Powder for solution for injection "Ampisulbin ®" is used in the treatment of infections caused by microorganisms sensitive to the components of the drug:
Upper and lower respiratory tract infections, including sinusitis, otitis media, epiglottitis and bacterial pneumonia; urinary tract infections and pyelonephritis; intra-abdominal infections, including peritonitis, cholecystitis, endometritis and pelvic inflammatory disease; bacterial septicaemia; skin, soft tissue, bone and joint infections; gonococcal infections.
The drug can be prescribed in the perioperative period to reduce the incidence of postoperative infections in patients who have undergone abdominal and pelvic surgery and who may have an infection in the abdominal cavity. In case of cesarean section or termination of pregnancy, the drug can be used for prophylaxis to reduce the incidence of postoperative sepsis.
It should be noted that sulbactam/ampicillin is ineffective against Pseudomonas aeruginosa.
Composition
1 vial contains (active ingredients) 1.5 g of a sterile mixture of ampicillin sodium salt and sulbactam sodium salt in a ratio of 2: 1, calculated as ampicillin 1.0 g and sulbactam 0.5 g
Contraindication
hypersensitivity to the components of the drug; history of hypersensitivity to penicillins and cephalosporins; infectious mononucleosis or lymphatic leukemia;
If 0.5% sterile lidocaine hydrochloride injection or another local anesthetic is used to reconstitute the powder, the contraindications specified in the instructions for medical use for the corresponding medicinal product should be taken into account.
Method of application
The drug "Ampisulbin ®" should be administered intramuscularly or intravenously (as a bolus injection or infusion).
To prepare for use, the drug should be diluted with sterile water for injection or another compatible solvent. After adding the solvent, wait a few minutes until the foam disappears completely, then visually assess the completeness of dissolution.
The drug should be dissolved with at least 3.2 ml of water for injection (or other compatible solution), respectively. Administer intramuscularly, as a bolus injection (over at least 3 minutes). At higher dilutions, the dose can be administered as a bolus or as an infusion (over 15-30 minutes).
For intramuscular use, the drug should be injected deep into the muscle; if the injections are painful, 0.5% sterile lidocaine hydrochloride injection or another suitable local anesthetic may be used to reconstitute the powder.
The maximum final concentration of sulbactam / ampicillin is 125 mg / 250 mg in 1 ml.
Treatment of infections caused by microorganisms sensitive to sulbactam and ampicillin
Adults. Depending on the severity of the infection, a daily dose of Ampisulbin® from 1.5 g to 12 g should be administered in divided doses every 6-8 hours (every 12 hours for less severe infections); the maximum daily dose should not exceed 12 g for Ampisulbin® (4 g for sulbactam).
Children, infants and neonates (from one week of age) should usually be given a daily dose of 150 mg/kg body weight (corresponding to 100 mg/kg/day of ampicillin and 50 mg/kg/day of sulbactam) divided into equal doses every 6 or 8 hours. Neonates during the first week of life (especially premature infants) should usually be given a dose of 75 mg/kg/day (corresponding to 25 mg/kg/day of sulbactam and 50 mg/kg/day of ampicillin) in divided doses every 12 hours.
For the prevention of surgical infections
The dose of Ampisulbin® is 1.5-3 g, and should be administered during induction anesthesia, allowing sufficient time to achieve effective serum and tissue concentrations during surgery. The dose may be repeated every 6-8 hours; the drug should generally be discontinued 24 hours after surgery, except when Ampisulbin® is administered for therapeutic purposes.
For the treatment of uncomplicated gonorrhea
"Ampisulbin ®" can be administered once at a dose of 1.5 g intravenously or intramuscularly. In order to maintain the concentration of sulbactam and ampicillin in the blood plasma, probenecid should be administered simultaneously at a dose of 1 g orally.
Duration of treatment
The duration of treatment depends on the severity of the infection and is usually 5-14 days, but in more severe cases it may be extended or ampicillin may be additionally prescribed. As a rule, treatment should be continued for another 48 hours after the body temperature has normalized and other signs and symptoms of bacterial infection have disappeared.
The duration of treatment for infections caused by hemolytic streptococci should be at least 10 days in order to avoid rheumatoid fever and glomerulonephritis.
Application features
Pregnant women
Ampicillin and sulbactam pass into breast milk in low concentrations. Experience with the use of sulbactam / ampicillin during breastfeeding is also insufficient. Until this is fully clarified, "Ampisulbin ®" should be used during pregnancy or breastfeeding only after a careful assessment of the benefit-risk ratio.
Children
Apply to children from birth.
Drivers
Studies to assess the effect of the drug "Ampisulbin ®" on the reaction rate when driving or working with other mechanisms have not been conducted. However, patients should be informed that cases of such isolated side effects as dizziness or increased fatigue may affect the reaction rate.
Overdose
The available data on the acute toxicity of ampicillin/sulbactam in humans are limited. It would be expected that an overdose of this medicinal product would lead to manifestations consistent with the side-effect profile of the drug "Ampisulbin ®". It is expected that in case of overdose, adverse reactions will be recorded more frequently and will be of a more severe degree. Very high doses of beta-lactam antibiotics may lead to epileptic seizures. Since both ampicillin and sulbactam are removed from the bloodstream by hemodialysis, hemodialysis may enhance the elimination of the medicinal product from the body in case of overdose in patients with impaired renal function. Anaphylactic shock, which is not poisoning, is observed very rarely, but is always life-threatening.
Therapy: Diazepam should be used to treat convulsions due to overdose. In case of anaphylactic shock, appropriate therapy should be initiated immediately.
Side effects
Blood and lymphatic system disorders: common (≥ 1/100 to < 1/10) - anemia, thrombocytopenia, eosinophilia.
Vascular disorders: often (≥ 1/100 to <1/10) - phlebitis.
Gastrointestinal: often (≥ 1/100 to < 1/10) - diarrhea, feeling of heaviness in the epigastric region, loss of appetite.
Hepatobiliary disorders: common (≥ 1/100 to < 1/10) - hyperbilirubinemia.
Interaction
Sulbactam/ampicillin should not be mixed with blood products or protein hydrolysates. Due to the chemical incompatibility between penicillins and aminoglycosides, which leads to inactivation of aminoglycosides, Ampisulbin® should not be mixed with aminoglycosides in the same syringe or infusion solution. The two substances should be administered at different sites with an interval of at least one hour.
Incompatibles, and therefore those that should be used separately, include, but are not limited to: metronidazole, injectable tetracycline derivatives such as oxytetracycline, rolitetracycline and doxycycline, as well as thiopental sodium, prednisolone, 2% novocaine, suxamethonium chloride and noradrenaline. Visible signs of incompatibility are precipitation, opacity or discoloration.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
