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8-MOP (Methoxsalen) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

D. DRUG INTERACTIONS:

See Warnings Section.

VIII. OVERDOSAGE

In the event of methoxsalen overdosage, induce emesis and keep the patient in a darkened room for at least 24 hours. Emesis is beneficial only within the first 2 to 3 hours after ingestion of methoxsalen, since maximum blood levels are reached by this time.

IV. CONTRAINDICATIONS

A. Patients exhibiting idiosyncratic reactions to psoralen compounds.

B. Patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism.

C. Patients exhibiting melanoma or possessing a history of melanoma.

D. Patients exhibiting invasive squamous cell carcinomas.

E. Patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses.

BIBLIOGRAPHY

  1. Pathak, M.A., Kramer, D.M., Fitzpatrick, T.B.: Photobiology and Photochemistry of Furocoumarins (Psoralens), SUNLIGHT AND MAN: Normal and Abnormal Photobiologic Responses. Edited by M.A. Pathak, L.C. Harbor, M. Seiji et al. University of Tokyo Press. 1974, pp. 335-368.
  2. Artuc, M., Stuettgen, G., Schalla, W., Schaefer, H., and Gazith, J.: Reversible binding of 5- and 8- methoxypsoralen to human serum proteins (albumin) and to epidermis in vitro: Brit. J. Dermat. 101, pp. 669-677 (1979).
  3. Mandula, B.B., Pathak, M.A., Nakayama, Y., and Davidson, S.J.: Induction of mixed-function oxidases in mouse liver by psoralens., Ibid, 99, pp. 687-692 (1978).
  4. Pathak, M.A., Fitzpatrick, T.B., Parrish, J.A.: PSORIASIS, Proceedings of the Second International Symposium. Edited by E.M. Farber, A.J. Cox, Yorke Medical Books, pp. 262-265 (1977).
  5. Dall' Acqua, F., Marciani, S., Ciavatta, L. Rodighiero, G.: Formation of interstrand cross-linkings in the photoreactions between furocoumarins and DNA; Z Naturforsch (B), 26, pp. 561-569 (1971).
  6. Cole, R.S.: Light-induced cross-linkings of DNA in the presence of a furocoumarin (psoralen), Biochem. Biophys. Acta, 217, pp. 30-39 (1970).
  7. Musajo, L., Rodighiero, G., Caporale, G., Dall' Acqua, F., Marciani, S., Bordin, F., Baccichetti, F., Bevilacqua, R.: Photoreactions between Skin-Photosensitizing Furocoumarins and Nucleic Acids, SUNLIGHT AND MAN; Normal and Abnormal Photobiologic Responses. Edited by M.A. Pathak, L.C. Harber, M. Seiji et al. University of Tokyo Press, pp. 369-387 (1974).
  8. Dall' Acqua, F., Vedaldi, D., Bordin, F., and Rodighiero, G.: New studies in the interaction between 8-methoxypsoralen and DNA in vitro; J. Investigative Dermat., 73, pp. 191-197 (1979).
  9. Yoshikawa, K., Mori, N., Sakakibara, S., Mizuno, N., Song, P.: Photo-Conjugation of 8-methoxypsoralen with Proteins; Photochem. & Photobiol. 29, pp. 1127-1133 (1979).
  10. Ortonne, J. P., MacDonald, D.M., Micoud, A., Thivolet, J.: PUVA-induced repigmentation of vitiligo: a histochemical (split-DOPA) and ultra-structural study: Brit. J. of Dermat., 101, pp. 1-12 (1979).
  11. Hakim, R.E., Griffin, A.C., Knox, J.M.: Erythema and tumor formation in methoxsalen treated mice exposed to fluorescent light; Arch. Dermatol. 82, pp. 572-577 (1960).
  12. Pathak, M.A., Daniels, F., Hopkins, C.E., Fitzpatrick, T.B.: Ultraviolet carcinogenesis in albino and pigmented mice receiving furocoumarins: psoralens and 8-methoxypsoralen, Nature 183, pp. 728-730 (1959).
  13. Stern, R.S., Thibodeau, L.A., Kleinerman, R.A., Parrish, J.A., Fitzpatrick, T.B., and 22 Participating Investigators: Risk of Cutaneous Carcinoma in Patients Treated with Oral Methoxsalen Photochemotherapy for Psoriasis: NEJM, 300. No. 15, pp. 809-813 (1979).
  14. Stern, R.S., Parrish, J.A., Zierler, S.: Skin Carcinoma in Patients with Psoriasis Treated with Topical Tar and Artificial Ultraviolet Radiation. Lancet, 1, pp. 732-735 (1980).
  15. Roenigk, Jr., H.H., and 12 Cooperating Investigators: Skin Cancer in the PUVA-48 Cooperative Study of Psoriasis. Program for Forty-First Annual Meeting for The Society of Investigative Dermatology, Inc., Sheraton Washington Hotel, Washington, D.C., May 12, 13, and 14, 1980. Abstracts JID, 74, No. 4, p. 250 (April, 1980).
  16. Stern et al., Malignant melanoma in patients treated for psoriasis with methoxsalen (psoralen) and ultraviolet A radiation (PUVA). The PUVA Follow-up Study. New England Journal of Medicine, 336:1041-1045, (April 10, 1997).
  17. Mosher, D.B., Pathak, M.A., Harris, T.J., Fitzpatrick, T.B.: Development of Cutaneous Lesions in Vitiligo During Long-Term PUVA Therapy. Program for Forty-First Annual Meeting for The Society for Investigative Dermatology, Inc., Sheraton Washington Hotel, Washington, D.C., May 12, 13, and 14, 1980. Abstracts JID, 74, No. 4, p. 259 (April, 1980).
  18. Cloud, T.M., Hakim, R., Griffin, A.C.: Photosensitization of the eye with methoxsalen. I. Acute effects; Arch. Ophthalmol. 64, pp. 346-352 (1960).
  19. Cloud, T.M., Hakim, R., Griffin, A.C.: Photosensitization of the eye with methoxsalen. II. Chronic effects, Ibid, 66, pp. 689-694 (1961).
  20. Freeman, R.G., Troll, D.: Photosensitization of the eye by 8-methoxypsoralen, JID, 53, pp. 449-453 (1969).
  21. Lerman, S., Megaw, J., Willis, I.: Potential ocular complications from PUVA therapy and their prevention; J. Invest. Dermtat., 74, pp. 197-199 (1980).

2579-03 EL

Manufactured by: Sun Pharmaceutical Industries, Inc.
Bryan, OH 43506 U.S.A.

Manufactured for: Valeant Pharmaceuticals North America
Aliso Viejo, CA 92656 U.S.A.
For questions call: 1 (800) 548-5100

Rev. 12-07

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