DrugindexOnline^{2nd edition}

Generic Name: Methoxsalen Lotion (meth-OX-ah-len)
Brand Name: Oxsoralen

Oxsoralen Lotion is powerful and could produce severe burns if improperly used. Oxsoralen Lotion must never be dispensed to a patient. A doctor using special light conditions must apply Oxsoralen Lotion.

Oxsoralen Lotion is used for:

Treating vitiligo in combination with controlled doses of ultraviolet A (UVA) or sunlight. It may also be used for other conditions as determined by your doctor.

Oxsoralen Lotion is a psoralen used in combination with light therapy. It works by making the skin more sensitive to UV light. It appears that this sensitivity results in damage to the skin cells when UV light treatment is given. Damaged skin cells grow more slowly and the rate of tissue growth is reduced.

Do NOT use Oxsoralen Lotion if:

• you are allergic to any ingredient in Oxsoralen Lotion or to similar medicines
• you have a light-sensitive disease (eg, the blood disease porphyria, lupus, xeroderma pigmentosum)
• you have a history of melanoma or certain types of skin cancer
• your skin is sensitive to the sun or light

Contact your doctor or health care provider right away if any of these apply to you.

Before using Oxsoralen Lotion:

Some medical conditions may interact with Oxsoralen Lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are fair-skinned, have a history of coal tar UV treatment, or ionizing radiation, or have taken arsenic compounds or oral psoralen UVA treatment
• if you have other skin conditions, an infection, or a history of heart or blood vessel disease

Some MEDICINES MAY INTERACT with Oxsoralen Lotion. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) because the effectiveness of Oxsoralen Lotion may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxsoralen Lotion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Oxsoralen Lotion:

Use Oxsoralen Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Oxsoralen Lotion is usually applied at your doctor's office or a clinic.
• This medicine is applied only in small well-defined lesions and preferably on lesions that can be protected by clothing or sunscreen from later exposure to UVA.
• If you miss a dose of Oxsoralen Lotion, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Oxsoralen Lotion.

Important safety information:

• After you begin Oxsoralen Lotion and light therapy, several weeks to months may pass before you see an improvement in your condition.
• Do not sunbathe for at least 24 hours before receiving Oxsoralen Lotion and light therapy. After your treatment, avoid any exposure to sunlight for at least 8 hours. This includes indirect light through a window or on cloudy days. If you can not avoid exposure to sunlight, wear protective clothing, or use a sunscreen with a sun protective factor (SPF) of 15 or greater, as directed by your doctor. Protect all areas of the body, including lips, from sun exposure. Do not sunbathe or use a tanning booth without checking with your doctor and wait at least 48 hours after your treatment.
• Serious burns from either UV light or sunlight (even through a window glass) can occur if the recommended doses of Oxsoralen Lotion or exposure schedules are not maintained.
• The treated area may be highly sensitive to sunlight for several days and may cause severe burning if exposed to additional UV or sunlight. Protect the treated areas with clothing or sunscreen.
• Return of skin color may begin after a few weeks, but significant color may require 6 to 9 months of treatment.
• Exposure to sunlight or UV radiation may cause early aging of the skin.
• During treatment with Oxsoralen Lotion and UVA light, wear total UVA absorbing/blocking goggles designed to provide maximal protection of the eyes.
• Protect stomach skin, breasts, genitals, and other sensitive areas for about one third of the exposure time until tanning occurs.Unless affected by disease, male genitals should be shielded.
• Be careful using Oxsoralen Lotion with other light-sensitizing medicines. Tell your doctor if you are taking any of the following medicines: anthralin, coal tar and derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics, halogenated salicylanilides, bacteriostatic soaps, staining dyes (eg, methylene blue, toluidine blue, rose bengal, methyl orange), sulfonamides, tetracyclines, or thiazide diuretics.
• LAB TESTS may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Oxsoralen Lotion with caution in the ELDERLY because they may be more sensitive to its effects.
• Oxsoralen Lotion is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Oxsoralen Lotion during pregnancy. It is unknown if Oxsoralen Lotion is excreted in breast milk. If you are or will be breast-feeding while you are using Oxsoralen Lotion, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Oxsoralen Lotion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness or redness of the skin; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; burns on the treated area from overexposure to UVA or sunlight; severe swelling or redness of the skin; swelling of the feet or lower legs; tenderness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blisters; burns. Oxsoralen Lotion may be harmful if swallowed.

Proper storage of Oxsoralen Lotion:

Oxsoralen Lotion is usually handled and stored by a health care provider. If you are using Oxsoralen Lotion at home, store Oxsoralen Lotion as directed by your pharmacist or health care provider. Keep Oxsoralen Lotion out of the reach of children and away from pets.

General information:

• If you have any questions about Oxsoralen Lotion, please talk with your doctor, pharmacist, or other health care provider.
• Oxsoralen Lotion is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Oxsoralen Lotion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.