METHOXSALEN capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHOXSALEN (UNII: U4VJ29L7BQ) (METHOXSALEN - UNII:U4VJ29L7BQ)

Available from:

Actavis Pharma, Inc.

INN (International Name):

METHOXSALEN

Composition:

METHOXSALEN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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