Generic Name and Formulations:
Methoxsalen 10mg; soft gel caps.
Bausch Health Companies Inc.
Indications for OXSORALEN-ULTRA:
Symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy.
Give only in conjunction with a schedule of controlled doses of long wave UV radiation. Do not sunbathe during the 24hr period prior to methoxsalen ingestion; avoid sun exposure for at least 8hrs after and do not sunbathe for 48hrs after. Wear UVA absorbing wrap-around sunglasses for 24hrs after. Apply sunscreen if sun exposure unavoidable; do not apply to areas affected by psoriasis until after UVA treatment. Give 1½–2hrs before UVA exposure with low fat food or milk. <30kg: 10mg. 30–50kg: 20mg. 51–65kg: 30mg. 66–80kg: 40mg. 81–90kg: 50mg. 91–115kg: 60mg. >115kg: 70mg. See literature for UVA exposure schedule.
Idiosyncratic reactions to psoralen compounds. History of light sensitive disease states (eg, lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, albinism). Melanoma or history of. Invasive squamous cell carcinomas. Aphakia.
Should be used only by experienced physicians. Not interchangeable with regular Oxsoralen or 8-MOP capsules.
To be used only by physicians with special training in photochemotherapy. Do not use interchangeably with Oxsoralen. Increased risk of ocular damage (eg, cataracts), aging of the skin, and skin cancer; monitor. Basal cell carcinoma. Previous radiation or aresenic therapy. Hepatic insufficiency. Cardiovascular disease. Perform ophthalmologic exam prior to start of therapy and then yearly. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Caution with concomitant photosensitizing agents (eg, anthralin, coal tar, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolones, halogenated salicylanilides, sulfonamides, tetracyclines, thiazides, certain organic staining dyes).
Nausea, nervousness, insomnia, depression; combined methoxsalen/UVA therapy: pruritus, erythema, edema, dizziness, headache, malaise, hypopigmentation, vesiculation, bullae formation, rash, herpes simplex, miliaria, urticaria, folliculitis, cutaneous tenderness, leg cramps, hypotension, extension of psoriasis.