Methoxsalen

What is methoxsalen used for?

Methoxsalen is a prescription medicine that is used used to treat white patches on your skin (vitiligo). It is used with light therapy.

Description

Methoxsalen Soft Gelatin Capsules USP contains 10mg methoxsalen. Methoxsalen occurs as white to pale yellow crystals and can be obtained naturally from seeds of Ammi majus and roots of Heracleum Candicans or through synthesis. Methoxsalen is practically insoluble in water, freely soluble in chloroform, soluble in boiling alcohol, in acetone, in acetic acid, in propylene glycol, and in benzene, sparingly soluble in boiling water and in ether. The chemical name of methoxsalen is 9-methoxy-7H-furo [3,2-g] [1] benzopyran-7-one; its empirical formula is C12H8O4 and the molecular weight is 216.19. The structural formula is:

Methoxsalen Capsules are available as soft gelatin capsules containing the following inactive ingredients: Citric acid anhydrous, D & C yellow 10, FD & C blue 1, Gelatin, Glycine, Glycerin, Isopropyl alcohol, Medium chain triglyceride, Polyethylene glycol 400, Polysorbate 80, Purified water, Titanium dioxide and Opacode black.

The opacode black contains Propylene glycol, Shellac glaze (Modified) IN SD-45, N-Butyl alcohol, Black iron oxide, Isopropyl alcohol and Ammonium hydroxide.

Before taking methoxsalen, tell your doctor:

For all patients taking methoxsalen:

• If you are allergic to methoxsalen; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Melanoma or squamous cell cancer.
• If you have ever had melanoma.
• If you sunburn easily.

Children:

• If your child is younger than 12 years of age. Do not give methoxsalen to a child younger than 12 years of age.

This is not a list of all drugs or health problems that interact with methoxsalen.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take methoxsalen with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take methoxsalen?

• Tell all of your health care providers that you take methoxsalen. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad burns may happen if methoxsalen is not used the right way. Follow what your doctor told you to do closely.
• Do not go over the time you are told to use.
• Sun or UV rays may age the skin and raise the chance of skin cancer.
• You will need to wear special sunglasses during and for 24 hours after treatment. Protect lips with lipstick that has sunscreen.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun. Keep protecting yourself from sunburn for as long as you were told by your doctor.
• It may take several months to see full effect.
• Talk with your doctor before you use other drugs or products on your skin.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using methoxsalen while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is methoxsalen best taken?

Use methoxsalen as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor or other healthcare provider will put on the skin.
• Wear gloves when touching methoxsalen.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of methoxsalen that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.
• Sunburn.
• Blisters or sores.

What are some other side effects of methoxsalen?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out methoxsalen?

• If you need to store methoxsalen at home, talk with your doctor, nurse, or pharmacist about how to store it.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

• NDC 64380-752-16
• Rx Only
•  (Methoxsalen Capsules, USP)
• 10 mg
• CAUTION: This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Each patient should be evaluated by determining the minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photoche-motheraphy with this dosage form.
• 50 Capsules

 

• 50 capsules Container label

 

SRC: NLM .