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Aqumeldi® is indicated for the treatment of heart failure in children from birth to less than 18 years1

Key Administration Information:

  • Removes the need to adapt adult formulations.2-4
  • Each mini orodispersible tablet is 2mm in size and contains 0.25mg of enalapril maleate1
  • Can be administered once or twice daily1
  • Rapidly disperses in the mouth without the need for water2
  • Multiple orodispersible tablets can be administered at the same time5,6
  • Can be administered through feeding tubes when dispersed1
  • 100 day expiry, once opened1

 

Key Dosing Information1

Please refer to the full SmPC before prescribing; including special populations dosing (e.g. renal impairment).

Starting/test dose: 0.01 to 0.04 mg/kg (max 2mg) as a single initial dose

Target/maintenance dose: 0.15 to 0.3 mg/kg (max 20 mg) per day in one or two divided doses. The dose should be individualised according to blood pressure, serum creatinine and potassium response.

Guidance on doses under 0.25mg: Doses less than 0.25mg can be achieved by placing one 0.25mg tablet in a 10ml oral syringe, adding tap water (sterile water if <6months) to the 10 ml graduation, rolling the syringe for 3 minutes to fully disperse the tablet and administering the required volume immediately to the patient (1ml will contain 0.025mg enalapril).

Aqumeldi® is now listed in the BNFC7

References

  1. Aqumeldi Summary of Product Characteristics, (January 2024)
  2. Bajcetic, M., et al. (2019). Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow up safety study. Contemporary Clinical Trials Communications. Vol15:100393.
  3. Thabet, Y., et al. (2018). Flexible and precise dosing of enalapril maleate for all paediatric age groups utilizing orodispersible minitablets. International Journal of Pharmaceutics. Vol 541(1–2): 136–42.
  4. Dosti, B., Malaj, L. (2016). Pediatric formulation of ranitidine using from commercially available tablets in Albania. International Journal of Pharma Sciences and Research. Vol.7(3):168-171.
  5. Data on file. 
  6. Cornilă, A., et al. (2022). Orally dispersible dosage forms for paediatric use: Current knowledge and development of nanostructure-based formulations. Pharmaceutics. Vol 14(8):1621.
  7. BNFC Enalapril Maleate. https://bnfc.nice.org.uk/drugs/enalapril-maleate/ - last accessed December 2024

UK-ENA-24-0041 | January 2025

Adverse Event Reporting Information

UK: Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard

Republic of Ireland: Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie.

Adverse events should also be reported to Proveca Limited. Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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