No

Psoralen

In conjunction with controlled exposure to ultraviolet light or sunlight for repigmentation of idiopathic vitiligo; increasing tolerance to sunlight with albinism; enhance pigmentation

C

Hypersensitivity to psoralens, melanoma, a history of melanoma, or other diseases associated with photosensitivity; porphyria, acute lupus erythematosus; patients <12 years of age

Serious burns from UVA or sunlight can occur if dosage or exposure schedules are exceeded; patients must wear protective eye wear to prevent cataracts; use with caution in patients with severe hepatic or cardiovascular disease

>10%:

Dermatologic: Itching

Gastrointestinal: Nausea

1% to 10%:

Central nervous system: Dizziness, headache, mental depression, insomnia, nervousness

Dermatologic: Severe burns from excessive sunlight or ultraviolet exposure

Gastrointestinal: Gastric discomfort

No data reported

Psoralens are thought to form covalent bonds with pyrimidine bases in DNA which inhibit the synthesis of DNA. This reaction involves excitation of the trioxsalen molecule by radiation in the long-wave ultraviolet light (UVA) resulting in transference of energy to the trioxsalen molecule producing an excited state. Binding of trioxsalen to DNA occurs only in the presence of ultraviolet light. The increase in skin pigmentation produced by trioxsalen and UVA radiation involves multiple changes in melanocytes and interaction between melanocytes and keratinocytes. In general, melanogenesis is stimulated but the size and distribution of melanocytes is unchanged.

Peak photosensitivity: 2 hours

Duration: Skin sensitivity to light remains for 8-12 hours

Absorption: Rapid

Half-life, elimination: ~2 hours

Children >12 years and Adults: Oral: 10 mg/day as a single dose, 2-4 hours before controlled exposure to UVA (for 15-35 minutes) or sunlight; do not continue for longer than 14 days

May cause dizziness, nervousness, insomnia, or depression

None reported

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. Avoid use of any other skin treatments unless approved by prescriber. You must wear protective eyewear during treatments. 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.

To minimize gastric discomfort, tablets may be administered with milk or after a meal; wear sunglasses during exposure and a light-screening lipstick; do not exceed dose or exposure duration

Tablet: 5 mg