Mahesh M
★    

India,
2015-09-15 10:03
(3935 d 19:23 ago)

Posting: # 15397
Views: 4,486
 

 FDA: Hydrocortisone [Regulatives / Guidelines]

In draft guidance of Hydrocortisone mentioned “A 4 mg dose of dexamethasone should be administered 10 hours prior to drug administration as a pre-treatment to lower endogenous hydrocortisone levels.“ But in guidance not mentioned regarding base line correction or pre dose samples.

Is it required to take pre dose samples for base line correction of hydrocortisone?

Please share your thoughts on it.
Thanks and regards
Mahesh


Edit: Subject line changed and guidance linked. [Helmut]
Mauricio Sampaio
★    

Brazil,
2015-09-16 07:50
(3934 d 21:36 ago)

@ Mahesh M
Posting: # 15402
Views: 3,439
 

 FDA: Hydrocortisone

Is it required to take pre dose samples for base line correction of hydrocortisone?


Dear Mahesh, the use of dexamethasone is decrease endogenous hydrocortisone levels. But the probability of minimum quantity exist!
Therefore, the base line correction and pre dose samples are required.

I hope this helps.
Mahesh M
★    

India,
2015-09-16 08:50
(3934 d 20:37 ago)

@ Mauricio Sampaio
Posting: # 15403
Views: 3,440
 

 FDA: Hydrocortisone

Hi Mauricio Sampaio,

Thank you so much for your response

Availability of literature, PAR and draft guidance not mentioned the same.

So I am searching for some more clarity, do you have some references regarding the same.

Thanks and regards
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