Description of the drug SUMAMED® for systemic use

Compound

The composition of the drug in all forms includes the active component azithromycin dihydrate .
Sumamed tablets also contain the following additional substances: anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, hypromellose, corn starch, magnesium stearate, MCC.

The capsules contain the following additional substances: sodium lauryl sulfate, MCC, magnesium stearate.

The powder from which the suspension is prepared contains the following additional substances: sodium phosphate, sucrose, hyprolose, xanthan gum, flavoring, colloidal silicon dioxide.

Release form, composition and packaging

Blue film-coated tablets at the fracture - from white to almost white.

Excipients:

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

Shell composition:

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

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

Release form

The drug is produced in the following forms:

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

Sumamed and Sumamed forte

Sumamed ®

and
Sumamed ® forte
(lat.
Sumamed ®
and
Sumamed ® forte
) are antibiotics of the macrolide class.
The active ingredient is azithromycin. In gastroenterology, Sumamed is known as one of the antibiotic drugs used as part of complex therapy for the eradication of Helicobacter pylori
.

Dosage forms of Sumamed and Sumamed forte

Sumamed
in Russia is presented in the following forms:

• film-coated tablets
  having a round (125 mg) or oblong (500 mg) shape with biconvex surfaces and the designation “PLIVA” on one side and “125” or “500” on the other. The shell is blue, the fractured appearance is from white to almost white
• gelatin capsules
  : hard, opaque, partly blue, partly blue, containing white to light yellow powder
• granular powder for the preparation of suspension for oral administration,
  white or light yellow, 100 mg/5 ml
• lyophilisate for the preparation of a
  white solution for infusion.

Sumamed forte
has a single dosage form: granulated
powder for the preparation of a suspension for oral administration,
white or light yellow in color with the smell of banana and cherry.
The medicinal properties of Sumamed are determined by the active substance and are described in the article azithromycin.

Microorganisms against which Sumamed is active or inactive

Sumamed is active against many microorganisms, including bacteria:

• gram-negative: Helicobacter pylori, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Neisseria gonorrhoeae, Prevotella bivia, Treponema pallidum, Borrelia burgdorferi, Campylobacter jejuni
  , as well as intracellular parasites:
  Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum, Mycoplasma pneumoniae
• gram-positive Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans
  , streptococci of groups C, F, G,
  Listeria monocytogenes, Corynebacterium spp.
  , as well as anaerobes:
  Peptococcus spp., Clostridium perfringens, Peptostreptococcus spp.
  and mycobacteria
  Mycobacterium avium complex
• gram-variable Gardnerella vaginalis.

Sumamed is not active against gram-positive bacteria resistant to erythromycin.

Professional medical publications regarding the use of Sumamed

• Grigoriev P.Ya., Yakovenko E.P., Soluyanova I.P. and others. Modern methods of therapy for peptic ulcer disease, their effectiveness and cost // Experimental and clinical gastroenterology. – 2003. – No. 3. – p. 21–25.

On the website gastroscan.ru in the literature catalog there is a section “Antibiotics used in the treatment of gastrointestinal diseases”, containing articles on the use of antimicrobial agents in the treatment of diseases of the digestive tract.

Other medicines containing the active ingredient azithromycin

In addition to Sumamed and Sumamed forte, the following drugs with the active ingredient azithromycin are (have been) registered in Russia: Azibiot, Azivok, Azidrop, Azimicin, Azitral, Azithromycin-BI, Azitrox, Azithromycin, Azithromycin-J, Azithromycin Zentiva, Azithromycin-Lexwm, Azithromycin McLeods , Azithromycin Sandoz, Azithromycin Forte, Azithromycin Forte-OBL, Azithromycin-OBL, Azithromycin Ecomed, AzitRus, AzitRus forte, Azicide, Zetamax retard, Z-factor, Zitnob, Zitrolide, Zitrolide forte, Zithrocin, Safocid, Sweetrox, Sumaclide, Sumaclide 1000 , Sumamecin, Sumamox, Sumatrolide solutab, Sumatrolide Solution Tablets, Tremak-Sanovel, Ecomed, Hemomycin.
Azithromycin brands sold in the West: Sumamed, Pfizer Zithromax, Zentiva Azitrox, AzaSite.

general information

According to the pharmacological index, Sumamed and Sumamed forte belong to the group “Macrolides and azalides”.
According to ATC, Sumamed is included in the group “J01 Antibacterial drugs for systemic use” and has the code “J01FA10 Azithromycin”. The manufacturer of Sumamed and Sumamed forte is Pliva Hrvatska doo, Croatia.

Official instructions from the manufacturer (pdf):

• Instructions for medical use of the drug Sumamed (film-coated tablets)
• Instructions for medical use of the drug Sumamed (lyophilisate for the preparation of solution for infusion)
• Instructions for medical use of the drug Sumamed (powder for the preparation of suspension for oral administration)
• Instructions for medical use of the drug Sumamed Forte (powder for the preparation of suspension for oral administration)

The FDA, in its March 12, 2013 communique, warns that azithromycin may cause QT prolongation and, as a result, arrhythmia.
It was found that the number of deaths from cardiovascular events in patients who underwent a five-day course of azithromycin therapy was greater than in those who took amoxicillin, ciprofloxacin, or did not take antibiotics at all. In comparison with those taking levofloxacin, the difference was not established. Sumamed and Sumamed forte have contraindications, side effects and application features; consultation with a specialist is necessary.

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pharmachologic effect

The drug Sumamed is antibiotic , a group of antibiotics - macrolides-azalides . Has a broad spectrum antimicrobial effect. Its mechanism of action is based on the ability to suppress microbial cell protein synthesis. As a result, the growth and reproduction of bacteria slows down. At high concentrations it acts as a bactericidal agent.

Wikipedia indicates that the active component of the drug demonstrates activity against a number of gram-negative and gram-positive anaerobes, as well as intracellular microorganisms, etc.

It should be borne in mind that microorganisms may exhibit resistance to the antibiotic or acquire such resistance over time. Initially, resistance to the drug is observed in gram-positive aerobes Staphylococcus spp., Enterococcus faecalis, in anaerobes - Bacteroides fragilis, in gram-positive bacteria that are resistant to erythromycin.

Pharmacokinetics and pharmacodynamics

As the abstract indicates, the active substance is absorbed quickly into the body, and its distribution also occurs quickly. After taking the drug in a dose of 500 mg, the level of bioavailability is 37%. The highest concentration in the blood is observed after 2-3 hours, it is equal to 0.4 mg/l. Binds to proteins by 7-50%.

Azithromycin is able to penetrate cell membranes, which is why the medicine can be used for infections caused by intracellular pathogens in the body. Phagocytes transport it to the site of infection, and there azithromycin is released.

Can pass through histohematic barriers. There is a 10-50 times higher concentration in cells and tissues compared to blood plasma . In foci of infection, the concentration of the substance is higher than in other tissues.

Demethylated in the liver. The half-life is 35-50 hours. From tissues, the half-life is longer. It is excreted unchanged, approximately 50% through the intestines, another approximately 6% through the kidneys.

Dosage regimen

The drug is prescribed orally 1 time/day, at least 1 hour before or 2 hours after meals. The tablets are taken without chewing.

Adults (including the elderly) and children over 12 years of age weighing more than 45 kg

the drug is prescribed in the form of tablets and capsules.

For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema) in adults and children over 12 years of age weighing more than 45 kg

the drug is prescribed at a dose of 500 mg 1 time/day for 3 days, the course dose is 1.5 g.
Children aged 6 months and older
are prescribed at the rate of 10 mg/kg body weight 1 time/day for 3 days, the course dose is 30 mg/kg.

For diseases of the stomach and duodenum associated with Helicobacter pylori

the drug is prescribed in powder form at a dose of 1 g/day for 3 days in combination with antisecretory agents and other drugs.

For 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 days 2 to 5 - 500 mg;
course dose - 3 g. Children aged 6 months and older
are prescribed on the 1st day at a dose of 20 mg/kg body weight and then from days 2 to 5 - daily at a dose of 10 mg/kg body weight, course dose - 60 mg /kg.

For moderate acne,

the ursual dose is 6.0 g.
Adults and children over 12 years of age weighing more than 45 kg
: Prescribed at a dose of 500 mg once a day for 3 days, then 500 mg once a week for 9 weeks. The first weekly dose should be taken 7 days after the first daily dose (8th day from the start of treatment), the subsequent 8 weekly doses should be taken at an interval of 7 days.

For sexually transmitted infections

, for the treatment
of uncomplicated urethritis/cervicitis caused by Chlamydia trachomatis,
the drug is prescribed in 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 (creatinine clearance > 40 ml/min)

no dose adjustment is required.

Rules for preparing and taking the suspension

Add 12 ml of distilled or boiled water to a bottle containing 17 g of powder. The volume of the resulting suspension is 23 ml. The shelf life of the prepared suspension is 5 days. Before use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is given a few sips of tea 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 in a dry place along with the drug.

Indications for use of Sumamed

Indications for the use of this drug are infectious and inflammatory diseases that are caused in the body by microorganisms that are sensitive to this drug:

• infections that affect the ENT organs and upper respiratory tract (with sinusitis , sinusitis , tonsillitis , otitis media , etc.);
• infections that affect the lower respiratory tract ( bronchitis , chronic bronchitis during exacerbation, pneumonia, etc.);
• acne vulgaris (moderate severity);
• infectious diseases of soft tissues ( impetigo , erysipelas , etc.);
• Lyme disease (early stage disease);
• infectious diseases of the genitourinary tract caused by Chlamydia trachomatis.

Contraindications

Contraindications for taking Sumamed are as follows:

• increased sensitivity to the components of the drug, as well as to erythromycin or ketolides , antibiotics from the macrolide ;
• severe liver or kidney dysfunction;
• taking the drug simultaneously with dihydroergotamine and ergotamine.

Children under 12 years of age should also not take 500 mg tablets or capsules. Children under 3 years of age should not take 125 mg tablets. Also, syrup (suspension) should not be given to children under 6 months of age.

With caution, Sumamed for adults is prescribed for myasthenia gravis , impaired liver and kidney function, people who have proarrhythmogenic factors, those undergoing treatment with antiarrhythmic drugs of classes IA and III, patients with severe heart failure, arrhythmia , bradycardia.

Contraindications to the use of the drug

- severe dysfunction of the liver and kidneys;

- lactation period (breastfeeding);

- simultaneous use with ergotamine and dihydroergotamine;

- increased sensitivity to macrolide antibiotics;

- 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).

Carefully _

The drug should be prescribed for moderate impairment of liver and kidney function, for patients with disorders or predisposition to arrhythmias and prolongation of the QT interval, together with terfenadine, warfarin, digoxin.

Side effects

The following side effects may occur during administration:

• Hematopoietic system: neutropenia , eosinophilia, leukopenia; in very rare cases - hemolytic anemia, thrombocytopenia.
• Infectious diseases: candidiasis , pharyngitis , pneumonia, respiratory diseases, gastroenteritis, rhinitis.
• Metabolism: anorexia .
• Nervous system: paresthesia , irritability , dizziness , drowsiness , headache , taste disturbance, insomnia , etc.
• Allergic manifestations: urticaria , hypersensitivity, angioedema .
• Visual organs: blurred vision.
• Hearing organs: vertigo, hearing loss, tinnitus.
• Cardiovascular system: palpitations, low blood pressure , flushing , ventricular tachycardia .
• Digestive system: diarrhea , vomiting , nausea , abdominal pain , flatulence , gastritis , constipation , belching , bloating, dysphagia , etc.
• Respiratory system: shortness of breath , nosebleeds.
• Liver and biliary tract: hepatitis , liver dysfunction , cholestatic jaundice .
• Skin and subcutaneous tissues: dry skin, dermatitis , rash, sweating , Stevens-Johnson syndrome , erythema multiforme.
• Musculoskeletal system: myalgia, osteoarthritis , back or neck pain, arthralgia.
• Reproductive system: testicular dysfunction, metrorrhagia.
• Urinary system: dysuria , pain in the kidneys, interstitial nephritis.
• Other side effects: malaise, asthenia, fatigue, chest pain, facial swelling , fever .
• Changes in a number of laboratory parameters.

Sumamed forte powder for suspension 200mg/5ml 16.74g (15ml) fl

Active substance

azithromycin

ATX code

J01FA10 (Azithromycin)

Release form, packaging and composition of the drug

Powder for suspension for oral administration

white to yellowish-white in color, with a characteristic banana aroma; after dissolution in water - a homogeneous suspension from white to yellowish-white color, with a characteristic banana aroma.

[PRING] sucrose* - 898.206 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, xanthan gum - 1.6 mg, banana flavor - 12 mg, vanilla flavor - 4.5 mg, titanium dioxide - 5 mg, colloidal silicon dioxide - 7 mg .

16.74 g (15 ml) - bottles (1) of high-density polyethylene with a volume of 50 ml with a resistant polypropylene cap, complete with a measuring spoon and/or syringe for dosing - cardboard packs.

Powder for suspension for oral administration

white to yellowish-white in color, with a characteristic strawberry aroma; after dissolution in water - a homogeneous suspension from white to yellowish-white color, with a characteristic strawberry aroma.

[PRING] sucrose* - 902.706 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, xanthan gum - 1.6 mg, strawberry flavor - 12 mg, titanium dioxide - 5 mg, colloidal silicon dioxide - 7 mg.

29.295 g (30 ml) - bottles (1) of high-density polyethylene with a volume of 100 ml with a resistant polypropylene cap, complete with a measuring spoon and/or syringe for dosing - cardboard packs.

Powder for suspension for oral administration

white to yellowish-white in color, with a characteristic raspberry aroma; after dissolution in water - a homogeneous suspension from white to yellowish-white color, with a characteristic raspberry aroma.

[PRING] sucrose* - 904.206 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, xanthan gum - 1.6 mg, raspberry flavor - 10.5 mg, titanium dioxide - 5 mg, colloidal silicon dioxide - 7 mg.

35.573 g (37.5 ml) - bottles (1) of high-density polyethylene with a volume of 100 ml with a resistant polypropylene cap, complete with a measuring spoon and/or syringe for dosing - cardboard packs.

* values ​​are based on the theoretical activity of the substance 95.4%; the amount of sucrose may vary depending on the actual activity of azithromycin.

Clinical and pharmacological group

Antibiotic of the macrolide group - azalide

Pharmacotherapeutic group

Antibiotic - azalide

pharmachologic effect

Suction

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

Distribution

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

Metabolism

In the liver it is demethylated, losing activity.

Removal

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

Pharmacokinetics in special clinical situations

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

Indications for use

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

• upper respiratory tract infections, including pharyngitis/tonsillitis, sinusitis, otitis media;
• lower respiratory tract infections, including acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia;
• infections of the skin and soft tissues, including erysipelas, impetigo, secondary infected dermatoses;
• Lyme disease (initial stage of borreliosis) - erythema migrans.

Dosage

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

Before each use of the drug, the contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained; if the required volume of the suspension is not taken from the bottle within 20 minutes after shaking, the suspension should be shaken again, the required volume is taken and given to the child.

The required dose is measured using a dosing syringe with a division value of 1 ml and a nominal suspension capacity of 5 ml (200 mg azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (100 mg azithromycin) or 5 ml (200 mg azithromycin), placed in a cardboard packaging along with the bottle.

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

For infectious and inflammatory diseases of the upper and lower respiratory tract, skin and soft tissues

the drug is prescribed at the rate of 10 mg/kg body weight 1 time/day for 3 days, the course dose is 30 mg/kg.

To accurately dose Sumamed® forte according to the child’s body weight, use the table below.

For pharyngitis/tonsillitis caused by Streptococcus pyogenes

, Sumamed® forte is used at a dose of 20 mg/kg/day for 3 days (course dose 60 mg/kg). The maximum daily dose is 500 mg.

Children weighing up to 10 kg

Sumamed® should be prescribed in powder form for the preparation of an oral suspension with a concentration of 100 mg/5 ml.

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

the drug is prescribed on the 1st day at a dose of 20 mg/kg/day, then from days 2 to 5 - at a dose of 10 mg/kg/day (course dose - 60 mg/kg).

When used in patients with impaired renal function with GFR 10-80 ml/min

no dose adjustment is required.

When used in patients
mild to moderate
liver dysfunction, no dose adjustment is required.

Elderly patients

no dose adjustment is required. In elderly patients, when using the drug Sumamed® forte, it is recommended to exercise special caution due to the possible presence of proarrhythmogenic factors that may increase the risk of developing cardiac arrhythmia and arrhythmias.

Rules for the preparation and storage of the suspension

To the contents of the bottle intended for the preparation of 15 ml of suspension (nominal volume),

Using a dosing syringe, add 9.5 ml of water. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 20 ml, which exceeds the nominal volume by approximately 5 ml. This is provided to compensate for the inevitable losses of suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 5 days.

To the contents of the bottle intended for the preparation of 30 ml of suspension (nominal volume),

Using a dosing syringe, add 16.5 ml of water. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 35 ml, which exceeds the nominal volume by approximately 5 ml. This is provided to compensate for the inevitable losses of suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 10 days.

To the contents of the bottle intended for the preparation of 37.5 ml of suspension (nominal volume),

Using a dosing syringe, add 20 ml of water. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be approximately 42.5 ml, which exceeds the nominal volume by approximately 5 ml. This is provided to compensate for the inevitable losses of suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 10 days.

Contraindications

• severe liver dysfunction;
• simultaneous use of ergotamine and dihydroergotamine;
• children up to 6 months;
• sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug.

Carefully

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

Overdose

Symptoms

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

Treatment:

taking activated carbon, conducting symptomatic therapy, monitoring vital functions.

Side effects

The frequency of side effects is classified according to WHO recommendations: very common (≥10%), common (≥1%, <10%), uncommon (≥0.1%, <1%), rare (≥0.01%, <0.1%) , very rare (<0.01%), unknown frequency - cannot be estimated based on the available data.

Infectious diseases:

uncommon - candidiasis, incl. mucous membrane of the oral cavity and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; very rarely - pseudomembranous colitis.

From the blood and lymphatic system:

uncommon: leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

Metabolism and nutrition:

infrequently - anorexia.

Allergic reactions:

uncommon - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.

From the nervous system:

often - headache; infrequently - dizziness, disturbance of taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste, myasthenia gravis, delirium, hallucinations.

From the side of the organ of vision:

infrequently - visual impairment.

Hearing and labyrinth disorders:

uncommon - hearing loss, vertigo; unknown frequency - hearing loss, incl. deafness and/or tinnitus.

From the cardiovascular system:

infrequently - a feeling of palpitations, “flushes” of blood to the face; unknown frequency - decreased blood pressure, increased QT interval on ECG, ari, ventricular tachycardia.

From the respiratory system:

infrequently - shortness of breath, nosebleeds.

From the gastrointestinal tract:

very often - diarrhea; often - nausea, vomiting, abdominal pain: infrequently - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - change in tongue color, pancreatitis.

From the liver and biliary tract:

uncommon - hepatitis; rarely - impaired liver function, cholestatic jaundice; unknown frequency - liver failure (in rare cases with death, mainly due to severe liver dysfunction), liver necrosis, fulminant hepatitis.

For the skin and subcutaneous tissues:

uncommon - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity reaction; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

From the musculoskeletal system:

uncommon - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.

From the kidneys and urinary tract:

uncommon - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.

From the genital organs and breast:

infrequently - metrorrhagia, testicular dysfunction.

Other:

uncommon - asthenia, malaise, feeling of fatigue, facial swelling, 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 - increased activity of AST, ALT, increased concentration of bilirubin in the blood plasma, increased concentration of urea in the blood plasma, increased concentration of creatinine in the blood plasma, change in the potassium content in the blood plasma, increased activity of alkaline phosphatase in the blood plasma, increased chlorine content in the blood plasma, increased blood glucose concentration, increased platelet count, increased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium content.

Overdose

Antacids

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

Cetirizine

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

Digoxin (P-glycoprotein substrates)

Simultaneous use of macrolide antibiotics, incl. azithromycin, with P-glycoprotein substrates such as digoxin, leads to increased concentrations 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 a minor effect on pharmacokinetics, incl. renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear. Azithromycin interacts weakly with isoenzymes of the cytochrome P450 system. Azithromycin has not been shown to participate in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or 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 were conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.

Atorvastatin

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on an HMC-CoA reductase inhibition assay). However, in the post-marketing period, isolated case reports of rhabdomyolysis have been received in patients receiving concomitant azithromycin and statins.

Carbamazepine

Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.

Cimetidine

In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected when cimetidine was administered 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 administered to healthy volunteers. Potentiation of the anticoagulant effect has been reported after 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 should be considered when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).

Cyclosporine

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days, followed by cyclosporine (10 mg/kg/day once), a significant increase in plasma Cmax and AUC0-5 of cyclosporine was detected. . Caution is advised when using these drugs together. If simultaneous use of these drugs is necessary, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.

Efavirenz

Concomitant 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

Concomitant 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 simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance.

Indinavir

The simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times a day for 5 days).

Methylprednisolone

Azithromycin does not have a significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in the equilibrium concentrations of azithromycin in the blood serum. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.

Rifabutin

The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood serum. Neutropenia has sometimes been observed with simultaneous use of azithromycin and rifabutin. 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 the 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 interaction between azithromycin and terfenadine. There have been isolated cases reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction occurred.

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

Theophylline

No interaction has been detected between azithromycin and theophylline.

Triazolam/midazolam

No significant changes in pharmacokinetic parameters were detected with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.

Trimethoprim/sulfamethoxazole

Concomitant use of trimethoprim/sulfamethoxazole with azithromycin did not show a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those found in other studies.

Storage conditions

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

Conditions for dispensing from pharmacies

The drug is available with a prescription.

SUM-RU-00376-DOK

Special Instructions

When using the drug Sumamed® forte in patients with diabetes mellitus, as well as on a low-calorie diet, it is necessary to take into account that the suspension contains sucrose (0.32 XE/5 ml). If you miss taking one drug, Sumamed® forte, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

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

The drug Sumamed® forte should be taken with caution in patients with mild to moderate liver dysfunction due to the possibility of developing fulminant hepatitis and severe liver failure.

If there are symptoms of liver dysfunction, such as rapidly increasing asthenia, jaundice, darkening of urine, tendency to bleeding, hepatic encephalopathy, therapy with Sumamed® forte should be stopped and a study of the functional state of the liver should be carried out.

If renal function is impaired in patients with GFR 10-80 ml/min, no dose adjustment is required; therapy with Sumamed® should be carried out with caution under monitoring the state of renal function.

As with the use of other antibacterial drugs, during therapy with Sumamed® forte, patients should be regularly examined for the presence of resistant microorganisms and signs of the development of superinfections, incl. fungal.

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

There is no data on 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 long-term use of the drug Sumamed® forte, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis, is possible. If antibiotic-associated diarrhea develops while taking Sumamed® forte, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. You should not use drugs that inhibit intestinal motility.

When treated with macrolides, incl. azithromycin, prolongation of cardiac repolarization and QT interval was observed, increasing the risk of developing cardiac arrhythmias, incl. ari, which can lead to cardiac arrest.

Caution should be exercised when using the drug Sumamed® forte 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, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with fluid and electrolyte disorders balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

The use of Sumamed® forte may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia.

Impact on the ability to drive vehicles and machinery

If undesirable effects on the nervous system and organ of vision develop, caution should be exercised when performing actions that require increased concentration and speed of psychomotor reactions.

Instructions for use of Sumamed (Method and dosage)

The drug should be taken 1 hour before meals or 2 hours after. As a rule, the medicine is taken once a day. There is no need to chew the tablets.

Sumamed tablets, instructions for use

In case of infectious diseases of the respiratory tract and ENT organs, the patient should receive 500 mg once a day for 3 days. In case of infectious diseases of soft tissues and skin, the antibiotic should be taken in the same way.

Patients with erythema migrans are prescribed 1 g of the drug on the first day of treatment, and 500 mg in the next 4 days.

For infectious diseases of the genitourinary tract, a dose of 1 g is prescribed once.

In the case of acne vulgaris, a dose of 500 mg is prescribed once a day, you need to drink it for three days, after which you need to take 500 mg of the drug once a week for 9 weeks.

Instructions for use of Sumamed for children

Children with infectious diseases of the respiratory tract and ENT organs, as well as with diseases of soft tissues and skin, are prescribed a dose of 10 mg per 1 kg of weight once a day for 3 days. So, children weighing 18-30 kg should receive 2 tablets of 125 mg per day (250 mg), children weighing 31-44 kg 3 tablets (375 mg).

Children with tonsillitis or pharyngitis caused by Streptococcus pyogenes are prescribed a dose of 20 mg per 1 kg of body weight per day for three days.

For Lyme disease, a dose is prescribed on the first day at the rate of 20 mg per 1 kg of weight per day, then for four days at a rate of 10 mg per 1 kg of weight once a day.

Suspension Sumamed, instructions for use

Children's syrup (suspension) is indicated for use in children from 6 months to 3 years. To measure the dose for children weighing up to 15 kg, use a syringe; for children weighing more than 15 kg, measure the dose with a measuring spoon.

Children with infectious diseases of the respiratory tract and ENT organs, as well as with diseases of soft tissues and skin, are prescribed a dose of 10 mg per 1 kg of weight once a day, drink for 3 days.

Children with tonsillitis or pharyngitis caused by Streptococcus pyogenes are prescribed a dose of 20 mg per 1 kg of weight per day, drink for 3 days.

For Lyme disease in the initial stage, a dose of 20 mg per 1 kg of weight per day is prescribed on the first day, then for four days at a rate of 10 mg per 1 kg of weight once a day.

Before use, you should read the instructions on how to prepare the Sumamed suspension. To do this, add 12 ml of water to the powder in the bottle using a syringe. Next, the contents of the bottle should be shaken well. The finished product can be stored for 5 days at a temperature of no more than 25 degrees. Before taking to children, shake the contents of the bottle. The dosage of Sumamed for children is carried out using a spoon or syringe. How to dilute Sumamed 100 mg / 5 ml can be found in the instructions.

Sumamed 100mg/5ml 20ml powder for suspension for oral administration

pharmachologic effect

Antibiotic azalide.

Composition and release form Sumamed 100mg/5ml 20ml powder for the preparation of suspension for oral administration

Powder - 1 g:

• active substance: azithromycin dihydrate* - 25.047 mg, equivalent to azithromycin 23.895 mg;
• excipients: sucrose* 929.753 mg, sodium phosphate 20.00 mg, hyprolose 1.60 mg, xanthan gum 1.60 mg, strawberry flavor 10,000 mg, titanium dioxide 5,000 mg, colloidal silicon dioxide 7,000 mg.

* values ​​are based on the theoretical activity of the substance 95.4%; the amount of sucrose may vary depending on the actual activity of azithromycin.

20.925 g of powder are placed in a 50 ml opaque white high-density PE bottle with a resistant polypropylene cap.

1 bottle along with instructions for use, a measuring spoon and/or a dosing syringe is placed in a cardboard box.

Description of the dosage form

The powder is white to yellowish-white in color with a characteristic strawberry odor. After dissolution in water - a homogeneous suspension of yellowish-white color with a characteristic strawberry odor.

Directions for use and doses

Orally, 1 time per day, 1 hour before or 2 hours after meals. After taking Sumamed®, the child must be offered to drink a few sips of water so that he can swallow the remainder of the suspension.

Before each dose of the drug, the contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained. If the required volume of suspension was not taken from the bottle within 20 minutes after shaking, the suspension should be shaken again, the required volume should be taken and given to the child.

The required dose is measured using a dosing syringe with a division value of 1 ml and a nominal suspension capacity of 5 ml (100 mg azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (50 mg azithromycin) or 5 ml (100 mg azithromycin), inserted in a cardboard package along with the bottle.

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

For infections of the upper and lower respiratory tract. ENT organs, skin and soft tissues

At the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose 30 mg/kg). For precise dosing of the drug Sumamed® in accordance with the child’s body weight:

• Body weight 5 kg - 2.5 ml (50 mg azithromycin) suspension per dose.
• Body weight 6 kg - 3.0 ml (60 mg of azithromycin) suspension per dose.
• Body weight 7 kg - 3.5 ml (70 mg azithromycin) suspension per dose.
• Body weight 8 kg - 4.0 ml (80 mg) suspension per dose.
• Body weight 9 kg - 4.5 ml (90 mg of azithromycin) suspension per dose.
• Body weight 10 kg - 5 ml (100 mg of azithromycin) suspension for 1 dose.

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

For Lyme disease (initial stage of borreliosis) - erythema migrans: on the 1st day at a dose of 20 mg/kg/day, then from the 2nd to the 5th day at a dose of 10 mg/kg/day (course dose 60 mg/kg).

If renal function is impaired: when used in patients with mild to moderate renal impairment (creatinine clearance more than 40 ml/min), no dose adjustment is required.

In case of liver dysfunction, no dose adjustment is required when used in patients with mild to moderate liver dysfunction.

Elderly patients: no dose adjustment is required.

Pharmacodynamics

Has a wide spectrum of antimicrobial action. By binding to the 50S ribosomal subunit, it inhibits the biosynthesis of microorganism proteins. In high concentrations it has a bactericidal effect. It is active against gram-positive, gram-negative anaerobes, intracellular and other microorganisms.

Has no effect on gram-positive bacteria resistant to erythromycin.

Pharmacokinetics

When taken orally, azithromycin is well absorbed and quickly redistributed from plasma to tissues and organs. After a single oral dose of 500 mg of azithromycin, 37% of the drug is absorbed and after 2-3 hours the Cmax of the drug is 0.41 mcg/ml in the plasma. It is known that food intake can reduce the absorption of azithromycin, however, due to the insufficiency of the manufacturer's own data on the effect of food on the pharmacokinetics of azithromycin when taking Sumamed® in the form of a suspension, it should be taken at least 1 hour before or after 2 h after eating.

The drug is rapidly distributed throughout the body, high concentrations, 50 times higher than the concentration of azithromycin in plasma, are observed in tissues. Depending on the organ/tissue, the drug concentration ranges from 1-9 mcg/ml. The volume of distribution averages 31 l/kg.

The therapeutic concentration of azithromycin in tissues is observed within 5-7 days after taking the last dose. Penetrates into cells, including phagocytes, which migrate to the site of inflammation, helping to create therapeutic concentrations of the drug that exceed the MIC for infectious agents. Concentrations of azithromycin in infected tissues are higher compared to uninfected tissues. It has a long T1/2 and is slowly eliminated from tissues (on average 2-4 days).

Excretion of azithromycin into bile is the main route of elimination. On average, up to 50% is excreted in bile in unchanged form. The remaining 50% is excreted in the form of 10 metabolites formed during the process of N- and O-demethylation, hydroxylation of desosamine and aglycone ring and as a result of cleavage of the cladinose conjugate. Metabolites do not have antibacterial activity. An average of 6% of the administered dose of the drug is excreted in the urine.

In elderly patients (over 65 years of age), the volume of distribution is slightly higher (30%) compared to patients under 45 years of age, which is not clinically significant and does not require dosage changes.

The pharmacokinetics of azithromycin in healthy volunteers after a single intravenous infusion lasting more than 2 hours at a dose of 1000-4000 mg (solution concentration 1 mg/ml) has a linear relationship and is proportional to the administered dose. T1/2 of the drug is 65-72 hours. The high level of observed volume of distribution (33.3 l/kg) and plasma clearance (10.2 ml/min/kg) suggests that the long T1/2 of the drug is a consequence of the accumulation of the antibiotic in tissues followed by its slow release.

In healthy volunteers, with an intravenous infusion of azithromycin at a dose of 500 mg (solution concentration 1 mg/ml) for 3 hours, the Cmax of the drug in the blood serum was 1.14 μg/ml. The minimum serum level (0.18 μg/ml) was observed over 24 hours and the area under the concentration-time curve was 8.03 μg/ml/h.

Similar pharmacokinetic values ​​were obtained in patients with community-acquired pneumonia who were prescribed intravenous infusions (3 hours) for 2 to 5 days. After daily administration of azithromycin at a dose of 500 mg (infusion duration - 1 hour) for 5 days, an average of 14% of the dose is excreted in the urine over a 24-hour dosing interval.

Indications for use Sumamed 100mg/5ml 20ml powder for the preparation of suspension for oral administration

• infections of the upper respiratory tract and ENT organs;
• lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens;;
• skin and soft tissue infections;
• genitourinary tract infections (urethritis, cervicitis).

Contraindications

• severe dysfunction of the liver and kidneys;
• lactation period;
• simultaneous use with ergotamine and dihydroergotamine;
• hypersensitivity to azithromycin and other components of the drug;
• increased sensitivity to macrolide antibiotics;
• 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).

Sumamed should be prescribed with caution in cases of moderate impairment of liver and kidney function, in patients with disorders or predisposition to arrhythmias and prolongation of the QT interval.

Application of Sumamed 100mg/5ml 20ml powder for the preparation of suspension for oral administration during pregnancy and breastfeeding

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

If it is necessary to use sumamed during lactation, breastfeeding should be stopped

special instructions

When using the drug Sumamed® in patients with diabetes mellitus, as well as on a low-calorie diet, it is necessary to take into account that the suspension contains sucrose (0.32 XE/5 ml).

If you miss 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.

The drug Sumamed® should be taken with caution in patients with mild to moderate liver dysfunction due to the possibility of developing fulminant hepatitis and severe liver failure.

If there are symptoms of liver dysfunction, such as rapidly increasing asthenia, jaundice, darkening of urine, tendency to bleeding, hepatic encephalopathy, therapy with Sumamed® should be stopped and a study of the functional state of the liver should be performed.

In case of mild to moderate renal dysfunction (creatinine clearance more than 40 ml/min), therapy with Sumamed® should be carried out with caution under monitoring the state of renal function.

As with the use of other antibacterial drugs, during therapy with Sumamed®, patients should be regularly examined for the presence of non-responsive microorganisms and signs of the development of superinfections, including fungal ones. The drug Sumamed® should not be used in longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.

There is no data on 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 long-term use of the drug Sumamed®, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis, is possible. If antibiotic-associated diarrhea develops while taking Sumamed®, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.

When treated with macrolides, including azithromycin, prolongation of cardiac repolarization and QT interval was observed, increasing the risk of developing cardiac arrhythmias, including arrhythmias, which can lead to cardiac arrest.

Caution should be exercised when using the drug Sumamed® in patients with the presence of proarrhythmogenic factors (especially in elderly patients), including 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, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with fluid and electrolyte disorders balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

The use of Sumamed® may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia.

Impact on the ability to drive vehicles and operate machinery

If undesirable effects on the nervous system and organ of vision develop, caution should be exercised when performing actions that require increased concentration and speed of psychomotor reactions.

Overdose

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

Treatment: gastric lavage, symptomatic therapy.

Side effects Sumamed 100mg/5ml 20ml powder for suspension for oral administration

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

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

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

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

Drug interactions

Sumamed® (capsules, film-coated tablets, powder for oral suspension)

Antacids (containing aluminum, magnesium, ethanol) and food intake significantly reduce the absorption of azithromycin (capsules and suspension), so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food. It does not bind to the enzymes of the cytochrome P-450 complex and, unlike macrolide antibiotics, to date there has been no interaction with theophylline, terfenadine, carbamazepine, methylprednisolone, cimetidine, triazolam, digoxin. Macrolides, when taken simultaneously with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs subject to microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents) slow down the elimination, increase the concentration and toxicity of these drugs, while with the use of azalides such an interaction has not been observed to date.

If it is necessary to take it together with warfarin, it is recommended to carefully monitor the PT (there may be an increase in PT and the incidence of hemorrhages). When macrolides are taken simultaneously with ergotamine and dihydroergotamine, their toxic effects (vasospasm, dysesthesia) may occur. Lincosamides weaken, and tetracycline and chloramphenicol enhance the effectiveness of azithromycin. Pharmaceutically incompatible with heparin.

Sumamed® (lyophilisate for the preparation of solution for infusion)

Although there is no data on interactions between azithromycin and ergot alkaloids, caution must be exercised as simultaneous administration can lead to an increase in the concentration of alkaloids in the blood and to the development of overdose symptoms (ergotism), which is observed when alkaloids are taken together with macrolides; Antibiotics of the macrolide group increase the blood concentration of theophylline, terfenadine, warfarin, carbamazepine, phenytoin, digoxin, cyclosporine, ergotamine, triazolam and midazolam, thereby enhancing their effect. Unlike macrolides, azithromycin does not inhibit cytochrome P450, therefore, when it is prescribed with the above drugs, similar interactions are not observed.

Interaction

The simultaneous use of antacids does not affect the bioavailability of azithromycin, but its maximum concentration in the blood decreases by 30%.

Simultaneous administration of macrolides with P-glycoprotein substrates leads to an increase in the concentration of P-glycoprotein substrate in the blood.

When azithromycin and Zidovudine , there is a slight effect on the pharmacokinetics of the glucuronide metabolite Zidovudine. Also, with the simultaneous use of these drugs, an increase in the concentration of phosphorylated zidovudine ( metabolite ) in peripheral blood mononuclear cells was observed.

There is a weak effect of azithromycin with isoenzymes of the cytochrome P450 .

Concomitant use with ergot alkaloid , since there is a theoretical possibility of ergotism .

When azithromycin and Atorvastatin , there were no changes in the concentrations of atorvastatin in the blood. But in the post-registration period, there were isolated cases of rhabdomyolysis in people who simultaneously received azithromycin and statins.

The simultaneous use of cimetidine in a single dose does not affect the pharmacokinetics of azithromycin if cimetidine was taken no earlier than 2 hours before azithromycin.

Prothrombin time should be monitored frequently if azithromycin and indirect oral anticoagulants are used concomitantly.

It is recommended to use azithromycin and Cyclosporine very carefully; if such a combination is necessary, the concentration of Cyclosporine in the blood plasma should be monitored and the dose adjusted.

With simultaneous use, the pharmacokinetics of Fluconazole , but the maximum concentration of azithromycin decreased. However, this had no clinical significance, which is why parallel use is allowed.

If azithromycin and Rifabutin , neutropenia is sometimes observed. However, the connection between these phenomena has not been reliably established.

With simultaneous treatment with macrolides and terfenadine, arrhythmia and prolongation of the QT interval may develop, for which Sumamed tablets in this case must be taken with caution.

Sumamed forte 200 mg/5 ml 15 ml portion d/susp. for oral administration

Instructions for medical use of the drug Sumamed® forte Trade name Sumamed® forte International nonproprietary name Azithromycin Dosage form Powder for the preparation of suspension for oral administration, 200 mg/5 ml Composition One bottle contains the active substance - azithromycin (in the form of azithromycin dihydrate) - 600 mg ( for a volume of 15 ml), 1200 mg (for a volume of 30 ml), 1500 mg (for a volume of 37.5 ml). Excipients: sucrose, sodium phosphate anhydrous, hydroxypropycellulose, xanthan gum, colloidal silicon anhydrous, cherry flavor, banana flavor and vanilla flavor. Description Granular powder from white to light yellow color with a characteristic odor of banana and cherry. The prepared solution is a homogeneous suspension of white or light yellow color with a characteristic odor of banana and cherry. Pharmacotherapeutic group Antibacterial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Azithromycin. ATC code J01FA10 Pharmacological properties Pharmacokinetics Azithromycin is rapidly absorbed when taken orally, due to its resistance to acidic conditions and lipophilicity. After a single oral dose, 37% of azithromycin is absorbed, and peak plasma concentration (0.41µg/ml) is recorded after 2-3 hours. The volume of distribution Vd is approximately 31 l/kg. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract, prostate gland, skin and soft tissues, reaching from 1 to 9 µg/ml depending on the type of tissue. The high concentration in tissues (50 times higher than the concentration in plasma) and the 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 sites of infection, where it is released through the process of phagocytosis. But, despite the high concentration in phagocytes, azithromycin does not affect their function. The therapeutic concentration lasts 5-7 days after ingestion of the last dose. When taking azithromycin, a transient increase in the activity of liver enzymes is possible. The removal of half the dose from the blood plasma is reflected in a reduction of half the dose in the tissues within 2-4 days. After taking the drug in the interval from 8 to 24 hours, the half-life is 14-20 hours, and after taking the drug in the interval from 24 to 72 hours - 41 hours, which allows you to take Sumamed® forte once a day. The main route of excretion is with bile. Approximately 50% is excreted unchanged, the other 50% is excreted in the form of 10 inactive metabolites. Approximately 6% of the dose taken is excreted by the kidneys. Pharmacodynamics The active substance of the drug Sumamed® forte - 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 at the site of inflammation, it causes a bactericidal effect. Azithromycin suppresses protein synthesis in sensitive microorganisms, showing activity against most strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms: Mycoplasma pneumoniae, Haemophilus ducreyi, Moraxella catarrhalis, Propionibacterium acnes, Gardnerella vaginalis, Actinomyces species, Bordetella pertussis, Borrelia burgdorferi, Mobiluncus species; Haemophilus influenzae, Streptococcus pyogenes, Haemophilus parainfluenzae, Streptococcus pneumoniae, Legionella pneumophila, Streptococcus agalactiae, Neisseria meningitides, Streptococcus viridans, Neisseria gonorrhoeae, Streptococcus group C, F, G, Helicobacter pylori, Peptococcus species, Campylobacter jejun i, 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 ); 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 - upper respiratory tract infections (bacterial pharyngitis/tosillitis, sinusitis, otitis media) - lower respiratory tract infections (bronchitis, community-acquired pneumonia, exacerbation of chronic bronchitis) - skin and soft tissue infections (chronic migratory erythema - the initial stage of Lyme disease, erysipelas, impetigo, secondary pyodermatoses) - infections of the stomach and duodenum caused by Helicobacter pylori Method of administration and dosage Sumamed® forte in the form of an oral suspension is taken 1 time per day 1 hour before or 2 hours after meals using a measuring spoon or dosage syringe . Infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema) The course dose is 30 mg/kg. Two treatment regimens are used: 1) 10 mg/kg body weight once a day for 3 days 2) 10 mg /kg body weight on the first day and 5 mg/kg body weight from the 2nd to the 5th day. For children, the drug is prescribed based on weight: Body weight Sumamed®forte powder for the preparation of oral suspension 200 mg/5 ml 10-14 kg 2.5 ml (100 mg) 15-25 kg 5 ml (200 mg) 25-34 kg 7.5 ml (300 mg) 35-44 kg 10 ml (400 mg) ≥ 45 kg 12.5 ml (500 mg) Azithromycin has been noted to be effective in the treatment of streptococcal pharyngitis in children as a single dose of 10 mg/kg or 20 mg/kg for 3 days. Penicillin is used to prevent pharyngitis caused by Streptococcus pyogenes with possible rheumatic fever as a concomitant disease. Chronic migratory erythema The course dose of the drug is 60 mg/kg: once a day, 20 mg/kg on the 1st day and 10 mg/kg on the subsequent days, from 2 to 5. Diseases of the stomach and duodenum associated with Helicobacter pylori: 20 mg/kg body weight 1 time per day in combination with antisecretory agents and other drugs. If a dose of the drug is missed, it must be taken immediately, and then subsequent doses should be taken at intervals of 24 hours. Kidney failure. In patients with mild renal dysfunction (GFR 10-80 ml/min), there is no need to change the dose. Patients with severely impaired renal function (GFR <10 ml/min) should use azithromycin with caution. Liver failure. Because azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with severe liver disease. No studies have been conducted to examine the effect of azithromycin on liver function. Elderly patients Elderly patients are prescribed the same dose as adults. Among elderly patients, proarrhythmogenic conditions are possible, so the drug is used with caution due to the risk of developing cardiac arrhythmia and bidirectional tachycardia. Method of preparing the suspension Each bottle should contain a suspension 5 ml more than the course dose. To prepare 15 ml of suspension, add 9.5 ml of water (20 ml of suspension) to a bottle containing 600 mg of azithromycin. To prepare 30 ml of suspension, add 16.5 ml of water (35 ml of suspension) to a bottle containing 1200 mg of azithromycin. To prepare 37.5 ml of suspension, add 20 ml of water (42.5 ml of suspension) to a bottle containing 1500 mg of azithromycin. Before use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is given a few sips of liquid to rinse and swallow the remaining amount of the suspension in the mouth. Side effects Common: - vomiting, diarrhea, abdominal pain, nausea, abdominal discomfort, paresthesia, taste disturbances, headache, arthralgia, fatigue Uncommon: - nervousness, insomnia, drowsiness, rapid heartbeat, shortness of breath, nosebleeds, constipation, flatulence , dyspepsia, gastritis, bloating, dry mouth, belching, salivary gland hypersecretion, urticaria, dermatitis, dry skin, vaginal infections, fungal infections, bacterial infection, gastroenteritis, respiratory disorders, oral candidiasis, leukopenia, neutropenia, eosinophilia, angioedema edema, hypersensitivity, visual impairment, hearing impairment, osteoarthritis, myalgia, back pain, dysuria, renal pain, metrorrhagia, testicular damage, malaise, fatigue, edema, chest pain, fever, peripheral edema, increased aspartate aminotransferase levels, increased levels alanine aminotransferase, increased blood bilirubin, increased blood urea, increased blood creatinine, abnormal blood potassium level, increased blood alkaline phosphatase level, increased glucose level, increased platelet level, decreased hematocrit, increased bicarbonate, abnormal sodium level, hypoesthesia , tinnitus, hepatitis, Stevens-Johnson syndrome, asthenia Rarely: - emotional agitation (agitation) - abnormal liver function, cholestatic jaundice - photosensitivity reactions Unknown: - pseudomembranous colitis, thrombocytopenia, hemolytic anemia, anaphylactic reaction, aggression, anxiety, delirium, hallucinations, fainting, convulsions, psychomotor hyperactivity, anosmia, ageusia, parosomia, myasthenia, hearing impairment, bidirectional tachycardia and arrhythmia including ventricular tachycardia, prolongation of the QT interval on the ECG, hypotension, pancreatitis, discoloration of the tongue, liver failure, fulminant hepatitis, liver necrosis, toxic epidermal necrolysis, erythema multiforme, arthralgia, acute liver failure, interstitial nephritis Contraindications Hypersensitivity to azithromycin, erythromycin or macrolide and ketolide antibiotics, or other components of the drug. Drug interactions Antacids: When studying the effect of simultaneous use of antacids on the pharmacokinetics of azithromycin, no changes in bioavailability were noted, although the maximum concentration of azithromycin in blood plasma decreased by 25%. Patients should not take azithromycin and antacids at the same time. Cetirizine: In healthy volunteers, co-administration of a 5-day course of azithromycin with cetirizine 20 mg at steady state did not result in pharmacokinetic interaction or significant changes in the QT interval. Didanosine (dideoxyinosine): Co-administration of 1200 mg/day azithromycin and 400 mg/day didanosine in 6 HIV-positive patients did not affect the steady-state pharmacokinetics of didanosine compared with placebo. Digoxin (P-gp substrates): Concomitant use of macrolide antibiotics, including azithromycin, with P-gp substrates such as digoxin results in increased serum levels of P-gp substrates. Therefore, when azithromycin is used concomitantly with P-glycoprotein substrates such as digoxin, be aware of the possibility of increased serum concentrations of P-glycoprotein substrates. Zidovudine: With a single dose of 1000 mg and repeated doses of 1200 mg or 600 mg of azithromycin, there was little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, taking azithromycin increased the concentration of phosphorylated zidovudine (a clinically active metabolite) in peripheral blood mononuclear cells. The clinical significance of these indicators remains uncertain, but they may be useful to patients. Azithromycin does not interact with the liver cytochrome P450 system. It does not participate in pharmacokinetic drug interactions, like erythromycin and other macrolides. Azithromycin does not induce or inactivate cytochrome P450 via the cytochrome-metabolite complex. Ergotamine derivatives: Due to the theoretical possibility of developing ergotism, simultaneous use of azithromycin with ergot derivatives is not recommended. Pharmacokinetic studies were conducted with azithromycin and the following drugs with known cytochrome P450-mediated metabolism. Atorvastatin: Coadministration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not change plasma concentrations of atorvastatin (based on HMG CoA reductase assay). However, post-marketing cases of rhabdomyolysis have been reported in patients receiving azithromycin with statins. Carbamazepine: In a pharmacokinetic interaction study of azithromycin in healthy volunteers, the drug did not have a significant effect on plasma levels of carbamazepine or its active metabolites. Cimetidine: No change in the pharmacokinetics of azithromycin was noted in a pharmacokinetic study examining the effect of a single dose of cimetidine taken 2 hours before azithromycin on the pharmacokinetics of azithromycin. Coumarin oral anticoagulants: In pharmacokinetic interaction studies, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. In the post-marketing period, there have been reports of increased anticoagulation after co-administration of azithromycin and oral coumarin anticoagulants. Although a causal relationship has not been established, the frequency of prothrombin time monitoring should be considered when prescribing azithromycin to patients receiving oral anticoagulants such as coumarin. Cyclosporine: In a pharmacokinetic study in healthy volunteers who received 500 mg/day oral azithromycin for 3 days followed by a single oral dose of 10 mg/kg cyclosporine, the Cmax and AUC0-5 of cyclosporine were significantly increased. Therefore, caution should be exercised before concomitant administration of these drugs is considered. If coadministration of these drugs is necessary, monitor cyclosporine levels and adjust the dose accordingly. Efavirenz: Coadministration of a single dose of azithromycin 600 mg and efavirenz 400 mg daily for 7 days does not result in clinically significant pharmacokinetic interactions. Fluconazole: Coadministration of a single dose of 1200 mg azithromycin does not alter the pharmacokinetics of a single dose of 800 mg fluconazole. The overall exposure and half-life of azithromycin were not altered by coadministration with fluconazole, however, a clinically insignificant decrease in Cmax (18%) of azithromycin was observed. Indinavir: Co-administration of a single dose of 1200 mg azithromycin did not have a statistically significant effect on the pharmacokinetics of indinavir administered at a dosage of 800 mg three times daily for 5 days. Methylprednisolone: ​​In a pharmacokinetic interaction study in healthy volunteers, azithromycin did not show a significant effect on the pharmacokinetics of methylprednisolone. Midazolam: In healthy volunteers, coadministration with azithromycin 500 mg/day for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15 mg midazolam. Nelfinavir: Co-administration of azithromycin (1200 mg) and nelfinavir at steady state (750 mg three times daily) resulted in increased azithromycin concentrations. No clinically significant side effects were observed and no dose adjustment is required. Rifabutin: Concomitant use of azithromycin and rifabutin did not affect the plasma concentrations of these drugs. Neutropenia was detected with simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship with concomitant use of azithromycin has not been established. Sildenafil: In normal healthy male volunteers, there is no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite. Terfenadine: No interaction between azithromycin and terfenadine has been reported in pharmacokinetic studies. In some cases, it is not possible to completely exclude the possibility of an interaction. However, no concrete evidence was obtained that such an interaction occurred. Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction between azithromycin and theophylline when administered concomitantly to healthy volunteers. Triazolam: In 14 healthy volunteers, coadministration of azithromycin 500 mg on day 1 and 250 mg on day 2 with 0.125 mg triazolam on day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared with coadministration of triazolam and placebo. Trimethoprim/sulfamethoxazole: Coadministration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with azithromycin 1200 mg on day 7 had no significant effect on the maximum concentration, total exposure, or elimination of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were similar to those observed in other studies. Special instructions The duration of use of the drug should not exceed the periods specified in the instructions. As in the case of other macrolides, rare serious allergic reactions were reported, including Quincke's edema and anaphylaxia. Some of these reactions to azithromycin lead to the development of recurrent symptoms and require a longer period of observation and treatment. It is the main organ for the removal of azithromycin, therefore, azithromycin should be prescribed with caution with a pronounced liver disease. In the case of signs and symptoms of liver dysfunction, such as rapidly developing asthenia associated with jaundice, dark urine, a tendency to bleeding or liver encephalopathy, and immediately conduct functional stamps of the liver / tests. With the development of liver dysfunction, stop the azithromycin intake. In patients receiving derivatives, the appearance of ergotism was provoked by the simultaneous intake of some macrolide antibiotics. There is no data regarding the possibility of interaction between knotweed and azithromycin. Nevertheless, due to the theoretical possibility of developing ergotism, azithromycin and derivatives are accepted separately. As with any antibiotics, it is recommended to monitor signs of superinfection caused by resistant microorganisms, including mushrooms. Diarrhea caused by Clostridium difficile (CDAD) was reported in all cases of using antibacterial agents, including azithromycin, and may vary by severity from mild diarrhea to severe colitis. Treatment with antibacterial agents changes the normal flora of the intestine, which leads to excessive growth C. Difficile. In patients with severe renal failure (SKF <10 ml / min), 33% an increase in the systemic effects of azithromycin was observed. Caution should be observed when using Sumamed® Forte in patients with the presence of pro -arrithmogenic facts (especially in elderly patients), including the congenital or acquired extension of the QT interval; In patients taking antiarrhythmic preparations of classes IA (quinidine, prokainamide), III (pre-Pofilida, amioodaron and Sotalol), cizidine, terphenadin, antipsychotic drugs (pimoside), antidepressants (citraloprams), fluoroquinolins (moxifloxacin), in violations of water-electro. cast Baoans, especially in the case of hypokalemia or hypomagnesia, clinically significant bradycardia, heart arrhythmias or severe heart failure. The use of Sumamed® Forte can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia. Sugarose drug contains sucrose. Patients with rare hereditary diseases of fructose intolerance, glucose and galactose malabsorption syndrome, or sugrazo-amomaltase deficiency should not take this drug. Pregnancy The use of the drug during pregnancy is possible when the expected benefit exceeds the potential risk to the fetus. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Sumamed® Forte do not affect the reaction rate when driving vehicles and working with other mechanisms. An overdose of data on an overdose of Sumamed® Forte is not. An overdose of macrolide antibiotics is manifested by nausea, vomiting and diarrhea. In the case of an overdose, it is necessary to take activated carbon and carry out symptomatic therapy aimed at maintaining the life functions of the body. The release form and packaging at 16.7 g, 29.30 g or 35.6 g of the powder of the drug are placed in a high -density polyethylene bottle, with a twisting lid with children's opening. 1 bottle with a measured spoon and/or syringe for dosing along with instructions for use in the state and Russian languages ​​are placed in a pack of cardboard. Store storage conditions at a temperature of not higher than 25 ° C to store in an inaccessible place for children! Shelf life 2 years. Cooked suspension: 15 ml - 5 days, 30 ml and 37.5 ml - 10 days. Do not use after the expiration date. Conditions of vacation from pharmacies according to the recipe manufacturer Pliva Krvatsk D.O.O. Proslaz Baruna Filippovich 25, 10000 racket, Croatia name and country of the owner of the registration certificate of Pliva Krvatsk D.O.O., Croatia, Croatia Address of the Organization Accepting Consumers from Consumers on Product Quality (Product): Ratiofarm Kazakhstan LLP 050000 Republic of Kazakhstan, Almaty, Al-Farabi Avenue 19, business center Nurly Tau 1b of 603.604 telephone, fax; 311-07-34 e-mail

special instructions

The drug is used with caution for the treatment of people with impaired liver function, both mild and moderate, as there is a possibility of developing severe liver failure and fulminant hepatitis .

Patients who ask doctors whether Sumamed is an antibiotic or not should note that it is an antibacterial drug. Therefore, constant monitoring for the development of superinfections and the presence of non-susceptible microorganisms is required. It is important to adhere to the dosage and duration of treatment indicated in the instructions. Therefore, Sumamed for sore throat in adults and children, as well as the treatment of frontal sinusitis and other diseases, can be practiced only after a doctor’s prescription.

With prolonged treatment, the patient may develop pseudomembranous colitis .

When using macrolides, patients experienced prolongation of cardiac repolarization and the QT interval. As a result, the risk of developing cardiac arrhythmias .

Treatment with Sumamed can lead to myasthenic syndrome or provoke an exacerbation of myasthenia gravis .

The safety and effectiveness of intravenous Sumamed in children and adolescents under 18 years of age has not been established.

People who need to limit their sodium intake should consider the sodium content of the medicine.

You should drive vehicles carefully and perform other actions that require concentration if the patient is undergoing treatment with Sumamed.

Sumamed 100 mg/5 ml po d/prig susp d/intra 20.925 g (20 ml)

Sumamed powder for suspension.
for oral administration 100 mg/5 ml
Latin name

Sumamed
Release form
Powder for the preparation of a suspension for oral administration
Packaging
In dark glass bottles of 50 ml;
complete with double-sided dosing spoon and dosing syringe; 1 set in box; Pharmacological action
Sumamed is an antibiotic of the macrolide group - azalide.
Has a wide spectrum of antimicrobial action. Binds to the 50S ribosomal subunit and inhibits protein biosynthesis in microorganisms. In high concentrations it has a bactericidal effect. Azithromycin is active against gram-positive aerobic bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, streptococci of groups C, F and G, Staphylococcus aureus, Staphylococcus epidermidis; some gram-positive anaerobic bacteria: Clostridium perfringens. Azithromycin is active against gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Helicobacter pylori, Gardnerella vaginalis, Campylobacter jejuni. Azithromycin is also active against intracellular and other microorganisms: Mycobacterium avium complex, Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Listeria monocitogenes, Borrelia burgdorferi, Treponema pallidum. Gram-positive bacteria resistant to erythromycin are resistant to the drug. Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: infections of the upper respiratory tract and ear (bacterial pharyngitis, tonsillitis, sinusitis, otitis media);
infections of the lower respiratory tract (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis); infections of the skin and soft tissues (chronic migratory erythema - initial stage, Lyme disease, erysipelas, impetigo, secondary dermatoses); sexually transmitted infections (urethritis, cervicitis); diseases of the stomach and duodenum associated with Helicobacter pylori. Contraindications:
severe impairment of liver and kidney function;
increased sensitivity to macrolide antibiotics; Caution: during pregnancy and lactation, with impaired liver and kidney function, patients with disorders or predisposition to arrhythmias and prolongation of the QT interval. Use during pregnancy and breastfeeding
During pregnancy, the drug should be administered only if the expected benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to administer Sumamed to women during lactation, it is necessary to decide on stopping breastfeeding. Special instructions
If you miss 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. The patient should be warned about the need to inform the doctor about the occurrence of any side effect.
Composition:
5 ml of the finished suspension contains azithromycin dihydrate 100 mg;
excipients: sucrose, sodium phosphate, hyprolose, xanthan gum, cherry, banana, vanilla flavors, colloidal silicon dioxide. The vial contains 400 mg of azithromycin. Method of administration and dosage
The drug is prescribed orally 1 time per day, at least 1 hour before or 2 hours after meals.
The required dose is measured using a syringe or measuring spoon: with a body weight of up to 15 kg, a syringe is used, with a body weight above 15 kg, a measuring spoon is used. For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues (with the exception of chronic migratory erythema), it is prescribed at the rate of 10 mg/kg of body weight 1 time/day for 3 days, the course dose is 30 mg/kg. For chronic migratory erythema: on day 1 at a dose of 20 mg/kg body weight and then from days 2 to 5 - daily at a dose of 10 mg/kg body weight, course dose 60 mg/kg. Rules for preparing the suspension Add 11 ml of water to the contents of the bottle and shake. The volume of the resulting suspension is 25 ml. The shelf life of the prepared suspension is 5 days. Before use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is allowed to drink a few sips of water in order to rinse and swallow the remaining amount of the suspension in the mouth. After use, the dosing syringe is disassembled, washed with running water, dried and stored in a dry place. Side effects
Occur rarely (in 1% of cases or less).
From the digestive system: melena, cholestatic jaundice, nausea, vomiting, diarrhea, constipation, loss of appetite, gastritis, reversible moderate increase in the activity of liver enzymes. From the urinary system: nephritis. From the reproductive system: vaginal candidiasis. From the cardiovascular system: palpitations, chest pain. From the central nervous system and peripheral nervous system: dizziness, headache, vertigo, drowsiness, increased fatigue; in children - headache (during treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disturbances. Allergic reactions: skin rashes, Quincke's edema, urticaria, conjunctivitis. Dermatological reactions: photosensitivity, itching. From the laboratory indicators: in some cases - neutrophilia, eosinophilia (changed indicators return to normal 2-3 weeks after cessation of treatment). Drug interactions
Antacids (containing aluminum, magnesium), ethanol and food intake significantly reduce the absorption of azithromycin (capsules and suspension), so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food .
Azithromycin, unlike other macrolide antibiotics, does not bind to isoenzymes of the cytochrome P450 system. To date, no interaction has been observed with theophylline, terfenadine, carbamazepine, triazolam, or digoxin. Macrolides, when taken simultaneously with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs subject to microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents), slow down the elimination, increase the concentration and toxicity of these drugs , while such interaction has not been observed to date with the use of azalides. If co-administration with warfarin is necessary, careful monitoring of prothrombin time is recommended. When macrolides are taken simultaneously with ergotamine and dihydroergotamine, their toxic effects (vasospasm, dysesthesia) may occur. Lincosamines reduce, and tetracycline and chloramphenicol increase the effectiveness of azithromycin. Pharmaceutically, azithromycin is incompatible with heparin. Overdose
Symptoms: nausea, vomiting, diarrhea, temporary hearing loss.
Treatment: symptomatic. Storage conditions
Store out of the reach of children at a temperature of 15 to 25C.
Shelf life:
2 years.
The shelf life of the prepared suspension is 5 days. Active ingredient
Azithromycin
Conditions for dispensing from pharmacies
By prescription
Dosage form
: oral suspension

The appearance of the product may differ from the photographs on the website.

Information about medications posted on the site is intended for specialists and includes materials from publications from different years. The information provided on the site is general and is presented for informational purposes only, does not replace consultation with a doctor and cannot serve as a guarantee of the positive effect of the drug. Tvoyaapteka.rf warns you about possible negative consequences that may arise as a result of incorrect use of the information presented on the site and strongly recommends that you consult with a specialist before choosing a drug.

You can find detailed and up-to-date instructions for the drug on the website of the State Register of Medicines www.grls.rosminzdrav.ru.

Sumamed's analogs

Level 4 ATC code matches:
Ecositrin

Azicine

Rovamycin

AzitRus

Safocid

Clarithromycin

Sumamed Forte

Klarbakt

Azithromycin

Azitro Sandoz

ZI-Factor

Azitral

Azimed

Azicide

Spiramycin-vero

Zitrolide

Ecomed

Macropen

Klacid SR

Klacid

There are both more expensive and cheaper analogues of Sumamed. What can replace the drug is determined only by the attending physician.

The following analogues of this medicine exist:

• Azithromycin
• Azicine
• Azitrox
• Zomax
• Azax
• Zitrox

The price of Sumamed analogues depends on the manufacturer and packaging. For example, the Russian analogue of Sumamed Azithromycin costs several times less. But you should not use a substitute yourself.

Sumamed or Azithromycin - which is better?

Azithromycin is a generic version of Sumamed, therefore, the price of Azithromycin is lower. Many patients are interested in what the difference between the drugs is, besides the cost. Azithromycin, as a copy, does not pass all the studies and tests, unlike Sumamed. Also, the composition of the tablet shells may differ in the preparations.

Sumamed or Suprax - which is better?

Suprax contains another active substance, cefixime . This substance has a pronounced bactericidal effect. But you need to take into account that the highest concentration after administration is achieved 4 hours after administration.

Which is better: Sumamed or Augmentin?

Augmentin contains the active substance amoxicillin , this antibiotic belongs to the group of penicillins. This remedy, unlike Sumamed, can be used from the first days of the baby’s life.

Z-Factor or Sumamed - which is better?

Zi-Factor is an analogue of Sumamed, containing a similar active substance. However, its price is lower.

Sumamed for children

Children under 12 years of age should not take 500 mg capsules and tablets; children under 3 years of age should not take 125 mg tablets. The syrup should not be taken until the child reaches 6 months of age. Basically, Sumamed suspension is prescribed for children. The dosage for children depends on the child's body weight. Children weighing 18-30 kg should receive antibiotic tablets at a dose of 250 mg per day, children weighing 31-44 kg - 375 mg per day. The dosage of the suspension for children also depends on body weight. Doses should be carefully measured to prevent an overdose in the child. Reviews indicate the effectiveness of the product for bronchitis in children, otitis media in children, etc.

It follows that the prescription should only be made by a pediatrician. Thus, 250 mg capsules can be taken by children only after a clear regimen has been prescribed by a doctor.

Reviews about Sumamed

There are different reviews about Sumamed on the forums. Many patients note that the antibiotic is convenient to take; they also write that it acts quickly for bronchitis, sore throat, and sinusitis. The suspension is also assessed positively by parents, as children like its taste, so it is easy to give to the child.

But there are also reviews that talk about side effects. In particular, when taking Sumamed, diarrhea and pain in the intestines sometimes occur. Parents who use Sumamed for children rarely leave reviews about side effects. They note that the product does not cause allergic reactions. Reviews from doctors are also mostly positive.

Sumamed price, where to buy

The price of Sumamed in tablets of 500 mg is from 350 to 450 rubles per pack of 3 pcs. You can buy Sumamed in Moscow at any pharmacy with a doctor's prescription. How much tablets cost in St. Petersburg depends on the place of sale. The cost of 125 mg tablets is from 300 to 400 rubles for 6 pieces. You can buy an antibiotic in 250 mg capsules at a price of 400 to 500 rubles for 6 capsules.

The price of the Sumamed suspension is on average 250 rubles per 50 ml bottle.

Suspension for children in Ukraine (Kyiv, Kharkov, etc.) costs, on average, 200-300 UAH. The powder from which baby syrup is made can be bought at any pharmacy.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Sumamed powder for suspension.
  for internal approx. 100mg/5ml/23ml 17gPliva Hrvatska d.o.o RUB 185 order
• Sumamed tablets p.p.o. 125 mg 6 pcs. Pliva Hrvatska d.o.o

  RUB 338 order

• Sumamed Forte powder for suspension. for internal approx. 200mg/5ml 35.37gPliva Hrvatska d.o.o

  RUR 556 order

• Sumamed Forte powder for suspension. for internal approx. 200mg/5ml 16.74gPliva Hrvatska d.o.o

  RUB 199 order

• Sumamed tablets p.p.o. 500mg 3 pcs.Pliva

  RUB 343 order

Pharmacy Dialogue

• Sumamed (por. d/p. suspension 100 mg/5 ml 17 g 20 ml) Pliva

  RUB 187 order

• Sumamed (tablet p/o 125 mg No. 6)Pliva

  RUB 343 order

• Sumamed capsules 250 mg No. 6Pliva

  RUB 377 order

• Sumamed tablets 500 mg No. 3Pliva

  402 rub. order

• Sumamed forte powder for suspension 200mg/5ml bottle 35.5mlPliva

  540 rub. order

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Pharmacy24

• Sumamed 1000 mg N3 tablets Pliva Hrvatska d.o.o., Croatia
  440 UAH order
• Sumamed forte 200 mg/5 ml 1500 mg 37.5 ml suspension

  262 UAH. order

• Sumamed forte 200 mg/5 ml 600 mg 15 ml suspension Pliva Hrvatska d.o.o., Croatia

  183 UAH order

• Sumamed forte raspberry 200 mg/5 ml 37.5 ml Pliva Hrvatska d.o.o., Croatia/AT Pharmaceutical plant TEVA, Ugorshchina

  259 UAH. order

• Sumamed 500 mg N6 tablets Pliva Hrvatska d.o.o., Croatia

  440 UAH. order

PaniPharmacy

• Sumamed forte liquid Sumamed forte powder 1500 mg for suspension 37.5 ml Croatia, Pliva

  208 UAH order

• Sumamed capsule Sumamed tablets 250 mg Croatia, Pliva

  192 UAH order

• Sumamed forte liquid Sumamed forte por. d/p susp. 200mg/5ml 37.5ml Croatia, Pliva

  216 UAH order

• Sumamed tablets Sumamed tablets 500 mg No. 3 Croatia, Pliva

  194 UAH order

• Sumamed forte liquid Sumamed forte powder for the preparation of suspension for oral use 200mg/5ml 30ml Croatia, Pliva

  210 UAH. order

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