Pharmacokinetics in children

No pharmacokinetic studies have been carried out in children.

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

Toxoplasmosis, congenital
Oral 0 months up to 1 year [1] [4] 100 mg/kg/day in 4 doses. In combination with pyrimethamine and folinic acid. Duration of treatment: during the first year of life

Toxoplasmosis, postnatal
Oral ≥ 2 months [4] 100 - 150 mg/kg/day in 4 doses. Max: 8 g/day. In combination with pyrimethamine and folinic acid. Duration of treatment: 21 days; in immunosuppression up to 1-2 weeks after the symptoms disappear.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Dose adjustment not needed

GFR 30-50 ml/min/1.73 m2

Dose adjustment not needed

GFR 10-30 ml/min/1.73 m2

50 percentage of single dose and dosing interval : 6 uur

GFR < 10 ml/min/1.73 m2

A general recommendation is not provided

Clinical consequences

In renal impairment, renal excretion of sulfadiazine and the N-acetyl metabolite decreases. This increases the risk of side effects.

Patients on dialysis

No data are available on dose adjustment for dialysis.

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

Nausea, vomiting, diarrhoea, dizziness, tinnitus, crystalluria, hypersensitivity reaction and abnormal blood counts.

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

Contra-indications in children

Serious abnormalities in the blood count, hypersensitivity to sulphonamides.

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

Caution is needed with exposure of the skin to sunlight or UV radiation due to the risk of photosensitivity. Stop the administration immediately if skin-related symptoms appear. It is recommended that an adequate fluid intake should be maintained or the urine made alkaline to prevent crystalluria.

Interactions

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

• ANTIINFECTIVES FOR SYSTEMIC USE
• ANTIBACTERIALS FOR SYSTEMIC USE

SULFONAMIDES AND TRIMETHOPRIM

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

Trimethoprim and derivatives
	Trimethoprim Related Medicines Menu">	J01EA01

Combinations of sulfonamides and trimethoprim, incl. derivatives
	Co-trimoxazole (sulfamethoxazole + trimethoprim) Related Medicines Menu">	J01EE01

References

1. Schmidt DR, et al., Treatment of infants with congenital toxoplasmosis: tolerability and plasma concentrations of sulfadiazine and pyrimethamine., Eur J Pediatr, 2006, 165, 19-25
2. 20McLeod R et al. , Outcome of treatment for congenital toxoplasmosis, 1981-2004: the National Collaborative Chicago-Based, Congenital Toxoplasmosis Study., Clin Infect Dis. , 2006, May 15;42(10), 1383-94
3. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
4. Heyl, SmPC Sulfadiazin-Heyl® 500 mg Tabletten (6814197.00.00), 12/2016

Changes

Therapeutic Drug Monitoring

Overdose