This is a continuation of the "Gripe, Plaquenil" thread. My understanding is that, though I thought the thread would be re-opened, apparently it is not to be.
I suppose that many will think I am being trite on this matter, and I understand this. It would seem ridiculous to me, also to keep harping on this. But, I feel guilty, as I did not fully read the challenge, and so did not fully answer the question to the best of my ability. And that is a diservice (sp?) to the topic. We are here to learn, no?
Anyway, the debate arose as to meaning of the work "contraindicated".
Challenge: "Is it contraindicated to take Accutane 'raw' orally?"
OK...what does the literature say?
LEXI-COMP's Drug Information Handbook, 12Th Ed, 2004, p. 805:
Contraindications: Hypersensitivity to isotretinoin or any component of the formulation; sensitivity to parabens, vitamin A, or other retinoids,: pregnancy.
Also, again, concerning administration:
Drug monograph, Isotretinion, LEXI-COMP, 12th ED, 2004, p. 807.
"Administer with food. Capsules can be swallowed, or chewed and swallowed. The capsule may be opened with a large needle and the contents placed on applesauce or ice cream for patients unable to swallow the capsule. Whole capsules can be swallowed with a full glass of liquid."
Ok...so it appears that as long as Iso does not cause a hypersensitivity rxn (look it up, Bradley), then it is "indicated" (FDA authorized for ). I did not emphasize the "FDA authorization" earlier. Too busy trying to run out the door but get reply to the thread, first.
I'd like to make the point now, that if the drug molecule (active ingredient) was going to cause a hypersens rxn, then it doesnt matter HOW the drug is administered --eg one of the most common ADR's is penicillin allergic rxns...whether infused via IV (Pen G) or given orally (Pen V), does not matter. The body recognizes the drug species (particular molecule) as being "alien", and attempts to destroy it, initiating a hypersens rxn.
Note that, as above, and as I posted prior, isotretinoin capsules can be chewed, or the capsule split and the active ingredient put on applesauce or ice cream. So, clearly, this medicine is safe for the mouth, oropharynx, and esophagus (not to mention stomach and SI).
So, if one were to either be 1) pregnant , or 2) have a hypersens rxn to iso (which would happen no matter HOW one administered it -- via oral, IV , IM, sublingual, etc) then one should not take it, period.
Concerning FDA approval (drug is "indicated"):
This means the experts at the FDA have reviewed the studies, statistics, etc, and determined that the med. in question is "useful" and statistically proven for a particular disease state, without side effects that otherwise would be so common or harmful as to outweigh its possible benefit(s).
In contrast to this is the "Unlabeled/Investigational" use where case reports and studies have shown efficacy regarding the drug in question for a particular disease state, but for which the data is still out regarding whether or not the drug is efficacious to, and safe enough to be prescribed generally and for this single purpose (disease state).
Sorry If I appear a little "meticulous" about these small details. But, sometimes its important (esp in pharmacy) to be.
Ok...Scotty, beam me up. Its been a long 3 days.
Perry "I will see you guys later" Jones