Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Bisacodyl

Generic name
Bisacodyl
Brand name
ATC Code
A06AB02

Pharmacokinetics in children

No pharmacokinetic data known for children.

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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

Constipation
  • Rectal
    • 2 years up to 11 years
      • 5 mg/day in 1 dose
  • Oral
    • 2 years up to 11 years
      • 5 mg/day in 1 dose
      • Directions for administration:

        Take in the evening before going to bed.

    • ≥ 11 years
      • 5 - 10 mg/day in 1 dose
      • Directions for administration:

        Take in the evening before going to bed.
Emptying the bowels
  • Oral
    • 4 years up to 11 years

      • 5 mg ORALLY on the evening before the procedure, followed by 5 mg RECTALLY the next morning.

    • ≥ 11 years

      • 10 mg ORALLY 1 day before the procedure in the morning, then 10 mg ORALLY in the evening before the procedure. Then 10 mg RECTALLY the next morning

    • ≥ 11 years

      • 10 mg ORALLY 1 day before the procedure in the morning, then 10 mg ORALLY in the evening before the procedure. Then 10 mg RECTALLY the next morning

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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.

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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

Abdominal cramps and diarrhoea.

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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

Sudden occurrence of abdominal pain, obstruction of the intestines and severe dehydration

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

In cases of obstipation, do not use in principle for longer than three consecutive days. When used under medical supervision bisacodyl, can be used for a longer period of time. In chronic or persistent obstipation in children under 10 years of age, bisacodyl should be administered under medical supervision. Using bisacodyl as preparation for diagnostic procedures, preoperative or postoperative treatments and in medical conditions where the stools have to be got moving should be done under medical supervision.
The tablets should be taken in their entirety without chewing with a little water or other fluids (not milk). Take the tablets in the evening before going to sleep, so that there will be a bowel movement the next morning.
 

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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
A06AB08
A06AB06
A06AB06
A06AB58
Bulk-forming laxatives
A06AC01
Osmotically acting laxatives
A06AD12
A06AD11
A06AD65
A06AD65
A06AD15
A06AD65
Enemas
A06AG
A06AG10
A06AG10
A06AG04
A06AG11
A06AG01
Other drugs for constipation
A06AX01
A06AX02

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References

  1. CBO, Richtlijn Obstipatie bij kinderen 0-18 jaar, www.cbo.nl, 2009
  2. Rapporteur’s Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended. Geraadpleegd op 19 maart 2010., Geraadpleegd 14 februari 2013, http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Bisacodyl_2010_07_45PaedPAR.pdf
  3. Boehringer Ingelheim B.V., SPC Dulcolax (RVG 03843/03844), www.cbg-meb.nl, geraadpleegd 14 februari 2013, http://db.cbg-meb.nl/IB-teksten/h03844.pdf
  4. Omega Pharma Nederland B.V, SPC Nourilax (RVG 34426), www.cbg-meb.nl, geraadpleegd 14 februari 2013, http://db.cbg-meb.nl/IB-teksten/h34426.pdf
  5. NHG, Standaard Obstipatie, Huisarts Wet, 2010, 53(9), 484-98
  6. EMA, Rapporteur’s Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended. , Geraadpleegd op 19 maart 2010.
  7. EMA, Rapporteur’s Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended., Geraadpleegd op 19 maart 2010.

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Changes

Changes