| Composition: |
| |
Each
3000 mg. vial ( under registeration)
contains:-
Sulbactam Sodium (the equivalent
of 1000 mg. Sulbactam ).
Ampicillin Sodium (the equivalent
of 2000 mg. Ampicillin ).
Each 1500
mg. vial contains:-
Sulbactam Sodium (the
equivalent of 500 mg. Sulbactam ).
Ampicillin Sodium (the equivalent
of 1000 mg. Ampicillin ).
Each
750mg. vial contains :-
Sulbactam Sodium (the
equivalent of 250 mg. Sulbactam ).
Ampicillin Sodium ( the equivalent
of 500 mg. Ampicillin ).
Each 375mg. vial contains :-
Sulbactam Sodium ( the equivalent
of 125 mg. Sulbactam ).
Ampicillin Sodium ( the equivalent
of 250 mg. Ampicillin ). |
| |
| Properties
: |
| |
Unictam
is an injectable combination consisting
of ampicillin sodium and the beta-lactamase
inhibitor sulbactam sodium for intravenous
and intramuscular injection.
Ampicillin is bactericidal through
the inhibition of cell wall mucopeptide
synthesis. Ampicillin has a broad
spectrum of activity against many
gram-positive and gram-negative aerobic
and anaerobic bacteria. Sulbactam
has a good inhibitory activity against
the clinically important plasmid mediated
beta-lactamases most frequently responsible
for drug resistance. The presence
of sulbactam in the combination effectively
extends the antibiotic spectrum of
ampicillin to include many bacteria
normally resistant to beta-lactam
antibiotics.
|
| |
| Pharmacokinetics
: |
| |
After 15 minutes of
intravenous infusion of 1.5 g Unictam,
peak serum levels of ampicillin ranging
from 40-71 mcg./ml. and from 21 to
40 mcg./ml. for sulbactam are attained.
After intramuscular injection of 1.5
g Unictam, peak serum levels ranging
from 8 to 37mcg / ml. for ampicillin
and from 6 to 24mcg. / ml. for sulbactam
are attained.
The mean serum half-life of both drugs
is approximately 1 hour. About 75
to 85 % of both ampicillin and sulbactam
are excreted unchanged in urine during
the first 8 hours after administration.
|
| |
| Microbiology
: |
| |
In vitro studies have
demonstrated the susceptability of
most strains of the following organisms
to the combination:
Gram-Positive Bacteria: Staphylococcus
aureus (beta-lactamase and non beta-lactamase
producing), Staphylococcus epidermidis
(beta-lactamase and non beta-lactamase
producing), Staphylococcus saprophyticus
(beta-lactamase and non beta-lactamase
producing) Streptococcus faecalis,
Streptococcus pneumoniae , Streptococcus
pyogenes and Streptococcus viridans
.
Gram-Negative Bacteria: Haemophilus
influenzae (beta-lactamase and non
beta-lactamase producing), Moraxella
catarrhalis (beta-lactamase and non
beta-lactamase producing) Escherichia
coli (beta - lactamase and non-beta
lactamase producing), Klebsiella species
(all known strains are beta-lactamase
producing) , Proteus mirabilis (beta-lactamase
and non beta-lactamase producing),
Proteus vulgaris, Provedencia rettgeri
, Provedencia stuartii , Morganella
morganii, Neisseria meningitidis and
Neisseria gonorrhoeae (beta-lactamase
and non beta-lactamase producing).
Anaerobes:Clostridium species,Peptococcus
species, Peptostreptococcus species,
Bacteroides species and Helicobacter
pylori.
|
| |
| Indications: |
| |
Unictam is
indicated for the treatment of infections
caused by susceptible microorganisms:
Skin and soft tissue infections.
Intra-abdominal infections.
Upper and lower respiratory tract
infections.
Urinary tract infections.
Gonococcal infections.
Bone and joint infections.
Septicemia. |
|
| Contraindications: |
|
| The use
of Sulbactam / Ampicillin combination
is contraindicated in individuals
with a history of hypersensitivity
reactions to any of the penicillins. |
|
| Precautions: |
|
Anaphylactic reactions
have been reported in patients with
penicillin hypersensitivity to multiple
allergens.
Pseudomembranous colitis has been
reported with nearly all antibacterial
agents including the combination:
Sulbactam / Ampicillin
A high percentage of patients with
mononucleosis who receive ampicillin
develop skin rash, the combination
Sulbactam / Ampicillin should not
be administered in these cases.
Pregnancy:
Category B. Unictam could be used
during pregnancy only if clearly needed.
Lactation:
Low concentrations of ampicillin
and sulbactam are excreted in the
milk. Caution should be exercised
when this combination is given to
a nursing mother.
Convulsions may occur, if the drug
is administered in high doses.
|
|
| Drug
Interactions: |
|
Probenecid decreases
the renal tubular secretion of ampicillin
and sulbactam.
Concurrent administration of allopurinol
and ampicillin increases the incidence
of rashes in patients recieving both
drugs .
Unictam and aminoglycosides should
not be reconstituted together due
to the in vitro inactivation of aminoglycosides
by ampicillin
|
|
| Adverse
Reactions: |
|
Unictam
is generally well tolerated. The most
frequently reported adverse reactions
are diarrhea in 3 % of the patients
and rash in less than 2 % of the patients.
Additional systemic reactions reported
in less than 1 % of patients were:
Itching, nausea, vomiting, fatigue,
headache, flatulance, glossitis, oedema,
substernal pain, epistaxis and mucosal
bleeding.
|
|
| Dosage
and Administration: |
|
The recommended adult
dosage of Unictam is 1.5 gm. to 3
gm. every six hours. The total dose
of sulbactam should not exceed 4 grams
per day (equivalent to 12 g. Unictam)
.
For IV administration, the dose can
be given by slow intravenous injection
over 10 - 15 minutes or can also be
delivered in greater dilutions with
50-100ml. of a compatible diluent
(Isotonic sodium chloride, 5% dextrose
in water or lactated ringer’s
solution) as an intravenous infusion
over 15 - 30 minutes . The combination
may be administered by deep intramuscular
injection.
|
|
| The
dosage for children, infants and neonates: |
|
150 mg/kg/day (corresponding
to sulbactam 50 mg/kg/day and ampicillin
100 mg/kg/day) divided every 6 to
8 hours.
In neonates during first week of life
(especially preterms), dosing is usually
every 12 hours.
|
|
| Dosage
in Renal Impairment: |
|
Creatinine clearance
>30ml/min: 1.5-3 g every 6-8 hours.
Creatinine clearance 15-29 ml/min:1.5-3
g every 12 hours.
Creatinine clearance < 15 ml/min.:
1.5-3 g every 24 hours.
|
|
| Package: |
|
Vial of 3000 mg ( under
registeration) . ( 1000 mg. sulbactam
+ 2000 mg. ampicillin ).
Vial of 1500 mg. ( 500 mg. sulbactam
+ 1000 mg. ampicillin ) + ampoule
5 ml. water for injection.
Vial of 750 mg. (250 mg. sulbactam+
500 mg. ampicillin ) + ampoule 2 ml.
water for injection.
Vial of 375 mg. (125 mg. sulbactam
+ 250 mg. ampicillin) + ampoule 2
ml. water for injection.
|
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