Glibenclamide

ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines ·
80870001

Articles

Medicine Compliance Aid Stability

genericTeva UK Ltd

Teva UK Ltd
generic
Tablets 2.5mg, 5mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Store in airtight containers
20 January 2015

Lactation Safety Information

Glybornuride

Glybornuride
Limited published evidence of safety
No adverse effects reported in breastfed infants
Only negligible amounts in breast milk
Monitor infant for signs of hypoglycaemia. Periodic infant blood glucose levels may be considered, especially in very young infants.
24 September 2020

New Medicines

Amglidia Neonatal diabetes mellitus

Information

Amglidia
New formulation
Ammtek

Development and Regulatory status

Launched
Launched
None
September 2019
Yes
Sep 19Available in the UK. Price: 600 microgram/ml sugar-free oral susp with 1ml or 5ml oral syringe, 30ml=£2,100. 6mg/ml sugar-free oral susp with 1ml or 5ml oral syringe, 30ml=£21,000 [4,5].
May 18Marketing authorisation received in the EU [3].
Feb 18EU positive opinion for treatment of neonatal diabetes. Has orphan drug status in EU [2].

Category

A sulfonylurea which stimulates insulin release from pancreatic beta-cells by inhibiting ATP-sensitive potassium channels. Oral suspension (0.6 mg/ml and 6 mg/ml).
Neonatal diabetes mellitus presents as hyperglycemia, failure to thrive and, in some cases, dehydration and ketoacidosis which may be severe with coma, in a child within the first months of life. Transient (TNDM) and permanent (PNDM) neonatal diabetes are rare conditions occurring in 1 in 300,000 to 400,000 live births [1].
Neonatal diabetes mellitus
Oral

Trial or other data

Feb 18Amglidia is a hybrid medicine of Daonil which has been authorised in the EU since 1 January 1969. Amglidia contains the same active substance as Daonil, but is approved for a different indication, and is available in a different formulation and strength. Studies have demonstrated the satisfactory quality, and relative bio-availability of Amglidia [2].

Evidence based evaluations

Stroke - treatment of large hemispherical infarction

Information

New formulation
Biogen
Biogen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

High affinity inhibitor of sulfonylurea receptor 1 (Sur1)-transient receptor potential melastatin (TRPM4) channels., which are expressed in the CNS only under conditions of ischaemia, hypoxia, and trauma.
Each year around 120,000 people in the UK have a first stroke and about 30,000 have a recurrent stroke. Stroke is the largest cause of disability in the UK and the third most common cause of death (after heart disease and cancer) [1].
Stroke - treatment of large hemispherical infarction
Intravenous infusion

Trial or other data

Feb 21Feb 21: PIII CHARM study (NCT02864953) is still recruiting, with an estimated primary completion date of Feb 2022 [5].