Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
METHOXSALEN (UNII: U4VJ29L7BQ) (METHOXSALEN - UNII:U4VJ29L7BQ)
Actavis Pharma, Inc.
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 Capsules, USP (Soft Gelatin Capsules) are intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation. - Patients exhibiting idiosyncratic reactions to psoralen compounds. - 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. - Patients with melanoma or with a history of melanoma. - Patients with invasive squamous cell carcinomas. - Patients with aphakia, because of the significantly increased risk of retinal damag
Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers as defined in the USP. BIBLIOGRAPHY Manufactured by: US Generics Program, a division of Procaps S.A. Calle 80 No. 78 B – 201 Barranquilla – Colombia South America Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 200009716 Revised – May 2015
Abbreviated New Drug Application
METHOXSALEN- METHOXSALEN CAPSULE, LIQUID FILLED ACTAVIS PHARMA, INC. ---------- METHOXSALEN CAPSULES, USP (SOFT GELATIN CAPSULES) RX ONLY CAUTION: METHOXSALEN IS A POTENT DRUG. READ ENTIRE BROCHURE PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION. Methoxsalen with 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 ultraviolent 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: Methoxsalen Capsules, USP (Soft Gelatin Capsules) should not be used interchangeably with regular methoxsalen capsules or methoxsalen hard gelatin capsules. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patient 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. DESCRIPTION Methoxsalen Capsules, USP (Soft Gelatin Capsules) 10 mg (8-methoxypsoralen). Methoxsalen, USP is a naturally occurring photoactive substance found in the seeds of the AMMI MAJUS (Umbelliferae) plant and in the roots of HERACLEUM CANDICANS. It belongs to a group of compounds known as psoralens, or furocoumarins. The chemical name of methoxsalen, USP is 9-methoxy-7H-furo [3,2-g] [1] benzopyran- 7-one; it has the following struc Izlasiet visu dokumentu