Didanosine
Generic name
Didanosine
Brand name
ATC Code
J05AF02
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Liquid formulation:
The variability in the absorbed amount of didanosine is greater in children than in adults. The absolute bioavailability of orally administered didanosine was approximately 36% after the first dose and 47% at steady state. After intravenous administration of didanosine at doses of 60 or 90 mg/m² or equivalent oral doses of 120 or 180 mg/m², didanosine concentrations in the cerebrospinal fluid were approximately 46% of the plasma levels measured at the same time. Didanosine concentrations were measurable in the cerebrospinal fluid until 3.5 hours after administration. Renal clearance represents about 59% of the overall body clearance (315 ml/min/m²), indicating that both renal and non-renal processes are involved in elimination. Approximately 17% of an oral dose of didanosine can be recovered from the urine. There is no evidence for accumulation of didanosine after oral administration for an average of 26 days.
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
| Treatment HIV infection |
|---|
|
Renal impaiment in children > 3 months
In reduced renal function in children, according to the manufacturer:
at a bodyweight of less than 60 kg:
- creatinine clearance 30-60 ml/min: 150 mg per day in 1-2 doses;
- creatinine clearance 10-30 ml/min: 100 mg per day;
- creatinine clearance less than 10 ml/min: 75 mg per day;
Patients on dialysis
Didanosine should preferably be used after dialysis; an additional dose after dialysis is not needed.
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
Rarely, in particular in children: changes in the retina (depigmentation) or the optic nerve.
Nucleoside and nucleotide analogues can cause mitochondrial damage (in children exposed in the womb and/or postnatally), resulting in haematological disorders, metabolic disorders and neurological disorders later.
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
Mitochondrial dysfunction has been reported in HIV-negative children who have been exposed in the womb and/or postnatally to nucleoside analogues, resulting in generally transient haematological (anaemia, neutropenia) and metabolic (hyperlactataemia and hyperlipasaemia) disorders, as well as neurological (hypertonia, convulsions, abnormal behaviour) disorders later.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
DIRECT ACTING ANTIVIRALS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | ||
|---|---|---|
| J05AB01 | ||
| J05AB12 | ||
| J05AB06 | ||
| J05AB16 | ||
| J05AB04 | ||
| J05AB11 | ||
| J05AB14 | ||
| Phosphonic acid derivatives | ||
|---|---|---|
| J05AD01 | ||
| Protease inhibitors | ||
|---|---|---|
| J05AE08 | ||
| J05AE10 | ||
| J05AE07 | ||
| J05AE02 | ||
| J05AE04 | ||
| J05AE03 | ||
| J05AE01 | ||
| Nucleoside and nucleotide reverse transcriptase inhibitors | ||
|---|---|---|
| J05AF06 | ||
| 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 | ||
References
- CBO, Richtlijn antiretrovirale therapie, www.cbo.nl, Herziene versie december 2007
- Bristol Meyers Squibb, SPC Videx RVG 30023, 03 feb 2010, www.cbg-meb.nl, http://db.cbg-meb.nl/IB-teksten/h30023.pdf (geraadpleegd 12 feb 2010)
- PENTA Steering Commitee, PENTA 2009 guidelines for the use of antiretroviral therapy, HIV Medicine, 2009, 10, 591-613
- Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children, Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, www.aidsinfo.nih.gov, 2010, http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf.
- Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life. , HIV Med, 2015, doi:10.1111/hiv.12217
- Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children., Guideline for the use of Antiretroviral agents in pediatric HIV infection, www.aidsinfo.nig.gov/contentfiles/lvguidelines/pediatricguidelines.pdf, Geraadpleegd 12 sept 2016, O1-O140
- Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life., HIV Med, 2015, doi:10.1111/hiv.12217
Changes
Therapeutic Drug Monitoring
Overdose
