- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
After a single dose of 25 mg/kg, the following parameters were determined in children (n= 20):
| Infants 1 months-1 year (n=8) | Infants 1 -2 years (n=12) | |
| Tmax (h) | 1 - 2 | 1 - 2 |
| Cmax (µg/mL) | 24,6 ± 5,0 | 20,4 ± 4,5 |
| T1/2 (h) | 2,3 | 1,8 |
[SmPC Grüncef®]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Streptococcal pharyngitis |
|---|
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Renal impaiment in children > 3 months
all indications except tonsillitis:
GFR >50 ml/min/1.73 m2: no dose adjustment needed
GFR 25-50 ml/min/1.73 m2: start at 100% of regular single dose, continue with 50% of regular daily dose in 2 single doses, dosing interval 12 hours
GFR 10-25 ml/min/1.73 m2: start at 100% of regular single dose, continue with 25% of regular daily dose once daily (dosing interval 24 hours)
GFR <10 ml/min/1.73 m2: start at 100 % of regular single dose, continue with 25% of regular daily dose once every 36 hours (dosing interval 36 hours
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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
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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 | ||
|---|---|---|
| J01DB04 | ||
| J01DB01 | ||
| J01DB03 | ||
| Second-generation cephalosporins | ||
|---|---|---|
| J01DC04 | ||
| 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
- INFECTOPHARM Arzneimittel und Consilium GmbH, SmPC GRÜNCEF® 500 mg/5 mL Trockensaft, Pulver zur Herstellung einer Suspension zum Einnehmen (2532.01.02), 09/2020
- INFECTOPHARM Arzneimittel und Consilium GmbH, SmPC GRÜNCEF® 1g Tabletten (179.00.02), 11/2018
- Peltola H,, Acute osteomyelitis in children, N Engl J Med, 2014, Jan 23;370(4), 352-60
- Lorrot M et al., Antibiotic therapy of bone and joint infections in children: proposals of the French Pediatric Infectious Disease Group., Arch Pediatr., 2017, S36-S41, DOI: 10.1016/S0929-693X(17)30517-1
- Peltola H et al., Clindamycin vs. first-generation cephalosporins for acute osteoarticular infections of childhood--a prospective quasi-randomized controlled trial, Clin Microbiol Infect, 2012, 18(6):582-589, DOI: 10.1111/j.1469-0691.2011.03643.x
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Changes
Changes
