Pharmacy No. 84. Delivery of medicines to your home and office.

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Ampicillin + Sulbactam

DOSAGE FORM. Powder for preparing a solution for intramuscular administration. Powder for preparing a solution for intravenous and intramuscular administration. COMPOUND. 1 bottle contains: - Ampicillin sodium (in terms of ampicillin) - 1000 mg, 500 mg, 250 mg. — Sulbactam sodium (in terms of sulbactam) – 500 mg, 250 mg, 125 mg. DESCRIPTION. White or almost white powder. Solvent is a clear, colorless liquid. PHARMACOTHERAPEUTIC GROUP. Antibiotic – semi-synthetic penicillin + β-lactamase inhibitor. ATX CODE. [J01CR01]. PHARMACODYNAMICS. The antibacterial component of the drug is ampicillin, an antibiotic from the group of semisynthetic penicillins, which has a bactericidal effect on sensitive microorganisms during the active reproduction phase by inhibiting the biosynthesis of cell wall mucopeptide. Sulbactam does not have clinically significant antibacterial activity (with the exception of Neisseriacae and Acinetobacter); it is an irreversible inhibitor of most major β-lactamases, which are produced by microorganisms resistant to β-lactam antibiotics. Sulbactam also binds to some penicillin-binding proteins, so some strains are more sensitive to the combination than to a single β-lactam antibiotic. Ampisid is active against a wide range of gram-positive and gram-negative bacteria, including Staphylococcus aureus and Staphylococcus epidermidis (including penicillin-resistant and some methicillin-resistant strains); Streptococcus pneumonia, Streptococcus faecalis and other streptococci, Haemophilus influenza and Haemophilus parainfluenzae (strains producing and not producing β-lactamases), Branhamella catarrhalis, Escherichia coli, Klebsiella spp., Proteus spp. (indole-positive, indole-negative), Morganella morganii, Citrobacter spp. And Enterobacter spp., Neisseria meningitidis and Neisseria gonorrhoeae; anaerobes, including Bacteroides fragilis, Peptococcus spp., Peptostreptococcus spp. and related species. PHARMACOKINETICS. Ampisid penetrates well into most tissues and fluids of the human body. Penetration through the blood-brain barrier is low, however, it improves with inflammation of the meninges. After intravenous or intramuscular administration, high concentrations of sulbactam and ampicillin in the blood are achieved; The half-life of both drugs is approximately one hour. Excreted by the kidneys - 70-80%, mainly unchanged, as well as with bile and breast milk. Sulbactam undergoes almost no metabolic transformations and is excreted by the kidneys mainly unchanged and only about 25% in the form of metabolites. In patients with severe renal failure (creatinine clearance ≤ 30 ml/min), the excretion of sulbactam and ampicillin is impaired to the same extent, so the ratio of their plasma concentrations does not change. INDICATIONS FOR USE. Infectious and inflammatory diseases caused by sensitive microorganisms: infections of the lower, upper respiratory tract and ENT organs (including sinusitis, otitis media and epiglotitis, bacterial pneumonia); infections of the urinary and genital organs (including pyelonephritis, endometritis, cystitis, urethritis); biliary tract infections (cholecystitis, cholangitis); intra-abdominal infections (including peritonitis); infections of the skin, soft tissues; infections of bones and joints. Septic endocarditis, sepsis; gonococcal infections. Prevention of postoperative complications during operations on the abdominal and pelvic organs. CONTRAINDICATIONS. Hypersensitivity to ampicillin and sulbactam and other β-lactam antibiotics, infectious mononucleosis, lymphocytic leukemia, severe liver and kidney dysfunction. With caution: pregnancy, lactation period. USE IN PREGNANCY AND LACTATION. If use during pregnancy is necessary, the expected benefit to the mother and the potential risk to the fetus should be assessed. If necessary, use during lactation should stop breastfeeding. METHOD OF APPLICATION AND DOSES. The drug is administered intramuscularly or intravenously (drip, stream). Standard dosage regimen. The following are the total doses of ampicillin and sultactam (in a 2:1 ratio). - Adults. From 1500 mg to 12000 mg per day. For mild infection – 1500-3000 mg per day in 2 administrations; for moderate cases - 3000-6000 mg per day in 3-4 administrations; in severe cases - 12,000 mg per day in 3-4 administrations. - For children. 150 mg/kg body weight per day (equivalent to 100 mg/kg/day ampicillin and 50 mg/kg/day sulbactam) every 6-8 hours in accordance with usual practice for the use of ampicillin. — Newborns under 1 week of age (especially premature ones). 75 mg/kg body weight per day with an interval of 12 hours. - Elderly patients. Usual doses for adults, not adjusted for age. — Use in patients with impaired renal function (creatinine clearance ≤ 30 ml/min). In such patients, ampisid should be administered less frequently in accordance with the usual practice of using ampicillin, increasing the interval between administrations of the drug. The duration of the course of therapy is 5-14 days, but in more severe cases it can be increased or ampicillin may be additionally prescribed. As always with antibiotic therapy, administration of ampisid should be continued in patients for at least 48 hours after the temperature has normalized and other pathological symptoms have disappeared. Dosing in special cases. - Uncomplicated gonorrhea. Single intramuscular injection of 1500 ampisid. In order to increase the duration of the content of sulbactam and ampicillin in plasma, probenecid should be prescribed simultaneously at a dose of 1000 mg orally. — Prevention of postoperative infections. Depending on the degree of infectious risk, 1500-3000 mg of ampiside is administered during induction of anesthesia. The dose may be repeated every 6 to 8 hours; For most surgical procedures, use of the drug is usually discontinued 24 hours after surgery, unless administration of the drug for therapeutic purposes is indicated. METHOD OF PREPARING SOLUTION. For intramuscular administration. The contents of the bottle are dissolved as follows.

Contents of the bottle	Solvent (lidocaine hydrochloride solution 0.5%)
375 mg	1 ml
750 mg	1.8 ml
1500 mg	3.5 ml

As with other intramuscular injections, ampisid is injected into a relatively large muscle (gluteus); Test aspiration helps avoid inadvertent injection into a blood vessel. The drug diluted with lidocaine cannot be administered intravenously. For intravenous administration. For initial dilution, the contents of the bottle are dissolved as follows.

Contents of the bottle	Solvent (water for injection)
375 mg	1 ml
750 mg	1.8 ml
1500 mg	3.5 ml

Then, for intravenous infusion, the solution prepared at the initial dilution, containing a single dose of the drug, is dissolved in 100-200 ml of 0.9% sodium chloride solution or 5% glucose solution. Injected at a rate of 60-80 drops per minute; for jet administration, the solution prepared at the initial dilution, containing a single dose of the drug, is dissolved in 10-20 ml of 0.9% sodium chloride solution and administered slowly over 3-5 minutes. SIDE EFFECTS. - Allergic reactions. Urticaria, skin hyperemia, angioedema, rhinitis, conjunctivitis, fever, arthralgia, eosinophilia, in rare cases, rash, itching, rarely - bronchospasm, eosinophilia, serum sickness, anaphylactic shock, very rarely encountered: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. - From the gastrointestinal tract. Nausea, vomiting, loss of appetite, diarrhea, pseudomembranous enterocolitis, liver dysfunction (cholestatic jaundice). - From the side of the hematopoietic organs and the hemostasis system. Anemia, hemolytic anemia, leukopenia, neutropenia, lymphopenia, thrombocytopenia and eosinophilia. - From the nervous system. Drowsiness, malaise, headache, and extremely rarely convulsions have been reported. — Laboratory indicators. Transient increase in the activity of alanine aminotransferase (ALT) and aspartic aminotransferase (AST), hyperbilirubinemia, azotemia, increased urea concentration, hypercreatinemia. — Local reactions. Phlebitis, pain along the vein, pain at the site of intramuscular injection. - Others. Cases of interstitial nephritis have been very rarely reported, and with long-term use, superinfection caused by drug-resistant microorganisms (candidiasis). OVERDOSE. It should be taken into account that high concentrations of β-lactam antibiotics in the cerebrospinal fluid can cause dysfunction of the central nervous system, including seizures. Both ampicillin and sulbactam are removed from the circulatory system by hemodialysis, therefore, in case of overdose in patients with impaired renal function, hemodialysis is recommended in order to accelerate the elimination of drugs from the body. INTERACTION WITH OTHER MEDICINES. - Anticoagulants. Penicillins can change platelet aggregation and hemocoagulation parameters (strengthen the effect of anticoagulants). - Drugs with a bacteriostatic effect (chloramphenicol, erythromycin, sulfonamide drugs and tetracyclines). Antagonistic action. — Oral contraceptives containing estrogen. Reduces the effectiveness of oral contraceptives, drugs whose metabolism produces para-aminobenzoic acid, and ethinyl estradiol (risk of breakthrough bleeding). - Methotrexate. Co-administration of penicillins led to a decrease in the clearance of methotrexate and an increase in its toxicity. Such patients should be monitored carefully. - Probenecid, diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that reduce tubular secretion. They increase the concentration of ampicillin and sulbactam in plasma, leading to their longer retention in the blood, lengthening the half-life and increasing the risk of toxicity. - Sulbactam is compatible with most solutions for intravenous administration, however, ampicillin and, therefore, ampiside are less stable in solutions containing dextrose or other carbohydrates; pharmaceutically incompatible with drugs containing blood products or protein hydrolysates, aminoglycosides. — Impact on laboratory parameters. Non-enzymatic methods for determining the concentration of glucose in urine, using Benedict's, Fehling's or Clinitest reagents, can give a false positive result. It was noted that the use of ampicillin in pregnant women led to a transient decrease in plasma levels of total bound estriol, estriol glucuronide, as well as bound estrone and estradiol. - Allopurinol. Increases the risk of developing skin rashes. - Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin). They have a synergistic effect. SPECIAL INSTRUCTIONS. — Serious and sometimes fatal allergic (anaphylactic) reactions have been described during treatment with penicillins. If an allergic reaction develops, the drug must be discontinued and appropriate treatment prescribed. If necessary, epinephrine (adrenaline), oxygen, and glucocorticosteroid hormones are prescribed intravenously and measures are taken to improve airway patency, including tracheal intubation. — When treating patients with sepsis, the development of a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible. - When treating patients on a low-sodium diet, it must be taken into account that 1500 mg of ampiside contains approximately 115 mg (5 mmol) of sodium. As with any antibiotic, ongoing monitoring is important to detect signs of overgrowth of nonsusceptible microorganisms, including fungi. If superinfection occurs, the drug should be discontinued and/or adequate therapy should be prescribed. — During long-term therapy with the drug, it is recommended to periodically monitor the function of internal organs, including the kidneys, liver and hematopoietic system. This is especially important for newborns (especially premature babies) and young children. RELEASE FORM. — Powder for the preparation of a solution for intramuscular administration: 1000 mg + 500 mg, 500 mg + 250 mg, 250 mg + 125 mg in a colorless glass bottle, sealed with a bromobutyl rubber stopper, crimped with an aluminum ring or an aluminum flip-off cap. Solvent (lidocaine hydrochloride solution 0.5%): 3.5 ml, 1.8 ml, 1 ml per clear glass ampoule. — Powder for the preparation of a solution for intravenous and intramuscular administration: 1000 mg + 500 mg, 500 mg + 250 mg, 250 mg + 125 mg in a colorless glass bottle, sealed with a bromobutyl rubber stopper, crimped with an aluminum ring or an aluminum flip-off cap . Solvent (lidocaine hydrochloride solution 0.5%): 3.5 ml, 1.8 ml, 1 ml per clear glass ampoule. 1 bottle of medication and 1 ampoule of solvent along with instructions for use in a cardboard box. 100 bottles of the drug are placed in a cardboard box (for hospitals) with instructions for use (50 pieces). BEST BEFORE DATE. 2 years. Do not use the drug after the expiration date. STORAGE CONDITIONS. At a temperature not exceeding 25ºC, in a dry place, protected from light. Keep out of the reach of children. After dissolution, the drug remains active for 14 days at a storage temperature of 2-8ºC. CONDITIONS OF VACATION FROM PHARMACIES. On prescription.