Please note this product has to be reconsitiued by the pharmacy before supplying to the patient, this is a 10 step process.
The reconstitution is a different process to normal powders for oral solution.
In January Rosemont Pharmaceuticals Ltd released a licensed version of Omeprazole oral suspension. This was previously available as a ‘Drug - Tariff Specials’ in England and Wales Drug tariff.
The table below shows the Dictionary of medicines and devices (dm+d) listing and also Rosemont’s listing with PIP Code for the two products.
| DM+D Listing | Details from Rosemont Pharmaceuticals Ltd | PIP Code | Price* |
| Omeprazole 20mg/5ml oral suspension sugar free | Omeprazole, Powder for Oral Suspension 4mg/ml (75ml) | 1236793 | £178.35* |
| Omeprazole 10mg/5ml oral suspension sugar free | Omeprazole, Powder for Oral Suspension 2mg/ml (75ml) | 1236785 | £92.17* |
*Prices correct at the time of writing.
A note about specials
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued guidance ‘The supply of unlicensed medicinal products (“specials”)’[1] in May 2014, which states:
- An unlicensed special should not be used where a product available and licensed in the UK could be used to meet a patient’s special need.
- Although MHRA does not recommend "off label" (outside of the licensed indications) use of products, if the UK licensed product can meet the clinical need, even "off-label", it should be used instead of an unlicensed product. Licensed products available in the UK have been assessed for quality safety and efficacy. If used "off-label" some of this assessment may not apply, but much will still be valid. This is better than the use of an un-assessed, unlicensed product. The fact that the intended use is outside of the licensed indications is therefore not a reason to use an unlicensed product. It should be understood that the prescriber’s responsibility and potential liability are increased when prescribing off-label.
- Anyone supplying an unlicensed medicinal product, where an equivalent licensed medicinal product is available must be satisfied as to the existence of a special need for the unlicensed medicinal product. MHRA expects that documentary evidence of this special need should be obtained by manufacturers, importers or distributors and that this evidence should be made available on request of the Licensing Authority. This may take the form of a prescriber’s letter, however an alternative fully documented audit trail through the supply chain confirming special need may be acceptable.
This means that if you try to order the ‘specials’ version Specials Manufacturers will advise you that a licensed product was available. If there is a clinical reason that you need the ‘specials’ version the specials manufacturer may supply if you provide a letter from the prescriber to confirm the special need for an unlicensed product over a licensed product.
A note about the products
Once reconstituted the product has a 28 day expiry and should be stored in a refrigerator (2°C - 8°C).
Instructions for initial constitution
Combination of powder in cap and bottle
- Shake the bottle for 10 seconds to loosen the powder.
- Twist the red cap anti-clockwise (see arrow on cap) until the seal is broken to release the powder in the red cap into the bottle.
- Twist the red cap back to the original position, securely fastening the red cap onto the bottle.
Constitution of the powder
- Shake the bottle vigorously for ten seconds to mix the powders.
- Tap the base of the bottle three times on a hard horizontal surface to make sure all powder is in the bottle and not in the cap.
- Remove the red cap from the bottle.
- Add 64ml of water by using a suitable measuring device up to the line on the label.
- Securely fasten the red cap onto the bottle and shake vigorously for 30 seconds.
Placement of syringe adaptor
- Remove the red cap and red ring and throw away.
- Insert the colourless, transparent Bottle Adaptor and replace the red cap with the grey plastic screw-cap.
- Leave for fifteen minutes for product to reach final consistency.
The reconstituted suspension will be a white/off-white/brownish suspension. It may contain dark specks due to the sweetener.
Each constituted bottle (90ml)
Further reading
https://www.rosemontpharma.com/products/omeprazole-powder-oral-suspension