AMPI 500
-
Chemical Name:
Ampicillin (Sodium) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Penicillin -
Pharmaceutical Form:
Vial -
Composition:
Ampicillin (Sodium) 500mg
AMPI
BROAD – SPECTRUM ANTIBIOTIC
1- COMPOSITION:
Injectable:
Available strengths:
- AMPI- 500 vial : Each vial contains Ampicillin Sodium equivalent to 500 mg ampicillin .
- AMPI - 1000 vial : Each vial contains Ampicillin Sodium equivalent to 1 gram ampicilline .
- AMPI - 2000 vial: Each vial contains Ampicillin Sodium equivalent to 2 grams ampicilline .
2- PHARMACOLOGY :
AMPI 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 AMPI includes gram-positive and gram-negative bacteria, and its antibacterial action is bactericidal. AMPI 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 .
3- PHARMACOKINETICS :
AMPI is stable in the presence of gastric acid and is quickly absorbed
when administrated orally ; producing therapeutically effective blood levels within 6-8 hours after administrations . When used parenterally AMPI 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 :
Infections caused by gram –positive micro-organisms and susceptible strains of gram-negative bacteria ; infections of respiratory tract , gastrointestinal , biliary and genito-urinary tracts . Various infections such as : endocarditis , pericarditis syphilis , rheumatic fever , infected wounds , pyoderma , erysipelas and for perioperative prophylaxis (pre and postoperative infection )
5- CONTRAINDICATIONS :
History of previous hypersensitivity reactions to any of the penicillins or cephalosporins .
6- PRECAUTION :
AMPI is not active against penicillinase staphylococci which are scarcely sensitive to penicillin , Crossed allergy with penicillin G is possible and exists between penicillins and cephalosporins .
During pregnancy and in new borns the product should be used only when absolutely necessary and under the direct supervision of the physician .
Hypersensitivity reactions and severe anaphylaxis have been reported primarily following parenteral use; rarely following oral administration. These adverse reactions are more apt to occur in individuals with a history of sensitivity to multiple allergens, asthma, hay fever and urticaria.
Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to Penicillins cephalosporins or other allergens.
Should an allergic reaction occur, ampicillin should be discontinued and the patient should be treated with the usual agents ( pressor amines, corticosterids, antihistamines) and in the case of anaphylaxis, immediate emergency treatment with adrenaline (epinephrine) and / or other opportune emergency measures should be initiated.
The prolonged use of penicillin, as with all other antibiotics, can favour the proliferation of micro-organisms not sensitive to the antibiotics (including mycotic organisms).
7- ADVERSE REACTIONS :
As with the use of penicillins in general, they are essentially limited to skin rash, pruritis, urticaria , nausea , vomiting , slight diarrhoea . All these adverse reactions disappear when the treatment is stopped .
8- DRUG INTERACTION:
Probenicid may interfere with the excretion of the drug.
9- DOSAGE :
PARENTERAL USE:
For adults and children weighing more than 40 kg:
Respiratory tract infections: 250 mg ,500 mg, or 1 gr , 2 gr . Every 6 to 12 hours.
Gastrointestinal infections:500 mg. Every 6 hours.
Biliary tract infections:250 mg to 500 mg every 6 hours-for gonorrheal urethritis 500 mg every 12 hours. For treatment of complications of gonorrheal urethritis such as prostatitis and epididymitis prolonged and intensive therapy is recommended.
Various infections: 500 mg to 1 gr every 4 to 6 hours.
In bacterial meningitis: 100 mg to 200 mg / kg / day in equally divided doses every 3 to 4 hours.
For children weighing less than 40 kg:
25 mg to50 mg / kg / day in equally divided doses every 4 – 6 or 12 hours depending upon the etiology and severity of the infection. The duration of therapy depends upon the seriousness of the case. Moreover treatment should be continued for a minimum of 48 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.
In case of severe renal failure , dose should be decreased .
10- DIRECTIONS FOR USE:
For Intramuscular use: Dissolve contents of a vial with the amount of sterile water for injection listed in the table below:
LABEL CLAIM RECOMMENDED AMOUNTS OF DILUENT
500 mg. 2 ml.
1 gram. 3 ml.
2 grams. 6 ml.
For administration by Intravenous drip:
Reconstitute the contents of the vial ( prior to adding to the intravenous solution). Thereafter, under normal conditions, the antibiotics will remain stable for at least 4 hours.
10- PACKAGING :
- 1 vial .
- 100 vials .