Pediatric Formulary

Dosages

Side effects in children

Warnings & precautions in children

Contra-indications in children

Interactions

Renal impairment

References

Hydrochlorothiazide

Generic name

Hydrochlorothiazide

Brand name

ATC Code

C03AA03

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Diuresis, hypertension, nephrogenic diabetes insipidus, hypercalciuria, bronchopulmonary dysplasia.
Oral Premature neonates: Gestational age < 30 weeks ^{[4] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19]} Initial dose: 1 mg/kg/day in 1 dose Maintenance dose: if hyponatraemia has not arisen after a few days: 2 mg/kg/day in 2 doses. 3 mg/kg/day may be needed in very severe BPD. Premature neonates: Gestational age ≥ 30 weeks ^{[4] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19]} 0.5 - 2 mg/kg/day in 2 doses. Max: 3 mg/kg/day. Term neonate ^{[4] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19]} 0.5 - 2 mg/kg/day in 2 doses. Max: 3 mg/kg/day. 1 month up to 18 years ^{[6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19]} 0.5 - 2 mg/kg/day in 1 - 2 doses. Max: 50 mg/day. Young children may need higher doses of up to 3 mg/kg/day. A single dose of 12.5 mg/day may already be enough in children aged > 12 years.

Diuresis, hypertension, nephrogenic diabetes insipidus, hypercalciuria, bronchopulmonary dysplasia.

Oral
- Premature neonates: Gestational age < 30 weeks
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  - Initial dose: 1 mg/kg/day in 1 dose
  - Maintenance dose: if hyponatraemia has not arisen after a few days: 2 mg/kg/day in 2 doses.
  - 3 mg/kg/day may be needed in very severe BPD.
- Premature neonates: Gestational age ≥ 30 weeks
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  - 0.5 - 2 mg/kg/day in 2 doses. Max: 3 mg/kg/day.
- Term neonate
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  - 0.5 - 2 mg/kg/day in 2 doses. Max: 3 mg/kg/day.
- 1 month up to 18 years
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  - 0.5 - 2 mg/kg/day in 1 - 2 doses. Max: 50 mg/day.
  - - Young children may need higher doses of up to 3 mg/kg/day.
    - A single dose of 12.5 mg/day may already be enough in children aged > 12 years.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

Patients on dialysis

Avoid using: thiazides have no effect in dialysis patients without residual diuresis.

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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 in children

Studies in adults have shown that prolonged use of hydrochlorothiazide makes the skin more susceptible to damage by UV radiation and thus can cause skin cancer [Pedersen 2018]. It is not known if the same effect occurs in children.

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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

Be careful in cases of arrhythmia, digoxin use or corticosteroids. Spironolactone should be added at low potassium levels (< 3.5 mmol/l).

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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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References

Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
Apotex Europe BV, SPC hydrochloorthiazide (RVG 52650) 13-12-2011, www.geneesmiddeleninformatiebank.nl
Pharmachemie BV, SPC Hydrochloorthiazide (RVG 09640) 19-01-2017, www.geneesmiddeleninformatiebank.nl
Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinie, 17 sept 2018
Mylan Pharmaceuticals Inc., FDA label Hydrochlorothiazide, www.accessdata.fda.gov, 2011, May
Flynn JT et al. , Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents., Pediatrics. , 2017 , Sep;140(3), pii: e20171904
Choi JN et al., Low-dose thiazide diuretics in children with idiopathic renal hypercalciuria. , Acta Paediatr, 2011 , Aug;100(8), e71-4
el-Dahr S et al, Hypercalciuria in the premature infant: influence of diuretic therapy and phosphate depletion., Am J Dis Child, 1988, Mar;142(3), 256-7
Naseri M et al. , Role of high-dose hydrochlorothiazide in idiopathic hypercalciuric urolithiasis of childhood. , Iran J Kidney Dis., 2011 , Jul;5(3), 162-8
Reusz GS et al. , Hydrochlorothiazide treatment of children with hypercalciuria: effects and side effects. , Pediatr Nephrol., 1993, Dec;7(6), 699-702
Weigert A et al. , Nephrolithiasis and Nephrocalcinosis in Childhood-Risk Factor-Related Current and Future Treatment Options., Front Pediatr., 2018, Apr 12;6, 98
Albersheim SG et al, Randomized, double-blind, controlled trial of long-term diuretic therapy for bronchopulmonary dysplasia., J Pediatr, 1989, Oct;115(4), 615-20
Engelhardt B et al. , Effect of spironolactone-hydrochlorothiazide on lung function in infants with chronic bronchopulmonary dysplasia., J Pediatr., 1989, Apr;114(4 Pt 1), 619-24
Andersen, O , The renin-aldosterone system in nephrogenic diabetes insipidus and the influence of hydrochlorothiazide and indomethacin, Acta Paediatr Scand, 1983, 72 (5):, 717-20
Kirchlechner, V. , Treatment of nephrogenic diabetes insipidus with hydrochlorothiazide and amiloride, Arch Dis Child, 1999, 80 (6), 548-52
Knoers, N. , Amiloride-hydrochlorothiazide versus indomethacin-hydrochlorothiazide in the treatment of nephrogenic diabetes insipidus, J Pediatr , 1990, 117(3), 499-502
Monnens, L. , Response to indomethacin and hydrochlorothiazide in nephrogenic diabetes insipidus." , Clin Sci (Lond), 1984, 66(6), 709-15
Rascher, W , Congenital nephrogenic diabetes insipidus-vasopressin and prostaglandins in response to treatment with hydrochlorothiazide and indomethacin, Pediatr Nephrol, 1987, 1 (3), 485-90
Smoyer, W. E. , Medical management of postobstructive polyuria, Am J Dis Child, 1991, 145 (12), 1345-8
Pedersen, SA et al., Hydrochlorothiazide use and risk of nonmelanoma skin cancer: A nationwide case-control study from Denmark, JAAD, 2018, 78(4), 673-81

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Hydrochlorothiazide

Hydrochlorothiazide

Pharmacokinetics in children

dose recommendation of formulary compared to licensed use (on-label versus off-label)

Available formulations

Dosages

Renal impaiment in children > 3 months

Patients on dialysis

Side effects in children

Contra-indications

Warnings & precautions in children

Interactions

References

Changes

Changes