ampicillin + sulbactam


Shanxi Taisheng


Endure Medical
Full Prescribing Info
Ampicillin sodium, sulbactam sodium.
Each vial contains: Ampicillin (as Sodium) 500 mg, Sulbactam (as Sodium) 250 mg.
Pharmacology: Sulbactam sodium has a greater activity against Type 1 β-lactamases than clavulanate, but does not penetrate the cell walls of Gram-negative bacteria as well as it extends the antibacterial spectrum of Ampicillin to include β-lactamase-producing strains of Acinetobacter, Bacteroides and other anaerobes, Branhamella, Enterobacter, E. coli, Neisseria, Klebsiella, Proteus and Staphylococcus. It has weak antibacterial activity of its own.
Ampicillin is an alternative drug against Klebsiella pneumoniae (with Sulbactam), indole-positive Proteus (M. morganii, Pr. vulgaris and Providencia rettgeri; with Sulbactam), Salmonella typhi, Shigella, Gardnerella vaginalis, H. influenzae or Nocardia.
Some of these readily acquire resistance by elaboration of penicillinase, so it is given often in combination with Sulbactam.
Sulbactam, a broad spectrum antibiotic and Ampicillin, a β-lactamase inhibitor is effective against Gram-positive, Gram-negative, and anaerobic organisms. High concentrations of Sulbactam and Ampicillin are achieved in the blood following intravenous or intramuscular administration and both components have a half-life of approximately one hour. Most of the Sulbactam/Ampicillin is excreted in the urine.
Pharmacokinetics: Approximately 80% of an intramuscular or intravenous dose of 500 mg is eliminated in the urine in this time. Several renal impairment markedly prolongs the persistence of the drug in the plasma. Peritoneal dialysis is ineffective in removing the drug from the blood. but hemodialysis removes about 40% of the body store in about 7 hours. Adjustment of the dose is required in the presence of renal dysfunction.
Ampicillin/Sulbactam I.M./I.V. is indicated for infections where beta-lactamase production is suspected. Typical indications are upper and lower respiratory tract infections including sinusitis, otitis media and epiglottitis; bacterial pneumonia; urinary tract infections and pyelonephritis; intra-abdominal infections including peritonitis, cholecystitis, endometritis and pelvic cellulitis; bacterial septicemia; skin, soft tissue, bone and joint infections and gonococcal infections.
Ampicillin/Sulbactam I.M./I.V may also be administered pre-operatively to reduce the incidence of post-operative wound infections in patients undergoing abdominal or pelvic surgery, in which peritoneal contamination may be present. In termination of pregnancy or caesarian section, Ampicillin/Sulbactam may be used as prophylaxis to reduce postoperative sepsis.
Since infection mononucleosis is viral in origin, Ampicillin should not be used in the treatment. A high percentage of patients with mononucleosis who receive Ampicillin develop a skin rash.
Dosage/Direction for Use
1.5 to 12 g/day in divided doses.
Mild infections: 1.5 g to 3 g.
Moderate infections: Up to 6 g.
Severe infections: Up to 12 g.
Neonate: 150 mg/kg/day.
Or as prescribed by the physician.
The use of this combination is contraindicated in individuals with a history of an allergic reaction to any of the penicillins.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy.
These reactions are more to occur in individuals with a history of penicillin hypersensitivity who have experience severe reactions when treated with cephalosporins.
Before therapy with penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If allergic reactions occur, the drug should be discontinued and the appropriate therapy instituted.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubations should be administered as indicated.
Special Precautions
As with any antibiotic preparation, constant observation for signs of overgrowth of non-susceptible organisms, including fungi, is essential. Should
Use In Pregnancy & Lactation
Animal reproduction studies have revealed no evidence of impaired fertility to harm the fetus due to Sulbactam and Ampicillin.
However, safety for use in pregnancy and lactation has not been established.
Adverse Reactions
As with other parenteral antibiotics, the principal side effects observed is injection site pain, especially associated with the intramuscular route of administration. A small number of patients may develop phlebitis after intravenous administration.
Gastro-intestinal: The most common are nausea, vomiting and diarrhea.
Skin/skin structure: The most common are rash, itching and other skin reactions.
Hematopoietic and Lymphatic system: Anemia, thrombocytopenia, eosinophilia and leukopenia have been reported during therapy with Ampicillin/Sulbactam sodium. These reactions are reversible on discontinuation of therapy and believed to be sensitivity reactions.
Hepatic: Transient elevations of alanine and aspartic transaminases have been observed.
It is expected that the adverse reaction associated with the use of ampicillin will be occasionally observed.
Caution For Usage
Directions for reconstitution: Solution is prepared immediately before use by addition of 1-10 mL water for injection. Prepared solution must be used immediately. Discard remaining solution after use.
Incompatibility: Do not use an additive with any other drug. Do not mix in any solutions other than those specifically recommended. Some drugs may be administered through the Y-tubing in small amounts.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01CR01 - ampicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Powd for inj (vial) 500 mg/250 mg 10's.
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