Pharmacokinetics in children

Folgende Parameter wurden von Nahata et al. (1999) und Sutton et al. (1986) ermittelt:

	Cl (ml/min/kg)	V (steady-state) (L/kg)	t1/2 (h)
Neugeborene			Sulbactam: 7,9 Ampicillin: sh. Monographie Ampicillin
Kinder 1 - 12 Jahre	Ampicillin: 4.76 ± 1.67 Sulbactam: 4.95 ± 1.70	Ampicillin: 0.32 ± 0.11 Sulbactam: 0.34 ± 0.12	Ampicillin: 0.77 ± 0.14 Sulbactam: 0.81 ± 0.12

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Bacterial infections
Oral ≥ 30 kg 750 - 1.500 mg/day in 2 doses. Amount of drug applies to Sultamicillin.. Intravenous preterm and term neonates Postnatal age < 7 days 50/25 mg/kg/day in 2 doses

Prophylaxis of postoperative wound infections after abdominal and pelvic surgery

Intravenous ≥ 1 year 50/25mg/kg per dose 60 minutes prior to surgery. Maximum 2000/1000mg/dose. The same dose can be applied a second time in case of excessive blood loss or if surgery exceeds two half-lifes. ≥ 1 year [5] 50/25mg/kg per dose 60 minutes prior to surgery. Maximum 2000/1000mg/dose. The same dose can be applied a second time in case of excessive blood loss or if surgery exceeds two half-lifes.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

No dosing adjustment required.

GFR 30-50 ml/min/1.73 m2

No dosing adjustment required.

GFR 10-30 ml/min/1.73 m2

100 percentage of single dose and dosing interval : 12 uur

GFR < 10 ml/min/1.73 m2

100 percentage of single dose and dosing interval : 24 uur
GFR <5ml/min/1.73 m2: 100% der Normdosis alle 48 h

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Ampicillin + Sulbactam should only be applied intramuscularly in neonates, infants and children <2 years if other routes of application won't be effective.

Renal and liver function and hematopoietic system need to be monitored in preterm and term neonates as well as in infants if duration of treatment is prolonged.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Pfizer, SmPC Unasyn Ftbl. (1-18707), https://www.univadis.at/, 11/2018
2. Astro, SmPC Ampicillin/Sulbactam 1,5 g Plv. z. Herst. e. Inj./Inf.lsg. (1-18599-P1), https://www.univadis.at/, 01/2019
3. Emergent Netherlands B.V., SmPC Vivotif 2x10^9 - 2x10^10 CFU magensaftresistente Hartkapsel (2-38557), https://www.univadis.at/, 03/2019
4. Daschner, M, Tabellarium Nephrologicum, 3. Auflage, 2009
5. Bratzler, D, et al., Clinical practice duidelines for antimicrobial prophylaxis in surgery, Surg Infect (Larchmt), 2013, 14(1), 73-156
6. Nahata, M, et al., Pharmacokinetics of ampicillin and sulbactam in pediatric patients, Antimicrob Agents Chemother, 1999, 43(5), 1225-1229
7. Sutton, AM, et al., Pharmacokinetic study of sulbactam and ampicillin administered concomitantly by intraarterial or intravenous infusion in the newborn, Rev Infect Dis, 1986, 8 Suppl 5, 518-22
8. Pfizer, SmPC Unasyn 1,5 g Tr.st.amp. (1-18599), https://www.univadis.at/, 11/2018

Changes

Therapeutic Drug Monitoring

Overdose