Spayzef

General characteristics. Structure:

Active ingredient: 250 mg or 500 mg of a tsefuroksim in the form of a tsefuroksim of an aksetil of DC гранул*.

Structure of granules of a tsefuroksim of an aksetil of DC: aksetit a tsefuroksim, starch prezhelatinizirovanny, croscarmellose sodium, sodium lauryl sulfate, silicon dioxide colloid.

Structure of a film cover: опадрай Y-1-7000 white ** (gipromelloz (E464), titanium dioxide (E171), macrogoal).

* the quantity of granules of a tsefuroksim of an aksetil is equivalent to 54.5% of a tsefuroksim (1.2 mg of a tsefuroksim of an aksetil are equivalent to 1 mg of a tsefuroksim).
** the quantity of a film cover опадрай white is taken Y-1-7000 from 10% by surplus taking into account losses by production.

Pharmacological properties:

Pharmacodynamics. Spayzef - a tsefalosporinovy antibiotic of the II generation of a broad spectrum of activity. Works bakteritsidno, breaks synthesis of a cell wall of bacteria.

Spayzef is steady against action of the majority beta лактамаз, is highly active concerning aerobic gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis (including the strains steady against penicillin and except for rare Methicillinum - resistant strains), Streptococcus pyogenes (and other beta and hemolitic streptococci), Streptococcus pneumoniae, Streptococcus of group B (Streptococcus agalactiae), Streptococcus mitis (viridans group), Bordetella pertusis; aerobic gram-negative bacteria: Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae (including ampicillin - resistant strains), Haemophilus parainfluenzae (including ampicillin - resistant strains), Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae (including the strains which are producing and not producing a penicillinase), Neisseria meningitidis, Salmonella spp.; anaerobic gram-positive bacteria: Peptococcus spp., Peptostreptococcus spp., Clostridium spp, Propionibacterium spp.; anaerobic gram-negative bacteria: Bacteroides spp, Fusobacterium spp., Borrelia burgdorferi.

Clostridium difficile, Pseudomonas spp are steady against Spayzef., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, Methicillinum - resistant strains of Staphylococcus aureus, Methicillinum - resistant strains of Staphylococcus epidermidi, Citobacter spp., Serratia spp., Legionella spp.

Pharmacokinetics. After intake by tsefuroksy aksetit it is soaked up from the digestive tract (DT) and quickly hydrolyzed in a mucous membrane of intestines and blood with a vyvobozhdeniye of a tsefuroksim in a system blood stream. After reception of tablets Spayzef the maximum concentration in blood is defined by 2-4 h. Extent of linkng of a tsefuroksim with proteins makes from 33% to 50%. Therapeutic concentration of a tsefuroksim are observed in pleural liquid, bile, a phlegm, skin and soft tissues. Spayzef does not biotransformirutsya in an organism, is allocated with kidneys in not changed look. The elimination half-life makes 1,2-1,6 h. At patients with a renal failure the elimination half-life increases and makes 1.9 - 16,1 h.

Indications to use:

— pneumonia, bronchitis, pharyngitis, tonsillitis, sinusitis;

— infections of urinary tract;

— infections of soft tissues and skin;

— infections of bones and joints;

— sepsis;

— meningitis;

— gonorrhea, the uncomplicated and disseminated gonococcal infections both at men, and at women;

— Lyme's disease at an early stage and the subsequent prevention of late manifestations at adults and children is more senior than 12 years;

— prevention of infectious complications at operations on bodies of a thorax, abdominal cavity, bodies of a small pelvis, joints.

Route of administration and doses:

Drug is recommended to be accepted after food. Duration and doses of use of tablets Spayzef depends on disease severity and a condition of the patient.

For adults the single dose at the majority of infections averages 250 mg of 2 times/days. Duration of treatment and the recommended doses at various diseases at adults and children are specified in the table.

At the majority of infections	on 250 mg 2nd time/day
Infections of urinogenital ways	on 125 mg of 2 times/days
Pyelonephritis	on 250 mg of 2 times/days
Lower respiratory tract infection of easy and average degree, for example bronchitis	on 250 mg of 2 times/days
Heavy lower respiratory tract infections or at suspicion of pneumonia	on 500 mg of 2 times/days
Uncomplicated gonorrhea	single dose of 1 g
Lyme's disease at adults and children is more senior than 12 years	on 500 mg of 2 times/days within 20 days
Acute average otitis at children is more senior than 6 years	250 mg of 2 times/days 10 days
Acute bacterial sinusitis at children is more senior than 6 years	250 mg of 2 times/days 10 days

Duration of reception averages 7 days (5-10 days).

Features of use:

Use at pregnancy and feeding by a breast. It is contraindicated in the I trimester of pregnancy. Use in II and III trimesters of pregnancy, and also in the period of a lactation perhaps in cases when the estimated advantage of therapy for mother exceeds potential risk for a fruit.

Use for children. It is contraindicated at children's age up to 6 years.

Special instructions. With extra care appoint Spayzef to patients with hypersensitivity to antibiotics of a petsitsillinovy row and other beta lactamelements.

At prolonged treatment the strengthened growth of steady microorganisms (Candida, Enterococci, Clostridium difficile) is possible that it can demand the treatment termination.

At emergence of diarrhea against the background of use of antibiotics, including Spayzef, it must be kept in mind a possibility of development of pseudomembranous colitis.

At treatment by drug Spayzef Lyme's diseases is sometimes marked out Yarisha-Gersgeymer's reaction. This reaction is a direct consequence of bactericidal action of Spayzef on an infestant – Borrelia burgdorferi spirochete, and is frequent and usually, spontaneously passing treatment effect. Patients have to be informed that these symptoms are a typical consequence of use of antibiotics at this disease.

At step therapy time of switching to peroral therapy is defined by weight of an infection, a clinical condition of patients and sensitivity of the activator. If there is no clinical effect within 72 h of an initiation of treatment, the parenteral course of therapy has to be continued.

Against the background of Spayzef's use it is dangerous to take alcoholic drinks since antabusopodobny actions can appear (diarrhea, nausea, tachycardia, face reddening, etc.)

Influence on ability to driving of motor transport and to control of mechanisms. As at administration of drug there can be dizziness cases, it is necessary to be careful at control of vehicles and other mechanisms.

Side effects:

Often: the strengthened growth of steady microorganisms of the sort Candida, an eosinophilia, a headache, dizziness, gastrointestinal frustration, including diarrhea, nausea, a stomach ache, temporary increase in activity of enzymes of a liver (ALT, nuclear heating plant, LDG).

Infrequently: positive reaction of Koombs, thrombocytopenia, leukopenia (sometimes sharply expressed), skin rash, vomiting.

Seldom: urticaria, itch, pseudomembranous colitis.

Very seldom: hemolitic anemia, fever, serum disease, anaphylaxis, jaundice (especially cholestatic), hepatitis, multiformny erythema, Stephens-Johnson's syndrome, toxic epidermal necrolysis (ekzantemalny necrolysis).

Interaction with other medicines:

Simultaneous peroral purpose of "loopback" diuretics slows down canalicular secretion, reduces renal clearance, increases concentration in plasma and increases T? tsefuroksima. At simultaneous use of Spayzef in high doses with aminoglycosides and diuretics the risk of emergence of nephrotoxic effects increases. Simultaneous introduction of Spayzef and a probenetsid leads to disturbance of excretion of Spayzef.

Contraindications:

— hypersensitivity to antibiotics of group of cephalosporins, penicillin and Carbapenums;

— pregnancy I trimester;

— children's age up to 6 years.

Overdose:

Symptoms: dizziness, headache, paresthesias.

Treatment: symptomatic. Drug is removed at a hemodialysis or peritoneal dialysis.

Storage conditions:

Issue conditions:

According to the recipe

Packaging:

10 pieces - packagings bezjyacheykovy planimetric (1) - packs cardboard.