Bactamed (Ampicillin/Sulbactam)
Pharmaceutical Form
Powder for injections
COMPOSITION
One vial contains
Sodium ampicillin
equivalent to 0.5 or 1.0 g of ampicillin
Sodium sulbactam
equivalent to 0.25 or 0.5 g of sulbactam.
Solvent: 1.8 or 3.5 ml
of 0.5% Lidocaine hydrochloride
THERAPEUTIC
INDICATIONS
Bactamed is applied for
treatment of infections, caused by microorganisms
sensible to ampicillin/sulbactam:
- Upper and lower
respiratory tracts infections;
- Urinary tracts
infections;
- Gynecological
infections;
- Intraabdominal
infections;
- Skin and soft
tissues infection;
- Joint and bone
infections;
- Bacterial
septicemia, decreasing of risk of sepsis following
abortation and cesarean operation
It is applied as
preoperational prophylaxis and in case of gonorrheal
infections.
CONTRAINDICATIONS
Bactamed IM is not
injected in case of hypersensitivity to penicillin.
A solvent containing lidocaine should not be used
in case of hypersensitivity to topical anesthetics
and any forms of cardiac blockage.
PRECAUTIONS
During Bactamed therapy
hypersensitive reactions may be observed.
Anaphylactic reaction of such type may be reported
in case of hypersensitivity to penicillin and
cephalosporin, therefore close taking of history
before therapy is required.
If allergic reactions
occur Bactamed should be discontinued. And it is
necessary to start antihistaminic and corticosteroid
therapy.
Functions of vitally
important organs (kidneys, liver, hemolytic system)
should be monitored during of prolonged therapy in
spite of intoxicity of penicillins.
Ampicillin/sulbactam has
not carcinogenic and mutagenic effects. It is not
applied in patents with infections mononucleosis
ADVERSE EFFECTS
Bactamed IM is well
tolerated by patients. However the following
reactions may be rarely reported:
- Locally: Pain in
injection site;
- GIT: Stomatitis,
darkening of tongue surface, gastritis, diarrhea,
enterocolitis, pseudomembranous colitis.
- Skin and soft
tissues: Skin rash, itching, urticaria, and
multiform erythema.
- Hematolytic:
Agranuloditosis, decreasing of hemoglobin,
hemotocrit, quantity of erythrocytes, leukocytes,
lymphocytes, thrombocyte quantity, or increasing of
quantity of lymphocytes, monocytes, eosinophils,
trombocytes. These changes are transient and blood
picture is normalized after drug discontinuation.
Consult a doctor in case
of unexpected effects appearance
DOSAGE AND
ADMINISTRATION
The daily dosage for
adults is from 1. 5 (1 g ampicillin/ 0.5g sulbactam)
to 12g/8g ampicillin (4 g sulbactam). The maximum
daily dose of sulbactam is 4 g. Depending on
severity of infectious process Bactamed is applied
in 6-8 hours. In case of infections of average
severity it is administered in 12 hours.
After dissolving
Bactamed is deeply intramuscularly injected. The
solution is used during 1 hour after constitution.
The elimination of ampicillin is changed in case of
renal disorder, but plasma level is unchanged.
The following scheme is
applied in these conditions:
|
Creatinine
clearance (ml/sec)
|
Dosage
|
Dosage interval
|
|
>30
|
1.5-3
|
6-8
|
|
15-29
|
1.5-3
|
12
|
|
5-14
|
1.5-3
|
24
|
The daily dosage for
infants and children is 150 mg/kg every 6-8 hours.
For dysmature infants and newborns during the first
week the dose is 150 mg/kg a day in 12 hours. The
therapy is 48 hours more after temperature
decreasing. Usually the duration of treatment is
5-14 days; in case of poor proceeding diseases the
therapy is continued. In case of prophylaxis of
surgical procedures 1.5-3 g of Bactamed is applied
for anesthesia to form sufficient concentrations and
it is reinjected in 6-8 hours after the first
introduction. If co-administration of Bactamed with
aminoglycosides is required, these drugs are
prepared separately and injected in different body
parts
PREPARATION OF THE
SOLUTION
After dissolving wait
foam disappearing and then inject intramuscularly.
0.5% lidocaine HCl is applied as a solvent.
Bactamed IM for
injections 0.75g 1.8 ml.
Bactamed IM for
injection 1.5 g 3.5 ml.
MANUFACTURED FORM
There is 1 vial of
Bactamed injections 0.75 g for intramuscular
injection and 1 ampoule with solvent – lidocaine in
a package.
There is 1 vial of
Bactamed injections 1.5 g for intramuscular
injection and 1 ampoule with solvent – lidocaine in
a package.
SALES TERMS
Sold under prescription.
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