Expiration dates: 03/2026
Structure and Composition:
The capsules
1 capsule contains Azithromycin (as dihydrate) 250 mg
Excipients: sodium lauryl sulfate magnesium stearate MCC
card of 6 pieces. in one blister box.
Tablets, film-coated
1 tablet contains azithromycin dihydrate 131.027 or 524.109 mg (Corresponds azithromycin - 125 and 500 mg)
Excipients:
Core: calcium hydrogen phosphate anhydrous, hypromellose, corn starch, pregelatinized starch, MCC, sodium lauryl sulfate, magnesium stearate
shell: hypromellose, dye indigo carmine (E132), polysorbate 80, titanium dioxide (E171), talc
in a blister pack 3 (500 mg) or 6 (125 mg) pieces. in one blister box.
Powder for suspension for oral administration (cooked suspension)
1 g contains Azithromycin (as dihydrate) 27.17 mg
excipients: saccharose, sodium carbonate anhydrous, sodium benzoate, tragacanth, titanium dioxide, glycine, colloidal silica, strawberry, apple and mint flavors
in dark glass bottles of 50 ml - 17 grams (complete with a dosing spoon, dosing syringe) in box 1 bottle.
Lyophilisate for solution for infusion
1 vial contains Azithromycin (as dihydrate) 524.1 mg (Corresponds azithromycin - 500 mg)
Excipients: citric acid monohydrate, sodium hydroxide
in bottles in cardboard pack of 5 bottles.
Sumamed forte
Powder for suspension for oral administration (cooked slurry)
5ml contains Azithromycin (as dihydrate) 200 mg
excipients: saccharose, anhydrous trisodium phosphate, hydroxypropyl xanthan gum, cherry flavoring J7549, 78701-31 banana flavoring, vanillin flavoring D-125,038, colloidal silicon dioxide
in bottles of 20, 35 or 42.5 ml (complete with a dosing spoon or a dosing syringe) in box 1 bottle.
Description pharmaceutical form:
Sumamed
Capsules: solid, gelatinous, opaque, size №1. Colour - blue, cover - blue. The contents of the capsule: a powder or compacted mass of white to light yellow in color, breaking up when pressed.
Tablets, film-coated cyan color, round (125 mg) and oblong (500 mg) to form biconvex surfaces and designation «PLIVA» - on one side and "125" or "500" - to another. Type in a break - from white to almost white.
Powder for oral suspension 100 mg / 5 ml: granular powder of white or light yellow color with a characteristic smell of a strawberry. After dissolution in water - a homogeneous suspension of white or pale-yellow color with a characteristic smell of a strawberry.
Lyophilisate for solution for infusion: dried powder or compacted mass of white.
Sumamed forte
Powder for suspension for oral administration: granular, white or light yellow color with a characteristic smell of banana and cherry. After dissolution in water - a homogeneous suspension of white or pale-yellow color with a characteristic smell of cherry and banana.
Pharmacokinetics:
When administered azithromycin is well absorbed and rapidly redistributed from plasma into tissues and organs. After a single oral administration of 500 mg of azithromycin 37% of the drug is absorbed, and after 2-3 hours in plasma Cmax observed drug - 0.41 g / ml. It is known that meal may reduce the absorption of azithromycin, however, due to failure in the firm-producer's own data on the effect of food on the pharmacokinetics of azithromycin when receiving Sumamed in suspension, it must be taken at least one hour before or two hours after meals .
The drug is rapidly distributed throughout the body, a high concentration of 50 times the concentration of azithromycin in plasma observed in tissues.
Depending on the organ / tissue concentration of the drug varies from 1.9 mg / ml. Vd averaged 31 l / kg.
Therapeutic concentration of azithromycin in tissues observed for 5-7 days after the last dose.
It penetrates into the cells, including phagocytes, which migrate into the inflammatory focus, contributing to the creation of therapeutic drug concentrations in excess of the MIC for infectious agents. The concentration of azithromycin in the infected tissues - higher compared to uninfected tissues.
It has a long T1 / 2 and is displayed slowly from the tissues (on average - 2-4 days). Excretion of azithromycin with bile - the main route of elimination. On average, up to 50% is excreted in the bile in unchanged form. The remaining 50% derived metabolites as 10, formed in the process N- and O-demethylation and hydroxylation of the aglycone ring desosamine and cladinose cleavage resulting conjugate. Metabolites have no antibacterial activity.
The urine output an average of 6% of the administered dose.
In elderly patients (65 years) Vd slightly higher (30%) compared to patients, aged less than 45 years, which is not clinically significant and does not require dose adjustments.
Pharmacokinetics of azithromycin in healthy volunteers after a single i / v infusion lasting more than two hours at a dose of 1000-4000 mg (concentration of the solution - 1 mg / ml) is linear and proportional to the administered dose. T1 / 2 of the drug is 65-72 hours. The observed high level Vd (33,3 l / kg) and plasma clearance (10.2 ml / min / kg), suggests that long T1 / 2 is the result of drug accumulation of the antibiotic in the tissues followed by slow its release.
In healthy volunteers, at / in infusion azithromycin 500 mg (concentration of the solution - 1 mg / ml) for 3 h Cmax of the drug in serum was 1.14 g / ml. The minimum level of serum (0.18 mg / ml) was observed during 24 hours and AUC was 8.03 g / ml · h. Similar pharmacokinetic values were obtained in patients with community-acquired pneumonia, who were appointed in / infusion (3-hour) for 2 to 5 days.
Following daily administration of azithromycin is 500 mg (infusion duration - 1 hour) for 5 days in an average 14% of the dose excreted in the urine over the 24 hour dosing interval.
Description of the pharmacological actions:
Azithromycin - bacteriostatic antibiotic with broad-spectrum macrolide-azalide. It has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of the microbial cell protein synthesis. By binding to the 50S-ribosomal subunit, inhibits peptidtranslokazu on broadcast stage and inhibits protein synthesis, slowing the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.
It has activity against a number of Gram-positive, Gram-negative, anaerobic, and other intracellular microorganisms.
Microorganisms can be initially resistant to antibiotics or may acquire resistance to it.
Most sensitive microorganisms
1. Gram-positive aerobes
Methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae penicillin Streptococcus pyogenes
2. Gram-negative aerobes
Haemophilus influenzae Haemophilus parainfluenzae Legionella pneumophila Moraxella catarrhalis Pasteurella multocida Neisseria gonorrhoeae
3. Anaerobes
Clostridium perfringens Fusobacterium spp. Prevotella spp. Porphyriomonas spp.
4. Other microorganisms
Chlamydia trachomatis Chlamydia pneumoniae Chlamydia psittaci Mycoplasma pneumoniae Mycoplasma hominis Borrelia burgdorferi
Organisms capable of developing resistance to azithromycin
gram-positive aerobes
Streptococcus pneumoniae penicillin-resistant
Initially resistant microorganisms
gram-positive aerobes
Enterococcus faecalis Staphylococcus (staphylococci metitsillinoustoychivye very high frequency have acquired resistance to macrolides)
Gram-positive bacteria resistant to erythromycin
Anaerobes
Bacteroides fragilis
Scale sensitivity of microorganisms presented in the table (see. Table 1).
Table 1
| MIC90&le0,01 µg/ml | |
| Mycoplasma pneumoniae | Haemophilus ducreyi |
MIC90 =0,01–0,1 µg/ml | |
| Moraxella catarrhalis | Propionibacterium acnes |
| Gardnerella vaginalis | Actinomyces spp. |
| Bordetella pertussis | Borrelia burgdorferi |
| Mobiluncus spp. | |
| MIC90 =0,01–2,0 µg/ml | |
| Haemophilus influenzae | Streptococcus pyogenes |
| Haemophilus parainfluenzae | Streptococcus pneumoniae |
| Legionella pneumophila | Streptococcus agalactiae |
| Neisseria meningitidis | Streptococcus viridans |
| Neisseria gonorrhoeae | Streptococcus группы С, F и G |
| Helicobacter pylori | Peptococcus spp. |
| Campylobacter jejuni | Peptostreptococcus |
| Pasteurella multocida | Fusobacterium necrophorum |
| Pasteurella melitensis | Clostridium perfringens |
| Bordetella parapertussis | Bacteroides bivius |
| Vibrio cholerae | Chlamydia trachomatis |
| Plesiomonas shigelloides | Chlamydia pneumoniae |
| Staphylococcus aureus | Ureaplasma urealyticum |
| Staphylococcus epidermidis | Listeria monocytogenes |
| MIC90 = 2,0–8,0 µg/ml | |
| Escherichia coli | Bacteroides fragilis |
| Salmonella enteritidis | Bacteroides oralis |
| Salmonella typhi | Clostridium difficile |
| Shigella sonnei | Eubacterium lentum |
| Yersinia enterocolitica | Fusobacterium imcleatum |
| Acinetobacter calcoaceticus | Aeromonas hydrophilia |
Azithromycin has no effect on gram-positive bacteria resistant to erythromycin.
Testimony:
Sumamed (capsule powder for oral suspension)
Sumamed forte (powder for oral suspension)
infections of the upper respiratory tract, ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, otitis media)
lower respiratory tract infections (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis)
Skin and soft tissue infections (chronic erythema migrans - the initial stage of Lyme disease, erysipelas, impetigo, secondary pyoderma)
infections, sexually transmitted infections (urethritis, cervicitis)
diseases of the stomach and duodenal ulcers associated with Helicobacter pylori.
Sumamed (tablets, film-coated)
infections of the upper respiratory tract, ENT organs (pharyngitis / tonsillitis, sinusitis, otitis media)
lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens)
Skin and soft tissue infections (acne vulgaris of moderate severity, erysipelas, impetigo, secondarily infected dermatoses)
the initial stage of Lyme disease (borreliosis) - erythema mygrans
urinary tract infections, transmitted Chlamidia trachomatis (urethritis, cervicitis).
Sumamed (lyophilisate for solution for infusion)
Treatment of severe infections caused by susceptible strains of microorganisms:
community-acquired pneumonia heavy flow due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae
infectious and inflammatory diseases of the pelvic organs heavy currents caused by Chlamydia trachomatis or Neisseria gonorrhoeae and Mycoplasma hominis.
Contraindications:
Sumamed (capsule powder for oral suspension)
Sumamed forte (powder for oral suspension)
hypersensitivity to macrolide antibiotics
severe liver and kidney function.
Carefully:
infants (due to lack of sufficient clinical experience)
pregnancy and lactation period, ie in cases where the expected benefits from its use outweighs the potential risk that exists when using any drug in these periods
impaired liver and kidney function
arrhythmia or predisposition to QT prolongation them interval (according to the literature, the incidence of 0.001% of cases).
Sumamed (tablets, film-coated)
hypersensitivity to macrolide antibiotics
severe liver and kidney function
Children under 12 years of age with a body weight less than 45 kg (for 500 mg tablets)
Children up to age 3 years (for tablets of 125 mg)
breast-feeding
concomitant use with ergotamine and dihydroergotamine.
Carefully:
moderate impaired liver and kidney function
arrhythmia or predisposition to them and lengthening the QT interval
co-administration of terfenadine, warfarin, digoxin.
Sumamed (lyophilisate for solution for infusion)
Hypersensitivity to macrolide antibiotics
severe liver and kidney function
breast-feeding
concomitant use of ergotamine and dihydroergotamine with
Children up to age 16 years.
Carefully:
moderate impaired liver and kidney function
arrhythmia susceptibility to arrhythmia, QT prolongation
co-administration of terfenadine, warfarin, digoxin.
Application of pregnancy and breastfeeding:
Azithromycin is used during pregnancy if the effect of the treatment exceeds the potential risk to the fetus. During treatment breast feeding is suspended drug.
Side effect:
Sumamed (capsule powder for oral suspension)
Sumamed forte (powder for oral suspension)
Most celebrated of adverse reactions, from mild to moderately severe, reversible after treatment or discontinuation of the drug.
On the part of the digestive tract: nausea, vomiting, bloating, constipation, abdominal pain, diarrhea, rarely - cholestatic jaundice, loss of appetite, gastritis rarely - candidiasis of the oral mucosa.
Allergic reactions: rash, itching, rash, rarely - angioneurotic edema and anaphylactic shock.
From the laboratory parameters: reversible increases in liver transaminases, bilirubin level, the number of eosinophils, these figures are returning to normal levels within 2-3 weeks after completion of therapy. In very rare cases, possibly a transient decrease in the number of neutrophils and eosinophils, but a causal relationship has not been found. Changed indicators to nourish limit of normal 2-3 weeks after cessation of treatment.
From the CCC: palpitations, chest pain.
From the nervous system: dizziness, vertigo, headache, paresthesia, agitation, drowsiness in children - a headache (in the treatment of otitis media), irritability, hyperkinesia, anxiety, neurosis, sleep disturbance.
With the genitourinary system: vaginal candidiasis, jade.
Other: conjunctivitis, photosensitivity, fatigue.
Sumamed (lyophilisates for solution for infusion tablets, film-coated)
Classification of adverse reactions of the frequency (the number of reported cases / number of patients): often - & ge1 / 100 and <1/10 uncommon - & ge1 / 1000 and <1/100 rarely - & ge1 / 1000 and <1/1000 rarely - <1 / 10000.
From the circulatory and lymphatic systems. Common to both forms: rarely - thrombocytopenia, neutropenia, eosinophilia.
On the part of the central nervous system. Common to both forms of dizziness / vertigo, headache, seizures, drowsiness, rarely - paresthesia, fatigue, insomnia, aggressiveness, anxiety, nervousness. For further lyophilisate: irritability, fainting.
From the senses. Common to both forms: rarely - tinnitus, reversible hearing impairment including deafness (when taking high doses for a long time), impaired perception of taste and smell. For the freeze-dried further. impaired vision.
From the CCC. Common to both forms: rarely - palpitations, arrhythmias, including ventricular tachycardia, an increase in the QT interval. For further lyophilisate: lowering blood pressure.
On the part of the digestive tract. Common to both forms: often - nausea, vomiting, diarrhea, abdominal pain and cramps rarely - diarrhea, flatulence, indigestion, anorexia, rarely - constipation, change the language of color, pseudomembranous colitis. For the freeze-dried further. rarely - cholestatic jaundice, hepatitis, changes in laboratory tests of liver function are rarely - pancreatitis, hepatic necrosis, hepatic failure (possibly fatal). For tablets, film-coated Optional: rarely - cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function is very rarely - liver dysfunction, hepatic necrosis (possibly fatal).
Allergic reactions. Common to both forms - itching, skin rashes, rarely - angioedema, rash, photosensitivity, anaphylactic reactions, including edema (in rare cases - fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
On the part of the musculoskeletal system. Common to both forms - rarely - arthralgia.
With the genitourinary system. Common to both forms - rarely - nephritis, acute renal failure.
Other. For tablets, film-coated: rarely - vaginitis, candidiasis. For the freeze-dried: Infrequent - candidiasis rarely - fatigue, malaise, anorexia, vaginitis, fungal infection of the mouth and genitals.
Local reactions. For the lyophilisate often - pain and inflammation at the injection site.
Drug Interactions:
Sumamed (capsules coated tablets powder for oral suspension)
Sumamed forte (powder for oral suspension)
Antacids do not affect the bioavailability of azithromycin, but reduce the maximum blood concentration of 30%, and the drug should be taken at least one hour before or two hours after administration of these drugs and food.
Azithromycin concentration does not affect carbamazepine, didanosine, rifabutin and methylprednisolone in blood when used together.
For parenteral administration, azithromycin does not affect the concentration of cimetidine, efavirenz, fluconazole, indinavir, midazolam, triazolam, in the blood of trimethoprim / sulfamethoxazole for sharing, but you should not exclude the possibility of such interactions in the appointment of azithromycin for oral administration.
Azithromycin has no effect on the pharmacokinetics of theophylline, but when coadministered with other macrolides theophylline concentration in blood plasma can rise.
If necessary, the joint use with cyclosporine is recommended to control the content of cyclosporine in the blood. Despite the fact that the data on the influence of azithromycin on a change in the blood concentration of cyclosporine no other members of the macrolide class capable of changing its level in the blood plasma.
When co-administered azithromycin digoxin and digoxin must monitor blood because Many macrolide digoxin enhance absorption in the gut, thereby increasing its concentration in blood plasma.
If necessary, co-administration with warfarin is recommended careful monitoring of PV.
It has been found that co-administration of terfenadine and macrolide antibiotics class causes elongation and fibrillation interval QT. On this basis, we can not exclude the development of the above-mentioned complications by sharing a terfenadine and azithromycin.
Since there is the possibility of inhibiting the enzyme CYP3A4 azithromycin in parenteral form with a joint appointment with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs, the metabolism of which is mediated by the enzyme, one should consider the possibility of such an interaction in the appointment of azithromycin for the reception inside.
When co-administered with nelfinavir may increase the frequency of side effects from the azithromycin.
When co-administered azithromycin and azithromycin AZT does not affect the pharmacokinetic parameters of AZT in the blood plasma or its renal excretion and its glucuronide metabolite. However, increasing the concentration of the active metabolite - phosphorylated AZT mononuclear cells in peripheral blood vessels. The clinical significance of this fact is not clear.
At simultaneous reception of macrolides with ergotamine and dihydroergotamine possible manifestation of their toxic effect.
Dosage and administration:
sumamed
Capsules
Inside, 1 time per day. Capsules are taken at least 1 hour before or 2 hours after eating.
Children 6 months of use the drug in an oral suspension or tablets of 125 mg.
With infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic erythema migrans)
Adults - 500 mg 1 time per day for 3 days (course dose - 1.5 g) for children - a rate of 10 mg / kg, 1 time per day for 3 days (course dose - 30 mg / kg).
Chronic erythema migrans. Adults - 1 times a day for 5 days: Day 1 - 1.0 g, and then (from the 2nd to 5th day), 500 mg (course dose - 3.0 g) to the children at the 1- day - 20 mg / kg, and then from the 2nd to 5th day - a daily dose of 10 mg / kg (course dose - 30 mg / kg).
For infections, sexually transmitted infections
Uncomplicated urethritis / cervicitis - 1 g once.
A method for preparing a suspension of
In a bottle containing 17 g powder, make 12 ml of distilled or boiled water. The volume of the resulting slurry - 23 ml. Shelf life of prepared suspension - 5 days. Before taking the contents of the vial thoroughly stirred until a homogeneous suspension. Immediately after receiving the suspension gives the child a few sips a drink teas in order to flush the remaining amount and swallow oral suspension.
After using a feeding syringe dismantled and washed in running water, dried and stored in a dry place with the drug.
Tablets, film-coated
Sumamed tablets 125 mg
Inside, not liquid, at least 1 hour before or 2 hours after a meal, 1 times a day. For children under 3 years are designated Sumamed suspension (100 mg / 5 mL).
Babies are metered based on the values of body weight: the body weight 18-30 kg - 2 tablets. 125 mg (250 mg) of 31-44 kg -. Table 3 (375 mg) is greater than or equal to 45 kg administered dose recommended for adults.
With infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues. At the rate of 10 mg / kg, 1 time per day for 3 days (course dose - 30 mg / kg). For the convenience of dosing is recommended to take into account the above information on this dosing based on body weight /
Due to the fact that the erythema migrans course dose 60 mg / kg (20 mg / kg one time a day on day 1, then - at the rate of 10 mg / kg one time a day, from 2 to 5 th day), which requires large quantities receiving 125 mg tablets, it is recommended to use of the drug Sumamed oral suspension 100 mg / 5 ml.
Sumamed tablets 500 mg
The inside is not liquid, 1 time a day, regardless of meals.
Adults (including the elderly) and children over 12 years weighing more than 45 kg /
With infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues. According to Table 1. (500 mg), 1 times a day for three days (a course dose - 1.5 g).
When acne vulgaris of moderate severity. Course dose - 6.0 g In Table 1. (500 mg), 1 time per day for 3 days, then - Table 1. (500 mg), 1 time per week for 9 weeks. Weekly first pill to be taken 7 days after the first pill daily (day 8 from the start of treatment), the next 8 weekly tabs - with an interval of 7 days.
If erythema migrans. 1 times a day for 5 days: Day 1 - 1.0 g (2 tablets at 500 mg.), Then (with the 2nd to 5th day) - Table 1. (500 mg) (course dose - 3.0 g).
If urinary tract infections caused by Chlamidia trachomatis (urethritis, cervicitis)
Uncomplicated urethritis / cervicitis - 1 g (2 tablets of 500 mg.) Once.
Appointment of patients with impaired renal function. For patients with moderate renal impairment (Cl creatinine> 40 ml / min) dose adjustment is not necessary.
sumamed
Lyophilisate for solution for infusion
B / in the form of infusion drip for 3 hours - at a concentration of 1 mg / ml, for 1 hour - at a concentration of 2 mg / ml. Avoid introducing higher concentrations due to the risk of reactions at the injection site.
Sumamed should not be administered intravenously or intramuscularly!
Community-acquired pneumonia: 500 mg once a day for at least two days. After the on / in the recommended appointment of azithromycin orally in a single daily dose of 500 mg to completion 7-10-day total course of treatment.
Infectious-inflammatory diseases of the pelvic organs: 500 mg / once in a day for 2 days. After the on / in the recommended appointment of azithromycin orally at a dose of 250 mg to complete a full 7-day total course of treatment.
Timing of the transition from / in the introduction of the drug into the reception determined by the physician in accordance with the data of the clinical examination.
Impaired renal function. For patients with moderate renal impairment (Cl creatinine> 40 ml / min) dose adjustment is not necessary.
Preparation of the infusion solution
The solution for infusion is prepared in 2 stages.
Stage 1 - Preparation of first solution: a vial of 500 mg was added 4.8 mL sterile water for injection and shaken thoroughly until complete dissolution of the powder. 1 ml solution containing 100 mg of azithromycin, it should be immediately used for further breeding. The reconstituted solution is checked for visible undissolved particles in the solution should otherwise not be used.
Stage 2 - secondary dilution of the reconstituted solution (100mg / mL) was carried out immediately prior to administration, according to the following table.
Table 2
| The concentration of azithromycin in the infusion solution, mg / ml | The amount of solvent, ml |
| 1,0 | 500 |
| 2,0 | 250 |
The primary solution was added to the vial with the solvent (0.9% sodium chloride, 5% dextrose, Ringer's solution) to a final concentration of 1.0-2.0 mg azithromycin / mL infusion solution.
