Oxsoralen-Ultra (Methoxsalen)

OXSORALEN-ULTRA™

ICN

Methoxsalen

Melanin Repigmentation – Tolerance Increase to Solar Exposure – Photochemotherapy of Atopic Dermatitis and Psoriasis

Indications And Clinical Uses: Repigmentation of idiopathic vitiligo; increasing tolerance to sunlight. Treatment of psoriasis and atopic dermatitis in combination with high intensity UVA light (photochemotherapy).

Contra-Indications: Hepatic insufficiency and in those diseases associated with photosensitivity; such as porphyria, acute lupus erythematosus, hydroa and polymorphic light eruptions. In leukoderma of infectious origin and in albinism, it increases tolerance to sunlight but has no effect on pigmentation. No preparation with any photosensitizing capacity, internal or external, should be used concomitantly with methoxsalen therapy. To date, the safety in young persons under 12 years of age has not been established and is, therefore, contraindicated.

Manufacturers’ Warnings In Clinical States: Methoxsalen is a potent drug. Read entire brochure before prescribing or dispensing this medication. Herpes simplex infection may occur during treatment. There is evidence that psoralens enter the eye lens for up to 12 hours after dosing. Patients should be instructed to wear sunglasses (grey or green plastic lenses) on the days they are being treated and should close their eyes during treatment with ultraviolet light.

Pregnancy and Lactation: The safety of methoxsalen during pregnancy or lactation has not been demonstrated for the mother or the child. Therefore, methoxsalen should be used during pregnancy only when, in the judgment of the physician, the probable benefits outweigh the possible risks.

Caution: Oxsoralen-Ultra should not be used interchangeably with regular Oxsoralen. 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.

Precautions: The physician should be familiar with the various characteristics of the drug and its established clinical use. Patients undergoing therapy should be subject to appropriate supervision so that signs or symptoms of possible toxic effects may be detected and evaluated with minimal delay.

There have not been any clinical reports or tests to verify that more severe reactions may result from the concomitant ingestion of furocoumarin-containing food while on methoxsalen therapy; but the physician should warn the patient that taking limes, figs, parsley, parsnips, mustard, carrots and celery, might be dangerous. Methoxsalen should be used with caution in patients with defective coagulation or in those patients being treated with anticoagulant drugs.

Adverse Reactions: The most common side effects of methoxsalen in combination with photochemotherapy are excessive erythema, nausea and pruritus. Occasionally, there may occur nervousness, insomnia or depression.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: The dosage of this medication must be carefully controlled. Overdosage and/or overexposure may result in serious burning and blistering. To prevent harmful effects, the physician should carefully instruct the patient to adhere to the prescribed dosage schedule and procedure. If an overdosage of methoxsalen has been taken, emesis should be encouraged. The treatment for severe reactions resulting from overdosage or overexposure should follow accepted procedures for treatment of severe burns.

Dosage And Administration: Adults and Children over 12 years of age: Methoxsalen should be taken after meals or with milk.

Vitiligo: 2 capsules daily, taken 1 1/2 to 2 hours before measured period of ultraviolet exposure or fluorescent black light.

Tolerance Increase to Sunlight: 2 capsules daily taken 2 hours before measured periods of exposure to sun or ultraviolet irradiation. Not to be continued for longer than 14 days. The dosage should not be increased as severe burning may occur.

Photochemotherapy Treatment of Psoriasis and Atopic Dermatitis: The dosage of methoxsalen is based upon the patient’s weight. The exposure of UVA is carried out in a specially designed system within 1 1/2 to 2 hours after drug ingestion. The initial exposure is based upon the patient’s skin type. Following the initial exposure and providing the patient does not develop an erythema greater than Grade 1, subsequent exposures of UVA should follow the recommendations outlined in the product brochure.

Availability And Storage: Each soft green gelatin capsule, printed ICN on one side and 650 on the other contains: methoxsalen USP 10 mg. Nonmedicinal ingredients: polyethylene glycol. Bottles of 50 and 100.

OXSORALEN-ULTRA™ ICN Methoxsalen Melanin Repigmentation – Tolerance Increase to Solar Exposure – Photochemotherapy of Atopic Dermatitis and Psoriasis

Connected Diseases :

Psoriasis

General Illness Information Medical Term: PSORIASIS Common Name: None Specified Description: Psoriasis is a recurrent skin condition which is characterized by macules and patches (flat…

Dermatitis, Atopic

General Illness Information Common Name: ECZEMA (Dermatitis, atopic) Medical Term: Eczema Description: It is a chronic, itchy inflammation of the upper layers of the skin….