Bactamed
(Ampicillin & Sulbactam)




COMPOSITION

Each 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

- Upper and lower respiratory tracts infections;
- Urinary tracts infections;
- Gynecological infections;
- Intraabdominal infections;
- Skin and soft tissue 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.

ADVERSE EFFECTS

- 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.

DOSAGE AND ADMINISTRATION

The daily dosage for adults is from 1.5 g (1 g ampicillin/0.5g sulbactam) to 12 g (8 g 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 moderate infections 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 (g) Dosage
interval
(h)
>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.

MANUFACTURED FORM

1 vial of Bactamed injections 0.75 g and 1 ampoule with solvent in a package. 1 vial of Bactamed injections 1.5 g and 1 ampoule with solvent in a package. 10 vials 0.75 g or 1.5 g Bactamed injections in box.

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