A newly licensed 1mg/ml Omeprazole Powder for Oral Suspension has been developed by Rosemont Pharmaceuticals to meet the special needs of babies from 1 to 12 months old who have gastro-oesophageal reflux disease (GORD). In infants, the symptoms of GORD can be particularly distressing for both the child and parent.
Previously, Rosemont Omeprazole Powder for Oral Suspension has been available in 2mg/ml and 4mg/ml strengths. However, the addition of the new 1mg/ml product ensures that the needs of all patient groups with GORD are sufficiently met.
The Rosemont range of Omeprazole Powder for Oral Suspension products are the only PPIs (proton pump inhibitors) indicated for use in babies from 1 month to 1 year. Symptoms of GORD in infants are usually resolved by 1 year of age1, so it is key that there is a licensed treatment option available for the 1 to 12 month patient group.
Rosemont Omeprazole Powder for Oral Suspension is the result of extensive research and development. The products have been developed in an innovative and patented packaging format that makes constitution easy, have a pre-constitution shelf life of 2 years and can be stored at an ambient temperature until after constitution. To enhance storage flexibility for the patient or parent, the constituted suspension can be stored at an ambient temperature for up to two days, after which it must be returned to cold chain storage.
The product avoids the limitations of enteric coated pellets, negates the need to crush tablets, open capsules, or order specials. The availability of the 1mg/ml product means healthcare professionals no longer need to prescribe or dispense an unlicensed omeprazole product to meet the needs of younger paediatric patients.
Across the product range, all ingredients have been carefully selected with no ethanol, sugar or propylene glycol and the flavourings used are natural. The 1mg/ml strength has a strawberry flavour to improve palatability and acceptability for infants. Strawberry flavour has been shown to be the favourite with children.
Uniquely, the 1mg/ml product can be mixed with a small quantity (10-15mls) of the baby’s milk to aid parents with administration.
The range of products are also licensed to be administered to patients with PEG (Percutaneous endoscopic gastrostomy) and NG (nasogastric) tubes. Through extensive testing, the 1mg/ml and 2mg/ml products have been proven to be effective in short, narrow bore NG tubes with only a 2ml flush volume.
The introduction of the 1mg/ml product marks a significant step forward in meeting the special needs of infants with GORD. The addition of this strength to the product range ensures that all patients groups with a clinical need for a liquid format omeprazole product are now sufficiently catered for.
For full product information:
Please view 1mg/ml Omeprazole Powder for Oral Suspension SmPC:
https://www.medicines.org.uk/emc/product/15055/smpc
Please view 2mg/ml Omeprazole Powder for Oral Suspension SmPC:
https://www.medicines.org.uk/emc/product/11031/smpc
Please view 4mg/ml Omeprazole Powder for Oral Suspension SmPC:
https://www.medicines.org.uk/emc/product/11032/smpc
For a video guide to constitution and abbreviated prescribing information for the Rosemont omeprazole product range, please visit:
https://www.rosemontpharma.com/omeprazole-pi
Adverse Drug Events
Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400
References:
- NICE. GORD in children: Summary. Available at: https://cks.nice.org.uk/topics/gord-in-children/. Accessed November 2023.
- Generation R. What flavour would children choose for their medicines? Available at: https://generationr.org.uk/what-flavour-would-children-choose-for-their-medicines/ Accessed November 2023.
This promotional article has been written by Rosemont Pharmaceuticals. Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Marketing Authorisation Holder: Xeolas Pharmaceuticals Limited. Hamilton Building, DCU, Glasnevin, Dublin 9, IRELAND.
ROS000019-038 DOP November 2023
