Сумамед® forte

General characteristics. Structure:

5 ml of the prepared suspension contain:
Active agent of azithromycin (in the form of a dihydrate) - 200 mg and
auxiliary components: sucrose, trisodium phosphate anhydrous, hydroxypropyl cellulose, xanthane gum, aroma of J7549 cherry, banana 78701-31, D-125038 vanilla, silicon dioxide colloid.

Description: the granulated powder of white or light yellow color with a characteristic smell of banana and cherry. After dissolution in water - homogeneous suspension of white or light yellow color with a characteristic smell of banana and cherry.

Pharmacological properties:

Pharmacodynamics. Possesses a wide range of antimicrobic action. Communicating with 50S-cybjedinitsey ribosomes, suppresses biosynthesis of proteins of a microorganism. In high concentration has bactericidal effect.

Has activity concerning a row gram-positive, gram-negative, anaerobe bacterias, intracellular and other microorganisms.

Minimum overwhelming concentration (MIC90) ≤ 0,01 mkg/ml 
 
 Mycoplasma pneumoniae Haemophilus ducreyi 
MIC90 = 0,01 – 0,1 mkg/ml 
Moraxella catarrhalis
Gardnerella vaginalis
Bordetella pertussis
 Mobiluncus species Propionibacterium acnes
Actinomyces species
Borrelia burgdorferi 
MIC90 = 0,1 – 2,0 mkg/ml 
  Haemophilus influenzae Streptococcus pyogenes 
 Haemophilus parainfluenzae Streptococcus pneumoniae 
 Legionella pneumophila Streptococcus agalactiae 
 Neisseria meningitidis Streptococcus viridans 
 Neisseria gonorrhoeae Streptococcus of group C, F and G 
 Helicobacter pylori Peptococcus species 
 Campylobacter jejuni Peptostreptococcus 
 Pasteurella multocida Fisobacterium necrophorum 
 Pasteurella melitensis Clostridium perfringens 
 Bordetella parapertussis Bacteroides bivius 
 Vibrio cholerae Chlamydia trachomatis 
 Plesiomonas shigelloides Chlamydia pneumoniae 
 Staphylococcus aureus Ureaplasma urealyticum 
 Staphylococcus epidermidis Listeria monocitogenes 
 MIC90 = 2,0 – 8,0 mkg/ml 
 Escherichia coli Bacteroides fragilis 
 Salmonella enteritidis Bacteroides oralis 
 Salmonella typhi Clostridium difficile 
 Shigella sonnei Eubacterium lentum 
 Yersinia enterocolitica Fusobacterium nucleatum 
 Acinetobacter calcoaceticus Aeromonas hydrophilia 

Pharmacokinetics. At intake azithromycin is well soaked up and quickly redistributed from plasma in fabrics and bodies. After a single dose in 500 mg of azithromycin of 37% of drug it is absorbed and in 2-3 hours in plasma the maximum concentration of drug - 0,41 mkg/ml is noted. It is known that meal can reduce azithromycin absorption, however because of insufficiency at manufacturing firm of own data on influence of food on azithromycin pharmacokinetics at Sumamed's reception in the form of suspension, it should be accepted, at least, in 1 hour prior to or in 2 hours after food.

Drug is quickly distributed on all organism, the high concentration of drug exceeding by 50 times concentration of azithromycin in plasma are observed in fabrics.

Depending on the location concentration of drug fluctuates within 1-9 mkg/ml. The volume of distribution averages 31 l/kg.

Therapeutic concentration of azithromycin in fabrics is noted within 5-7 days after reception of the last dose.

Gets in cells, including phagocytes which migrate in the inflammation center, promoting creation of the therapeutic concentration of drug exceeding the minimum overwhelming concentration for contagiums. Concentration of azithromycin in the infected fabrics higher in comparison with not infected fabrics.

Drug has high intracellular activity since in phagocytes high concentration of azithromycin are created.

Possesses a long elimination half-life and it is slowly brought out of fabrics (on average 2-4 days). Removal of azithromycin with bile – the main way of removal. On average to 50% it is removed with bile in an invariable form. Other 50% are removed in the form of 10 metabolites formed in the course of N-and O-demethylation, a hydroxylation of a dezozamin and an aglikonovy ring and as a result of splitting of a kladinoza of a conjugate. Metabolites have no antibacterial activity.

With urine 6% of the entered drug dose are removed on average.

At elderly patients (65 years are more senior) the volume of distribution slightly higher (30%) in comparison with patients, which age less than 45 years that clinically not significantly and does not demand change of a dosage.

Indications to use:

• Infections of ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis);
• Lower respiratory tract infections (bacterial bronchitis, intersticial and alveolar pneumonia, exacerbation of chronic bronchitis);
• Infections of skin and soft tissues (the chronic migrating erythema - an initial stage of a disease of Lyme, an ugly face, impetigo, secondary pyodermatoses);
• Infections, sexually transmitted (urethritis, cervicitis)
• The diseases of a stomach and a 12-perstny gut associated with Helicobacter pylori.

Route of administration and doses:

Inside, 1 time a day, at least, in 1 hour prior to or in 2 hours after food.

At an infection of upper and lower respiratory tracts, skin and soft tissues (except for the chronic migrating erythema) a total dose of 30 mg/kg, i.e. 10 mg/kg of body weight once in days within 3 days.

To children dose proceeding from weight:

Body weight                     drug Volume, in ml
                                  (amount of azithromycin in mg)
10-14                      kg 2,5 ml (100 mg)
15-24                      kg 5,0 ml (200 mg)
25-34                      kg 7,5 ml (300 mg)
35-44                      kg 10,0 ml (400 mg)
≥ 45                        kg 12,5 ml (500 mg)
 
At the chronic migrating erythema the total dose of drug makes 60 mg/kg: once in day on 20 mg/kg – in the 1st day and on 10 mg/kg - in the next days from 2 to 5 day.

At the diseases of a stomach and a 12-perstny gut associated with Helicobacter pylori:

20 mg/kg of body weight once in day in combination with anti-secretory means and other medicines according to the recommendation of the doctor.

If the dose of drug was passed, it needs to be accepted, whenever possible, at once, and then to accept the subsequent doses at an interval of the 24th hour.

At infections, sexually transmitted

Uncomplicated urethritis / cervicitis – 1 g once.

Complicated, it is long the proceeding urethritis/cervicitis caused by Chlamydia trachomatis - on 1 g three times at an interval of 7 days (1-7-14). Course dose of 3 g.

Way of preparation of suspension  

For preparation of 15 ml of suspension (nominal volume) it is necessary to add to the bottle containing 600 mg of azithromycin 8 ml of water (the actual volume - 20 ml of suspension).

For preparation of 30 ml of suspension (nominal volume) it is necessary to add to the bottle containing 1200 mg of azithromycin 14,5 ml of water (the actual volume - 35 ml of suspension).

For preparation of 37,5 ml of suspension (nominal volume) it is necessary to add to the bottle containing 1500 mg of azithromycin 16,5 ml of water (the actual volume – 42,5 ml of suspension).

Each bottle has to contain suspensions 5 ml more course dose for fuller extraction of drug from a bottle.

Period of validity of the prepared suspension of 5 days at a temperature not above 25 °C.

By means of the syringe for dosing measure a necessary amount of water, add to a bottle with powder. Before reception bottle contents  are carefully shaken up before receiving homogeneous suspension.

For dosing of ready suspension use the syringe or a measured spoon. Directly after suspension reception to the child allow to drink several drinks of tea or juice to wash away and swallow the remained amount of suspension in an oral cavity.

After use the syringe is disassembled and washed out flowing water, dried and stored together with drug.

Features of use:

In case of the admission of reception of one dose of drug - it is necessary to accept the passed dose as soon as possible, and the subsequent - with breaks at 24 o'clock

There is no need for longer, than recommended in the application instruction, courses of treatment.

Side effects:

The majority of noted side reactions from lungs to moderately heavy are also reversible after the termination of a course of treatment or drug withdrawal.

From digestive tract: nausea, vomiting, a meteorism, a lock, abdominal pains, diarrhea, seldom cholestatic jaundice, a loss of appetite, gastritis, it is very rare – a candidiasis of a mucous membrane of an oral cavity.

Allergic reactions: rash, skin itch, small tortoiseshell; seldom Quincke's disease and acute anaphylaxis.

From laboratory indicators:

reversible increase in activity of hepatic transaminases, bilirubin, number of eosinophils; these indicators are returned to normal level in 2-3 weeks after the end of therapy.

In extremely exceptional cases perhaps taking place decrease in number of neutrophils against the background of therapy by azithromycin, however relationship of cause and effect is not revealed.

From cardiovascular system: heartbeat, thorax pain.

From a nervous system: dizziness, вертиго, a headache, paresthesias, excitement, drowsiness, children have a headache (at therapy of average otitis), irritability, a hyperkinesia, uneasiness, neurosis, sleep disorders.

From urinogenital system: vaginal candidiasis, nephrite.

Others: conjunctivitis, photosensitization, increased fatigue,

It is necessary to inform the attending physician on emergence of any side effect.

Interaction with other medicines:

• Antiacid means and meal substantially reduce suspension azithromycin absorption therefore drug should be accepted, at least, in one hour prior to or in two hours after reception of these drugs and food.
• At a concomitant use of makrolidny antibiotics and drugs of alkaloids of an ergot development of an ergotism is possible, however there are no drugs of derivative alkaloids of an ergot and azithromycin given about interaction.
• Interaction of makrolidny antibiotics with digoxin, cyclosporine, astemizoly, triazolamy, midazolam or alfentanil is noted. Though there are no data on interaction of azithromycin and above-mentioned medicines, it is recommended to carry out under observation of the doctor a concomitant use of azithromycin with these drugs.
• Influence of azithromycin on concentration in blood of theophylline, a terfenadin, carbamazepine, Methylprednisolonum and Cimetidinum as, unlike the majority of macroleads, azithromycin does not contact a complex R-450 cytochrome is noted.
• At joint reception with warfarin increase in a prothrombin time and frequency of emergence of hemorrhages is possible.

Contraindications:

• Hypersensitivity to antibiotics of group of macroleads;
• Heavy abnormal liver functions.

With care: the newborn (due to the lack of sufficient clinical experience), at pregnancy and in the period of a lactation i.e. when the expected advantage of its use exceeds the potential risk existing when using any drug during these periods; At abnormal liver functions, the patient having disturbances or predisposed to arrhythmias and lengthening of an interval of QT (according to literature occurrence in 0,001% of cases) to take drug also with caution.

Overdose:

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

Storage conditions:

List B
To store at a temperature not above 25 °C.
To store in the place, unavailable to children.

Period of validity
Powder for suspension preparation - 2 years.
The prepared suspension – 5 days at a temperature not above 25 °C.
Not to apply after a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 16,740 g or 29,295 g or 35,573 g of powder place in a glass bottle of brown color of 50 ml or 100 ml with a polypropylene resistant cover.

1 bottle together with the application instruction, a measured bilateral spoon and/or the syringe for dosing is put in a cardboard pack.