulting suspension is 23 ml. The shelf life of the prepared suspension is 5 days. 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 tea in order to rinse and swallow the remaining amount of the suspension in the mouth.

After use, the syringe is disassembled and washed with running water, dried and stored in a dry place with the drug.

Side effect

Determining the frequency of adverse reactions: often (> 1/100 and< 1/10), иногда (>1/1000 and< 1/100), редко (>1/10 000 and< 1/1000), очень редко (< 1/10 000).

From the hematopoietic system: rarely - thrombocytopenia, neutropenia, eosinophilia.

From the side of the central nervous system and peripheral nervous system: sometimes - dizziness / vertigo, headache, drowsiness, convulsions; rarely - paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

From the sense organs: rarely - tinnitus, reversible hearing loss up to deafness (when taken in high doses for a long time), impaired perception of taste and smell.

From the side of the cardiovascular system: rarely - palpitations, arrhythmias, including ventricular tachycardia, an increase in the QT interval, bidirectional ventricular tachycardia.

From the digestive system: often - nausea, vomiting, diarrhea, abdominal pain and cramps; sometimes - diarrhea, flatulence, indigestion, anorexia; rarely - constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in the values ​​of laboratory parameters of liver function; very rarely - abnormal liver function and liver necrosis (possibly fatal).

Allergic reactions: sometimes - itching, skin rashes; rarely - angioedema, urticaria, photosensitivity, anaphylactic reaction (in rare cases fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the musculoskeletal system: sometimes - arthralgia.

From the urinary system: rarely - interstitial nephritis, acute renal failure.

Others: rarely - vaginitis, candidiasis.

Contraindications to the use of the drug

- severe violations of the liver and kidneys;

- lactation period (breastfeeding);

- simultaneous reception with ergotamine and dihydroergotamine;

- hypersensitivity to macrolide antibiotics;

- children's age up to 12 years and body weight less than 45 kg (for capsules and tablets 500 mg);

- children's age up to 3 years (for tablets 125 mg).

WITH caution drug should be prescribed with moderate impairment of liver and kidney function, patients with impaired or predisposed to arrhythmias and prolongation of the QT interval, together with terfenadine, warfarin, digoxin.

The use of the drug during pregnancy and lactation

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

If necessary, the use of the drug during lactation, breastfeeding should be discontinued.

Application for violations of liver function

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

Application for violations of kidney function

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

special instructions

In case of missing one dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

As well as during any antibiotic therapy, in the treatment with azithromycin, superinfection (including fungal) may be added.

In the treatment of pharyngitis / tonsillitis caused by Streptococcus pyogenes, as well as for the prevention of acute rheumatic fever, penicillin is usually the drug of choice. Azithromycin is also active against streptococcal infection in these cases, but is ineffective in preventing the development of acute rheumatic fever.

The patient should be warned about the need to inform the doctor about the occurrence of any side effect.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: symptomatic therapy.

drug interaction

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

With simultaneous use, azithromycin does not affect the concentration of carbamazepine, didanosine, rifabutin and methylprednisolone in the blood.

When administered parenterally, azithromycin does not affect the plasma concentrations of cimetidine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole in case of combination therapy, however, the possibility of such an interaction should not be excluded when prescribing the drug Sumamed ® inside.

Azithromycin does not affect the pharmacokinetics of theophylline, however, when co-administered with other macrolides, theophylline plasma concentration may increase.

If necessary, joint use with cyclosporine, it is recommended to control the content of cyclosporine in the blood. Despite the fact that there are no data on the effect of azithromycin on changes in the concentration of cyclosporine in the blood, other members of the macrolide class are able to change its concentration in blood plasma.

When taking digoxin and azithromycin together, it is necessary to control the concentration of digoxin in the blood, because. many macrolides increase the absorption of digoxin from the intestine, thereby increasing its concentration in blood plasma.

If co-administration with warfarin is necessary, careful monitoring of prothrombin time is recommended.

It was found that the simultaneous use of terfenadine and antibiotics of the macrolide class causes arrhythmia and prolongation of the QT interval. Based on this, it is impossible to exclude the development of these complications when taking terfenadine and azithromycin together.

Since there is a possibility of azithromycin inhibition in the parenteral form of the CYP3A4 isoenzyme when co-administered with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs, the metabolism of which occurs with the participation of this isoenzyme, the possibility of such an interaction should be considered when prescribing azithromycin for taking inside.

When azithromycin and zidovudine are taken together, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or the excretion by the kidneys of it and its glucuronide metabolite. However, the concentration of the active metabolite, phosphorylated zidovudine, increases in mononuclear cells of peripheral vessels. The clinical significance of this fact is not clear.

With the simultaneous administration of macrolides with ergotamine and dihydroergotamine, their toxic effects may occur.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

List B. The drug should be stored out of the reach of children at a temperature of 15 ° to 25 ° C. Shelf life of the drug in the form of capsules and coated tablets - 3 years, powder for suspension for oral administration - 2 years, prepared suspension - 5 days.

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Sumamed can be called one of the most effective and popular antibiotics, which is a preparation of the macrolide group. Adults often take it for otitis media, sinusitis, bronchitis and some other infectious diseases. Is such antibacterial drug children, in what forms it is used in childhood, how long do you need to drink such a remedy and what analogue is it permissible to replace?

Release form

Sumamed is a product of the Israeli company Teva, but is produced in Croatia. It is presented in pharmacies in a large assortment of dosage forms. There are such types of drugs:

• A powder from which a suspension is made before starting treatment. Such Sumamed is placed in plastic white bottles that can hold 50 ml of liquid. The powder itself has a yellowish tint and the smell of strawberries. A measuring syringe is attached to the bottle, and sometimes a measuring spoon.
• Dispersible tablets. They are sold depending on the dosage from 1 to 6 pieces in one pack. They have an almost white color and a flat round shape. On one side of the medication, you can see the inscription "TEVA" and a number indicating the content of the active substance. Such a medicine can be both swallowed and dissolved in water to obtain an orange-flavoured suspension.

• Coated tablets. This form of the drug is sold in packs of 3 or 6 pieces and is represented by round and oval convex blue tablets. Depending on the dosage, on one of their sides there is a mark 125 or 500. On the other side of the tablets there is an inscription "PLIVA".
• Capsules. This type of Sumamed is sold in boxes of 6 hard gelatin capsules. They have a blue body and a blue cap, and inside is a white-yellow powder.
• Lyophilisate. This medicine is a white powder placed in transparent glass vials. It is sold in 5 bottles per pack and is not used in childhood.

Sumamed Forte is produced separately, which is presented only as a powder for suspension preparation. It has a white-yellow hue and a banana, raspberry or strawberry flavor. It is placed in white plastic bottles with a capacity of 50 or 100 ml.

Compound

The action of any form of Sumamed provides azithromycin dihydrate. Its dosage in different versions of the drug is different:

• The finished suspension of Sumamed contains such a substance in an amount of 20 mg per 1 ml (100 mg per 5 ml).
• The amount of azithromycin in Sumamed Forte suspensions is 40 mg per 1 ml (200 mg per 5 ml).
• One dispersible tablet may contain the active ingredient at a dose of 125, 250, 500 or 1000 mg.
• In one coated tablet, this substance is contained in an amount of 125 or 500 mg.
• One capsule contains 250 mg of azithromycin.

The composition of excipients in different forms of Sumamed is also different:

• Hyprolose, sucrose, titanium and silicon dioxide, xanthan gum and sodium phosphate are added to the suspension (both in regular Sumamed and in Forte). Depending on the taste of the finished product, it also has a strawberry, raspberry or banana flavor.
• In order for the dispersible tablet to hold its shape but be able to quickly dissolve in water, the active substance in its composition is supplemented with microcrystalline cellulose, povidone k30, silicon dioxide, sodium lauryl sulfate, crospovidone and magnesium stearate. For a sweet taste, aspartame, sodium saccharinate and banana or orange flavor are added to the preparation.
• The core of the coated tablets consists of starch, magnesium stearate, calcium hydrogen phosphate, MCC, hypromellose and sodium lauryl sulfate. For the manufacture of a dense shell of this form of Sumamed, talc, hypromellose, polysorbate 80, titanium dioxide and a dye are used.
• The contents of the capsules, in addition to azithromycin, include magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate, and their shell is made of gelatin with the addition of dyes.

Operating principle

Sumamed has the ability to act on various microorganisms by suppressing the synthesis of protein molecules in their cells. Having penetrated into the bacteria, azithromycin attaches to their ribosomes and interferes with the work of special enzymes that are important for the formation of proteins. The result of this influence will be a slowdown in the reproduction and growth of microbes, that is, the effect of the drug is bacteriostatic. However, in high dosages, the drug can also destroy pathogens (act bactericidal).

The drug is effective against many types of bacteria, including pneumococcus, legionella, pyogenic streptococcus, moraxella, Haemophilus influenzae, clostridium, staphylococcus, chlamydia, borrelia, gonococcus and other microorganisms. However, some staphylococci and streptococci may be resistant to Sumamed. The drug does not work on bacteroids and enterococci.

Indications

The medication is prescribed for infectious diseases that provoke pathogens included in the spectrum of action of azithromycin. The medicine is given:

• with sinusitis, tonsillitis, inflammation of the middle ear and other lesions of the upper respiratory tract, including bacterial complications after SARS;
• with pneumonia, inflammation of the bronchi and other diseases of the respiratory tract, the symptoms of which are heat and cough with purulent sputum;
• with bacterial infections of soft tissues and skin;
• at initial stage borreliosis;
• with inflammation of the urinary tract caused by chlamydia.

At what age are they prescribed?

All types of Sumamed are prohibited for children of the first 6 months of life. Infants older than six months of age are allowed to give only the drug in suspension. At the same time, Sumamed suspension is prescribed to patients under three years of age, since for older children its volume will be too large. As for the Forte drug, it can also be given from the age of 6 months, but only to those children whose weight has exceeded 10 kg. This medication is prescribed for preschoolers, children aged 6-9 years, and adolescents, and even adult patients.

Solid forms of Sumamed are not used in the treatment of babies under 3 years of age. For children older than three years, the medicine is selected taking into account the required dose and the child's ability to swallow the medicine. Children 3-4 years old are more often given dissolving tablets with a dosage of 125 and 250 mg. For the treatment of children aged 5-11 years, dispersible tablets are also in demand, but if the child is able to easily swallow the medicine in the shell, this form can also be given at a dosage of 125 mg.

Capsules and tablets containing 500 mg of azithromycin are prescribed for patients over 12 years of age, but can also be used in younger children if their weight exceeds 45 kg.

Contraindications

Treatment with Sumamed is prohibited:

• if the child has intolerance to its main component or any of the excipients;
• if the patient has previously been diagnosed with an allergy to other macrolides;
• if the patient's liver function is impaired due to severe diseases of this organ;
• if the child has severe kidney disease.

The suspension is also not used in children with fructose intolerance and other disorders of sugar absorption. Dispersible tablets should not be taken with phenylketonuria, because they contain aspartame. Cautious administration of the drug is required for patients with dehydration, diabetes, heart rhythm disturbances, myasthenia gravis and some other pathologies.

Side effects

The body of young patients sometimes reacts to Sumamed with diarrhea, nausea or headaches. In addition, the use of the drug often affects the blood, reducing the number of some cells and increasing the number of others. In more rare cases, the drug provokes back pain, allergies in the form of a rash, shortness of breath, fever, fatigue, swelling, increased sweating and other symptoms.

If they appeared after one or more doses of Sumamed, you should tell your doctor about this in order to change the treatment.

Instructions for use

How to take the suspension?

To prepare a liquid medicine, use a measuring syringe. With its help, they collect the right amount of water (it is noted in the instructions for the powder), pour it into the bottle, close it with a cork and shake vigorously. Since the active substance settles to the bottom of the vial over time, the medication must be shaken again before each use.

The suspension is taken once a day at a dosage that the doctor should calculate, taking into account the weight of the child and his disease. The medicine is taken either after a meal (after about 2 hours), or one hour before any meal. The interval for applying the suspension should be 24 hours.

If the next dose is missed, it is advised to drink it immediately when it is discovered, and then give the drug at intervals of 24 hours.

You can give medicine to a child directly from a dosing syringe, drawing up the suspension to the desired mark. Also in some packages there is a measuring spoon that allows you to collect 2.5 and 5 ml of medication. It is not recommended to dilute the finished suspension with water. If such a medicine is too sweet for a child, it is better to let him swallow the medicine first, and then offer some clean water to drink the medicine down. The syringe and spoon after taking the medication must be washed and dried.

The dose of the drug per day for a particular child must be calculated separately. If a small patient infection ENT organs, skin or respiratory tract, then for every kilogram of its weight you need 10 mg of the active ingredient. In this amount, the medication is taken for 3 days. For example, a baby's body weight is 12 kg, then he is prescribed 120 mg of azithromycin per day, which corresponds to 6 ml of suspension per dose and 18 ml of medication for the entire course of therapy. Such a child can also be given Sumamed Forte - its single dose, taking into account the doubled amount of azithromycin, will be only 3 ml.

If pyogenic streptococcus has become the cause of the disease, the medication is also prescribed for a 3-day course, but a single / daily dose will be 20 mg / kg. With borreliosis, Sumamed is used for 5 days, while on the first day the child must take the medicine at the rate of 20 mg / kg, and the remaining period of treatment daily dose calculated by multiplying the patient's weight by 10 mg.

How are solid forms prescribed?

Dissolving tablets can be swallowed and washed down with water, or one tablet can be dissolved in 50 ml of water and given to the child to drink such a liquid medicine. Coated tablets and capsules should be swallowed without biting with clean water.

Any of these variants of Sumamed is taken once a day, and a single dose and duration of treatment depend on the diagnosis, the age of the child and his weight. In most cases, the drug is prescribed at the rate of 10 mg of azithromycin per 1 kg of the patient's weight and is used at this dose for 3 days in a row:

• If the child's weight is between 18 and 30 kg, he is given at one time 2 dispersible tablets of 125 mg or 1 dispersible tablet of 250 mg. Also, such a patient can be given 2 tablets in a 125 mg shell, if he is able to swallow them without chewing.
• If the child weighs 30-45 kg, then he needs 375 mg of azithromycin per dose, which corresponds to three 125 mg dissolvable tablets or 1.5 250 mg tablets (they can be divided by risk). In addition, a patient with this body weight can take three 125 mg coated tablets at once. Usually, in patients 7-8 years old and older, there are no problems with swallowing such Sumamed.
• If the child weighs more than 45 kg or he is already 12 years old, then 500 mg of azithromycin is considered a single dose of the drug, that is, he can be given 2 Sumamed capsules at once, one 500 mg coated tablet or one 500 mg dispersible tablet. If forms with a lower content of azithromycin are used, then they are drunk in larger quantities in order to obtain the desired dose, for example, if 125 mg coated tablets are bought, the teenager must swallow 4 of them at once.

When infected with pyogenic streptococcus, chlamydia or borrelia, the dose and duration of treatment will be different. The maximum dosage of Sumamed per day for children under 12 years old is 500 mg.

Overdose

An excess amount of suspension or a higher dose of tablets causes vomiting, temporary hearing loss, severe nausea, diarrhea and other negative symptoms. If an overdose is detected, it is recommended to consult a doctor and give the child symptomatic drugs that he will prescribe.

Interaction with other drugs

Treatment with Sumamed can affect the intake of some other medicines, which are indicated in the instructions for the selected form of the drug.

Before you start taking an antibiotic, you should clarify whether there are any funds that the child is already receiving in such a list.

Terms of sale

All forms of Sumamed, as well as others antibacterial agents are bought by prescription. To purchase them, you must first show the child to the doctor and get a prescription from him for the right medication. The price of the drug is affected by its form and dosage. A bottle of suspension costs about 200 rubles, and for a bottle of raspberry or strawberry Forte powder, you need to pay about 550 rubles.

The average price of 6 125 mg coated tablets is 300-330 rubles, a pack of 125 mg dispersible tablets is 400 rubles, and six capsules is about 460 rubles.

Storage conditions

Sumamed in any form can be stored at room temperature, including the prepared suspension. The drug must be kept out of the reach of children. The shelf life of sealed powder bottles and dispersible tablets is 2 years, while coated tablets and capsules are 3 years. After preparation, Sumamed suspension and Forte banana suspension can be stored for only 5 days, and Forte with raspberry or strawberry flavor can be stored for up to 10 days.