Non ionic surfactant. polyoxyethylated castor oil used to dissolve water insoluble drugs. Greater specific gravity than water, and high viscosity.
Adverse reactions have been described with numerous drugs.
ALTHESIN (alphaxalone), EPONTOL (propanidid): withdrawn from the market,
DIPRIVAN (propofol), DAKTARIN (miconazole), KONAKION (vitamin K1), STESOLID MR (diazepam): reformulated without cremophor E.L.
SANDIMMUNE (cyclosporine), TAXOL (paclitaxel), VUMON (teniposide), DIDEMNIN B (didemnin B): currently in use.
General: anaphylactic shock.
Cutaneous: urticaria, generalized erythema.
A few cases with positive intradermal tests with cremophor 0.2 mg/ml to 20 mg/ml.
No specific IgE found.
IgE-mediated hypersensitivity (few cases).
Non IgE-mediated hypersensitivity (IgG 4).
Complement activation (+++).
Non specific histamine release.
Avoid use as excipient if possible.
In the case of intravenous cyclosporine: proper mixing during the preparation of the infusion, and avoidance of polyvinylchlorure in the set-up. This could be extrapolated to other drugs containing cremophor E.L .