Meladinine

Uses

What is Meladinine® (Methoxsalen) used for?

Meladinine® is used along with controlled ultraviolet light (UVA) to help control severe psoriasis. It may also be used for other skin conditions (vitiligo, cutaneous T-cell lymphoma-CTCL).

Meladinine® works by making the skin more sensitive to UVA light. For the treatment of psoriasis, this combination helps to slow the overgrowth of skin cells. For the treatment of vitiligo, this combination helps to increase the number of pigment-producing cells (melanocytes) in the skin.

Meladinine® may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should I take Meladinine® (Methoxsalen)?

Do not sunbathe for 24 hours before taking methoxsalen and having the UVA light treatment.

Meladinine® tablets:

• Do not crush, break, or chew the tablets. Swallow Meladinine® whole with a glass of water.
• Take this medication by mouth with food or milk, usually 2 to 4 hours before your UVA light treatment or as directed by your doctor.
• Taking Meladinine® with food helps to increase absorption of the medication and also decreases nausea.

Meladinine® topical:

This medication is applied by a health care professional to affected areas of the skin before your UVA light treatment.

Ask your health care provider any questions you may have about how to use Meladinine®.

How do I store Meladinine® (Methoxsalen)?

Meladinine® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Meladinine® in the bathroom or the freezer. There may be different brands of Meladinine® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Meladinine® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Meladinine® (Methoxsalen)?

Consult with your doctor or pharmacist, if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Meladinine® or other medications.
• You have any other illnesses, disorders, or medical conditions.
• You have any other types of allergies, such as to foods, dyes, preservatives, or animals.

Is it safe during pregnancy or breastfeeding?

Pregnancy:

There are no adequate studies in women for determining risk when using Meladinine® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Meladinine®. Meladinine® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Breastfeeding:

Not known whether excreted in breast milk; use caution.

Always consult your health care provider prior to using this medication if you are pregnant, breastfeeding.

Side effects

What side effects can occur from Meladinine® (Methoxsalen)?

Here are side effects:

• Nausea
• Trouble sleeping 
• Mild itching/drying/reddening/darkening of skin
• Allergic reaction, includingrash, itching/swelling (especially of the face/tongue/throat)
• Severe dizziness
• Trouble breathing.

Tell your doctor right away 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)
• Unusual growths/moles/skin sores
• Decreased/blurred vision

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Meladinine® (Methoxsalen)?

Meladinine® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

These are interactions may occur:

• Using Meladinine® may increase plasma concentration of drugs metabolised by CYP2A6 isoenzyme.
• Additive effect with other systemic or topical photosensitising agents (e.g. anthralin, coal tar, nalidixic acid).

Does food or alcohol interact with Meladinine® (Methoxsalen)?

Meladinine® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Meladinine® (Methoxsalen)?

Meladinine® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have, especially:

• Basal cell carcinoma
• History of basal cell carcinoma
• Previous arsenic therapy
• Previous x-ray
• Grenz ray therapy
• Cardiac diseases or those unable to tolerate prolonged standing or exposure to heat stress
• Gastrointestinal diseases or chronic infection
• Hepatic impairment

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this medication.

What is the dose of Meladinine® (Methoxsalen) for an adult?

Repigmentation of vitiliginous areas

• Oral route: 20 mg or up to 600 mcg/kg 2-4 hr before measured periods of UVA exposure depending on the preparation, given twice weekly or on alternate days, w/ at least 48-hr intervals.
• Topical/Cutaneous: As 1% solution (diluted to 0.1-0.01%): Apply over lesions then expose to UVA immediately after application or wait up to 2 hours. Protect the area surrounding the lesion with a sunscreen. Wash and protect lesions from light after treatment; protection may be up to ≥48 hours. Treatment is usually repeated once weekly. Substantial repigmentation usually requires 6-9 months of treatment.

Psoriasis

• Oral: Up to approximate 600 mcg/kg, given 1.5-3 hours before UVA exposure, depending on the preparation. Treatment is usually given twice weekly or increased as necessary, with at least 48-hr intervals between doses. If there is no or minimal response after the 15th PUVA treatment, dose may be increased by 10 mg and this dose used for the remainder of the treatment course.
• Topical/Cutaneous: As a 0.15% solution (diluted to 0.015%, if necessary): Apply to affected areas 15 min before UVA exposure. Alternatively, patient may take a whole body bath in Meladinine® solution for 15 min followed by immediate UVA exposure. For treating affected areas, immerse the affected areas for 15 min into 3 mg/l soln of hand and foot soaks followed by a 30-min delay before UVA exposure. Baths or soaks are given twice weekly.

What is the dose of Meladinine® (Methoxsalen) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Meladinine® (Methoxsalen) available?

Meladinine® is available in the following dosage forms and strengths:

• Meladinine® tablets: 10 mg Méthoxsalène
• Meladinine® topical solution: 0,1% Méthoxsalène
• Meladinine® topical solution: 0,75% Méthoxsalène

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

It is also important to carry a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking with you in case of emergencies.

What should I do if I miss a dose?

If you miss a dose of Meladinine®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.