Melanin Repigmentation – Photochemotherapy of Atopic Dermatitis and Psoriasis
Indications And Clinical Uses: Repigmentation of vitiliginous lesions, to protect against solar sensitivity. Oral route is preferred if extensive repigmentation is desired, since topical application can only be applied to a small area at a time.
For treatment of psoriasis and atopic dermatitis in combination with high intensity UVA light.
Contra-Indications: Hepatic insufficiency. Diseases associated with photosensitivity, such as porphyria, acute lupus erythematosus or infectious leukoderma. Safety in those 12 years and under, in people with aphasia, in pregnant women or in women of childbearing age has not been established. In albinism it increases tolerance to sunlight, but has no effect on pigmentation. No preparation with any photosensitizing capacity, internal or external, should be used concomitantly with methoxsalen therapy.
Manufacturers’ Warnings In Clinical States: Methoxsalen is a potent drug and it is recommended that the entire brochure be read before prescribing or dispensing the information.
Pregnancy and Lactation: Safety during pregnancy or lactation has not been demonstrated. Use in these conditions should be undertaken only when in the judgment of the physician, the probable benefits outweigh the possible risks.
All patients should wear goggles and should close their eyes during treatment with UV light.
Precautions: Should be used only by healthy adults, and use solely to produce a cosmetic tan is unwise because of its potential toxicity and equivocal results. When used to increase tolerance to sunlight and accelerate suntan, it should not be given for periods exceeding 2 weeks. When used in patients with vitiligo, liver function tests should be performed monthly for first few months and occasionally thereafter. If impairment of liver function is suspected, give smaller doses or discontinue drug.
There have not been any clinical reports or tests to verify that more severe reactions may result from the concomitant ingestion of food containing furocoumarin while on methoxsalen therapy; but the physician should warn the patient that eating limes, figs, parsley, parsnips, mustard, carrots and celery, might be dangerous. Methoxsalen should be used with caution in patients with defective coagulation or in those patients being treated with anticoagulant drugs.
Adverse Reactions: Occasionally, nervousness, insomnia or depression may occur.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: The dosage of this medication must be carefully controlled. Overdosage and/or overexposure may result in serious burning and blistering. To prevent harmful effects, the physician should carefully instruct the patient to adhere to the prescribed dosage schedule and procedure. If an overdose has been taken, emesis should be encouraged. The treatment for severe reactions resulting from overdosage or overexposure should follow accepted procedures for treatment of severe burns.
Dosage And Administration: Capsules: Should be taken after meals or with milk. For solar sensitivity and tanning: 20 mg 2 hours before exposure to sunlight. The exposure time during the first 3 or 4 days should be limited to 30 minutes or less. Exposure time, but not dosage may be increased thereafter.
Vitiligo: Adults and children over 12 years: 20 mg 2 to 4 hours before exposure to a source of ultraviolet light. Children 6 to 12 years: 10 to 20 mg daily. Children up to 6 years: 10 mg daily.
For photochemotherapy treatment of psoriasis and atopic dermatitis see product brochure.
Lotion: Apply once weekly to a few depigmented areas and expose to ultraviolet light for a maximum period of 1 minute. When an artificial source of ultraviolet light is used, the initial exposure should be made with 50% of the minimal erythemic dose. Sites of application should be alternated. When oral and topical therapy is used, topically treated areas must be protected from daily exposure to ultraviolet light. Lotion is for use only in vitiligo, not tanning.
Availability And Storage: Capsules: Each light pink capsule, printed ICN 600 contains: methoxsalen USP 10 mg. Bottles of 28 and 100.
Lotion: Each mL contains: methoxsalen USP 1%. Bottles of 30 mL.
OXSORALEN ICN Methoxsalen Melanin Repigmentation – Photochemotherapy of Atopic Dermatitis and Psoriasis