Posology : מינונים

4.2 Posology and method of administration
Adult Patients and adolescent (over 40 kg)
For IV administration, the dose can be given by slow intravenous injection over at least 10–15 minutes or can also be delivered in greater dilutions with 50–100 mL of a compatible diluent as an intravenous infusion over 15–30 minutes.

AmpiSulVenir may be administered by deep intramuscular injection.

The recommended adult dosage of AmpiSulVenir is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of AmpiSulVenir, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam.
The total dose of sulbactam should not exceed 4 grams per day.


-   Pediatric Patients 1 Year of Age or Older
The recommended daily dose of AmpiSulVenir in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of AmpiSulVenir, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of AmpiSulVenir administered via intramuscular injection in pediatric patients have not been established.
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous AmpiSulVenir.

-   Impaired Renal Function
In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of AmpiSulVenir in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:

TABLE 1
AmpiSulVenir Dosage Guide For Patients With Renal Impairment
Creatinine Clearance         Ampicillin/Sulbactam          Recommended (mL/min/1.73m2)              Half-Life (Hours)             AmpiSulVenir Dosage 30                            1                   1.5-3.0 g q 6h-q 8h 15-29                           5                     1.5-3.0 g q 12h 5-14                           9                     1.5-3.0 g q 24h

When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males            weight (kg)  (140 – age)
72  serum creatinine

Females 0.85  above value
Duration of administration
The treatment is usually continued until 48 hours after fever and abnormal signs have resolved. Treatment is normally administered for 5 to 14 days, but it should be prolonged or an additional dose of ampicillin should be administered in case of very severe infections. The total dosage of sulbactam should not exceed 4 g per day.
Therapy over at least 10 days is indicated in the treatment of infections with beta-haemolytic streptococci in order    to    prevent      late     complications      (e.g.    rheumatic      fever,  glomerulonephritis).


Administration
The combination of ampicillin and sulbactam may be administered by either intramuscular or intravenous route.
Aminoglycosides are inactivated in vitro by ampicillin: therefore the mixing of aminoglycosides with ampicillin and sulbactam must be avoided in the solution for application. There should be a time limit of at least one hour between the separate applications. The site of injection of aminoglycosides should be different from that of Ampicillin and Sulbactam.
The following drugs should be applicated separately either, because there are incompatibilities, too: metronidazole,  tetracycline-   derivates, thiopental    sodium,    prednisolone,  procaine      2%, suxamethoniumchloride and noradrenaline.
Intravenous use
Ampicillin and sulbactam can be reconstituted with water for injection or with compatible solutions.
Ampicillin and sulbactam can be administered by bolus intravenous injection over at least 3 minutes or by intravenous infusion in 15 to 30 minutes (see section 6.6).
Intramuscular use
The sterile dry powder may be dissolved in water for injections or in lidocaine hydrochloride 5 mg/ml (0,5%) solution (see section 6.6). Ampicillin and sulbactam should be administered by deep intramuscular injection (for contraindications see section 4.3).