Sumamed: instructions for use of tablets (500\250) and suspensions (200). Sumamed: what is it prescribed for (powder), dosage, Sumamed analogues how to take a suspension

Hello friends!
It so happened that I had purulent tonsillitis twice with a difference of 4 weeks. And if in the first case I overcame the disease with the antibiotic Amoxicillin, then a month later, taking this antibacterial drug for a week did not give me a complete recovery and not all of the pustules in the long-suffering throat disappeared. This may be due to the fact that the bacteria have developed resistance to Amoxicillin or too little time has passed since the last therapy with this antibiotic. In any case, the sore throat remained untreated, and the prospect of making complications against this background did not please me, so I had to poison my body with Sumamed as prescribed by the doctor. About him and will be discussed today.
In the nearest pharmacy, I got 2 different forms of antibiotic release, tablets and capsules, because. both the first and the second were in a single copy. Each package is designed for 3 days of admission, and I was prescribed Sumamed for 5 days. I did not go to another pharmacy, I took what I had.

An object: Sumamed tablets 500mg and Sumamed capsules 250mg
Manufacturer: Pliva Hrvatska d.o.o., Israel
Active substance: Azithromycin
Price: 600 rubles
Where could I buy: pharmacy, prescription
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‎‏

- Antibiotic Amoxicillin;
- Antibiotic Suprax - very fast acting!
- Influenza shot Sovigripp;
- Pulmicort: emergency help for bronchospasm;
- Vaccine PNEUMO-23 against pneumococcal infection;

Sumamed®

International non-proprietary name

Azithromycin

Dosage form

Capsules, 250 mg

Composition

One capsule contains

active substance - azithromycin dihydrate, 250 mg,

Excipients: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate,

composition of the capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), sulfur dioxide.

Description

Size 1 hard gelatin capsules with blue body and blue cap. The contents of the capsules are crystalline powder from white to light yellow.

Pharmacotherapeutic group

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

ATX code J01FA10

Pharmacological properties

Pharmacokinetics

Azithromycin is rapidly absorbed oral intake, which is 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 the plasma concentration) and long half-life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in the low pH environment surrounding lysosomes. The ability of azithromycin to accumulate in lysosomes is especially important for the elimination of intracellular pathogens. Phagocytes deliver azithromycin to the sites of infection, where it is released during phagocytosis. But despite the high concentration in phagocytes, azithromycin does not affect their function. Therapeutic concentration remains 5-7 days after ingestion of the last dose. When taking azithromycin, a transient increase in the activity of liver enzymes is possible. Removal of half the dose from 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.

Minimum inhibitory concentration that inhibits 90% of 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 species

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

Acute and chronic bronchitis, interstitial and alveolar pneumonia

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

- h diseases of the stomach and duodenum associated with Helicobacter pylori

Gonorrheal and non-gonorrheal urethritis and/or cervicitis

Dosage and administration

Sumamed capsules 250 mg are taken once a day 1 hour before meals or 2 hours after meals.

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

With uncomplicated urethritis and / or cervicitis, a single dose of 1 g (4 capsules of 250 mg) is prescribed.

In Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g (4 capsules of 250 mg) is prescribed on the first day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g).

For diseases of the stomach and duodenum associated with Helicobacter pylori, Sumamed is prescribed 1 g (4 capsules of 250 mg) per day for 3 days as part of combination therapy.

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.

For the treatment of children, it is necessary to use children's forms of Sumamed: Sumamed 125 mg and Sumamed 100 mg / 5 ml, Sumamed Forte 200 mg / 5 ml.

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 kidney failure

Fatigue, convulsions

Change in taste and smell

Arthralgia

Vaginitis, candidiasis, superinfections

Anaphylactic shock including edema (in rare cases leading to death)

Contraindications

Known hypersensitivity to macrolide antibiotics

Severe liver and kidney dysfunction

Children's age up to 18 years (due to the presence of the dye)

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 indirect action possibly bleeding. 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 are reported side effects when taking antibiotics of the macrolide group: 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

6 capsules are placed in a blister pack of aluminum foil and PVC film. One blister pack with instructions for use medical use in the state and Russian languages ​​are placed in a cardboard pack.

Storage conditions

Store below 25°C

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer

Pliva Hrvatska d.o.o.

Arrival of barun Filippovich 25,

10 000 Zagreb, Croatia

Registration certificate holder

"Teva Pharmaceutical Enterprises Ltd, Israel

Address of the organization accepting claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Ratiopharm Kazakhstan LLP

050000 Republic of Kazakhstan

Sumamed is an antibiotic intended for a wide range of applications. The active ingredient - azalide - is a representative of a new group of macroids. Active action is manifested only when a concentrated amount of the drug is reached in the area of ​​action.

In the active phase, Sumamed inhibits the synthesis of protein formations of microbes, slows down the growth of bacteria, affects their reproduction. Medicine recommended for use in diseases caused by infections of the respiratory tract, various tonsillitis, sinusitis.

Release form and composition

The drug is produced in the following forms:

1. Tablets 125 mg - biconvex, round, blue, film-coated. There are engravings "PLIVA" and "125". The blister contains 6 tablets.
2. Tablets 500 mg - biconvex, oval, blue, film-coated. On a break, a white tablet. There are engravings "PLIVA" and "500". The blister contains 3 tablets.
3. Gelatin capsules have a blue body and a blue cap, inside the capsule is a powder or mass that has a white or light yellow color. The blister contains 6 capsules.
4. The powder from which Sumamed suspension is prepared has a white or light yellow color. It is granular, with a banana or cherry flavor. A homogeneous suspension is prepared from the powder. It is contained in 50 ml bottles, the kit includes a measuring spoon or syringe for dosing.

The composition of the preparation of all forms includes the active component of azithromycin dihydrate.

Pharmacodynamics

It has a wide spectrum of antimicrobial activity.

Active against a number of gram-positive bacteria: Streptococcus pneumoniae, S. pyogenes, S. agalactiae, S. viridans, group C, F and G streptococci, Staphylococcus aureus, S. epidermidis. It has no effect on Gram-positive bacteria resistant to erythromycin. Effective against gram-negative microorganisms: Haemophilus influenzae, H. parainfluenzae and H. ducreyi, Moraxella catarrhalis, Bordetella pertussis and B. parapertussis, Neisseria gonorrhoeae and N. meningitidis, Brucella melitensis, Helicobacter pylori, Gardnerella vaginalis.

Acts on sensitive anaerobic microbes: Clostridium spp., Peptostreptococcus spp., Peptococcus spp. In addition, it is effective against intracellular and other microorganisms, including: Legionella pneumophila, Chlamydia trachomatis and C. pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Listeria monocitogenes, Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni, Mycobacteria avium complex.

Indications for use

Indications for the use of Sumamed are infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• lower respiratory tract infections ( acute bronchitis, exacerbation chronic bronchitis, pneumonia, incl. caused by atypical pathogens);
• infections of the upper respiratory tract and ENT organs (pharyngitis / tonsillitis, sinusitis, otitis media);
• the initial stage of Lyme disease (borreliosis) - migrating erythema (erythema migrans);
• infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, acne vulgaris medium degree severity (for tablets));
• urinary tract infections (urethritis, cervicitis) caused by Chlamydia trachomatis (for tablets and capsules).

Contraindications

Refrain from appointment in the presence of such circumstances:

1. Creatinine clearance less than 40 ml / min;
2. Ergotamine, dihydroergotamine;
3. Allergies to ingredients;
4. Severe kidney pathology (Child-Pugh class 6);
5. Patients under 12 years of age weighing less than 45 kg - for tablets and capsules 500 mg; up to 3 years - for the table. 125 mg up to 6 months. - any form).

Accept, but with warnings for signs characteristic of:

1. Prolonged QT interval;
2. With the introduction of antiarrhythmic drugs (quinidines, procainamide, dofetililid, amiodarone, sotalol);
3. Myasthenic symptoms;
4. Moderate renal dysfunction and creatinine clearance greater than 40 ml / min;
5. proarrhythmic manifestations;
6. When taking cisapride, terfenadine;
7. Violated metabolic processes, hypokalemia, hypomagnesemia;
8. Clinical bradycardia, arrhythmia, severe heart failure;
9. Use of antidepressants (citalopram) antipsychotics(pimozide);
10. Taking fluoroquinolones;
11. Treatment with digoxin, warfarin, cyclosporine.

During pregnancy and breastfeeding

If the expected benefit of the drug is higher possible danger for the fetus, according to a doctor's prescription, Sumamed can be used. Breastfeeding is suspended for this period. WHO allows azithromycin as an antibiotic for the treatment of chlamydial infections in pregnant women.

Side effect

Side effects occur infrequently and rarely, except for some. The body can be affected by such disorders:

1. Nervous system: often - headache; infrequently - paresthesia, taste disturbance, drowsiness, nervousness, dizziness, insomnia; rarely - agitation; frequency unknown - loss or perversion of smell, loss of taste sensations, psychomotor hyperactivity, convulsions, myasthenia gravis, fainting, delirium, aggression, anxiety, hypesthesia, hallucinations;
2. Infectious diseases: infrequently - respiratory diseases, pharyngitis, rhinitis, candidiasis (including the genitals and oral mucosa), gastroenteritis, pneumonia; frequency unknown - pseudomembranous colitis;
3. Digestive system: very often - diarrhea; often - abdominal pain, nausea, vomiting; infrequently - gastritis, constipation, dysphagia, belching, dyspepsia, bloating, flatulence, dryness of the oral mucosa, increased secretion salivary glands, ulcers of the oral mucosa; very rarely - discoloration of the tongue, pancreatitis;
4. Cardiovascular system: infrequently - flushing of the face, palpitations; frequency unknown - ventricular tachycardia, an increase in the QT interval on the ECG, a decrease blood pressure, pirouette-type arrhythmia;
5. Liver and biliary tract: infrequently - hepatitis; rarely - cholestatic jaundice, impaired liver function; frequency unknown - liver failure (in some cases with lethal outcome mainly as a result of severe liver dysfunction), fulminant hepatitis, liver necrosis;
6. Hematopoietic system: eosinophilia, neutropenia, leukopenia; very rarely - hemolytic anemia, thrombocytopenia;
7. Respiratory system: infrequently - nosebleeds, shortness of breath;
8. Metabolism: infrequently - anorexia;
9. Urinary system: infrequently - pain in the kidneys, dysuria; frequency unknown - acute renal failure, interstitial nephritis;
10. Organs of vision and hearing, labyrinth disorders: infrequently - visual impairment, vertigo, hearing disorder; frequency unknown - hearing impairment, incl. tinnitus and/or deafness;
11. Reproductive system: infrequently - testicular dysfunction, metrorrhagia;
12. Skin and subcutaneous tissues: infrequently - dermatitis, urticaria, dry skin, itching, sweating, rash; rarely - photosensitivity; frequency unknown - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
13. Musculoskeletal system: infrequently - back and neck pain, myalgia, osteoarthritis; frequency unknown - arthralgia;
14. Local reactions with intravenous administration: often - pain and inflammation at the injection site;
15. Allergic reactions: infrequently - hypersensitivity reaction, angioedema; frequency unknown - anaphylactic reaction;
16. Laboratory data: often - monocytophilia, basophilia, neutrophilia, eosinophilia, lymphopenia, an increase in the number of platelets, a decrease in the concentration of bicarbonates in the blood plasma, an increase in sodium in the blood, an increase in the activity of alanine aminotransferase, aspartic aminotransferase and alkaline phosphatase, a change in the content of potassium in the blood plasma, an increase in hematocrit , increase in the concentration of bilirubin, urea, creatinine, glucose, chlorine in blood plasma.
17. Others: infrequently - malaise, asthenia, fatigue, chest pain, swelling of the face, peripheral edema, fever.

Instructions for use Sumamed

Film-coated tablets, dispersible tablets and capsules. Sumamed is taken orally 1 hour before a meal or 2 hours after a meal.

• tonsillitis / pharyngitis caused by Streptococcus pyogenes: 20 mg / kg once a day, the course of treatment is 3 days (the maximum dose is 500 mg per day);
• infections of the upper respiratory tract, respiratory tract, soft tissues and skin: 10 mg / kg of body weight once a day, the course of treatment is 3 days;
• the initial stage of borreliosis: on the first day - 20 mg / kg once a day, on the following days - 10 mg / kg once a day, the course of treatment is 5 days.

• infections of the upper respiratory tract, respiratory tract, soft tissues and skin: 500 mg once a day, the course of treatment is 3 days; with moderate acne vulgaris after a standard 3-day course, treatment is continued for another 9 weeks (500 mg once a week);
• the initial stage of borreliosis: 1000 mg on the first day, 500 mg on subsequent days, the course of treatment is 5 days;
• uncomplicated cervicitis/urethritis: 1000 mg once.

Lyophilisate for solution for infusion

Sumamed is administered intravenously by drip for 1 hour (at a solution concentration of 2 mg / ml) or 3 hours (at a solution concentration of 1 mg / ml). Intramuscular or intravenous jet administration is prohibited.

The solution for infusion is prepared in 2 stages:

1. Preparation of the reconstituted solution. Add 4.8 ml of water for injection to the vial with lyophilizate and shake thoroughly until the powder is completely dissolved. 1 ml of the resulting solution contains 100 mg of azithromycin. The reconstituted solution is inspected for the presence of undissolved particles. If they are found, the solution cannot be used.
2. dilution of the reconstituted solution. Ringer's solution, 0.9% sodium chloride solution, or 5% dextrose solution can be used as a solvent. The volume of solvent depends on the required final concentration of azithromycin. To obtain a solution of 1 mg / ml, 500 ml of solvent is required, 2 mg / ml - 250 ml. The prepared solution is used immediately (provided that there are no visible undissolved particles, if any are found, the solution cannot be used).

• infectious and inflammatory diseases of the pelvic organs: 500 mg once a day for 2 days (maximum up to 5 days), then once a day, 250 mg of Sumamed in dosage form for oral administration; the general course of treatment is 7 days.
• community-acquired pneumonia: 500 mg once a day for 2 days (at the discretion of the doctor, the course can be extended to 5 days), then the patient is transferred to the oral form of Sumamed at a dose of 500 mg once a day; the general course of treatment is 7-10 days;
• Patients with impaired renal and / or liver function of mild to moderate severity, as well as the elderly, dose adjustment is not required.

Suspension for oral administration

Sumamed in the form of a suspension for oral administration is prescribed to children aged 6 months to 3 years. The drug is taken once a day 1 hour before a meal or 2 hours after a meal. The suspension should be washed down with a small amount of water.

1. To prepare the suspension, 12 ml of water is added to the contents of the powder vial and shaken thoroughly until a homogeneous consistency is obtained. The resulting volume will be about 25 ml, which is 5 ml more than the nominal volume. This discrepancy is provided in order to compensate for the inevitable loss of suspension when dosing Sumamed. The finished suspension can be stored for no more than 5 days at a temperature not exceeding 25 ° C.
2. The prepared suspension must be thoroughly shaken before each dose. The prescribed dose is measured using the supplied dosing syringe or measuring spoon, which should be rinsed and dried after each use.

Interaction with drugs

Simultaneous use of Sumamed with:

1. Chloramphenicol or tetracyclines: increased effectiveness of Sumamed;
2. Dihydroergotamine or ergot alkaloids: strengthening their action;
3. Ethanol, antacids or food: slowing down the absorption of Sumamed;
4. Lincosamines: reduced effectiveness of Sumamed;
5. Carbamazepine, Valproic acid, Phenytoin, Bromocriptine, xanthine derivatives, Hexobarbital, Disopyramide, Theophylline or oral hypoglycemic drugs: increasing their concentration and reducing their elimination time.
6. Indirect anticoagulants or Cycloserine: slowing down their excretion, increasing their concentration and toxicity.

Antacids. Do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and eating.
Cetirizine. The simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to a pharmacokinetic interaction and a significant change in the QT interval.
Didanosine (dideoxyinosine). The simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected patients did not reveal changes in the pharmacokinetic indications of didanosine compared with the placebo group.
Digoxin (P-glycoprotein substrates). The simultaneous use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin, leads to an increase in the concentration of P-glycoprotein substrate in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.
Zidovudine. The simultaneous use of azithromycin (single dose of 1000 mg and multiple doses of 1200 or 600 mg) has little effect on the pharmacokinetics, including the excretion of zidovudine or its glucuronide metabolite by the kidneys. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear. Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It has not been found that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes.
Ergot alkaloids. Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended. Pharmacokinetic studies have been conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.
Atorvastatin. Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter plasma concentrations of atorvastatin (based on MMC-CoA reductase inhibition assay). However, in the post-registration period, there have been isolated reports of cases of rhabdomyolysis in patients receiving both azithromycin and statins.
Carbamazepine. In pharmacokinetic studies involving healthy volunteers, there was no significant effect on the concentration of carbamazepine and its active metabolite in plasma in patients who received azithromycin concomitantly.
Cimetidine. In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, there were no changes in the pharmacokinetics of azithromycin, provided that cimetidine was used 2 hours before azithromycin.
Indirect anticoagulants (coumarin derivatives). In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin given to healthy volunteers. Potentiation of the anticoagulant effect has been reported after the simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, consideration should be given to the need for frequent monitoring of PT when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).
Cyclosporine. In a pharmacokinetic study involving healthy volunteers who took oral azithromycin (500 mg/day once) for 3 days, and then cyclosporine (10 mg/kg/day once), a significant increase in plasma Cmax and AUC0-5 hours was found. cyclosporine. Caution should be exercised when these drugs are used concomitantly. If it is necessary to use these drugs simultaneously, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.
Efavirenz. The simultaneous use of azithromycin (600 mg/day once) and efavirenz (400 mg/day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.
Fluconazole. The simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1 / 2 of azithromycin did not change with the simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin (by 18%) was observed, which had no clinical significance.
Indinavir. The simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times a day for 5 days).
Methylprednisolone. Azithromycin does not significantly affect the pharmacokinetics of methylprednisolone.
Nelfinavir. The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in serum Css of azithromycin. clinically significant side effects was not observed and dose adjustment of azithromycin with its simultaneous use with nelfinavir is not required.
Rifabutin. The simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in the blood serum. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.
Sildenafil. When used in healthy volunteers, there was no evidence of an effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.
Terfenadine. In pharmacokinetic studies, there was no evidence of an interaction between azithromycin and terfenadine. Isolated cases have been reported where the possibility of such an interaction could not be completely ruled out, but there was no concrete evidence that such an interaction took place. It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.
Theophylline. There was no interaction between azithromycin and theophylline.
Triazolam/midazolam. Significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses have not been identified.
trimethoprim/sulfamethoxazole. The simultaneous use of trimethoprim / sulfamethoxazole with azithromycin did not reveal a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.

Registration number П N015662/04-230315
Trade name of the drug: SUMAMED®
International non-proprietary name: azithromycin
Dosage form: film-coated tablets.
Composition
1 film-coated tablet contains:
active substance azithromycin dihydrate 131.027 mg or 524.109 mg, respectively, in terms of azithromycin 125.00 mg or 500.00 mg;
Excipients:
core: calcium hydrogen phosphate anhydrous 29.873 mg / 93.891 mg, hypromellose 1.50 mg / 6.00 mg, corn starch 12.00 mg / 48.00 mg, pregelatinized starch 12.00 mg / 40.00 mg, microcrystalline cellulose 10, 00 mg/33.60 mg, sodium lauryl sulfate 0.60 mg/2.40 mg, magnesium stearate 3.00 mg/12.00 mg; shell: hypromellose 3.40 mg / 13.60 mg, dye indigo carmine (E132) 0.10 mg / 0.40 mg, titanium dioxide (E171) 0.56 mg / 2.24 mg, polysorbate 80 0.14 mg / 0.56 mg, talc 2.80 mg/11.20 mg.
Description: 125 mg * - Round, biconvex tablets of blue color, with "PLIVA" engraved on one side and "125" on the other side.
500 mg * - Oval, biconvex tablets of blue color, with "PLIVA" engraved on one side and "500" on the other side.
*Kind view - from white to almost white.
Pharmacotherapeutic group: antibiotic-azalide
ATX: J01FA10.

Pharmacological properties

Pharmacodynamics. Azithromycin is a broad-spectrum bacteriostatic antibiotic from the group of azalide macrolides. It has a wide spectrum of antimicrobial activity. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of microbial cells. By binding to the 50S subunit of the ribosome, it inhibits the peptide translocase at the translation stage and inhibits protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.
It has activity against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.
Microorganisms may initially be resistant to the action of an antibiotic or may acquire resistance to it.

Scale of sensitivity of microorganisms to azithromycin (Minimum inhibitory concentration (MIC), mg/l):

Microorganisms MIC, mg/l
Sensitive Resistant

Staphylococcus ≤ 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 susceptible microorganisms
1. Gram-positive aerobes
Staphylococcus aureus methicillin-susceptible
Streptococcus pneumoniae penicillin-susceptible
Streptococcus pyogenes

2. Gram-negative aerobes
Haemophilus infuenzae
Haemophilus parainfuenzae
Legionella pneumophila
Moraxella catarrhalis
Pasteurella multocida
Neisseria gonorrhoeae

3. Anaerobes
Clostridium perfringens
Fusobacterium spp.
Prevotella spp.
Porphyriomonas spp.

4. 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

intrinsically resistant microorganisms
Gram-positive aerobes
Enterococcus faecalis
Staphylococci (methicillin-resistant staphylococci with a very high frequency of acquired 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, bioavailability is 37% (the “first pass” effect), the maximum concentration (0.4 mg / l) in the blood is created after 2-3 hours, the apparent volume of distribution is 31.1 l / kg, protein binding inversely proportional to the concentration in the blood and is 7-50%. 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. It easily passes histohematic barriers and enters the tissues. The concentration in tissues and cells is 10-50 times higher than in plasma, and the focus of infection is 24-34% higher than in healthy tissues.
Azithromycin has a very long half-life - 35-50 hours. The half-life from tissues is much longer. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is excreted mainly unchanged - 50% by the intestines, 6% by the kidneys. Demethylated in the liver, losing activity.

Indications for use

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;
Infections of the skin and soft tissues (acne vulgaris of moderate severity, erysipelas, impetigo, secondarily infected dermatoses);
The initial stage of Lyme disease (borreliosis) is migratory erythema (erythema migrans);
Urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Contraindications

Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug; severe liver dysfunction; severe renal dysfunction (creatinine clearance (CC) less than 40 ml / min), childhood up to 12 years with body weight less than 45 kg (for 500 mg tablets); children's age up to 3 years (for tablets 125 mg); simultaneous reception with ergotamine and dihydroergotamine.

Carefully

myasthenia; impaired liver function of mild to moderate severity; impaired renal function of mild and moderate severity (CC more than 40 ml / min); in patients with the presence of proarrhythmic factors (especially in elderly patients): with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water and electrolyte balance, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporine.

Use during pregnancy and during breastfeeding

During pregnancy and during breastfeeding used only if the intended benefit to the mother outweighs the potential risk to the fetus and child. If necessary, the use of the drug during breastfeeding is recommended to suspend breastfeeding.
WHO recommends azithromycin as the drug of choice for the treatment of chlamydial infection in pregnant women.

Dosage and administration

Inside, without chewing, at least 1 hour before or 2 hours after a meal, 1 time per day.
Adults and children over 12 years of age weighing more than 45 kg
For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues:
1 tablet (500 mg) 1 time per day for 3 days (course dose 1.5 g).
With acne vulgaris of moderate severity: 1 tablet (500 mg) 1 time per day for 3 days, then 1 tablet (500 mg) 1 time per week for 9 weeks (course dose 6.0 g).
The first weekly tablet should be taken 7 days after taking the first daily tablet (8th day from the start of treatment), the next 8 weekly tablets - with an interval of 7 days.
In Lyme disease (the initial stage of borreliosis) - migrating erythema (erythema migrans): 1 time per day for 5 days: 1st day - 1.0 r (2 tablets of 500 mg), then from the 2nd to the 5th day - 1 tablet (500 mg) (course dose 3.0 g).
For urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): uncomplicated urethritis / cervicitis - 1 g (2 tablets of 500 mg) once.
Children aged 3 to 12 years weighing less than 45 kg:
For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: at the rate of 10 mg/kg of body weight 1 time per day for 3 days (course dose 30 mg/kg). For ease of dosing, it is recommended to use table No. 1.

Table number 1. Calculation of the dose of the drug Sumamed® for children weighing less than 45 kg

Body weight Dose of azithromycin tablets 125 mg
18-30 kg 2 tablets (250 mg azithromycin)
31-44 kg 3 tablets (375 mg azithromycin)
at least 45 kg, use the doses recommended for adults

In children under 3 years of age, it is recommended to use Sumamed®, powder for oral suspension 100 mg / 5 ml and Sumamed® forte, powder for oral suspension 200 mg / 5 ml.
With pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed® is used at a dose of 20 mg / kg / day for 3 days (course dose 60 mg / kg). Maximum daily dose is 500 mg.
In Lyme disease (the initial stage of borreliosis) - migrating erythema (erythema migrans): 20 mg / kg 1 time per day on the 1st day, then at the rate of 10 mg / kg 1 time per day from the 2nd to the 5th day.
For ease of use in children with a course dose of 60 mg / kg, it is recommended to take Sumamed®, powder for oral suspension 100 mg / 5 ml and Sumamed® forte, powder for oral suspension 200 mg / 5 ml.
In case of impaired renal function: when used in patients with impaired renal function of mild to moderate severity (CC more than 40 ml / min), dose adjustment is not required.
In case of impaired liver function: when used in patients with mild to moderate hepatic impairment, dose adjustment is not required.
Elderly patients: dose adjustment is not required. Since the elderly may already have current proarrhythmic conditions, caution should be exercised when using the drug Sumamed® due to the high risk of developing cardiac arrhythmias, including torsades de pointes.

Side effect

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%; unknown frequency - cannot be estimated from the available data.
Infectious diseases: infrequently - candidiasis, including the mucous membrane of the oral cavity and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency - pseudomembranous colitis.
On the part of the blood and lymphatic system: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.
From the side of metabolism and nutrition: infrequently - anorexia.
Allergic reactions: infrequently - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.
From the side nervous system: often - headache; infrequently - dizziness, taste disturbance, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste sensations, myasthenia gravis, delirium, hallucinations.
On the part of the organ of vision: infrequently - visual impairment.
On the part of the organ of hearing and labyrinth disorders: infrequently - hearing loss, vertigo; unknown frequency - hearing impairment, including deafness and / or tinnitus.
From the side of cardio-vascular system: infrequently - a feeling of palpitations, "tides" of blood to the face; unknown frequency - lowering blood pressure, an increase in the QT interval on the electrocardiogram, pirouette-type arrhythmia, ventricular tachycardia.
From the side respiratory system: infrequently - shortness of breath, epistaxis.
From the side gastrointestinal tract: very often - diarrhea; often - nausea, vomiting, abdominal pain; infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - discoloration of the tongue, pancreatitis.
From the side of the liver and biliary tract: infrequently - hepatitis; rarely abnormal liver function, cholestatic jaundice; unknown frequency - liver failure (in rare cases with a fatal outcome, mainly against the background of severe liver dysfunction); liver necrosis, fulminant hepatitis.
On the part of the skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - a photosensitivity reaction; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
From the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.
From the side of the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.
From the genital organs and mammary gland: infrequently - metrorrhagia, impaired testicular function.
Other: infrequently - asthenia, malaise, feeling of fatigue, swelling of the face, chest pain, fever, peripheral edema.
Laboratory data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease in the concentration of bicarbonates in the blood plasma; infrequently - an increase in the activity of aspartate aminotransferase, alanine aminotransferase, an increase in the concentration of bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the content of potassium in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the content of chlorine in the blood plasma , increase in blood glucose concentration, increase in platelet count, increase in hematocrit, increase in plasma bicarbonate concentration, change in plasma sodium content.

Overdose

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

Interaction with other drugs

Antacids
Antacids do not affect the bioavailability of azithromycin, but reduce the maximum concentration in the blood by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and eating.
cetirizine
The simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to a pharmacokinetic interaction and a significant change in the QT interval.
Didanosine (dideoxyinosine)
The simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected patients did not reveal changes in the pharmacokinetic indications of didanosine compared with the placebo group.
Digoxin (P-glycoprotein substrates)
The simultaneous use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin, leads to an increase in the concentration of P-glycoprotein substrate in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.
Zidovudine
The simultaneous use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has little effect on the pharmacokinetics, including renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.
Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It has not been found that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes.
Ergot alkaloids
Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended.
Pharmacokinetic studies have been conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.
Atorvastatin
Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter plasma concentrations of atorvastatin (based on MMC-CoA reductase inhibition assay). However, in the post-registration period, there have been isolated reports of cases of rhabdomyolysis in patients receiving both azithromycin and statins.
Carbamazepine
In pharmacokinetic studies involving healthy volunteers, there was no significant effect on the concentration of carbamazepine and its active metabolite in plasma in patients who received azithromycin concomitantly.
Cimetidine
In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, there were no changes in the pharmacokinetics of azithromycin, provided that cimetidine was used 2 hours before azithromycin.
Indirect anticoagulants (coumarin derivatives)
In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin given to healthy volunteers. Potentiation of the anticoagulant effect has been reported after the simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, consideration should be given to the need for frequent monitoring of prothrombin time when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).
Cyclosporine
In a pharmacokinetic study involving healthy volunteers who took oral azithromycin (500 mg/day once) for 3 days, and then cyclosporine (10 mg/kg/day once), a significant increase in maximum plasma concentration (Cmax) and areas under the concentration-time curve (AUC0-5) of ciclosporin. Caution should be exercised when these drugs are used concomitantly. If it is necessary to use these drugs simultaneously, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.
Efavirenz
The simultaneous use of azithromycin (600 mg/day once) and efavirenz (400 mg/day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.
Fluconazole
The simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life of azithromycin did not change with the simultaneous use of fluconazole, however, a decrease in the Cmax of azithromycin (by 18%) was observed, 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 three times a day for 5 days).
Methylprednisolone
Azithromycin does not significantly affect the pharmacokinetics of methylprednisolone.
Nelfinavir
The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the equilibrium concentrations of azithromycin in the blood serum. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when co-administered with nelfinavir.
Rifabutin
The simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in the blood serum. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.
Sildenafil
When used in healthy volunteers, there was no evidence of an effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.
Terfenadine
In pharmacokinetic studies, there was no evidence of an interaction between azithromycin and terfenadine. Isolated cases have been reported where the possibility of such an interaction could not be completely ruled out, but there was no concrete evidence that such an interaction took place.
It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.
Theophylline
There was no interaction between azithromycin and theophylline.
Triazolam/midazolam
Significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses have not been identified.
trimethoprim/sulfamethoxazole
The simultaneous use of trimethoprim / sulfamethoxazole with azithromycin did not reveal a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.

special instructions

In case of missing one dose of Sumamed®, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.
Sumamed® should be taken at least one hour before or two hours after taking antacids.
Sumamed® should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe liver failure.
If there are symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, dark urine, a tendency to bleeding, hepatic encephalopathy, Sumamed® therapy should be discontinued and a study of the functional state of the liver should be carried out.
In case of impaired renal function, mild and moderate severity (CC more than 40 ml / min), Sumamed® therapy should be carried out with caution under the control of the state of kidney function.
As with the use of other antibacterial drugs, during therapy with Sumamed®, patients should be regularly examined for the presence of non-susceptible microorganisms and signs of the development of superinfections, including fungal infections.
The drug Sumamed® should not be used for longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us 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 with the simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is not recommended.
With prolonged use of the drug Sumamed®, it is possible to develop pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis. With the development of antibiotic-associated diarrhea while taking the drug Sumamed®, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.
In the treatment of macrolides, including azithromycin, there was an increase in cardiac depolarization and the QT interval, which increase the risk of developing cardiac arrhythmias, including torsades de pointes.
Caution should be exercised when using Sumamed® in patients with proarrhythmic factors (especially in elderly patients), including those 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, with 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.

Influence on the ability to drive vehicles and mechanisms

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

Release form
Film-coated tablets 125 mg and 500 mg.
125 mg: 6 tablets in a PVC/aluminum foil blister.

500 mg: 3 tablets in a PVC/aluminum foil blister.
1 blister with instructions for use in a cardboard box.

Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Best before date
3 years
Do not use after the expiration date.

Terms of dispensing from pharmacies
On prescription.

Manufacturer
Pliva Hrvatska d.o.o.
Barun Filipović 25, 10 000 Zagreb, Republic of Croatia