Methoxsalen soft-gelatin capsules
Generic Name: methoxsalen (meth-OX-a-len)
Brand Name: Oxsoralen-Ultra
Methoxsalen soft-gelatin capsules, used along with ultraviolet (UV) radiation, can cause serious damage to the eyes and skin, including skin cancer. It should only be used in patients with severe, disabling psoriasis that has not responded to other treatment. Discuss any questions or concerns with your doctor.
Do not switch brands of methoxsalen soft-gelatin capsules (hard-gelatin and soft-gelatin capsules) without talking with your doctor.
Methoxsalen soft-gelatin capsules are used for:
Treating severe, disabling psoriasis. It is used along with UV radiation.
Methoxsalen soft-gelatin capsules are a psoralen. 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 methoxsalen soft-gelatin capsules if:
- you are allergic to any ingredient in methoxsalen soft-gelatin capsules or to similar medicines
- you have a history of a light-sensitive condition (eg, albinism, lupus, porphyria, xeroderma pigmentosum)
- you have aphakia (you do not have a lens in your eye)
- you have a history of melanoma or certain other 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 methoxsalen soft-gelatin capsules:
Some medical conditions may interact with methoxsalen soft-gelatin capsules. 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 have a history of skin cancer or other skin conditions
- if you have an infection, cataracts or other eye problems, liver or kidney problems, heart disease or blood vessel disease, high blood pressure, or stomach problems
- if you have had x-ray, grenz ray, arsenic, or radiation therapy
- if you are unable to stand for long periods of time or if you do not tolerate heat well
Some MEDICINES MAY INTERACT with methoxsalen soft-gelatin capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anthralin, coal tar or coal tar derivatives, griseofulvin, nalidixic acid, phenothiazines (eg, chlorpromazine), quinolone antibiotics (eg, levofloxacin), sulfonamides (eg, sulfamethoxazole), sulfonylureas (eg, glipizide), tetracycline antibiotics (eg, doxycycline), or thiazides (eg, hydrochlorothiazide) because they may increase the risk of severe sunburn
- Hydantoins (eg, phenytoin) because they may decrease the effectiveness of methoxsalen soft-gelatin capsules
- Cyclosporine because the risk of its side effects may be increased by methoxsalen soft-gelatin capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if methoxsalen soft-gelatin capsules 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 methoxsalen soft-gelatin capsules:
Use methoxsalen soft-gelatin capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with methoxsalen soft-gelatin capsules. Talk to your pharmacist if you have questions about this information.
- Take methoxsalen soft-gelatin capsules by mouth with low-fat food or milk.
- Take methoxsalen soft-gelatin capsules before ultraviolet A (UVA) exposure according to your doctor's instructions. The amount of time you take methoxsalen soft-gelatin capsules before UVA exposure depends on the condition being treated.
- If nausea occurs, take methoxsalen soft-gelatin capsules in 2 divided doses 30 minutes apart.
- If you miss a dose of methoxsalen soft-gelatin capsules, check with your doctor because it may be necessary to reschedule your light therapy.
Ask your health care provider any questions you may have about how to use methoxsalen soft-gelatin capsules.
Important safety information:
- Methoxsalen soft-gelatin capsules may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to methoxsalen soft-gelatin capsules. Using methoxsalen soft-gelatin capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Different brands of this drug are not interchangeable because they have significant differences in how they act in the body.
- Do not sunbathe or use a tanning booth for at least 24 hours before receiving methoxsalen soft-gelatin capsules and light therapy. Do not sunbathe or use a tanning booth for at least 48 hours after your treatment. Check with your doctor before you sunbathe or use a tanning booth.
- 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 cannot 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 apply sunscreen to the psoriasis areas until after you have received UV treatment.
- Serious burns from either UV light or sunlight (even through a window glass) can occur if you use more than the recommended dose of methoxsalen soft-gelatin capsules or if you use it for longer than prescribed.
- During treatment with methoxsalen soft-gelatin capsules and UVA light, wear total UVA absorbing/blocking goggles designed to provide maximal protection of the eyes. This may decrease the risk of cataracts from methoxsalen soft-gelatin capsules.
- To protect your eyes, wear special wrap-around sunglasses that absorb UVA during daylight hours for 24 hours after taking methoxsalen soft-gelatin capsules. Regular sunglasses do not adequately protect your eyes because they allow light to enter from the side.
- You will need to have an eye exam before starting methoxsalen soft-gelatin capsules. You will also need to have an eye exam once per year thereafter.
- 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. Discuss any questions with your doctor.
- Exposure to sunlight or UV radiation may cause early aging of the skin.
- Methoxsalen soft-gelatin capsules increases the risk of skin cancer. Discuss any questions or concerns with your doctor.
- Tell your doctor if you use certain antibacterial or deodorant soaps or certain dyes (eg, methyl orange, methylene blue, rose bengal, toluidine blue). They may increase the risk of severe sunburn with methoxsalen soft-gelatin capsules.
- Itching may be relieved by applying a bland moisturizing cream or lotion. Check with your doctor if itching persists or is severe.
- Tell your doctor if you lose or gain weight while you are using methoxsalen soft-gelatin capsules. Your dose may need to be changed.
- Lab tests, including complete blood cell counts and liver and kidney function tests, may be performed while using methoxsalen soft-gelatin capsules. These tests may be used to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use methoxsalen soft-gelatin capsules with caution in the ELDERLY; they may be more sensitive to its effects.
- Methoxsalen soft-gelatin capsules should be used with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if methoxsalen soft-gelatin capsules may cause harm to the fetus. Do not become pregnant while you are using it. If you become pregnant, contact your doctor. You will need to discuss with your doctor the benefits and risks of using methoxsalen soft-gelatin capsules while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking methoxsalen soft-gelatin capsules.
Possible side effects of methoxsalen soft-gelatin capsules:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Mild itching; mild, temporary redness of the skin; nausea; nervousness; trouble sleeping.
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; change in the appearance of a mole; depression; new growth on the skin; severe itching or redness of the skin; severe or persistent dizziness; unusual swelling or blistering of the skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of methoxsalen soft-gelatin capsules:
Store methoxsalen soft-gelatin capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep methoxsalen soft-gelatin capsules out of the reach of children and away from pets.
- If you have any questions about methoxsalen soft-gelatin capsules, please talk with your doctor, pharmacist, or other health care provider.
- Methoxsalen soft-gelatin capsules are 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take methoxsalen soft-gelatin capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about methoxsalen soft-gelatin capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to methoxsalen soft-gelatin capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using methoxsalen soft-gelatin capsules.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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