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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

INN: Azithromycin

Manufacturer: Pliva Hrvatska d.o.o.

Anatomical-therapeutic-chemical classification: Azithromycin

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 013198

Registration period: 22.05.2018 - 22.05.2023

KNF (drug is included in the Kazakhstan National Formulary of Medicines)

ALO (Included in the Free Outpatient Drug Supply List)

ED (Included in the List of drugs in the framework of the guaranteed volume of medical care, subject to purchase from a single distributor)

Limit purchase price in the Republic of Kazakhstan: 396.03 KZT

Instruction

Tradename

Sumamed®

International non-proprietary name

Azithromycin

Dosage form

Film-coated tablets, 500 mg

Compound

One tablet contains

active substance - azithromycin dihydrate, 500 mg

Excipients: calcium hydrogen phosphate anhydrous, hypromellose 15 mPa s, corn starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate

shell composition: hypromellose 15mPa s, titanium dioxide (E171), indigo carmine (E 132), polysorbate 80, talc, purified water.

Description

Light blue film-coated tablets, oblong, biconvex, marked "PLIVA" on one side and "500" and "500" on the other side.

Pharmacotherapeutic group

Antimicrobials for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Azithromycin.

ATX code J01FA10

Pharmacological properties

Pharmacokinetics

Azithromycin is rapidly absorbed when taken orally, due to its stability in an 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

Azithromycin is a broad-spectrum antibiotic, the first representative of a new subgroup of macrolide antibiotics - azalides. It has a bacteriostatic effect, but when high concentrations are created in the focus of inflammation, it causes a bactericidal effect. By binding the 50S ribosomal subunit, azithromycin inhibits protein synthesis in susceptible 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

Pharyngitis/tonsillitis, sinusitis, otitis media

Bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis

Chronic erythema migrans - the initial stage of Lyme disease, erysipelas, impetigo, secondary pyodermatoses

Diseases of the stomach and duodenum associated with Helicobacter pylori

Gonorrheal and non-gonorrheal urethritis and/or cervicitis

Dosage and administration

Sumamed® tablets 500 mg are taken once a day 1 hour before meals or 2 hours after meals.

For infections of the upper and lower respiratory tract, infections of the skin and soft tissues, 500 mg / day are prescribed for 3 days (course dose - 1.5 g).

With uncomplicated urethritis and / or cervicitis, a single dose of 1 g (2 tablets of 500 mg) is prescribed.

In Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g (2 tablets of 500 mg) is prescribed on the first day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g).

In diseases of the stomach and duodenum associated with Helicobacter pylori, Sumamed® is prescribed 1 g (2 tablets of 500 mg) per day for 3 days as part of combination therapy.

For the treatment of acne vulgaris, the following scheme is used:

500 mg daily as a single dose for 3 days, then 500 mg once a week for 9 weeks, with the dose of the second week to be taken 7 days after taking the first tablet. The next 8 doses are taken 7 days apart. The total dose is 6 g.

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.

In the elderly and in patients with impaired renal function, there is no need to change the dosage.

Side effects

Often (> 1/100, < 1/10)

Nausea, vomiting, diarrhea, abdominal pain

Not often(>1/1000,< 1/100)

Loose stools, flatulence, indigestion, loss of appetite

Rare(> 1/1000, < 1/100)

Headache, dizziness, drowsiness, convulsions, dysgeusia

Thromocytopenia

Aggression, agitation, restlessness, nervousness, insomnia

Paresthesia and asthenia

Hearing loss, deafness and tinnitus

Tachycardia, arrhythmia with ventricular tachycardia, prolongation of the QT interval

Tongue discoloration, constipation, pseudomembranous colitis

Transient rise in the level of liver aminotransferases, bilirubin,

cholestatic jaundice, hepatitis

Hypersensitivity reactions (redness, skin rash, itching, urticaria,

angioedema, photosensitivity), erythema multiforme,

Steven-Johnson syndrome and toxic epidermal necrolysis,

Arthralgia

Very rare (> 1/10000, < 1/1000)

Interstitial nephritis, acute renal failure

Fatigue, convulsions

Change in taste and smell

Arthralgia

Vaginitis, candidiasis, superinfections

Anaphylactic shock including edema (rarely resulting in death)

Contraindications

Known hypersensitivity to macrolide antibiotics

Severe liver and kidney dysfunction

Children's age up to 18 years (due to the presence of dye indigo carmine E 132)

First trimester of pregnancy and lactation

Drug Interactions

Antacids significantly reduce the absorption of Sumamed®, so the drug should be taken one hour before or two hours after taking these drugs. Macrolide antibiotics interact with cyclosporine, astemizole, triazolam, midazolam or alfentanil. Careful monitoring is recommended while taking these drugs.

Azithromycin does not affect cytochrome P-450 and therefore does not interact with theophylline, terfenadine, carbamazepine, methylprednisolone, didanosine and cimetidine.

With the simultaneous use of azithromycin and anticoagulants of indirect action, bleeding is possible. Therefore, it is necessary to control prothrombin time.

With a combination of azithromycin and digoxin, an increase in the concentration of digoxin in the blood is possible, so it is necessary to control the level of digoxin in the blood and adjust its dose.

Zidovudine: Azithromycin increases the concentration of the active phosphorylated metabolite of zidovudine in the blood. However, the clinical significance of this pharmacokinetic interaction is currently unclear.

Rifabutin: the combined use of azithromycin and rifabutin did not change their plasma concentration. However, neutropenia was observed, the cause-effect relationship between the development of an adverse reaction and the use of this combination has not been established.

special instructions

The following side effects have been reported with macrolide antibiotics: ventricular arrhythmia, including ventricular tachycardia and flutter-fibrillation (ventricular), in patients with a prolonged QT interval.

Extremely rarely, during treatment with azithromycin, there may be flutter-flicker (ventricular) and subsequent myocardial infarction in individuals with a history of arrhythmia.

Prolonged cardiac repolarization and intervalQT, which increased the risk of developing cardiac arrhythmia and flutter / ventricular fibrillation, were observed in the treatment of other macrolide antibiotics. A similar effect of azithromycin cannot be completely excluded in patients at increased risk for prolonged cardiac repolarization.

Pregnancy

The use of the drug in the second and third trimesters of pregnancy is possible when the expected benefit outweighs the potential risk to the fetus.

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

During treatment with the drug, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities.

Overdose

There are no data on overdose with Sumamed. Overdose of macrolide antibiotics is manifested by reversible hearing loss, severe nausea, vomiting and diarrhea.

Treatment: it is necessary to induce vomiting and immediately carry out symptomatic therapy.

Release form and packaging

INN: Azithromycin

Manufacturer: Pliva Hrvatska d.o.o.

Anatomical-therapeutic-chemical classification: Azithromycin

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 013198

Registration period: 22.05.2018 - 22.05.2023

KNF (drug is included in the Kazakhstan National Formulary of Medicines)

ALO (Included in the Free Outpatient Drug Supply List)

ED (Included in the List of drugs in the framework of the guaranteed volume of medical care, subject to purchase from a single distributor)

Limit purchase price in the Republic of Kazakhstan: 396.03 KZT

Instruction

Tradename

Sumamed®

International non-proprietary name

Azithromycin

Dosage form

Film-coated tablets, 500 mg

Compound

One tablet contains

active substance - azithromycin dihydrate, 500 mg

Excipients: calcium hydrogen phosphate anhydrous, hypromellose 15 mPa s, corn starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate

shell composition: hypromellose 15mPa s, titanium dioxide (E171), indigo carmine (E 132), polysorbate 80, talc, purified water.

Description

Light blue film-coated tablets, oblong, biconvex, marked "PLIVA" on one side and "500" and "500" on the other side.

Pharmacotherapeutic group

Antimicrobials for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Azithromycin.

ATX code J01FA10

Pharmacological properties

Pharmacokinetics

Pharmacodynamics

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

Pharyngitis/tonsillitis, sinusitis, otitis media

Bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis

Chronic erythema migrans - the initial stage of Lyme disease, erysipelas, impetigo, secondary pyodermatoses

Diseases of the stomach and duodenum associated with Helicobacter pylori

Gonorrheal and non-gonorrheal urethritis and/or cervicitis

Dosage and administration

Sumamed® tablets 500 mg are taken once a day 1 hour before meals or 2 hours after meals.

For infections of the upper and lower respiratory tract, infections of the skin and soft tissues, 500 mg / day are prescribed for 3 days (course dose - 1.5 g).

With uncomplicated urethritis and / or cervicitis, a single dose of 1 g (2 tablets of 500 mg) is prescribed.

In diseases of the stomach and duodenum associated with Helicobacter pylori, Sumamed® is prescribed 1 g (2 tablets of 500 mg) per day for 3 days as part of combination therapy.

For the treatment of acne vulgaris, the following scheme is used:

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.

In the elderly and in patients with impaired renal function, there is no need to change the dosage.

Side effects

Often (> 1/100, < 1/10)

Nausea, vomiting, diarrhea, abdominal pain

Not often(>1/1000,< 1/100)

Loose stools, flatulence, indigestion, loss of appetite

Rare(> 1/1000, < 1/100)

Headache, dizziness, drowsiness, convulsions, dysgeusia

Thromocytopenia

Aggression, agitation, restlessness, nervousness, insomnia

Paresthesia and asthenia

Hearing loss, deafness and tinnitus

Tachycardia, arrhythmia with ventricular tachycardia, prolongation of the QT interval

Tongue discoloration, constipation, pseudomembranous colitis

Transient rise in the level of liver aminotransferases, bilirubin,

cholestatic jaundice, hepatitis

Hypersensitivity reactions (redness, skin rash, itching, urticaria,

angioedema, photosensitivity), erythema multiforme,

Steven-Johnson syndrome and toxic epidermal necrolysis,

Arthralgia

Very rare (> 1/10000, < 1/1000)

Interstitial nephritis, acute renal failure

Fatigue, convulsions

Change in taste and smell

Arthralgia

Vaginitis, candidiasis, superinfections

Anaphylactic shock including edema (rarely resulting in death)

Contraindications

Known hypersensitivity to macrolide antibiotics

Severe liver and kidney dysfunction

Children's age up to 18 years (due to the presence of dye indigo carmine E 132)

First trimester of pregnancy and lactation

Drug Interactions

Azithromycin does not affect cytochrome P-450 and therefore does not interact with theophylline, terfenadine, carbamazepine, methylprednisolone, didanosine and cimetidine.

With the simultaneous use of azithromycin and anticoagulants of indirect action, bleeding is possible. Therefore, it is necessary to control prothrombin time.

special instructions

Extremely rarely, during treatment with azithromycin, there may be flutter-flicker (ventricular) and subsequent myocardial infarction in individuals with a history of arrhythmia.

Pregnancy

The use of the drug in the second and third trimesters of pregnancy is possible when the expected benefit outweighs the potential risk to the fetus.

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

During treatment with the drug, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities.

Overdose

There are no data on overdose with Sumamed. Overdose of macrolide antibiotics is manifested by reversible hearing loss, severe nausea, vomiting and diarrhea.

Treatment: it is necessary to induce vomiting and immediately carry out symptomatic therapy.

Release form and packaging

The page contains instructions for use Sumameda. It is available in various dosage forms of the drug (forte, tablets 125 mg and 500 mg, capsules 250 mg, suspension, injections in ampoules for injection), and also has a number of analogues. This annotation has been verified by experts. Leave your feedback about the use of Sumamed, which will help other site visitors. The drug is used for various diseases (tonsillitis, bronchitis, pneumonia and other infections). The tool has a number of side effects and features of interaction with other substances. Doses of the drug differ for adults and children. There are restrictions on the use of the drug during pregnancy and during breastfeeding. Treatment with Sumamed can only be prescribed by a qualified doctor. The duration of therapy may vary and depends on the specific disease.

Instructions for use and dosage

The drug is administered orally 1 time per 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 old weighing more than 45 kg are prescribed the drug in the form of tablets and capsules.

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

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

In 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 per day for 3 days in combination with antisecretory agents and other drugs.

With migrating erythema, the drug is prescribed 1 time per 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 are prescribed 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.

For moderate acne, the course dose is 6.0 g. Adults and children over 12 years old weighing more than 45 kg are prescribed at a dose of 500 mg 1 time per 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.

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

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

How to dilute and take 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.

Sumamed forte (as a suspension)

Inside, 1 time per day, at least 1 hour before or 2 hours after a meal.

For infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic erythema migrans) - a total dose of 30 mg / kg, i.e. 10 mg/kg once a day for three days.

In chronic migrating erythema, the total dose of the drug is 60 mg / kg: on the 1st day - once 20 mg / kg; on the following days (from the 2nd to the 5th) - 10 mg / kg.

In diseases of the stomach and duodenum associated with Helicobacter pylori: 20 mg / kg once a day in combination with an antisecretory agent and other drugs as recommended by a physician.

In the event that a dose of the drug was missed, it should, if possible, be taken immediately, and then subsequent doses - with an interval of 24 hours.

For sexually transmitted infections

Uncomplicated urethritis / cervicitis - 1 g, once.

Suspension preparation method

To prepare 15 ml of suspension (nominal volume), add 8 ml of water to a vial containing 800 mg of azithromycin (actual volume is 20 ml of suspension).

To prepare 30 ml of suspension (nominal volume), it is necessary to add 14.5 ml of water to a vial containing 1400 mg of azithromycin (actual volume is 35 ml of suspension).

To prepare 37.5 ml of suspension (nominal volume), it is necessary to add 16.5 ml of water to a vial containing 1700 mg of azithromycin (actual volume is 42.5 ml of suspension).

Each vial should contain a suspension of 5 ml more than the course dose for a more complete extraction of the drug from the vial.

The shelf life of the prepared suspension is 5 days, at a temperature not exceeding 25 ° C.

Using a dosing syringe, measure the required amount of water, add to the vial with the powder. Before use, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained.

For dosing the finished suspension, use a syringe or measuring spoon.

Immediately after taking the suspension, the child is allowed to drink a few sips of tea or juice in order to wash off 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 with the drug.

Release form

Film-coated tablets 125mg and 500mg.

Capsules 250 mg.

Lyophilisate for solution for infusion (injections in ampoules for injection) 500 mg.

Powder for suspension for oral administration 100 mg/5 ml.

Sumamed- a bacteriostatic broad-spectrum antibiotic from the group of azalide macrolides. The mechanism of action of azithromycin (the active substance of the drug Sumamed) is associated with the suppression of protein synthesis of the microbial cell. 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.

In most cases, Sumamed is active against aerobic gram-positive and gram-negative bacteria, anaerobic bacteria, other microorganisms: Chlamydia trachomatis (chlamydia), Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae (mycoplasma), Mycoplasma hominis, Borrelia burgdorferi.

Pharmacokinetics

After oral administration, Sumamed is well absorbed and rapidly distributed in the body. 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. Demethylated in the liver, losing activity. 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

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);
infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those 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) - migratory erythema (erythema migrans);
urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Contraindications

severe violations of the liver and kidneys;
lactation period (breastfeeding);
simultaneous reception with ergotamine and dihydroergotamine;
hypersensitivity to macrolide antibiotics;
children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg);
children's age up to 3 years (for tablets 125 mg).

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.

A negative effect of the joint intake of Sumamed and alcohol (hepatotoxic effect) was noted.

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.

Side effect

thrombocytopenia, neutropenia, eosinophilia;
dizziness;
headache;
drowsiness;
convulsions;
insomnia;
hyperactivity, aggressiveness, anxiety, nervousness;
noise in ears;
reversible hearing loss up to deafness (when taken in high doses for a long time);
impaired perception of taste and smell;
heartbeat;
arrhythmia, including ventricular tachycardia;
nausea, vomiting;
diarrhea, constipation;
abdominal pain and spasms;
flatulence;
anorexia;
hepatitis;
itching, skin rashes;
angioedema;
hives;
anaphylactic reaction (in rare cases fatal);
joint pain;
vaginitis;
candidiasis.

drug interaction

Antacids do not affect the bioavailability of azithromycin, but reduce Cmax 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, Sumamed does not affect plasma concentrations of cimetidine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole in combination therapy, but the possibility of such an interaction should not be ruled out when prescribing Sumamed orally.

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 Sumamed 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.

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.

Analogues of the drug Sumamed

Structural analogues for the active substance:

Azivok;
Azimicin;
Azitral;
Azitrox;
Azithromycin;
Azithromycin Forte;
Azithromycin dihydrate;
AzitRus;
AzitRus forte;
Azicide;
Vero Azithromycin;
Zetamax retard;
Zitnob;
Zitrolide;
Zitrolide forte;
Zitrocin;
Sumazid;
Sumaclid;
Sumamed forte;
sumamecin;
sumamecin forte;
Sumamox;
Sumatrolide solutab;
Tremak Sanovel;
Hemomycin;
Ecomed.

Use in children

Contraindicated in children under 12 years of age and weighing less than 45 kg (for 500 mg capsules and tablets) and under 3 years of age (for 125 mg tablets).

Use during pregnancy and lactation

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

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

Release form

Compound

Active ingredient: azithromycin Excipients: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Base volume: Capsule Active ingredient concentration (mg): 250 mg.

Pharmacological effect

Bacteriostatic antibiotic of the macrolide-azalide group. has a wide spectrum of antimicrobial activity. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of microbial cells. binding to the 50s subunit of the ribosome, it inhibits the peptide translocase at the translation stage and inhibits protein synthesis, slowing down the growth and reproduction of bacteria. in high concentrations, it has a bactericidal effect. It has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms. Microorganisms may initially be resistant to the action of an antibiotic or may acquire resistance to it. Microorganism sensitivity scale to azithromycin (mic, mg / l) microorganisms mic (mg/l)susceptible resistantstaphylococcus ≤1 >2streptococcus a, b, c, g ≤0.25 >0.5streptococcus pneumonia ≤0.25 >0.5haemophilus influenzae ≤0.12 >4moraxella catarrhalis ≤0.5 >0.5neisseria gonorrhoeae ≤0.25 >0.5in most cases the drug sumamed is 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 capable of developing resistance to azithromycin: gram-positive aerobes - streptococcus pneumoniae (penicillin-resistant strains). initially resistant microorganisms: gram-positive aerobes - enterococcus faecalis , staphylococci (methicillin-resistant strains of staphylococcus show a very high degree of resistance to macrolides); gram-positive bacteria resistant to erythromycin; anaerobes - bacteroides fragilis.

Pharmacokinetics

After oral administration, azithromycin is well absorbed and rapidly distributed in the body. After a single dose of 500 mg, the bioavailability is 37% due to the first pass effect through the liver. Cmax in 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 Vd 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 Demethylates in the liver, losing activity. Elimination T1 / 2 is very long - 35-50 hours .T1 / 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

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); - infections of the lower respiratory tract (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 (moderate acne, 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).

Contraindications

Severe violations of the liver and kidneys; - lactation period (breastfeeding); - simultaneous administration with ergotamine and dihydroergotamine; - hypersensitivity to antibiotics of the macrolide group; - children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg ); - children under 3 years of age (for tablets 125 mg). With caution, the drug should be prescribed for 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.

Precautionary measures

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Use during pregnancy and lactation

During pregnancy and during breastfeeding, the use of the drug is possible only if the expected potential benefit of therapy for the mother outweighs the potential risk to the fetus and child. If necessary, the use of the drug during lactation, breastfeeding should be suspended.

Dosage and administration

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 with a body weight of more than 45 kg are prescribed in the form of tablets and capsules. 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. Body weight Amount of azithromycin (in tablets 125 mg) 18-30 kg 2 tablets (250 mg) 31-44 kg 3 tablets (375 mg) ≥ 45 kg prescribe doses recommended for adults In infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues (with the exception of chronic migratory erythema), adults and children over 12 years old weighing more than 45 kg, the drug is prescribed at a dose of 500 mg 1 time / day daily for 3 days, course dose - 1.5 g. Children aged 6 months and older are prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days, course dose - 30 mg / kg. In diseases of the stomach and duodenum intestines 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. With 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 are prescribed 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. For moderate acne, the course dose is 6.0 g. Adults and children over 12 years old weighing more than 45 kg Assign at 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), subsequent 8 weekly doses should be taken 7 days apart. Chlamydia trachomatis, the drug is prescribed at a dose of 1 g once; for the treatment of complicated long-term urethritis / cervicitis caused by Chlamydia trachomatis, 1 g is prescribed 3 times with an interval of 7 days (days 1, 7, 14), the course dose is 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 Into 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 wash off and swallow the remaining amount of the suspension in the oral cavity. After use, the syringe is disassembled and washed with running water, dried and stored in a dry place with the drug.

Side effects

Determining the frequency of adverse reactions: often (> 1/100 and 1/1000 and 1/10 000 and

Overdose

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: symptomatic therapy.

Interaction with other drugs

AntacidsAntacids do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so Sumamed should be taken at least 1 hour before or 2 hours after taking these drugs and meals. Cetirizine Simultaneous use for 5 days in healthy volunteers azithromycin with cetirizine (20 mg) did not lead to pharmacokinetic interaction and a significant change in the QT interval. Didanosine (dideoxyinosine) indicators of didanosine compared with the placebo group. Digoxin (P-glycoprotein substrates) Simultaneous use of macrolide antibiotics, incl. azithromycin, with substrates of P-glycoprotein, such as digoxin, leads to an increase in the concentration of substrate P-glycoprotein in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum. Zidovudine renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear. Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It has not been revealed that azithromycin is involved in a pharmacokinetic interaction similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of isoenzymes of the cytochrome P450 system. Ergot alkaloids Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended. atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter plasma concentrations of atorvastatin (based on MMC-CoA reductase inhibition assay). However, in the post-registration period, there have been isolated reports of cases of rhabdomyolysis in patients receiving both azithromycin and statins. Carbamazepine In pharmacokinetic studies involving healthy volunteers, there was no significant effect on the concentration of carbamazepine and its active metabolite in plasma in patients who received azithromycin concomitantly. Cimetidine cimetidine 2 hours before azithromycin. Indirect anticoagulants (coumarin derivatives) In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of warfarin when taken in a single dose of 15 mg by healthy volunteers. Potentiation of the anticoagulant effect has been reported after the simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time when using azithromycin in patients receiving oral anticoagulants of indirect action (coumarin derivatives) should be taken into account. Cyclosporine In a pharmacokinetic study involving healthy volunteers who took orally for 3 days azithromycin (500 mg / day once), and then cyclosporine (10 mg / kg / day once), there was a significant increase in Cmax in blood plasma and AUC0-5 of cyclosporine. Caution should be exercised when these drugs are used concomitantly. If necessary, the simultaneous use of these drugs, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly. Efavirenz significant pharmacokinetic interaction. Fluconazole Simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1 / 2 of azithromycin did not change with the simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance. Indinavir The simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir ( 800 mg 3 times / day for 5 days). Methylprednisolone Azithromycin does not significantly affect the pharmacokinetics of methylprednisolone. Nelfinavir Simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in Css of azithromycin in plasma. No clinically significant side effects were observed and dose adjustment of azithromycin with its simultaneous use with nelfinavir is not required. Rifabutin Simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in the blood plasma. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Despite the fact that neutropenia was associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established. Cmax of sildenafil or its main circulating metabolite. Terfenadine In pharmacokinetic studies, there was no evidence of an interaction between azithromycin and terfenadine. Isolated cases have been reported where the possibility of such an interaction could not be completely ruled out, but there was no concrete evidence that such an interaction took place. It was found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval. Theophylline No interaction between azithromycin and theophylline was detected. Triazolam / midazolam trimethoprim/sulfamethoxazole with azithromycin showed no significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.

special instructions

In case of missing one dose of the drug, the missed dose should be taken as soon as possible, and subsequent ones should be taken at intervals of 24 hours. Sumamed should be taken at least 1 hour before or 2 hours after taking antacids. use with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe liver failure. If there are symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, dark urine, bleeding tendency, hepatic encephalopathy, Sumamed therapy should be discontinued and a study of the functional state of the liver should be performed. In case of impaired renal function in patients with GFR 10-80 ml / min dose adjustment is not required, therapy with Sumamed should be carried out with caution under the control of the state of kidney function. fungal. The drug Sumamed should not be used for longer courses than indicated in the instructions, because. The pharmacokinetic properties of azithromycin make it possible to recommend a short and simple dosing regimen. There is no evidence of a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism while using macrolides with ergotamine and dihydroergotamine derivatives, this combination is not recommended. With prolonged use of Sumamed, it is possible the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis. With the development of antibiotic-associated diarrhea while taking the drug Sumamed, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit intestinal motility. When treating with macrolides, incl. azithromycin, there was an increase in cardiac repolarization and the QT interval, which increase the risk of developing cardiac arrhythmias, incl. pirouette-type arrhythmias. Care should be taken when using the drug Sumamed in patients with the presence of proarrhythmogenic factors (especially in elderly patients), incl. with congenital or acquired prolongation of the QT interval; in patients taking antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), in patients with impaired water - electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure. The use of the drug Sumamed can provoke the development of myasthenic syndrome or exacerbate myasthenia gravis. /5 ml). Influence on the ability to drive vehicles and control mechanisms With the development of undesirable effects on the part of the nervous system and the organ of vision, care should be taken when performing actions that require increased concentration of attention and speed of psychomotor reactions.