- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Following plasma levels were determined at steady state and 2 h after application [SmPC Biocef Plv.]:
| C 2 h (mg/L) | C steady-state (mg/L) | |
| 1 – 7 months | 2,7 | 0,2 bis 0,3 |
| 7 months – 2 years | 2,0 | 0,2 bis 0,3 |
| 2 – 12 years | 0,1 |
Absorption rate is about 50%. Fulton (2001) und Kearns (1994):
absorption constant:
<5 years: 1,12 ± 0,77 h<sup>-1</sup>
≥5 years: 0,73 ± 0,18 h<sup>-1</sup>
Cl/F:
<5 years: 0,57 ± 0,16 L/h/kg
≥5 years: 0,36 ± 0,1 L/h/kg
Vdss/F:
<5 years: 1,52 ± 0,56 L/kg
≥5 years: 0,89 ± 0,3 L/kg
t ½:
1 bis 17 years: 1,7 h
Cefpodoxim is eliminated primarily renal unchanged.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Bacterial infections |
|---|
|
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
No adjustment necessary.GFR 30-50 ml/min/1.73 m2
No adjustment necessary.GFR 10-30 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 24 uurGFR < 10 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 48 uurPatients on dialysis
4 mg/kg after dialysis.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Diarrhea ocurrs more often in children aged 1 month to 2 years (12,8%) than in older ones (6%). 8,5% of children aged between 1 month and 3 years suffer diaper rash [Fulton 2001].
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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
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| First-generation cephalosporins | ||
|---|---|---|
| J01DB05 | ||
| J01DB04 | ||
| J01DB01 | ||
| J01DB03 | ||
| Second-generation cephalosporins | ||
|---|---|---|
| J01DC04 | ||
| J01DC03 | ||
| J01DC02 | ||
| Third-generation cephalosporins | ||
|---|---|---|
| J01DD08 | ||
| J01DD01 | ||
| J01DD52 | ||
| J01DD02 | ||
| J01DD14 | ||
| J01DD04 | ||
| Fourth-generation cephalosporins | ||
|---|---|---|
| J01DE01 | ||
| Monobactams | ||
|---|---|---|
| J01DF01 | ||
| Carbapenems | ||
|---|---|---|
| J01DH03 | ||
| J01DH51 | ||
| J01DH02 | ||
| MONOBACTAMS | ||
|---|---|---|
| J01DF01 | ||
| Other cephalosporins and penems | ||
|---|---|---|
| J01DI02 | ||
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References
- Kearns, GL, et al., Single dose pharmacokinetics of cefpodoxim proxetil in infants and children, Drug Invest, 1994, 7(5), 221-233
- Arznei und Vernunft, Leitlinie Antiinfektiva: Einsatz in Therapie und Prophylaxe, http://www.arzneiundvernunft.at/DE/Home.aspx, 2010
- Fulton, B, et al., Cefpodoxim proxetil: a review of its use in the management of bacterial infections in pediatric patients, Pediatr Drugs, 2001, 3(2), 137-58
- Kearns, GL, et al., Cefpodoxim pharmacokinetics in children: effect of food, Pediatr Infect Dis J, 1998, 17(9), 799-804
- Sandoz, SmPC Biocef Plv. 40 mg/5 ml Plv. z. Herst. e. Susp. z. Einn. (1-26599), 08/2018
- Daiichi Sankyo Europe GmbH, SmPC Orelox® junior 40 mg/5 ml, Granulat zur Herstellung einer Suspension zum Einnehmen (28955.00.00), 06/2020
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Changes
Changes
