- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
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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
| Follow-on therapy for retinitis based on cytomegalovirus (CMV) |
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Renal impaiment in children > 3 months
Application in cases of reduced renal function (creatinine clearance less than 30 ml/min) is contraindicated.
In cases of reduced renal function (creatinine clearance 30-80 ml/min) in adults: the manufacturer’s recommendations are followed for determining the dosage.
The dose in reduced renal function varies depending on the indication. The manufacturer quotes the creatinine clearance in ml/min/kg bodyweight. This is based on the following formulae: for men, (140-age)/(72 x serum creatinine); for women, (140-age)/(72 x serum creatinine) x 0.85. Age is expressed as a number of years and serum creatinine in mg/dl, where 1 mg/dl creatinine = 88.4 μmol/l.
CMV retinitis in patients with HIV infections, CMV disease in patients with HRT:
- creatinine clearance 1.0-1.4 ml/min/kg bodyweight: induction 135 mg/kg/day in 3 doses or 140 mg/kg/day in 2 doses; maintenance 70-90 mg/kg/day in a single dose;
- creatinine clearance 0.8-1.0 ml/min/kg bodyweight: induction 105 mg/kg/day in 3 doses or 100 mg/kg/day in 2 doses; maintenance 50-65 mg/kg/day in a single dose;
- creatinine clearance 0.6-0.8 ml/min/kg bodyweight: induction 80 mg/kg/day in 1-2 doses; maintenance 80-105 mg/kg every 48 hours;
- creatinine clearance 0.5-0.6 ml/min/kg bodyweight: induction 60 mg/kg/day in 1-2 doses; maintenance 60-80 mg/kg every 48 hours;
- creatinine clearance 0.4-0.5 ml/min/kg bodyweight: induction 50 mg/kg/day in 1-2 doses; maintenance 50-65 mg/kg bodyweight every 48 hours;
- creatinine clearance less than 0.4 ml/min/kg bodyweight: treatment with foscarnet is not recommended;
- haemodialysis: treatment with foscarnet is not recommended.
CMV infection in the gastrointestinal tract in patients with HIV infections:
- creatinine clearance 1.0-1.4 ml/min/kg bodyweight: induction 140 mg/kg/day in 2 doses;
- creatinine clearance 0.8-1.0 ml/min/kg bodyweight: induction 100 mg/kg/day in 2 doses;
- creatinine clearance 0.6-0.8 ml/min/kg bodyweight: induction 80 mg/kg/day in a single dose;
- creatinine clearance 0.5-0.6 ml/min/kg bodyweight: induction 60 mg/kg/day in a single dose;
- creatinine clearance 0.4-0.5 ml/min/kg bodyweight: induction 50 mg/kg/day in a single dose;
- creatinine clearance less than 0.4 ml/min/kg bodyweight: treatment with foscarnet is not recommended;
- haemodialysis: treatment with foscarnet is not recommended.
CMV viraemia in patients with HRT:
- creatinine clearance 1.0-1.4 ml/min/kg bodyweight: induction 90 mg/kg/day in 2 doses; maintenance 70-90 mg/kg/day in a single dose;
- creatinine clearance 0.8-1.0 ml/min/kg bodyweight: induction 70 mg/kg/day in 2 doses; maintenance 50-65 mg/kg/day in a single dose
- creatinine clearance 0.6-0.8 ml/min/kg bodyweight: induction 50 mg/kg/day in 2 doses; maintenance 80-105 mg/kg every 48 hours;
- creatinine clearance 0.5-0.6 ml/min/kg bodyweight: induction 40 mg/kg/day in 2 doses; maintenance 60-80 mg/kg every 48 hours;
- creatinine clearance 0.4-0.5 ml/min/kg bodyweight: induction 30 mg/kg/day in 2 doses; maintenance 50-65 mg/kg every 48 hours;
- creatinine clearance less than 0.4 ml/min/kg bodyweight: treatment with foscarnet is not recommended;
- haemodialysis: treatment with foscarnet is not recommended.
Aciclovir-resistant herpes simplex infection:
- creatinine clearance 1.0-1.4 ml/min/kg bodyweight: induction 90 mg/kg/day in 3 doses;
- creatinine clearance 0.8-1.0 ml/min/kg bodyweight: induction 60 mg/kg/day in 3 doses;
- creatinine clearance 0.6-0.8 ml/min/kg bodyweight: induction 50 mg/kg/day in 2 doses;
- creatinine clearance 0.5-0.6 ml/min/kg bodyweight: induction 40 mg/kg/day in 2 doses;
- creatinine clearance 0.4-0.5 ml/min/kg bodyweight: induction 30 mg/kg/day in 2 doses;
- creatinine clearance less than 0.4 ml/min/kg bodyweight: treatment with foscarnet is not recommended;
- haemodialysis: treatment with foscarnet is not recommended.
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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 in children
Foscarnet should be reserved for children who are hypersensitive to ganciclovir, get severe bone marrow depression as a side effect, or in whom ganciclovir resistance is suspected or proven. Quantitative monitoring of CMV DNA concentrations in the blood and/or secreta is very important here, for as long as genetic determination of GCV resistance is technically not possible
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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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| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | ||
|---|---|---|
| J05AB01 | ||
| J05AB12 | ||
| J05AB06 | ||
| J05AB16 | ||
| J05AB04 | ||
| J05AB11 | ||
| J05AB14 | ||
| Protease inhibitors | ||
|---|---|---|
| J05AE08 | ||
| J05AE10 | ||
| J05AE07 | ||
| J05AE02 | ||
| J05AE04 | ||
| J05AE03 | ||
| J05AE01 | ||
| Nucleoside and nucleotide reverse transcriptase inhibitors | ||
|---|---|---|
| J05AF06 | ||
| J05AF02 | ||
| J05AF09 | ||
| J05AF10 | ||
| J05AF05 | ||
| J05AF04 | ||
| J05AF07 | ||
| J05AF13 | ||
| J05AF13 | ||
| J05AF01 | ||
| Non-nucleoside reverse transcriptase inhibitors | ||
|---|---|---|
| J05AG06 | ||
| J05AG03 | ||
| J05AG04 | ||
| J05AG01 | ||
| J05AG05 | ||
| Neuraminidase inhibitors | ||
|---|---|---|
| J05AH02 | ||
| J05AH01 | ||
| Antivirals for treatment of HIV infections, combinations | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Other antivirals | ||
|---|---|---|
| J05AX28 | ||
| J05AX12 | ||
| J05AX07 | ||
| J05AX09 | ||
| J05AX08 | ||
| J05AX24 | ||
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Integrase inhibitors | ||
|---|---|---|
| J05AJ04 | ||
| Antivirals for treatment of HCV infections | ||
|---|---|---|
| J05AP54 | ||
| J05AP57 | ||
| J05AP51 | ||
| J05AP08 | ||
| J05AP55 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Furth van AM et al, Werkboek Infectieziekten bij Kinderen, VU Uitgeverij, 1999
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Changes
Changes
