מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Methoxsalen (UNII: U4VJ29L7BQ) (Methoxsalen - UNII:U4VJ29L7BQ)
Bausch Health US, LLC
Methoxsalen
Methoxsalen 10 mg
ORAL
PRESCRIPTION DRUG
Photochemotherapy (methoxsalen with long-wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long-wave ultraviolet radiation. A. Patients exhibiting idiosyncratic reactions to psoralen compounds. B. Patients possessing a specific history of light-sensitive disease states should not initiate methoxsalen therapy except under special circumstances. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. C. Patients with melanoma or with a history of melanoma. D. Patients with invasive squamous cell carcinomas. E. Patients with aphakia because of the significantly increased risk of retinal damage due to the absence of lenses.
Oxsoralen-Ultra Capsules, each containing 10 mg of methoxsalen (8-methoxypsoralen) are available in green soft gelatin capsules in white plastic bottles of 50 (NDC 0187-0650-42), with VRX imprinted on one side of the capsule and 650 imprinted on the other side. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
New Drug Application
OXSORALEN-ULTRA- METHOXSALEN CAPSULE, LIQUID FILLED BAUSCH HEALTH US, LLC ---------- OXSORALEN-ULTRA CAPSULES (METHOXSALEN CAPSULES, USP) 10 MG CAUTION: METHOXSALEN IS A POTENT DRUG. READ ENTIRE BROCHURE PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION. Methoxsalen with ultraviolet (UV) radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. The use of psoralen and ultraviolet radiation therapy should be under constant supervision of such a physician. For the treatment of patients with psoriasis, photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis is certain. Because of the possibilities of ocular damage, aging of the skin, and skin cancer (including melanoma), the patient should be fully informed by the physician of the risks inherent in this therapy. CAUTION: Oxsoralen-Ultra (Methoxsalen Soft Gelatin Capsules) should not be used interchangeably with regular Oxsoralen or 8-MOP (Methoxsalen Hard Gelatin Capsules). This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patients should be treated in accordance with the dosimetry specifically recommended for this product. The minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form should be determined. I. DESCRIPTION Oxsoralen-Ultra (methoxsalen capsules, USP) contains 10 mg methoxsalen (8-methoxsalen). 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, freely soluble in chloroform, soluble in boiling alcohol, in acetone, in acetic acid, in propylene glycol, and קרא את המסמך השלם