Oxamp 500 mg 1 pcs powder for solution for injection

Pharmacodynamics and pharmacokinetics

Oxamp is a combination antibiotic, the effectiveness of which is based on the combined effects of its active ingredients.

Semi -synthetic penicillin - ampicillin acid -resistant and has a bactericidal effect on gram -positive , not producing penicillinase , bacteria (Staphylococcus spp., Streptococcus pneumoniae, streptococcus spp.), And granting microorganisms (neiss Eria Gonorrhoeae, Haemophilus Influenzae, Proteus Mirabilis, Neisseria Meningitidis, Salmonella Spp., Escherichia coli, Shigella spp.).

Semi -synthetic penicillino -resistant antibiotic - oxacillin , belonging to a group of penicillins , is also acid -resistant and manifests a fatal bactericidal effect on gram -positive bacteria (Staphylococcus spp., Actinimyces spp., Streptococcus spp., Bacillalus Anthracis , spore -forming anaerobic sticks, including Clostridium, Corynebacterium Diphtheriae ,) and gram-negative cocci (Neisseria meningitidis, Neisseria gonorrhoeae), as well as Escherichia coli, Haemophilus influenzae, Proteus mirabilis, Klebsiella pneumoniae, Treponema spp., Actinomyces spp.

The following are resistant to the combined effects of the drug: Morganella morganii, Providencia rettgeri, Pseudomonas aeruginosa and other gram-negative non-fermenting bacteria , as well as most strains of Proteus vulgaris.

Plasma TCmax of both active ingredients, when taken orally, is 90-120 minutes.

Excretion from the body is carried out with urine and partially with bile.

No accumulation was observed upon repeated administration.

Oxamp-sodium 500 mg No. 1 por.d/sol.d/in.flak.

APPROVED by the Order of the Chairman of the Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan dated "____" __________ 200__ No. ____________________ Instructions for the medical use of the drug Oxamp®-SODIUM Trade name Oxamp®-sodium International nonproprietary name No Dosage form Powder for the preparation of solution for injection 0.5 d Composition active substances: ampicillin sodium salt (in terms of ampicillin) – 0.3335 g oxacillin sodium salt (in terms of oxacillin) – 0.1665 g. Description White powder with a yellowish tint, odorless. Hygroscopic. Pharmacotherapeutic group Penicillins in combination with beta-lactamase inhibitors. Combination of penicillins ATC code J01CR50 Pharmacological properties Pharmacokinetics After intramuscular administration of Oxamp sodium, the maximum concentration of ampicillin in the blood is achieved after 1 hour, after intravenous administration - 15 minutes after injection. Therapeutically significant concentrations of the antibiotic in the blood are maintained for 4-6 hours. A relatively small portion (10-30%) binds to plasma proteins. Ampicillin penetrates well into body tissues and fluids. Penetrates through the placenta. With meningitis, the concentration of ampicillin in the cerebrospinal fluid can be 70-95% of its concentration in the blood plasma. Practically does not undergo biotransformation. The half-life is 1-1.5 hours, in patients with impaired renal function - 7-20 hours. It is excreted unchanged mainly by the kidneys. Ampicillin sodium salt does not accumulate with repeated administrations. After intramuscular administration of Oxamp sodium, the maximum concentration of oxacillin in the blood plasma is achieved after 1-2 hours. The time for maintaining therapeutic concentrations in the blood ranges from 3 to 4 hours. Plasma protein binding is 93%. In pleural fluid the drug is found in concentrations reaching 10%, synovial and ascitic fluid - 50%, bile - 5-8% relative to its concentration in blood serum. Oxacillin does not penetrate the intact blood-brain barrier; with inflammation of the meninges, penetration increases. Penetrates the placental barrier and is found in breast milk. Excretion is carried out mainly by the liver. Pharmacodynamics Oxamp-sodium has a broad antibacterial spectrum, combining the spectra of ampicillin and oxacillin. Oxamp sodium blocks the synthesis of bacterial cell walls by disrupting the late stages of peptidoglycan synthesis (prevents the formation of peptide bonds by inhibiting transpeptidase), causing lysis of dividing bacterial cells. OKSAMP-sodium is active in relation to gram-positive ones (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae, Bacillus anthracis, Corynebacterium diphtheriae, anaerobic spore-forming beads) and granular) Neisseria Gonorrhoeae, Neisseria Meningitidis, Escherichia Coli, Salmonella Spp., Shigella spp., Proteus mirabilis, Haemophilus influenzae, Actinomyces spp., Treponema spp.) microorganisms. Pseudomonas aeruginosa and most strains of Proteus vulgaris, Proteus rettgeri, and Proteus morganii are resistant to the drug. Indications for use - septicemia - pneumonia, empyema - abscesses, phlegmons - cholecystitis - pyelitis, cystitis - osteomyelitis - postoperative wound infections - infected burns - cervicitis, gonorrhea - dysentery, salmonellosis - infections in newborns (infection of amniotic fluid, risk of aspiration pneumonia) . Method of administration and dosage: Intramuscularly or intravenously (stream or drip at a rate of 60-80 drops/min). A single dose for adults and children over 14 years of age is 0.5-1 g, daily dose is 2-4 g; newborns, premature babies and children under 1 year old - 100-200 mg/kg/day, 1-7 years old - 100 mg/kg/day, 7-14 years old - 50 mg/kg/day. The daily dose is administered in 4 doses, with an interval of 6 hours. In case of severe infection, the indicated doses are increased by 1.5-2 times. The maximum daily dose for an adult is 8 g. The duration of treatment is from 5-7 days to 10 days. For intramuscular administration, the contents of the bottle (0.5 g) are dissolved in 5 ml of water for injection. For intravenous drip administration to adults, a single dose is dissolved in 100-200 ml of isotonic sodium chloride solution or 5% glucose solution. For drip administration to children, a 5% glucose solution (30-100 ml depending on age) is used as a solvent. The solutions are used immediately after preparation (adding other medications to the prepared solution is unacceptable). Side effects Sometimes - change in taste, nausea, vomiting, diarrhea, dysbacteriosis - urticaria, conjunctivitis, rhinitis - headache Rarely - pseudomembranous enterocolitis - anemia, leukopenia, neutropenia - superinfection - fever, arthralgia, eosinophilia, angioedema, hyperemia of the skin Very rarely - anaphylactic shock - development of phlebitis and periphlebitis (possibly with intravenous administration); pain at the injection site (possible with intramuscular injection) Contraindications - hypersensitivity to drugs of the penicillin group and other beta-lactam antibiotics - infectious mononucleosis - lymphocytic leukemia - severe liver dysfunction Drug interactions Probenecid, by blocking tubular secretion, increases the concentration of oxacillin and ampicillin in the blood serum. Antacids, glucosamine, laxatives, food, aminoglycosides (when administered enterally) slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic. Oxamp increases the effectiveness of indirect anticoagulants (suppresses intestinal flora, reduces the synthesis of vitamin K and the prothrombin index), reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol (risk of bleeding). Diuretics, allopurinol, tubular secretion blockers, phenylbutazone, non-steroidal anti-inflammatory drugs increase the concentration of the drug in plasma, which increases the risk of toxic effects. Special instructions During treatment with the drug, systematic monitoring of renal, liver and peripheral blood function is necessary. Patients with impaired renal function require adjustment of the dosage regimen in accordance with the creatinine clearance value. When used in high doses in patients with renal failure, toxic effects on the central nervous system are possible. For bronchial asthma, hay fever and other allergic diseases, the drug is used with caution while prescribing desensitizing agents. Pregnancy and lactation Use during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. The drug is excreted in breast milk in low concentrations. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms: Use caution while using the drug due to the possible occurrence of headaches. Use strictly as prescribed by a doctor. Overdose: No symptoms identified; neurotoxic effects may develop. Treatment is symptomatic. Release form and packaging Powder for the preparation of solution for injection 0.5 g. 50 bottles along with 1-5 instructions for medical use are placed in a cardboard box. Storage conditions Store in a dry place, protected from light at a temperature not exceeding +20 ° C. Keep out of the reach of children! Shelf life: 2 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Russian Federation, 640008, Kurgan, Constitution Avenue, 7. tel./fax

Indications for use

Infections of bacterial origin due to exposure to sensitive pathogens:

• tonsillitis;
• sinusitis;
• bronchitis;
• otitis media ;
• pneumonia;
• cholecystitis;
• cholangitis;
• pyelonephritis;
• cystitis;
• pyelitis;
• urethritis;
• cervicitis;
• gonorrhea;
• soft tissue and skin infections;
• impetigo;
• erysipelas;
• dermatoses (secondarily infected), etc.

Infections of newborns:

• respiratory failure , if necessary, use of resuscitation measures;
• infection of amniotic fluid;
• danger of developing aspiration pneumonia .

Severe infections:

• postpartum infection;
• sepsis;
• meningitis;
• endocarditis.

Prevention of complications that arise during the postoperative period (also against the background of immunodeficiency).

Side effects

• change in taste;
• anemia;
• skin hyperemia;
• angioedema;
• fever;
• rhinitis;
• nausea;
• arthralgia;
• vomit;
• conjunctivitis;
• eosinophilia;
• hives;
• dysbacteriosis;
• anaphylactic shock (rare);
• superinfection;
• diarrhea;
• leukopenia;
• pseudomembranous enterocolitis (rare);
• neutropenia.

Overdose

In case of an overdose of Oxamp-Sodium, the following were observed: headaches , nausea (with or without vomiting), tremors , diarrhea , convulsions .

Symptomatic treatment is indicated, with possible, if necessary, hemodialysis .

Oxamp capsules, instructions for use

Instructions for use of Oksamp involve oral administration of capsules, dividing the daily dosage into 4-6 doses and the duration of treatment, depending on the indications and severity of symptoms, from 5 to 14 days.

A single dosage for patients over 14 years of age is 500-1000 mg, daily dosage is 2000-4000 mg.

Children's daily dosages are calculated based on the age and weight of the child, and are: for children 3-7 years old - 100 mg/kg, for children 7-14 years old - 50 mg/kg.

For children

The drug Oxamp-Sodium, as directed by a pediatrician and in the dosages recommended above, can be prescribed to children from the moment of birth.

How to dilute Oxamp for injections for children

According to the instructions, for intramuscular injections of the drug, its recommended dose, taking into account the weight and age of the child, should be diluted in 10 ml of water daily . But some doctors, in order to anesthetize the injection itself, advise adding Lidocaine or Novocaine , for example in a 1:1 ratio with water (5ml:5ml) or in other proportions. Let us remind you that these drugs themselves can cause various allergic manifestations , including severe ones, so they should be prescribed exclusively by a pediatrician.

Interaction

Food, Glucosamine , antacids , laxatives, aminoglycosides reduce and slow down absorption, and taking ascorbic acid increases it.

Bacteriostatic drugs ( tetracyclines , chloramphenicol , lincosamides , macrolides , sulfonamides ) exhibit an antagonistic effect, and bactericidal antibiotics ( Rifampicin , cephalosporins , aminoglycosides , Vancomycin ) have a synergistic effect.

Concurrent use of Allopurinol increases the risk of developing a skin rash .

Oxamp increases the effect of indirect anticoagulants (inhibiting intestinal microflora, reducing the prothrombin index and the production of vitamin K).

The drug reduces the effectiveness of oral contraceptives , ethinyl estradiol (breakthrough bleeding is possible), as well as drugs whose metabolism produces PABA.

NSAIDs , diuretics , tubular secretion blockers, Allopurinol , Phenylbutazone , and other drugs that inhibit tubular secretion increase the plasma concentration of Oxamp, which can increase its possible toxic effects.

special instructions

During long-term treatment, it is necessary to monitor the functional state of the kidneys, hematopoietic organs and liver.

In cases of hypersensitivity to penicillins , allergic cross-reactions with cephalosporin antibiotics .

The possibility of superinfection (due to an increase in insensitive microflora) may require a change in antibiotic therapy .

When taking large dosages in patients with kidney pathologies , toxic manifestations on the central nervous system are possible.

Contraindications

The use of Oxamp-Sodium is contraindicated in case of hypersensitivity to its ingredients, lymphocytic leukemia and infectious mononucleosis .

Prescribe the drug with caution when:

• history of bleeding
• kidney pathologies;
• history of allergic manifestations and/or bronchial asthma ;
• enterocolitis , with previous antibiotic therapy ;
• as well as children whose mothers have a history of hypersensitivity to penicillins .

Analogs

Level 4 ATX code matches:
Arlet

Ecoclave

Panclave

Amoxiclav

Oxamp-Sodium

Amoxicillin + Clavulanic acid

Augmentin

Ampisid

Amoxil K 625

Flemoklav Solutab

Sultasin

• Amoxiclav;
• Ampisid;
• Augmentin;
• Klamosar;
• Bactoclav;
• Honeyclave;
• Libaccil;
• Sulbacin;
• Flemoklav Solutab;
• Fibell;
• Ecoclave , etc.