Oxsoralen label

Oxsoralen

Oxsoralen Recall

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Side Effects & Adverse Reactions

 
SKIN BURNS
 
Serious skin burns from either UVA or sunlight (even through window glass) can result if recommended exposure schedule is exceeded and/or protective covering or sunscreens are not used. The blistering of the skin sometimes encountered after UV exposure generally heals without complication or scarring. (Farrington Daniels, Jr., M.D., personal communication). Suitable covering of the area of application or a topical sunblock should follow the therapeutic UVA exposure.
 
CARCINOGENICITY

 
Animal Studies. Topical methoxsalen has been reported to be a potent photocarcinogen in certain strains of mice. (Pathak et al 1959)
5.
 
Human Studies. None of our clinical investigators reported skin cancer as a complication of topical treatment for vitiligo. However, it is recommended that caution be exercised when the patient is fair-skinned, has a history of prior coal tar UV treatment, or has had ionizing radiation or taken arsenical compounds. Such patients who subsequently have
oral psoralen – UVA treatment (PUVA) are at increased risk for developing skin cancer.
 
CONCOMITANT THERAPY
 
Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange.
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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

As a topical repigmenting agent in vitiligo in conjunction with controlled doses of ultraviolet A (320-400 nm) or sunlight.

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History

There is currently no drug history available for this drug.

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Other Information

Oxsoralen Lotion is a clear, colorless to straw colored liquid with an odor of acetone. Each ml. of Oxsoralen Lotion contains 10 mg. methoxsalen in an inert vehicle containing alcohol (71% v/v), propylene glycol, acetone, and purified water.

Methoxsalen occurs as white to pale yellow crystals and can be obtained naturally from seeds of Ammi majus and roots of Heracleum Candicans or through synthesis. Methoxsalen is practically insoluble in water, sparingly soluble in ether, soluble in ether, soluble in acetone and acetic acid, freely soluble in chloroform. The chemical name of methoxsalen is 9-methoxy-7H-furo (3, 2g) (1)-benzopyran-7-one; its empirical formula is C12H804 andthe molecular weight is 216.19. The structural formula is:

Chemical Structure
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Oxsoralen Manufacturers

  • Valeant Pharmaceuticals North America Llc
    Oxsoralen | Valeant Pharmaceuticals North America Llc
    No Recall

    Oxsoralen | Valeant Pharmaceuticals North America Llc

    Oxsoralen | Valeant Pharmaceuticals North America Llc

    OXSORALEN Lotion is applied to a well-defined area of vitiligo by the physician and the area is then exposed to a suitable source of UVA. Initial exposure time should be conservative and not exceed that which is predicted to be one-half the minimal erythema dose. Treatment intervals should be regulated by the erythema response; generally once a week is recommended or less often depending on results. The hands and fingers of the person applying the medication should be protected by gloves or finger cots to avoid photosensitization and possible burns.

    Pigmentation may begin after a few weeks but significant repigmentation may require 6 to 9 months of treatment. Periodic re-treatment may be necessary to retain all of the new pigment. Idiopathic vitiligo is reversible but not equally reversible in every patient. Treatment must be individualized. Repigmentation will vary in completeness, time of onset, and duration. Repigmentation occurs more rapidly in fleshy areas such as face, abdomen, and buttocks and less rapidly over less fleshy areas such as the dorsum of the hands or feet.

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