Ampicillin+Sulbactam, 1 g+0.5 g

Pharmacotherapeutic group:

Penicillin semisynthetic antibiotic + beta-lactamase inhibitor

ATC code: J01CR

Pharmacodynamics:

Indications

Infectious inflammatory diseases caused by ampicillin+sulbactam-sensitive strains of microorganisms:

– ENT organ infections (including. Sinusitis media otitis tonsillitis);

– respiratory infections (acute and acute exacerbation of chronic bronchitis pneumonia pulmonary abscess empyema pleura);

– infectious endocarditis bacterial meningitis sepsis;

– uncomplicated and complicated abdominal infections (cholecystitis cholangitis peritonitis abdominal abscess);

– urinary tract infections (acute and exacerbation of chronic pyelonephritis pyelitis);

– pelvic inflammatory diseases (salpingitis salpingo-oophoritis tuboovarian abscess endometritis pelvio-peritonitis);

– gonococcal infection:

– skin and soft tissue infections (rye abscess phlegmon wound and postoperative infection);

– bone and joint infections.

Prevention of postoperative complications during abdominal and pelvic surgeries.

Active ingredient

Composition

Per 1 vial:

How to take, the dosage

Intravenously (by trickle and drip) intramuscularly. The route of administration depends on the severity of the infection and the dose chosen. The following are the total doses of ampicillin and sulbactam (in a 2:1 ratio).

In adults and children over 12 years of age and weighing more than 40 kg for the treatment of moderate infections, administer 15 g every 6 hours by IV or IV.

In case of severe infections – 3 g every 6 hours. The maximum daily dose of sulbactam should not exceed 4 g which corresponds to a daily dose of the drug of 12 g.

The treatment should be continued for at least another 2-3 days after the disappearance of clinical symptoms of the disease. Duration of treatment is 5-14 days; however, in more severe cases it may be increased or an additional ampicillin may be prescribed.

In uncomplicated gonorrhea, 15 g once.

For prevention of postoperative infection, 15-3 g during anesthesia then for 24 hours after surgery in the same dose every 6-8 hours.

In children older than 1 month and up to 12 years of age (or body weight less than 40 kg) the drug is administered in a dose of 150 mg/kg/day which is divided into 3-4 injections. In severe infection the dose may be increased to 300 mg/kg/day. Duration of therapy should not exceed 14 days.

In premature infants and children of the first week of life the daily dose of the drug is 75 mg/kg divided into two doses.

In children aged 7 days to 28 days the drug is administered in a dose of 150 mg/kg/day divided into 3 intravenous infusions.

In patients with impaired renal function the dosing regimen is adjusted according to creatinine clearance (CK) values.

In children with renal insufficiency (CK values less than 30 ml/min) the drug is administered in usual single doses (50-75 mg/kg) increasing intervals between doses as indicated for adults.

Preparation of solutions:

For preparation of the solution for intravenous injection, sterile water for injection 05% procaine solution 05% lidocaine solution is used as a solvent. In a bottle containing 15 g of the drug 4 ml of the solvent is added.

Interaction

In concomitant use with indirect anticoagulants ampicillin + sulbactam potentiates their action; reduces the effectiveness of oral contraceptives drugs in the metabolism of which para-aminobenzoic acid and ethinylestradiol are formed (risk of bleeding “breakthrough”).

When used concomitantly with aminoglycosides a pronounced synergistic bactericidal effect against Gram-positive and Gram-negative bacteria is observed.

Pharmaceutically incompatible with blood products or protein hydrolysates of aminoglycosides. If the drug is used concomitantly with aminoglycosides, do not mix the drugs in the same syringe or infusion system; if administered v/m, inject into different parts of the body; if administered intravenously, inject separately, following a specific sequence with as long a time interval between injections as possible, or use separate intravenous catheters.

Probenecid allopurinol phenylbutazone nonsteroidal anti-inflammatory drugs decrease tubular secretion of ampicillin and sulbactam and increase their half-life. Diuretics decrease clearance of penicillins.

Bactericidal antibiotics (including cephalosporins cycloserine vancomycin rifampicin aminoglycosides) have a synergistic effect; bacteriostatic antibiotics (including macrolides chloramphenicol lincosamides tetracyclines) – antagonistic. Concomitant use of ampicillin and allopurinol increases the risk of skin rash.

Special Instructions

In long-term use of the drug, periodic monitoring of renal liver function and total blood count should be performed.

Before initiating therapy, a thorough history of previous allergic reactions to beta-lactam antibiotics should be taken. If an allergic reaction develops, the drug should be discontinued immediately.

When using the drug both against and 2-3 weeks after discontinuation of treatment the development of diarrhea caused by Clostridium difficile (pseudomembranous colitis) is possible. In mild cases, treatment withdrawal and use of ion-exchange resins (colestiramine colestipol) in severe cases, compensation for fluid loss of electrolytes and protein is indicated by administration of vancomycin or metronidazole. Do not use drugs inhibiting intestinal peristalsis.

The use of ampicillin + sulbactam (as well as other antibiotics) can lead to superinfection which requires withdrawal of the drug and appropriate treatment.

Possible detection of a false positive Coombs test for glucose in the urine (when using the Benedict or Fehling method).

When treating patients with sepsis, a bacteriolysis reaction (Jarisch-Herxheimer reaction) may develop.

There are no data on the negative effect of the drug in the recommended doses on the ability to drive or operate machinery. However, taking into account the possibility of side effects on central nervous system side effects, caution should be exercised when carrying out potentially hazardous activities requiring high concentration and quick psychomotor reactions.

Synopsis

Contraindications

Hypersensitivity to any of the components of the drug and other beta-lactam antibiotics; infectious mononucleosis (including the appearance of a crust-like rash) lympholeukemia.

The safety of ampicillin+sulbactam in patients with end-stage chronic renal failure (creatinine clearance less than 5 ml/min) has not been established.

When using lidocaine procaine as a solvent – hypersensitivity to local anesthetics of the amide type severe shock intracardiac conduction blockade severe heart failure.

Bronchial asthma pollinosis and other allergic diseases liver failure chronic gastrointestinal disease with a history of previous colitis associated with the use of antibacterial drugs renal dysfunction elderly age.

Side effects

Allergic reactions: urticaria hyperemia skin itching Quincke’s edema rhinitis conjunctivitis fever arthralgia anaphylactic shock Stevens-Johnson syndrome multiforme exudative erythema toxic epidermal necrolysis.

Digestive system disorders: nausea vomiting decreased appetite diarrhea flatulence glossitis pseudomembranous colitis increased “hepatic” transaminase activity.

Hematopoietic organs: hemolytic anemia decrease in hemoglobin thrombocytopenia eosinophilia leukopenia neutropenia lymphopenia lymphocytosis thrombocytosis monocytosis false positive Coombs test.

Central nervous system: drowsiness headache.

Laboratory measures: azotemia increased plasma urea concentration hypercreatininemia decreased serum protein content leukocyturia cylinduria.

Local reactions: pain at the injection site if administered by injection; if administered intravenously – phlebitis, thrombophlebitis.

Others: discomfort- pain in the chest- sore throat- dysuria- edema- bleeding; with long-term treatment- candidiasis- development of superinfection.

Overdose

Symptoms: neurological disorders up to convulsions (especially in patients with impaired renal function) nausea vomiting diarrhea impaired water-electrolyte balance (as a consequence of vomiting and diarrhea).

The treatment: symptomatic therapy; in severe cases – hemodialysis.

Pregnancy use

Pregnant use is possible only if the estimated benefit to the mother exceeds the potential risk to the fetus.

Ampicillin and sulbactam penetrate into the breast milk in low concentrations. If it is necessary to use the drug during lactation, breastfeeding should be stopped.