| Composition
: |
| |
Each
tablet contains:
Sultamicillin tosylate 506.3mg.(equivalent
to 375mg Sultamicillin ).
Each
5ml: reconstituted
suspension contains: Sultamicillin
250mg.  |
| |
| Properties
and Clinical pharmacology: |
| |
Unictam is double ester
in which ampicillin and the Beta-Lactamase
inhibitor sulbactam are linked via
a mythylene group. Following oral
administration, Unictam is hydrolysed
during absorption to provide sulbactam
and ampicillin in a 1:1 molar ratio
in the systemic circulation. The bioavailability
of an oral dose is 80% of an equal
intravenous dose of sulbactam and
ampicillin.
Administration following food does
not affect the systemic bioavailability
of Unictam. Peak serum levels of ampicillin
following are approximately twice
those of an equal dose of oral ampicillin.
Elimination half-lives are approximately
0.75 and 1 hour for sulbactam and
ampicillin, respectively with 50-75%
of each agent being excreted unchanged
in the urine. Sulbactam is an irreversible
inhibitor of most important beta-lactamases
that occur in penicillin-resistant
organisms.
Ampicillin is the bactericidal component
of this product which acts against
sensitive organisms during the stage
of active multiplication by the inhibition
of biosynthesis of cell wall mucopeptide.
|
| |
| Microbiology: |
| |
| Unictam is effective
against a wide range of gram-positive
and gram-negative bacteria including:
Staphlococcus aureus and epidermidis
( including penicillin resistant and
some methicillin resistant strains
), streptococcus species, Haemophilus
influezae and parainfluezae ( both
beta-lactamase positive and negative
strains ) Branhamella catarrhalis,
anaerobe including Bacteroides and
related species, Escherichia coli,
Klebsiella species, Proteus species
( both indole-positive and indole-negative
) Enterobacter species, Morganella
morganii, Citrobacter species, Neisseria
meningitidis and Neisseria gonorrhoeae. |
| |
| Indications: |
| |
Unictam
is indicated for infections caused
by susceptible microorganisms.Typical
indications are:
 Upper
respiratory tract infections including
sinusitis, otitis media and tonsillitis.
Lower
respiratory tract infections including
bacterial pneumonias and bronchitis.
Urinary
tract infections and pyelonephritis.
Skin
soft tissue infections.
Gonococcal
infections.
Unictam
oral forms may also indicated in patients
requiring Ampicillin/Sulbactam therapy
following treatment with parentral
form. |
| |
| Contraindication: |
| |
| Unictam is contraindicated
in individuals with a history of an
allergic reaction to any of the penicillins. |
|
| Precautions: |
|
Occasionally severe
hypersensitivity reactions have been
reported in patients on penicillin
therapy.
Pregnancy: Safety for use in pregnancy
has not been established.
Lactation: low concentrations of ampicillin
and sulbactam are excreted in the
milk, caution should be exercised
when Unictam is administrated to a
nursing mother.
Infants: Because renal function is
not fully developed in neonates, this
should be considered when using Unictam
in neonates. |
|
| Drug
Interactions: |
|
| The concurrent administration
of allopurinol and ampicillin increases
the incidence of rashes, however there
are no data concerning concurrent
administration of Sultamicillin itself
and allopurinol. |
|
| Adverse
Reactions: |
|
Unictam is generally
well tolerated. The majority of side
effects are normally tolerated with
continued treatment.
Gastrointestinal: Diarrhea, nausea,
vomiting and abdominal pain.
Skin: Rash and itching.
Miscellaneous: Drowsiness, fatigue
and headache have been rarely observed. |
|
| Dosage
and Administrations: |
|
Adults: 375 –
750 mg twice daily.
Children: weighing less than 30kg,
25-50 mg/kg/day in 2 divided doses
depending on the severity of the infection.
Treatment of Gonorrhoea: 2.25 gm (
Six 375 mg tablets ) as single oral
dose can be given.
In patients with severe renal impairment
( Creatinine Clearance < 30ml/min.
), the dose should be administered
less frequently in accordance with
usual practice for ampicillin.
The reconstituted oral suspension
must be stored under refrigeration
and discarded after 14 days. |
|
| Package: |
|
Unictam 375mg. tablet,
pack of 12 tablets.
Unictam powder,bottle contains 3 g
sultamicillin plus 2 ampoules of water
for reconstitution 20 ml each. |
| |
