E-drug: rationale of dexamethasone combination?
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Dear E-druggers,
There is a request for registration of a product in Thailand for
export. This product was not approved before in Thailand. I am wonder
about the rationale of this combination and indication. I also would like
to ask which country approved or rejected or banned this product. UN
Consolidated List 1994 did not mention about ban or withdraw of this
product.
Detail of product.
Content: Dexamethasone, Indomethacin, Vitamin B1, Vitamin B6, Vitamin B12,
Magnesium Stearate.
Indication : Rheumatoid arthritis, osteoarthritis, rheumatic fever,
ankyposing spondylitis, myalgia, neuritis, bursitis,
headache.
Dose : One capsule 3 to 4 times daily to be taken after food...
Your response will not only help Thai FDA but also other developing
country drug regulatory authority.
Thanks,
Niyada Kiatying-Angsulee
Faculty of Pharmaceutical Sciences
Chulalongkorn University Bangkok 10330
tel. +662-2188374 fax. +662-2558227
email: kniyada@chula.ac.th
---Note from the moderator:
Sounds like a pretty horrible combination! What dosages involved?
The European Union does have a policy on combination drugs. As this
product combines two different active ingredients with potentially serious
side-effects in a fixed-dose combination (indomethacin, dexametasone)
I would be surprised if any EU drug regulatory authority would pass
this product. There is little proof that the added vitamins are effective
for the rather wide and vague indications. How about vitamine B12
resorption in oral dosage forms? etc etc.
Any country that has registered dexamethasone-indomethacin combinations?
E-drug moderator
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