Ampicillin plus Sulbactam Eberth

Powder for solution for injection

Ampicillin plus Sulbactam Eberth

dosage/strength

dosage form

pack size

 

pharmaceutical registration number

SmPC

1 g/0,5 g

powder for solution for injection

10 vials

N3

11138664

2 g/1 g

powder for solution for injection

10 vials each 20 ml

N3

11138670

2 g/1 g

powder for solution for injection

10 vials each 50 ml

N3

11138687

Active substances:
Ampicillin sodium + Sulbactam sodium

Pharmacotherapeutic group: 
Ampicillin is a semi-synthetic, non beta-lactamase-resistant aminopenicillin. Sulbactam is a beta-lactamase inhibitor with a structure similar to that of ampicillin and other penicillins.
ATC code: J01CR01

Mechanism of action:
The mechanism of action of ampicillin is based on suppression of bacterial wall synthesis (in the growth phase) via blockade of the penicillin-binding proteins (PBPs) such as the transpeptidases. This results in a bactericidal action.

In combination with sulbactam, the inactivation of ampicillin by certain beta-lactamases is inhibited. Sulbactam protects ampicillin from degradation by most beta-lactamases of staphylococci and several plasmid-encoded beta-lactamases (e.g. TEM, OXA, SHV, CTX-M) and certain chromosomally encoded beta-lactamases of Gram-negative bacteria. These beta-lactamases are present in, for example, Escherichia coli, Klebsiella spp., Proteus mirabilis and Haemophilus influenzae. The antibacterial spectrum of action of ampicillin is broadened to include bacteria whose beta-lactamases are inhibited by sulbactam.

Therapeutic indications:
Ampicillin plus Sulbactam Eberth is indicated in the treatment of the following infections in adults and children:

  • Severe infections of the throat, nose and ear (such as mastoiditis, peritonsillar infections, epiglottitis and sinusitis with associated severe systemic signs and symptoms)
  • Acute exacerbations of chronic bronchitis (after adequate diagnosis)
  • Community-acquired pneumonia
  • Urocystitis
  • Pyelonephritis
  • Skin and soft tissue infections, especially cellulitis, animal bites, severe dental abscesses with spreading cellulitis
  • Bone and joint infections, especially osteomyelitis
  • Intra-abdominal infections
  • Female genital infections

Prophylaxis of infections associated with major surgery in adults, such as:

  • in the stomach and intestinal tract
  • in the pelvic cavity
  • on the head and neck
  • in the biliary tract