- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Infants and children
- After application of 10mg/kg or 15mg/kg on an empty stomach peak serum levels of 10,8 mg/l or 13,1 mg/l were observed, respectively. 10-days treatment with Cefaclor didn't result in accumulation of the drug.
- Results of pharmacokinetic investigations on children don't deviate from those on adults. E.g. half-life is the same order of magnitude.
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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
| Severe infections, middle ear inflammation, and infections caused by less susceptible microorganisms |
|---|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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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
Serum disease-like reactions (multiform erythema and rash accompanied by arthralgia with and without fever) are more common in children than in adults. They usually occur after the second or third dose and are probably allergic. The symptoms disappear within a few days after discontinuation of the drug.
Cefaclor can lead to tooth discoloration in children. Good oral hygiene can help to prevent tooth discoloration [SmPC Cec Ftbl].
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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 | ||
|---|---|---|
| J01DC03 | ||
| J01DC02 | ||
| Third-generation cephalosporins | ||
|---|---|---|
| J01DD08 | ||
| J01DD01 | ||
| J01DD13 | ||
| 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
- Eurocept BV, SPC Ceclor suspensie 25 mg/ml (RVG 08152) 14-4-2016, www.geneesmiddeleninformatiebank.nl, Geraadpleegd 28 okt 2016
- Aliud Pharma, SmPC Cefaclor AL 250/500 Hartkapseln (32827.00.00 / 32827.01.00), 02/2017
- Dr. Friedrich Eberth Arzneimittel GmbH, SmPC Panoral 500 mg Hartkapseln (28200.01.00), 11/2017
- Hexal, SmPC CEC 250/500 mg Filmtabletten (37023.00.00 / 6803213.00.00), 06/2015
- Hexal, SmPC CEC / CEC forte Trockensaft (24629.00.00 / 24629.01.00), 01/2016
- Dr. Friedrich Eberth Arzneimittel GmbH, SmPC Panoral Trockensaft 125/250 mg/ 5 mL (37.00.01/ 37.01.01), 12/2017
- InfectoPharm, SmPC InfectoCef 125/250/500 Saft (27.11.1996 / 27.11.1996 / 15.11.2005), 06/2016
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Changes
Changes
