No

Psoralen

Oral: Symptomatic control of severe, recalcitrant disabling psoriasis, not responsive to other therapy when diagnosis has been supported by biopsy. Administer only in conjunction with a schedule of controlled doses of long wave ultraviolet (UV) radiation; also used with long wave ultraviolet (UV) radiation for repigmentation of idiopathic vitiligo.

Topical: Repigmenting agent in vitiligo, used in conjunction with controlled doses of UVA or sunlight

C

Diseases associated with photosensitivity, cataract, invasive squamous cell cancer, known hypersensitivity to methoxsalen (psoralens), and children <12 years of age

Family history of sunlight allergy or chronic infections; lotion should only be applied under direct supervision of a physician and should not be dispensed to the patient; for use only if inadequate response to other forms of therapy, serious burns may occur from UVA or sunlight even through glass if dose and or exposure schedule is not maintained; some products may contain tartrazine; use caution in patients with hepatic or cardiac disease

>10%:

Dermatologic: Itching

Gastrointestinal: Nausea

1% to 10%:

Cardiovascular: Severe edema, hypotension

Central nervous system: Nervousness, vertigo, depression

Dermatologic: Painful blistering, burning, and peeling of skin; pruritus, freckling, hypopigmentation, rash, cheilitis, erythema

Neuromuscular & skeletal: Loss of muscle coordination

Symptoms of overdose include nausea, severe burns; follow accepted treatment of severe burns; keep room darkened until reaction subsides (8-24 hours or more)

Increased toxicity: Concomitant therapy with other photosensitizing agents such as anthralin, coal tar, griseofulvin, phenothiazines, nalidixic acid, sulfanilamides, tetracyclines, thiazides

Bonds covalently to pyrimidine bases in DNA, inhibits the synthesis of DNA, and suppresses cell division. The augmented sunburn reaction involves excitation of the methoxsalen molecule by radiation in the long-wave ultraviolet light (UVA), resulting in transference of energy to the methoxsalen molecule producing an excited state ("triplet electronic state"). The molecule, in this "triplet state", then reacts with cutaneous DNA.

Metabolism: In the liver with >90% of dose appearing in urine as metabolites

Bioavailability: May be less with the capsule than with the liquid-encapsulated preparation

Time to peak serum concentration: Oral: 2-4 hours

Psoriasis: Adults: Oral: 10-70 mg 11/2 -2 hours before exposure to ultraviolet light, 2-3 times at least 48 hours apart; dosage is based upon patient's body weight and skin type

Vitiligo: Children >12 years and Adults:

Oral: 20 mg 2-4 hours before exposure to UVA light or sunlight; limit exposure to 15-40 minutes based on skin basic color and exposure

Topical: Apply lotion 1-2 hours before exposure to UVA light, no more than once weekly

To reduce nausea, oral drug can be administered with food or milk or in 2 divided doses 30 minutes apart; avoid furocoumarial-containing foods (limes, figs, parsley, celery, cloves, lemon, mustard, carrots)

May cause nervousness, dizziness, or depression

Concurrent use with psychotropics may produce additive photosensitivity

No information available to require special precautions

No effects or complications reported

This medication is used in conjunction with specific ultraviolet treatment. Follow prescriber's directions exactly for oral medication which can be taken with food or milk to reduce nausea. Consult prescriber for specific dietary instructions. Avoid use of any other skin treatments unless approved by prescriber. Control exposure to direct sunlight as per prescriber's instructions. If sunlight cannot be avoided, use sunblock (consult prescriber for specific SPF level), wear protective clothing and wraparound protective eyewear. Consult prescriber immediately if burning, blistering, or skin irritation occur. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

If burning or blistering or intractable pruritus occurs, discontinue therapy until effects subside. Do not sunbathe for at least 24 hours prior to therapy or 48 hours after PUVA therapy. Avoid direct and indirect sunlight for 8 hours after oral and 12-48 hours after topical therapy. If sunlight cannot be avoided, protective clothing and/or sunscreens must be worn. Following oral therapy, wraparound sunglasses with UVA-absorbing properties must be worn for 24 hours. Do not exceed prescribed dose or exposure times.

Capsule: 10 mg

Lotion: 1% (30 mL)

Solution: 20 mcg/mL