OXSORALEN-ULTRA- 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:

Bausch Health US, LLC

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 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.

Product summary:

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).

Authorization status:

New Drug Application

Summary of Product characteristics

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