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

Interactions
PK
Renal impairment
References

Scopolamine, butyl

Generic name
Scopolamine, butyl
Brand name
ATC Code
A03BB01

Pharmacokinetics in children

No pharmacokinetic studies have been carried out in 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

For halting contractions of the gastro-intestinal tract
  • Rectal
    • 6 years up to 18 years
      • Butylscopolaminebromide: 10 mg/dose, as required, max. 6 times daily.
  • Oral
    • ≥ 6 years
      • Butylscopolaminebromide: 10 - 20 mg/dose 3-5x daily.
For halting contractions of the gastro-intestinal tract, bile ducts and urinary tract
  • Intramuscular
    • 2 years up to 6 years
      • Butylscopolaminebromide: 5 mg/dose 1-3 times daily.
    • 6 years up to 16 years
      • Butylscopolaminebromide: 10 mg/dose 1-3 times daily.
    • ≥ 16 years
      • Butylscopolaminebromide: 20 mg/dose 1-3 times daily.
  • Intravenous
    • 2 years up to 6 years
      • Butylscopolaminebromide: 5 mg/dose 1-3 times daily.
    • 6 years up to 16 years
      • Butylscopolaminebromide: 10 mg/dose 1-3 times daily.
    • ≥ 16 years
      • Butylscopolaminebromide: 20 mg/dose 1-3 times daily.

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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

Dry mouth, tachycardia, dizziness. A slight increase in heart rate can also be noted on parenteral administration, as can blood pressure drops and (at high dosages) transient accommodation disorders.

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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

Butylscopolamine as a suppository is not effective against colic resulting from gallstones or kidney stones

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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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Belladonna alkaloids, tertiary amines
A03BA01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Boehringer Ingelheim, SmPC Buscopan (RVG 03834, 03835, 38356) 22 feb 2014, Geraadpleegd 31 okt 2014
  3. EurimPharm Arzneimittel, SmPC Buscopan 10 mg Dragees (66748.00.00), 10/2017
  4. Sanofi-Aventis, SmPC Buscopan® Dragées 10 mg (6191661.00.01), 10/2017
  5. Sanofi-Aventis, SmPC Buscopan® Ampullen 20 mg/1 ml, Injektionslösung (6191661.00.00), 06/2017
  6. Sanofi-Aventis, SmPC Buscopan® Plus, Filmtabletten (2476.00.00), Zäpfchen (2476.00.01), 10/2017
  7. AVOXA, ABDA-Datenbank Wirkstoffdossier Butylscopolamin, 06/2017
  8. ratiopharm, SmPC BS-ratiopharm® 20 mg/ml Injektionslösung (6145187.00.00), 01/2018
  9. Sanofi-Aventis, SmPC Buscopan® Ampullen 20 mg/1 ml, Injektionslösung (6191661.00.00), 06/2017
  10. Sanofi-Aventis, SmPC Buscopan® Plus, Filmtabletten (2476.00.00), Zäpfchen (2476.00.01), 10/2017
  11. Opella Healthcare Austria GmbH, SmPC Buscopan® 10 mg - Zäpfchen (Z.Nr.: 7647), 11-2014

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Changes

Changes