Oxsoralen-Ultra

DRUG DESCRIPTION

Oxsoralen-Ultra (methoxsalen, 8-methoxypsoralen) Capsules, 10 mg. Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant and in the roots of Heracleum Candicans. It belongs to a group of compounds known as psoralens, or furocoumarins. The chemical name of methoxsalen is 9-methoxy-7H-furo [3,2-g] [1] benzopyran-7-one; it has the following structure:

OXSORALEN-ULTRA (Methoxsalen) Structural Formula Illustration

What are the possible side effects of methoxsalen (8-Mop, Oxsoralen-Ultra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Methoxsalen is expected to produce skin redness that may not occur until several hours after your UVA treatment. This redness may last for 2 or 3 days. You may also have slight swelling. These are normal effects of the medication and UVA treatment.

Call your doctor at once if you have a serious side effect such as:

  • severe skin redness within 24...

Read All Potential Side Effects and See Pictures of Oxsoralen-Ultra »

What are the precautions when taking methoxsalen capsules (Oxsoralen-Ultra)?

Before taking methoxsalen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: conditions that make you sensitive to light (such as lupus, certain porphyrias, xeroderma pigmentosum, albinism), skin cancer (melanoma, basal cell or squamous cell carcinomas), removal of natural lens in the eye, coal tar/UVB treatment, radiation treatment, arsenic treatment, cataracts, liver disease, heart disease, kidney disease.

Before having surgery, tell your doctor or dentist about all the products you use...

Read All Potential Precautions of Oxsoralen-Ultra »


Oxsoralen-Ultra Consumer (continued)

SIDE EFFECTS: Nausea or trouble sleeping may occur with methoxsalen. Mild itching/drying/reddening/darkening of skin may occur when methoxsalen is used along with UVA light treatment. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If needed, consult your doctor or pharmacist about which products (such as a moisturizer) to use to help treat dry/itchy skin.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe reddening of skin, blistering/peeling/burning of skin, thinning/wrinkling skin, painful browning/whitening/yellowing of nails, swelling ankles, mental/mood changes (such as depression, nervousness).

Tell your doctor immediately if any of these rare but serious side effects occur: unusual growths/moles/skin sores, decreased/blurred vision.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking methoxsalen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: conditions that make you sensitive to light (such as lupus, certain porphyrias, xeroderma pigmentosum, albinism), skin cancer (melanoma, basal cell or squamous cell carcinomas), removal of natural lens in the eye, coal tar/UVB treatment, radiation treatment, arsenic treatment, cataracts, liver disease, heart disease, kidney disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Oxsoralen-Ultra Patient Information Including Side Effects

Brand Names: 8-Mop, Oxsoralen-Ultra

Generic Name: methoxsalen (oral) (Pronunciation: meth OX a len)

  • 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 is methoxsalen (Oxsoralen-Ultra)?

Methoxsalen is a naturally occurring substance that is reactive to light. It works by enhancing the body's sensitivity to ultraviolet light A (UVA).

Methoxsalen is used in combination with UVA light therapy to treat severe psoriasis.

Methoxsalen may also be used for other purposes not listed in this medication guide.

What are the possible side effects of methoxsalen (Oxsoralen-Ultra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Methoxsalen is expected to produce skin redness that may not occur until several hours after your UVA treatment. This redness may last for 2 or 3 days. You may also have slight swelling. These are normal effects of the medication and UVA treatment.

Call your doctor at once if you have a serious side effect such as:

  • severe skin redness within 24 hours after UVA treatment;
  • severe itching, swelling, or skin discomfort;
  • blisters, pimples, or skin rash;
  • feeling like you might pass out; or
  • worsening of your psoriasis.

Less serious side effects may include:

  • nausea, upset stomach;
  • headache, dizziness;
  • depressed mood;
  • sleep problems (insomnia);
  • feeling nervous;
  • leg pain; or
  • mild skin itching or tenderness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about methoxsalen (Oxsoralen-Ultra)?

You should not use this medication if you are allergic to methoxsalen, or if you have a history of skin cancer or damage to the lenses of your eyes due to surgery, injury, or genetic condition.

Before taking methoxsalen, tell your doctor if you have lupus, porphyria, heart disease, kidney or liver disease, a history of cataracts, a skin pigment disorder, if you are extremely sensitive to sunlight, or if you have recently gained or lost weight.

There are many other drugs that can interact with methoxsalen, including drugs applied to the skin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

After taking methoxsalen and receiving UVA treatment, you must protect your eyes and skin from natural sunlight (even sun shining through a window).

Wear wraparound UVA-absorbing sunglasses for at least 24 hours after your light treatment, even while you are indoors near a window.

You may develop cataracts if you do not properly protect your eyes after you are treated with methoxsalen and UVA treatment.

Use a sunscreen with a minimum SPF of 15, and wear protective clothing including a hat and gloves for at least 8 hours after your light treatment.

Follow your doctor's instructions about applying topical psoriasis medications or any moisturizing lotions after your methoxsalen and UVA treatment.

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