Oksamsar - instructions for use, doses, side effects, contraindications

Combined antibiotic, combining the spectrum of action of ampicillin and oxacillin. Ampicillin - semi-synthetic penicillin, it acts bactericidal, acid-fast. It is active against gram-positive, non-retentive penicillinase (Staphylococcus spp., Streptococcus spp., Including Streptococcus pneumoniae), and Gram-negative (Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Salmonella spp., Shigella spp., Pprotus mirabilis, Naomophilus influenzae ) of microorganisms. Oxacillin - Penicillin-resistant semisynthetic antibiotic from the penicillin group, acid-fast; has a bactericidal action against gram-positive microorganisms (Staphylococcus spp.,Streptococcus spp., Incl. Streptococcus pneumoniae, Astinimyces spp., Vasillus anthracis, Sorinbacterium diphtheriae, anaerobic spore-forming rods, incl. Clostridium spp.), Gram-negative cocci (Neisseria gonorrhoeae, Neisseria meningitidis), Escherichia coli, Proteus mirabilis, Naomophilus influenzae, Clebsiella pneumoniae, Treponema spp.

The action of the drug is resistant to Psedomonas aeruginosa and other non-fermenting Gram-negative bacteria, most of the strains of Rroteus vulgaris, Rrovidencia rettgeri, Morganella morganii.

Pharmacokinetics:

The time to reach the maximum concentration of both antibiotics in the blood is 0.5-1 h after intramuscular (IM) administration. With intravenous (intravenous) injection in the blood, drug concentrations are rapidly created that exceed those in the IM injection.

Ampicillin is distributed evenly in the organs and tissues of the body, it is found in therapeutic concentrations in pleural, peritoneal, amniotic and synovial fluids, cerebrospinal fluid, contents of blisters, urine (high concentrations), intestinal mucosa, bones, gallbladder, lungs, female genital tissues, bile, bronchial secretion (in the purulent bronchial secretion, the accumulation is weak), paranasal sinuses, middle ear fluid (with its inflammation), saliva, fetal tissues. Poorly penetrates the blood-brain barrier (BBB) (permeability increases with inflammation of the meninges).

Oxacillin in the pleural fluid is found in a concentration of 10%, synovial and ascitic fluid - 50%, bile - 5-8% in relation to its concentration in the blood plasma. Does not penetrate intact GEB, with inflammation of the meninges, penetration increases. Penetrates through the placental barrier, is found in breast milk.

Both antibiotics are excreted by the kidneys, partly with bile. When repeated injections are not cumulated.

Indications:

Infectious inflammatory diseases caused by microorganisms sensitive to the preparation: sinusitis, tonsillitis, otitis media; bronchitis, pneumonia; cholangitis, cholecystitis; pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, cervicitis; infections of the skin and soft tissues: erysipelas, impetigo, secondarily infected dermatoses.

Prevention of postoperative complications during surgical interventions (including against the background of immunodeficiency), infections in newborns (infection of the amniotic fluid, impaired breathing of the newborn, requiring the use of resuscitative measures, the risk of aspiration pneumonia).

Severely leaking infections (sepsis, endocarditis, meningitis, postpartum infection).

Contraindications:

Hypersensitivity (including to other penicillins, to beta-lactam antibiotics), infectious mononucleosis, lymphocytic leukemia.

Carefully:

Chronic renal failure (CRF), children born to mothers with hypersensitivity to penicillins.

Allergic reactions in history and / or bronchial asthma, renal failure, history of bleeding, enterocolitis on the background of antibiotics (in the anamnesis).

Pregnancy and lactation:The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped (it is excreted in breast milk).

Dosing and Administration:

In / m and in / in (struyno, drip).

The daily dose for adults and children over 14 years old is 3-6 g; for newborns, prematurity and children under 1 year - 100-200 mg / kg / day; 1-6 years -100 mg / kg / day; 7-14 years - 50 mg / kg / day. The daily dose is administered in 3-4 doses, with an interval of 6-8 hours. If necessary, these doses can be increased by 1.5-2 times. Children aged over 14 years are prescribed a dose of adults.The duration of treatment depends on the severity of the disease and ranges from 5 to 7 days to 3 weeks or more.

For the / m introduction, the contents of the vial are dissolved in 5 ml of water for injection.

For IV injection (for 2-3 minutes) a single dose is dissolved in 10-15 ml of water for injection or 0.9% solution of sodium chloride.

For IV injection of adults, a single dose is dissolved in 100-200 ml of a 0.9% solution of sodium chloride or 5% solution of dextrose and injected at a rate of 60-80 cap / min; Children as a solvent use 30-100 ml of a 5-10% solution of dextrose. In / in the drug administered for 5-7 days, followed by a transition (if necessary) to the / m introduction.

The solutions are used immediately after preparation; it is unacceptable to mix them with other medicines.

Side effects:

Ampicillin. Allergic reactions: itching and flaky skin, urticaria, rhinitis, conjunctivitis, angioedema, fever, arthralgia, eosinophilia, erythematous and maculopapular rash, exfoliative dermatitis, multiform exudative erythema (including Stevens-Johnson syndrome), reactions similar to serum sickness, in isolated cases anaphylactic shock.

From the digestive system: dysbacteriosis, stomatitis, gastritis, dry mouth, taste change, abdominal pain, vomiting, nausea, diarrhea, glossitis, impaired liver function, moderate increase in the activity of "liver" transaminases, pseudomembranous colitis.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): leukopenia, neutropenia, thrombocytopenia, agranulocytosis, anemia.

From the central nervous system (CNS): agitation or aggressiveness, anxiety, confusion, behavior change, depression, convulsions (with high-dose therapy).

Oxacillin. Allergic reactions: allergic reactions (pruritus, hives, less often - angioedema, bronchospasm, in rare cases, anaphylactic shock, eosinophilia);

From the digestive system: dyspepsia (nausea, vomiting, diarrhea); pseudomembranous enterocolitis, candidiasis of the oral cavity, vaginal candidiasis; hepatotoxic effect - often develops at a dose of 6 g / day (hyperthermia, nausea, vomiting, icterus sclera or skin, increased activity of "liver" transaminases).

Local reactions: phlebitis and periphlebitis (with intravenous administration); when intramuscular - pain at the injection site, infiltration.

Other: interstitial nephritis, nephropathy, superinfection (especially in patients with chronic diseases or reduced resistance of the body), vaginal candidiasis.

Laboratory indicators: leukopenia, neutropenia, anemia, hematuria, proteiuria, interstitial nephritis. In these cases, the antibiotic is canceled and desensitizing therapy is administered.

Overdose:

Symptoms: manifestations of toxic effects on the central nervous system (especially in patients with renal insufficiency); nausea, vomiting, diarrhea, violation of water - electrolyte balance.

Treatment: symptomatic. It is excreted by hemodialysis.

Interaction:

Ampicillin. Pharmaceutically incompatible with aminoglycosides.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic. Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives,drugs, in the process of metabolism of which parahaminobenzoic acid is formed, ethinyl estradiol (in the latter case, the risk of bleeding "breakthrough" is increased).

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of ampicillin in the plasma (by reducing tubular secretion). Allopurinol increases the risk of skin rash. Reduces clearance and increases the toxicity of methotrexate.

Oxacillin. Increases the toxicity of methotrexate (competition for tubular secretion); it may be necessary to increase the doses of calcium folinate (antidote of folic acid antagonists) and its longer use.

It is necessary to avoid joint use with other drugs that have a hepatotoxic effect.

It is not recommended to apply simultaneously with bacteriostatic antibiotics (decreased efficiency).

Drugs that block tubular secretion, increase the concentration of ok-satsillinav blood.

Special instructions:

When signs of anaphylactic shock appear, urgent measures must be taken to remove the patient from this condition: the introduction of epinephrine, glucocorticosteroid agents (hydrocortisone or prednisolone) and antihistamines, if necessary, carry out artificial ventilation of the lungs.

In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.

The possibility of developing superinfection (due to the growth of insensitive microflora) requires a corresponding change in antibacterial therapy.

In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

When used in high doses in patients with renal insufficiency, a toxic effect on the central nervous system is possible.

Effect on the ability to drive transp. cf. and fur:Care must be taken when driving a vehicle or potentially dangerous machinery.

Form release / dosage:Powder for the preparation of solution for intravenous and intramuscular injection 375 mg + 125 mg.

Packaging:

For 500 mg of the amount of active substances in a bottle of glass tube for medicines with a capacity of 10 ml hermetically sealed with a rubber stopper, crimped with an aluminum cap.

By 1; 5 or 10 bottles in an individual pack of cardboard together with instructions for use or 50 bottles with an equal number of instructions for use are placed in a box of cardboard (for hospitals).

Packaging complete with solvent-water for injection. The kit includes:

a) 1 vial of the drug and 1 ampoule with water for injection for 5 ml;

b) 5 vials of the drug and 5 vials of water for injection for 5 ml;

c) 10 vials of the drug and 10 ampoules of water for injection for 5 ml.

The kit is placed in an individual pack of cardboard along with instructions for medical use and a scapegrator ampoule.

When using ampoules with an incision, a ring of fracture or a break point, the ampoule scaper is not inserted.

Storage conditions:In a dry, dark place at a temperature of no higher than 20 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N002766 / 01

Date of registration:29.08.2008 / 13.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia

Manufacturer: & nbsp

BIOCHEMIST, OJSC Russia

Representation: & nbspBIOCHEMICAL JSC BIOCHEMICAL JSC Russia

Information update date: & nbsp23.05.2017

Illustrated instructions

Instructions

Oksamsar® (Oxamsar®)