AMPICTAM 750
-
Chemical Name:
Ampicillin (Sodium) +Sulbactam (Sodium) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Penicillin -
Pharmaceutical Form:
Vial -
Composition:
Ampicillin (Sodium) 500mg+Sulbactam (Sodium) 250mg
AMPICTAM Vial
1- Composition :
- AMPICATAM –750 Vial
Each vial contains : Ampicillin Sodium equivalent to Ampicillin 500 mg + Sulbactam Sodium equivalent to Sulbactam 250 mg .
- AMPICTAM 1.5 Vial :
Each vial contains : Ampicillin Sodium equivalent to Ampicillin 1 gr + Sulbactam Sodium equivalent to Sulbactam 0,5 gr .
- AMPICTAM – 3 Vial :
Each vial contains: Ampicillin Sodium equivalent to Ampicillin 2 grams + Sulbactam Sodium equivalent to Sulbactam 1 gram
2 - PHARMACOLOGY
Ampicillin with Sulbactam : The sodium salts of Ampicillin and sulbactam are given intramuscularly or intravenously in the treatment of infections due to beta - lactamase producing organisms .
1- AMPICILLIN is a derivative of 6–amino penicillanic acid belonging to the group of semisynthetic pencillins , more precisely , it is the 6 D(-) alpha – amino phenyl acetamido penicillanic acid .
The spectrum of antibacterial action of Ampicillin includes gram-positive and gram-negative bacteria, and its antibacterial action is bactericidal. Ampicillin is effective against the following organisms:
GRAM –POSITIVE ORGANISMS:
Hemolytic and non-hemolytic streptococci; diplococcus pneumonia; non-penicillinase producing staphylococci; clostridia spp; bacillus anthracis; c.xerosis; enterococci.
GRAM-NEGATIVE ORGANISMS:
H.influenzae; b.fundulformis; n.gonorrhoeae; proteus mirabillis; salmonella ; shigella ;
E.coli .
2- SULBACTAM : is a penicillanic acid sulphone with beta – lactamase inhibitory properties. It is an irreversible inhibitor of several beta – lactamases produced by gram – negative bacteria including bacteroides fragilis and other Bacteroides Spp., Haemophilus ducreyi, H . influenzae
Moraxella (Branhamella) Catarrhalis, Neisseria gonorrhoeae, and some Enterobacteriaceae, as well as those produced by staphylococci. Sulbactam can therefore enhance the activity of penicillins against many resistant strains of bacteria.
3- PHARMACOKINETICS :
The pharmacokinetics of parenteral sulbactam and ampicillin are similar.
When used parenterally AMPICTAM produces elevated blood , biliary and urinary concentrations without causing local irritation . Ampicillin is non – toxic , usually well tolerated , and only minimally serum-bound .
4- INDICATIONS :
All infections treated with ampicillin and various infections where betalactamase production is suspected as for example :
- Bone and joint infections .
- Upper and lower respiratory tract infections .
- Genito-urinary tract infections.
- Skin infections
- Prophylaxis in Surgical infection
- Biliary tract infections
- Enteritis
- Gonorrhoea
- Meningitis
- Peritonitis, septicaemia
5- Contra – indications :
Hypersensitivity to Penicillins
6- PRECAUTIONS :
- Drug should be discontinued if a skin rash occurs.
- During pregnancy and Lactation the product should be used only when absolutely necessary and under the direct supervision of the physician .
- During Renal Failure should be used under the direct supervision of the physician
7- DRUG INTERACTIONS :
Ampicillin may decrease the efficacy of oestrogen – containing oral contraceptives.
Probenecid may elongate the excretion of the Ampicillin and may dilute its concentration and it should not be co-administrated with Allopurinol .
8- SIDE EFFECTS :
It may rarely cause : skin rashes, gastrointrstinal disturbances as particularly diarrhoea.
9- DOSAGADMINISTRATION :
E AND Usual dose : 1,5 gr (1 vial 1,5 gr.) every 6 hours
Severe infections : 3 gr ( 1 vial 3 gr. ) every 6 hours
Children : 150 mg / kg / day ( 1 vial 750 ) or As directed by the physician
10- DIRECTIONS FOR USE:
For Intramuscular Use:
- Dissolve the contents of a vial ( 750 ) with ( 3.2 ml containing Lidocaine ) of sterile water for injection (and shake until complete dissolution )
- Dissolve the contents of a vial ( 1.5 gr ) with ( 3.2 ml containing Lidocaine ) of sterile water fo injection (and shake until complete dissolution )
- Dissolve the contents of a vial (3 gr) with( 6.4 ml containing Lidocaine ) of sterile water for injection
(and shake until complete dissolution )
For Intravenous administration :
- Dissolve the contents of a vial ( 750 ) with ( 3.2 ml) of sterile water for injection
Slow - venous injection during 10-15 minutes .
- Dissolve the contents of a vial ( 1.5 gr ) with ( 3.2 ml) of sterile water for injection
Slow - venous injection during 10-15 minutes
- Dissolve the contents of a vial (3 gr) with ( 6.4 ml) of sterile water for injection
Slow - venous injection during 10-15 minutes
11- PACKAGING :
- 1 VIAL
- 100 VIALS