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Articles

Safety in Lactation: Corticosteroids

9 November 2020There is very limited information on the use of corticosteroids during breastfeeding, although they are likely to be present in milk. Avoid prolonged high dose…

What injections can be given orally or via enteral feeding tubes?

6 November 2020This updated Medicines Q&A is a quick reference summary to different types of enteral feeding tubes, in relation to medication issues. Not all enteral feeding…

Safety in Lactation: Topical corticosteroids

23 September 2020Topical corticosteroids are considered to pose a negligible risk to a breastfeeding infant as long as precautions are taken to avoid direct contact of the…

Safety in lactation: Drugs for chronic bowel disorders

21 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Aminosalicylates for chronic bowel disorders Mesalazine…

Safety in Lactation: Drugs for oral ulceration and inflammation

21 September 2020The use of oropharyngeal anti-inflammatories/analgesics is not considered to present any risk to a breastfeeding infant. Doxycycline is considered to present negligible risk when used…
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Refrigerated Storage

TimodineAlliance Pharmaceuticals

Alliance Pharmaceuticals
Timodine
Cream (contains nystatin, dimeticone, hydrocortisone and benzalkonium chloride)

Contact Alliance Pharmaceuticals in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

19 March 2021
London MI Service

Medicine Compliance Aid Stability

genericAmdipharm Mercury Co Ltd

Amdipharm Mercury Co Ltd
generic
Tablets 10mg, 20mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from light
Protect from light. Store in airtight containers.
19 February 2015

PlenadrenViroPharma Ltd

ViroPharma Ltd
Plenadren
Tablets m/r 5mg, 20mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from light
Protect from light. Store in airtight containers.
19 February 2015

genericAuden Mckenzie

Auden Mckenzie
generic
Tablets mucoadhesive buccal 2.5mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Mucoadhesive buccal tablets.
1 September 2015

Lactation Safety Information

Oral / parenteral

Oral / parenteral
Yes
No published evidence of safety
Normal component of breast-milk
Used in full-term neonates from birth
Doses up to 160mg daily unlikely to cause adverse effects in the infant
9 November 2020

Local injection

Local injection
Yes
11 September 2020

In the ear

In the ear
Yes
Only available in combination with gentamicin for which there are no additional risks
11 September 2020

Orophayngeal - buccal tablets

Orophayngeal -
buccal tablets
Yes
11 September 2020

Topical

Topical
Yes
Low potency
There are no additional risks when used in combination topical preparations containing antimicrobials or urea
11 September 2020

Rectal for inflammatory bowel disease

Rectal
for inflammatory bowel disease
Yes
-
No published evidence of safety after rectal administration
Small amounts in breast milk after oral administration
Doses up to 50mg orally daily unlikely to cause adverse effects in the infant
11 September 2020

New Medicines

EfmodyAdrenal insufficiency due to congenital adrenal hyperplasia in adults - extended-release formulation

Information

Efmody
New formulation
Diurnal
Diurnal

Development and Regulatory status

Launched
Approved (Licensed)
Phase III Clinical Trials
September 2021
Yes
Yes
Sep 21Efmody 5mg and 10mg modified-release capsules available in the UK. Price for 50 capsules = £135.00 and £270.00 respectively [18].
Jul 21Approved in UK as a treatment for adult and adolescent patients aged 12 years and over with congenital adrenal hyperplasia (CAH) [17].
Jun 21Approved in EU [16]
Mar 21Recommended for EU approval by CHMP - the full indication is "Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults." It should be prescribed by physicians experienced in the treatment of CAH [15].
Jan 21Diurnal submit MAA to MHRA [14].
Dec 19Filed in the EU [13].
Nov 19Diurnal still expect to submit a MAA by end of 2019 [12].
Mar 19Diurnal report positive outcome from meeting with EMA to discuss regulatory pathway for Chronocort; no further trials are required. Diurnal intend to submit a EU MAA for Chronocort in Congenital Adrenal Hyperplasia (CAH) Q4 2019 [11].
Dec 18Diurnal submit a regulatory package for scientific advice in EU. Subject to the outcome of this advice, the company anticipate filing a MAA Q4 2019 [10].
Oct 18The manufacturer, following PIII trial results, said that "...we will now analyse the full data set from this trial, along with interim data from the ongoing Chronocort® long-term dosing study, to determine next steps in Chronocort development, and discuss these with the regulatory authorities.".[9]
Jan 18Diurnal expect to submit MAA by the end of 2018 [8].
Jan 18Two PIII studies in are ongoing in EU - EUDRA CT 2015-005448-32 and EUDRA CT 2015-000711-40 [7].
Jan 18Recruitment to two PIII trials (NCT03062280 and NCT02716818) is underway in US [6].
Feb 16Diurnal expect to submit a marketing authorisation application for Chronocort® by the end of 2017, with launch in 2018 [5].
Mar 15Diurnal are planning a pivotal large multi-centre PIII study, to start in 2015 [4].
Mar 15Granted orphan drug status in US [4].
Jul 05Granted orphan drug status in EU to treat CAH [3].

Category

A glucocorticoid receptor agonist providing delayed release of hydrocortisone to allow synchronisation with natural release of glucocorticoid in early hours of the morning.
Prevalence of congenital adrenal hyperplasia in the UK is 1 in 12,000 [1].
Adrenal insufficiency due to congenital adrenal hyperplasia in adults - extended-release formulation
Oral

Trial or other data

Oct 18Results from PIII trial (n=122) showed that chronocort was no better at controlling sex hormones than conventional glucocorticoid doses in pts with congenital adrenal hyperplasia (CAH). In the trial, pts and randomised to continue on standard-of-care regimes or switch to twice-daily doses of Chronocort. Over 24 weeks, investigators analysed the change in 17-hydroxyprogesterone levels.[9]
Dec 13PII (NCT01735617) study completes [2].
Dec 12PII (NCT01735617) study to gather safety and effectiveness information about Chronocort® to treat patients with CAH. The objective of the study is to measure levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease. 16 patients will be recruited in the US [3].

Evidence based evaluations

SMC