Ампиокс®-натрий

General characteristics. Structure:

Active ingredient: 133,4 mg or 333,5 mg of ampicillin of sodium (in terms of active agent), 66,6 mg or 166,5 mg of Oxacillinum of sodium (in terms of active agent).

Pharmacological properties:

Pharmacodynamics. Ампиокс®-натрий - the combined antibiotic, possesses the wide antibacterial range combining ranges of ampicillin and Oxacillinum. Ampicillin - semi-synthetic penicillin, works bakteritsidno, кислотоустойчив.

It is active concerning gram-positive (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae) and gram-negative (Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Salmonella spp., Shigella spp., Proteus mirabilis, Haemophilus influenzae) microorganisms.

Oxacillinum - a semi-synthetic antibiotic from group of penicillin, steady against action of a penicillinase; possesses bactericidal action concerning gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., including Streptococcus pneumoniae, Bacillus anthracis, Corynebacterium diphtheriae, anaerobic spore-forming sticks, including Clostridium spp.), gram-negative cocci (Neisseria gonorrhoeae, Neisseria meningitidis), Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Klebsiella pneumoniae, Actinomyces spp., Treponema spp.

Pseudomonas aeruginosa, the majority of strains of Proteus vulgaris, Providencia rettgeri, Morganella morganii are steady against action of Ampioksa®-natriya.

Pharmacokinetics. The maximum concentration of both antibiotics in blood are found in 0,5-1 h after intramuscular introduction. At intravenous administration in blood quickly (in 5-10 min.) the concentration of drug exceeding those at intramuscular introduction are created.

Drug well gets into different bodies and fabrics. Are brought out of an organism preferential by kidneys, partially with bile. At repeated introductions in an organism of the patient do not kumulirut.

Indications to use:

The infectious and inflammatory diseases caused by sensitive microflora: sinusitis, tonsillitis, average otitis; bronchitis, pneumonia; cholangitis, cholecystitis; pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, cervicitis; infections of skin and soft tissues: the ugly face, impetigo for the second time infected a dermatosis; dysentery, salmonellosis, salmonellonositelstvo.

Prevention of postoperative complications at surgical interventions (including against the background of an immunodeficiency), infections at newborns (infection of amniotic liquid; the disturbance of breath of the newborn demanding use of resuscitation measures, danger of developing of aspiration pneumonia). Sepsis, endocarditis, meningitis, puerperal infection.

Route of administration and doses:

Ампиокс®-натрий enter intramusculary or intravenously (struyno or kapelno). At parenteral administration the single dose of drug for adults and children is more senior than 14 years makes 0,5-1 g, a daily dose of 2-4 g. To newborn, premature children and children till 1 year drug appoint in a daily dose 100-200 mg/kg, to children from 1 year to 7 years - on 100 mg/kg/days; from 7 to 14 years - 50 mg/kg/days; 14 years - in a dose of adults are more senior. At the heavy course of infections the specified doses can be increased by 1,5-2 times. The daily dose is entered into 3-4 receptions with an interval of 6-8 h.

Duration of treatment is from 5-7 days up to 3 weeks (depending on disease severity). Solutions for intramuscular introduction are prepared, adding to bottle contents (133,4 mg + 66,6mg) or (333,5 mg + 166,5 mg) 2 or 5 ml of water for injections respectively. For intravenous jet administration drug (single dose) is dissolved in 10-15 ml of water for injections or isotonic solution of sodium chloride and entered slowly within 2-3 min.

For intravenous drop administration by the adult drug (single dose) is dissolved in 100 - 200 ml of isotonic solution of sodium chloride or 5-10% of solution of glucose and entered with a speed of 60-80 thaws a minute. At drop introduction to children as solvent use 5-10% glucose solution (30-100 ml depending on age). Intravenously the drug is administered by 5-7 days, with the subsequent transition to intramuscular introduction.

Solutions use right after preparation, addition to them of other medicines is inadmissible.

Features of use:

Use at pregnancy and in the period of a lactation. Use of drug during pregnancy is possible only in that case when the estimated advantage for mother exceeds potential risk for a fruit. In need of use of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination (it is allocated with breast milk).

At course treatment it is necessary to carry out control of a condition of function of bodies of a hemopoiesis, a liver and kidneys. Patients with a renal failure need correction of the mode of dosing according to values of clearance of creatinine.

At use of high doses for patients with a renal failure perhaps toxic action on the central nervous system the Possibility of development of superinfection (due to growth of microflora, insensitive to it) demands corresponding change of antibacterial therapy.

At the patients having hypersensitivity to penicillin cross allergic reactions with tsefalosporinovy antibiotics are possible. At emergence of allergic reactions it is necessary to stop administration of drug and to carry out the desensibilizing therapy.

At emergence of signs of an acute anaphylaxis urgent measures have to be taken for removal of the patient from this state: introduction of Epinephrinum (adrenaline), glucocorticosteroids (a hydrocortisone or Prednisolonum) and antihistamines, if necessary carry out artificial ventilation of the lungs.

Side effects:

Allergic reactions: skin rash, a small tortoiseshell, a dermahemia, a Quincke's edema, rhinitis, conjunctivitis, fever, an arthralgia, an eosinophilia and others, in rare instances - development of an acute anaphylaxis.

From digestive tract: dysbacteriosis, taste change, vomiting, nausea, diarrhea, it is rare - a pseudomembranous coloenteritis.

From bodies hemopoiesis: leukopenia, neutropenia, anemia.

Local reactions: phlebitis and a periphlebitis (at intravenous administration); at intramuscular - in an injection site infiltrate, morbidity.

Others: superinfection.

Interaction with other medicines:

Bactericidal antibiotics (including aminoglycosides, cephalosporins, Vancomycinum, rifampicin) have sinergidny effect; bacteriostatic drugs (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) - antagonistic.

Increases efficiency of indirect anticoagulants (suppressing intestinal microflora, reduces synthesis of vitamin K and a prothrombin ratio); reduces efficiency of oral contraceptives, medicines in the course of which metabolism paraaminobenzoic acid, ethinylestradiol - risk of development of bleedings of "break" is formed.

Diuretics, Allopyrinolum, blockers of canalicular secretion, phenylbutazone, пробенецид, the non-steroidal anti-inflammatory drugs and other medicines blocking canalicular secretion increase concentration of drug in plasma that increases risk of development of toxic action.

Allopyrinolum increases risk of development of skin rash.

Contraindications:

Hypersensitivity, infectious mononucleosis, lymphoid leukosis.

With care - to the children who were born at mothers with hypersensitivity to penicillin.

Overdose:

Data on overdose are absent.

Storage conditions:

Period of validity - 2 years. Not to use after the expiry date specified on packaging. List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Powder for preparation of solution for intravenous and intramuscular administration (133,4 mg + 66,6 mg) and (333,5 mg + 166,5 mg). Powder for preparation of solution for intramuscular introduction (133,4 mg + 66,6 mg) and (333,5 mg + 166,5 mg). On (133,4 mg + 66,6 mg) or (333,5 mg + 166,5 mg) the sums of active agents in the bottles with a capacity of 10 ml which are hermetically corked by rubber bungs, pressed out by caps aluminum or the import combined caps with plastic disks. 1 bottle together with the application instruction is placed in a pack from a cardboard. 5 bottles place in a blister strip packaging from a film polyvinyl chloride. 1, 2 blister strip packagings together with the application instruction place in a pack from a cardboard. 5 or 10 bottles together with the application instruction place in a pack with an insert with cells for bottles in 1 or 2 rows from a cardboard. Packaging for hospitals 50, 108, 115, 888 bottles together with application instructions place in a box from a cardboard. 10, 20, 30, 40, 50, 70, 100, 200 blister strip packagings together with application instructions place in a box from a cardboard.