Methoxsalen 10mg Capsules

Methoxsalen is a psoralen derivative that, when activated by long-wave ultraviolet light (UVA, 320-400 nm), intercalates into DNA and forms covalent bonds with pyrimidine bases (primarily thymine). This leads to the formation of monofunctional and bifunctional (cross-links) adducts, inhibiting DNA synthesis and cell proliferation. In psoriasis, this action reduces the hyperproliferation of epidermal cells. In vitiligo, it stimulates melanocytes to produce melanin.

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Sunburn
Changes in the color or size of a mole
Depression
A skin lump or growth
Severe dizziness or fainting
Swelling
Changes in eyesight

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:

Skin irritation
Itching
Redness
Upset stomach
Feeling nervous and excitable
Trouble sleeping

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Squamous cell cancer
+ Aphakia (absence of a lens in your eye)
A history of melanoma
If you experience sensitivity to light, which can be caused by various health conditions. If you are unsure whether you have a condition that may increase your sensitivity to light, consult your doctor or pharmacist.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. As directed by your doctor, have your blood work checked and undergo eye exams to monitor your condition.

To minimize potential risks, avoid sunbathing within 24 hours before taking this drug and undergoing light therapy. Discuss any concerns with your doctor. During and for 24 hours after treatment, wear special sunglasses to protect your eyes. Additionally, apply lipstick with sunscreen to protect your lips.

Do not take this medication for a longer duration than prescribed by your doctor. Be aware that exposure to sun or UV rays can cause premature aging of the skin and increase the risk of skin cancer. You may also be more susceptible to sunburn. To protect yourself, avoid direct sunlight, sunlamps, and tanning beds, and use sunscreen regularly. Wear protective clothing and eyewear to prevent sunburn. Continue to take these precautions for as long as advised by your doctor.

Before using any other medications or products on your skin, including soaps, consult with your doctor. Note that blood clots have been reported in patients taking this medication for graft-versus-host disease, although this is not an approved use for this drug. If you have any questions or concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more prone to side effects. This medication may harm an unborn baby, so if you may become pregnant, use birth control while taking this medication. If you become pregnant, notify your doctor immediately.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Not explicitly contraindicated with specific drugs, but concurrent use with other photosensitizing agents should be avoided or used with extreme caution.

• Other photosensitizing agents (e.g., phenothiazines, sulfonamides, tetracyclines, thiazide diuretics, nalidixic acid, griseofulvin, some tricyclic antidepressants, some oral hypoglycemics): Increased risk of severe burns and phototoxicity.
• CYP2A6 inhibitors (e.g., amiodarone, cimetidine, ketoconazole): May increase methoxsalen levels and enhance photosensitivity.
• CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine, mexiletine): May increase methoxsalen levels and enhance photosensitivity.

• CYP2A6 inducers (e.g., rifampin, carbamazepine, phenobarbital): May decrease methoxsalen levels, potentially reducing efficacy.
• CYP1A2 inducers (e.g., omeprazole, tobacco smoking): May decrease methoxsalen levels, potentially reducing efficacy.

• Not specifically identified as minor interactions; most interactions are related to photosensitivity or CYP metabolism.

• Nausea
• Vomiting
• Dizziness
• Headache
• Nervousness
• Insomnia
• Depression
• Severe itching (pruritus)
• Erythema (redness)
• Blistering
• Edema (swelling)
• Pain or tenderness of skin
• New skin lesions (moles, freckles, non-healing sores)
• Changes in vision

Methoxsalen is Pregnancy Category C. While animal studies have shown some adverse effects, human data are limited. Due to its mechanism of action (DNA damage) and potential for genotoxicity, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Many clinicians would advise against its use during pregnancy.

Methoxsalen is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant (e.g., photosensitivity, potential for genotoxicity), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Avoid breastfeeding during treatment and for at least 24 hours after the last dose.

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended due to the increased risk of long-term side effects, particularly skin cancer, in a population with a longer life expectancy.

Use with caution in elderly patients. They may be more susceptible to the adverse effects of methoxsalen and UVA therapy, including skin cancer, cataracts, and severe burns. Close monitoring of skin and eyes is essential.

• Methoxsalen therapy (PUVA) requires precise timing of drug administration relative to UVA exposure to maximize efficacy and minimize side effects.
• Strict adherence to sun protection measures (sunglasses, protective clothing, sunscreen) for at least 24 hours post-dose is paramount to prevent severe burns and long-term complications.
• Patients must be educated on the long-term risks, especially skin cancer and cataracts, and the importance of lifelong skin and eye surveillance.
• Nausea is a common side effect; taking the medication with food or milk can help mitigate this.
• The total cumulative UVA dose should be carefully monitored throughout the patient's lifetime to minimize long-term risks.

• Topical corticosteroids
• Vitamin D analogs (e.g., calcipotriene)
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
• Other phototherapy (e.g., Narrowband UVB)
• Systemic agents for psoriasis (e.g., methotrexate, cyclosporine, acitretin)
• Biologic agents for psoriasis (e.g., TNF-alpha inhibitors, IL-17 inhibitors, IL-23 inhibitors)
• Excimer laser (for localized psoriasis/vitiligo)
• Topical agents for vitiligo (e.g., topical corticosteroids, topical calcineurin inhibitors)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.