- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
After rectal administration, the effect occurs within 2-3 min
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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
| Emptying the rectum, sigmoid and the lower part of the descending colon |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
Electrolyte imbalances have been observed with high blood levels of phosphate (hyperphosphataemia) and low levels of calcium (hypocalcaemia). Infants and young children may experience severe clinical symptoms more rapidly; a small number of fatal cases of hyperphosphataemia (with hypocalcaemia, hypernatraemia and acidosis) have occurred after the use of laxatives containing sodium phosphate, as a result of overdosing the sodium phosphate solution.
Reported are: vomiting, diarrhoea, pain in the lower abdomen or abdominal cramp, nausea and local irritation.
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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 in children
Moderate and severe renal insufficiency, hyperphosphataemia, cardiac failure, congenital megacolon and Hirschsprung’s disease.
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
Long-term repeated use is not recommended and may lead to dependency. Caution is recommended in infants and young children as they are more susceptible to side effects occurring due to dehydration and disrupted electrolyte balance. Recovery from the toxic effects of taking an excessively high dose can be achieved by intravenous administration of calcium gluconate plus rehydration.
Serious toxicity can occur when the enema is not excreted.
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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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| Softeners, emollients | ||
|---|---|---|
| A06AA01 | ||
| Contact laxatives | ||
|---|---|---|
| A06AB02 | ||
| A06AB08 | ||
| A06AB06 | ||
| A06AB06 | ||
| A06AB58 | ||
| Bulk-forming laxatives | ||
|---|---|---|
| A06AC01 | ||
| Osmotically acting laxatives | ||
|---|---|---|
| A06AD12 | ||
| A06AD11 | ||
| A06AD65 | ||
| A06AD65 | ||
| A06AD15 | ||
| A06AD65 | ||
| Enemas | ||
|---|---|---|
| A06AG | ||
| A06AG10 | ||
| A06AG10 | ||
| A06AG04 | ||
| A06AG11 | ||
| Other drugs for constipation | ||
|---|---|---|
| A06AX01 | ||
| A06AX02 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Mendoza J, et al, Systematic review: the adverse effects of sodium phosphate enema., Aliment Pharmacol Ther., 2007, 26, 9-20
- Tramedico BV, SPC Colex (RVG 07194) 09-01-2018, www.geneesmiddeleninformatiebank.nl
- Kneepkens CMF, et al, NVK Werkboek gastro-enterologie, Sectie Kindergastro-enterologie en Voeding van de Nederlandse Vereniging voor Kindergeneeskunde, 2002
- CBO, Richtlijn Obstipatie bij kinderen 0-18 jaar, www.cbo.nl, 2009
- Diemel JM, et al, NHG-Standaard Obstipatie, Huisarts Wet, 2010, 53(9), 484-98
- Hansen SE, et al, Safety and efficacy of milk and molasses enemas compared with sodium phosphate enemas for the treatment of constipation in a pediatric emergency department, Pediatr Emerg Care, 2011, Dec;27(12), 1118-20
- Ladenhauf HN, et al, Severe hyperphosphatemia after administration of sodium-phosphate containing laxatives in children: case series and systematic review of literature, Pediatr Surg Int., 2012, Aug;28(8), 805-14
- Kostic D, et al, Flow-through peritoneal dialysis in neonatal enema-induced hyperphosphatemia., Pediatr Nephrol., 2010, Oct;25(10), 2183-6
- Marek I, et al, Phosphatintoxikation nach Klysmagabe--eine lebensgefährliche iatrogene Komplikation [Phosphate Intoxication after Application of Enema--a Life-threatening Iatrogenic Complication, Klin Padiatr., 2015, Jul:227(4), 235-8
- Becknell B, et al, Hemodialysis for near-fatal sodium phosphate toxicity in a child receiving sodium phosphate enemas., Pediatr Emerg Care, 2014, Nov:30(11), 814-7
- Akyildiz B, et al , Ileus and Intra-Abdominal Hypertension due to Phosphate- Containing Enema. , Indian J Pediatr., 2016, Nov; 83(11), 1346-8
- Núñez Sánchez MJ, et al , Tetany secondary to phosphate enema toxicity, case report. , Rev Chil Pediatr., 2017, Jun:88(3), 383-7
- Akyildiz B, et al, Ileus and Intra-Abdominal Hypertension due to Phosphate- Containing Enema., Indian J Pediatr., 2016, Nov; 83(11), 1346-8
- Núñez Sánchez MJ, et al, Tetany secondary to phosphate enema toxicity, case report., Rev Chil Pediatr., 2017, Jun:88(3), 383-7
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