Active Ingredient: Sultamicillin
For the treatment of the following infections caused by susceptible microorganisms:
As step down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral ampicillin-sulbactam.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, between 25 milligrams sultamicillin per kilogram of body weight and 50 milligrams sultamicillin per kilogram of body weight, 2 times daily.
Regimen B: Oral, 750 milligrams sultamicillin, 2 times daily, over the duration of 5 to 14 days.
Usual dose in adults and children weighing ≥30 kg is 750 mg twice daily.
Usual duration of treatment: 5 to 14 days which may be extended depending on the type and severity of infection.
For:
Regimen A: Intravenous, 75 milligrams sultamicillin per kilogram of body weight, 4 times daily, over the duration of 14 days.
Regimen B: Intravenous, between 1.5 milligrams sultamicillin and 3 milligrams sultamicillin, daily, 4 doses in total.
The recommended daily dose of sultamicillin 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 sultamicillin, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of sultamicillin 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. The recommended dosage 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 sultamicillin, 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.
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 sultamicillin.
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