"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
Oxsoralen-Ultra Patient Information including How Should I Take
In this Article
- What is methoxsalen (Oxsoralen-Ultra)?
- What are the possible side effects of methoxsalen (Oxsoralen-Ultra)?
- What is the most important information I should know about methoxsalen (Oxsoralen-Ultra)?
- What should I discuss with my health care provider before taking methoxsalen (Oxsoralen-Ultra)?
- How should I take methoxsalen (Oxsoralen-Ultra)?
- What happens if I miss a dose (Oxsoralen-Ultra)?
- What happens if I overdose (Oxsoralen-Ultra)?
- What should I avoid while taking methoxsalen (Oxsoralen-Ultra)?
- What other drugs will affect methoxsalen (Oxsoralen-Ultra)?
- Where can I get more information?
What should I discuss with my health care provider before taking methoxsalen (Oxsoralen-Ultra)?
You should not use this medication if you are allergic to methoxsalen, or if you have:
- a history of skin cancer;
- lupus, porphyria, albinism, or other conditions that make you more sensitive to light; or
- damage to the lenses of your eyes caused by surgery, injury, or genetic condition.
Before your UVA treatment: Do not expose your skin to sunlight for at least 24 hours before you take methoxsalen. Avoid applying sunscreen to areas of psoriasis that will be treated with UVA therapy.
You may need to have your eyes examined before you start taking methoxsalen.
To make sure you can safely take methoxsalen, tell your doctor if you have any of these other conditions:
- heart disease;
- kidney disease;
- liver disease;
- a history of cataracts;
- a skin pigment disorder;
- if you are extremely sensitive to sunlight;
- if you have ever received radiation or x-ray therapy; or
- if you have recently gained or lost weight.
FDA pregnancy category C. It is not known whether methoxsalen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether methoxsalen passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using methoxsalen.
How should I take methoxsalen (Oxsoralen-Ultra)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Taking too much methoxsalen can cause your skin to be overly sensitive to light, and severe sunburn may result.
Take this medication with low-fat food or milk if it upsets your stomach.
The methoxsalen soft gelatin capsule is more easily absorbed in the body than the hard gelatin capsule. For this reason, you may be sensitive to UVA treatment more quickly after taking the soft gelatin capsule.
Methoxsalen is usually taken 90 minutes to 2 hours before you are scheduled to receive UVA treatment. The timing of your medication may depend on whether you are taking the soft gelatin capsule or the hard gelatin capsule. You may need to keep taking methoxsalen once every other day after your UVA treatment.
Methoxsalen will make your skin more sensitive to sunlight and sunburn may result, which could interfere with your psoriasis treatment.
For at least 8 hours after you take methoxsalen:
- Avoid exposure to sunlight or tanning beds.
- Even sunlight shining through clouds or through a glass window can expose you to harmful UV rays.
- Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors or near a window.
- Do not apply sunscreen to areas of active psoriasis that will be treated with UVA therapy.
For 24 to 48 hours after you receive UVA treatment:
- You must protect your skin and eyes from natural sunlight (even sun shining through a window).
- Wear sunglasses for at least 24 hours after treatment.
- For utmost protection, wear a pair of wraparound UVA-absorbing sunglasses, even while you are indoors near a window.
- Do not expose your skin to sunlight or tanning beds for at least 48 hours. Wear protective clothing including a hat and gloves. Use a sunscreen with a minimum SPF of 15, and apply it to all uncovered skin areas exposed to light.
You may develop cataracts if you do not properly protect your eyes after you are treated with methoxsalen and UVA treatment.
Follow your doctor's instructions about applying topical psoriasis medications or any moisturizing lotions after your methoxsalen and UVA treatment.
While taking methoxsalen, check your skin regularly for signs of skin cancer, such as a small growth or nodule, a scaly or crusted lesion, a brownish spot or speckles, or a change in the size, color, or feel of a mole. After receiving UVA treatments, you may need to check your skin for signs of cancer throughout the rest of your life.
Store at room temperature away from moisture and heat.
Additional Oxsoralen-Ultra Information
- Oxsoralen-Ultra Drug Interactions Center: methoxsalen rapid oral
- Oxsoralen-Ultra Side Effects Center
- Oxsoralen-Ultra Overview including Precautions
- Oxsoralen-Ultra FDA Approved Prescribing Information including Dosage
Oxsoralen-Ultra - User Reviews
Oxsoralen-Ultra User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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