Ampioks-sodium - instructions for use, doses, side effects, contraindications

Ampiox® sodium is a combined antibiotic with a broad antibacterial spectrum combining the spectra of ampicillin and oxacillin. Ampicillin - semi-synthetic penicillin, it acts bactericidal, acid-fast. Active with 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. Oxacillin - semisynthetic antibiotic from the penicillin group, resistant to the action of penicillinase; has bactericidal action against 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.

To the action of Ampioxa®-sodium are stable Pseudomonas aeruginosa, most strains Proteus vulgaris, Providencia rettgeri, Morganella morganii.

Pharmacokinetics:

The maximum concentrations of both antibiotics in the blood are detected 0.5-1 hour after intramuscular injection. With intravenous administration in the blood quickly (after 5-10 minutes), drug concentrations are created that exceed those of intramuscular injection. The drug penetrates well into various organs and tissues. They are excreted from the body mainly by the kidneys, in part with bile.

With repeated injections in the body, the patient is not cumulated.

Indications:

Infectious-inflammatory diseases caused by sensitive microflora: 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; dysentery, salmonellosis, salmonellae.

Prevention of postoperative complications during surgical interventions (including against 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).

Sepsis, endocarditis, meningitis, postpartum infection.

Contraindications:

Hypersensitivity, infectious mononucleosis, lymphocytic leukemia.

Carefully:Children born to mothers with hypersensitivity to penicillins.

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 use the drug during lactation, the question of stopping breastfeeding (excreted in breast milk).

Dosing and Administration:

Ampiox®-sodium is administered intramuscularly or intravenously (either jet or drip).

In case of parenteral administration, a single dose of the drug for adults and children over the age of 14 is 0.5-1 g, daily dose 2-4 g. Newborns, premature infants and children under 1 year of age are prescribed in a daily dose of 100-200 mg / kg, children from 1 year to 7 years - 100 mg / kg / day; from 7 to 14 years - 50 mg / kg / day; over 14 years - in the adult dose. In severe infection, these doses may be increased by 1 ,5 - 2 times.

The daily dose is administered in 3 to 4 doses at intervals of 6-8 h.

Duration of treatment from 5 - 7 days to 3 weeks (depending on the severity of the disease). Solutions for intramuscular administration are prepared by adding to the contents of the vial (133.4 mg + 66.6 mg) or (333.5 mg + 166.5 mg) 2 or 5 ml of water for injection, respectively. For intravenous fluid administration, the preparation (single dose) is dissolved in 10-15 ml of water for injection or isotonic sodium chloride solution and injected slowly for 2-3 minutes.

For intravenous drip injection, adults (one-time dose) are dissolved in 100-200 ml of isotonic sodium chloride solution or 5-10% glucose solution and injected at a rate of 60 to 80 drops per minute. When drip introduction to children as a solvent used 5-10% glucose solution (30 - 100 ml, depending on age).Intravenously, the drug is administered for 5-7 days, with a subsequent transition to intramuscular injection.

Solutions used immediately after preparation, it is unacceptable to add other drugs to them.

Side effects:

Allergic reactions: skin rash, hives, skin hyperemia, Quincke's edema, rhinitis, conjunctivitis, fever, arthralgia, eosinophilia and others, in rare cases - the development of anaphylactic shock.

From the gastrointestinal tract: dysbacteriosis, taste change, vomiting, nausea, diarrhea, rarely - pseudomembranous enterocolitis.

From the hematopoiesis: leukopenia, neutropenia, anemia;

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

Other: superinfection.

Overdose:Data on overdose are absent.

Interaction:

Bactericidal antibiotics (including aminoglycosides, cephalosporins, 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 oral contraceptives, drugs, in the process of metabolism which produces paraaminobenzoic acid, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics, allopurinol, tubular secretion blockers, phenylbutazone, probenecid, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of the drug in the plasma, which increases the risk of developing toxic effects.

Allopurinol increases the risk of skin rash.

Special instructions:

In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys. Patients with impaired renal function require correction of the dosing regimen in accordance with the values of creatinine clearance. When using high doses in patients with renal insufficiency, a toxic effect on the central nervous system

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 allergic reactions occur, it is necessary to stop the drug administration and conduct desensitizing therapy.

When there are signs of anaphylactic shock, urgent measures should be taken to remove the patient from this condition: the introduction of epinephrine (adrenaline), glucocorticosteroids (hydrocortisone or prednisolone) and antihistamines, if necessary, carry out artificial ventilation of the lungs.

Form release / dosage:

Powder for the preparation of a solution for intravenous and intramuscular administration (133.4 mg + 66.6 mg) and (333.5 mg + 166.5 mg), (133.4 mg + 66.6 mg) and (333.5 mg +166.5 mg).

Packaging:

According to (133.4 mg + 66.6 mg) and (333.5 mg + 166.5 mg), the sums of active substances in 10 ml vials, hermetically sealed with rubber stoppers, crimped with aluminum or imported combination caps with plastic discs

1 bottle together with the instruction for use is placed in a pack of cardboard.

5 bottles are placed in a contour mesh package made of a polyvinyl chloride film.

1, 2 contoured cell packs together with instructions for use are placed in a pack of cardboard.

5 or 10 vials together with the instruction for use are placed in a pack with an insert with cells for bottles in 1 or 2 rows of cardboard.

Packing for hospitals.

50, 108, 115, 888 vials, together with instructions for use, are placed in a cardboard box.

10, 20, 30, 40, 50 contour mesh packages together with instructions for use are placed in a cardboard box.

Storage conditions:

List B. In dry_, protected from light, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N000315 / 01

Date of registration:13.10.2008

Expiration Date:Unlimited

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Information update date: & nbsp19.08.2017

Illustrated instructions

Instructions

Ampiox®-sodium (Ampiox®-sodium)