1. READING GUIDE

Generic name
1. READING GUIDE
Brand name
ATC Code
V04C
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1. READING GUIDE

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The section on pharmacokinetics describes how the body absorbs, distributes and processes the drug and how the drug leaves the body again. The following parameters are important in interpreting the correct dose for a child in relation to the same data in adults or other age categories:

  • Volume of distribution (Vd)
  • Half-life (t½)
  • Clearance (Cl)
  • Maximum serum concentration (Cmax)
  • Time to reach Cmax (Tmax)

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

Interpretation dosing recommendations
  • Route of administration not applicable
    • 0 years up to 18 years
        • A dosage recommendation specifies the indication, route of administration, and age.
        • The dosage recommendations given in the Formulary are noted as total daily dosage. Then it is indicated in how many doses the daily dosage should preferably be divided, followed by the maximum daily dosage.
        • In cases where a dosage range is indicated (200 - 400mg/kg/day) dosing should be based on clinical response and indication.

        • MAXIMUM DOSIS.
          • In general, pediatric doses should not exceed the adult dosage unless otherwise stated.
          • When a maximum dose is mentioned in the Formulary, it means that the calculated dose based on the child's weight should NOT exceed the maximum dose.  If the calculated dosage is LOWER than the maximum dosage, do not increase to the maximum dosage.

        Example 1:
        1-3 mg/kg/day, max 100 mg/day; child weighs 40 kg
        Based on the dosage recommendation, a child weighing 40 kg will receive 120 mg/day, however the maximum dosage is 100 mg/day. The maximum dosage should NOT be exceeded.

        Example 2:
        1-3 mg/kg/day, max 100 mg/day: child weighs 20 kg.
        Based on the dosage recommendation, a child weighing 20 kg will receive 60 mg/day. This is below the maximum dose of 100mg/day. However, this does not mean that the dose may be increased to the maximum dose of 100 mg/day.

        • In more recent monographs (updated or created after 2015) the orginal studies and other data that substantiate the dose recommendations are linked to a dose recommentation. In older monographs this feature is implemented with updates to the monograph. In all monographs the overview of references that were used to compile the monographs is listed in the reference section.  

Renal impaiment in children > 3 months

The dose adjustment recommendations apply to children older than 3 months with impaired renal function. In younger children, renal function is not yet fully developed and this has already been taken into account when formulating the dosage advice. 

The amount of scientific literature on the use of medicines in children with impaired renal function is very limited. Therefore, in the absence of specific scientific literature, the KNMP dosage recommendations for adults with impaired renal function are used as a starting point. These literature-based recommendations were drawn up by a working group of nephrologists, clinical pharmacologists and (hospital) pharmacists. In addition, the recommendations from the SmPC and the book "Drug prescribing in renal failure" (Aronoff et al. 2007) are also consulted. However, these recommendations are not leading, but serve only as a reality check, given the lack of substantiation. Therefore, these sources are also not mentioned in the Children's Formulary.

The KNMP dosage recommendations for adults with reduced renal function are then translated, in consultation with paediatric nephrologists, into dosage recommendations for children with reduced renal function.

 

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

If specific adverse reactions have been reported in children or the occurrence of the adverse reaction (frequency) differs from that reported in adults, this information is included in this section. This section should be read as a supplement to the general adverse reactions section.

 

For the general section:

General information on adverse reactions is taken from the <.....> with permission. The information from the <.....> is mainly based on the information on side effects in the SmPC. This information usually relates to adults. Specific information on adverse reactions in children is included in the section on adverse reactions in children.  (adjust accoring to national practices)

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

Contra-indications in children

If specific contraindications apply in children, this information is included in this section. This section should be read as a supplement to the contraindications general section.

For the general section, adjust according to local practices:

General information on contraindications is taken from the <....> with permission. The information from the <.....> is mainly based on the information on contraindications in the SmPC. This information usually relates to adults. Specific information on contraindications in children is included in the section contraindications in children. 

For the interactions section: adjust to local practices

Information on interactions is taken with permission from the <......... >

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

If specific warnings and precautions apply in children, this information is included in this section. This section should be read as a supplement to the section on Warnings and Precautions General.

For the general section, adjust according to national practices

General information on warnings and precautions is taken from the <....> with permission. The information from the <....> is primarily based on the information on warnings and precautions in the SmPC.  Specific warnings and precautions in children are included in the section warnings and precautions in children. 

Interactions

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

VARIOUS

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

ALLERGENS
V01AA03
V01AA02
v01aa
ALL OTHER THERAPEUTIC PRODUCTS
V03AB27
V03AB16
V03AE07
V03AX03
V03AC03
V03AC02
V03AC01
V03AH01
V03AB24
V03AB25
V03AF03
V03AB33
V03AF01
V03AB17
V03AB15
V03AB13
V03AB19
V03AE01
V03AB14
V03AF07
V03AE02
V03AE01
V03AB06
V03AB35
DIAGNOSTIC AGENTS
V04CE
GENERAL NUTRIENTS
V06DD
V06DD
THERAPEUTIC RADIOPHARMACEUTICALS
V10AA

References

  1. GUIDELINES, Guidelines are used as a reference for determining relevant indications for use. When original studies are cited in addition to a guideline, the guideline is NOT used to support the dosing recommendation. , If a guideline is the only reference, the dosage from the guideline has also been adopted, pending review of the scientific literature.
  2. ORIGINAL STUDIES, When information in the paediatric Formulary is based on original scientific studies, these studies are listed in the reference list
  3. SmPC, The summary of product characteristics (SmPC) is the official product information from the manufacturer. If the SmPC is the only reference listed, the dosage recommendation is in accordance with the SmPC ('on-label') , If other original studies are cited in addition to the SmPC, the SmPC is only partially used for substantiation.
  4. SmPC, The summary of product characteristics (SmPC) is the official product information from the manufacturer. If the SmPC is the only reference listed, the dosage recommendation is in accordance with the SmPC ('on-label'), If other original studies are cited in addition to the SmPC, the SmPC is only partially used for substantiation.
  5. GUIDELINES, Guidelines are used as a reference for determining relevant indications for use. When original studies are cited in addition to a guideline, the guideline is NOT used to support the dosing recommendation., If a guideline is the only reference, the dosage from the guideline has also been adopted, pending review of the scientific literature.

Changes

Therapeutic Drug Monitoring


Overdose