Pharmacokinetics in children

No information

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

Hypertension
Oral 1 month up to 18 years 1 - 2 mg/kg/day in 1 - 2 doses. Max: 6 mg/kg/day.

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

50 percentage of single dose and dosing interval : 12 up to 24 uur
check creatinine and potassium levels before starting and within 2 weeks of starting and at least once a year thereafter (depending on patient's clinical condition).

GFR 10-30 ml/min/1.73 m2

Avoid use.

GFR < 10 ml/min/1.73 m2

Avoid use

Clinical consequences

Hyperkalemia may occur with decreased renal function. Potassium sparing agents may increase this risk. In addition, half-life and AUC of triamterene increase.

Clinical implications:
Symptoms of hyperkalemia include limb paresthesias, lethargy, confusion, weakness, paralysis, hypotension, cardiac arrhythmias (often the first clinical symptom), and heart block. The normal range of potassium in serum is given as 3.5-5.0 mmol/l. Clinically significant hyperkalemia occurs at a concentration greater than 6 mmol/l; values greater than 7-9 mmol/l are usually lethal.

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

Side effects

No information is present at this moment.

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

Cave hyperkalemia and hypokalemia. 

Hyperkalemia may occur and cause cardiac arrhythmias. Check electrolytes regularly, especially if hyperkalemia is more likely. If hyperkalemia is suspected, make an ECG. 

Hypokalemia may lead to arrhythmias or potentiate the action of concomitantly administered digitalis glycosides.

Interactions

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

• CARDIOVASCULAR SYSTEM
• DIURETICS

ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS

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

Aldosterone antagonists
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References

1. Heijden, van der AJ et al, Werkboek Kindernefrologie, VU Uitgeverij, 2002, 1e druk
2. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021

Changes

Therapeutic Drug Monitoring

Overdose