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:

Oceanside Pharmaceuticals

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:

Methoxsalen Capsules, USP, each containing 10 mg of methoxsalen (8-methoxypsoralen) are available in green soft gelatin capsules in white plastic bottles of 50 (NDC 68682-065-10), 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 Authorized Generic

Summary of Product characteristics

METHOXSALEN- METHOXSALEN CAPSULE, LIQUID FILLED
OCEANSIDE PHARMACEUTICALS
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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: Methoxsalen Capsules, USP 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
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 in
benzene, sparingly soluble in boiling water and in ether. The chemi