Ultra-Medanine

Composition:
Each capsule contains:
Methoxsalen                10 mg

Pharmacological properties:
Methoxsalen acts as a photosensitizer. Administration of the drug and subsequent exposure to UVA can lead to cell injury. Orally administered methoxsalen reaches the skin via the blood and UVA penetrates well into the skin. Sufficient cell injury leads to inflammatory reactions, the inflammation is followed by repair which is manifested by increased melanization of the epidermis and thickening of the stratum corneum. In the treatment of psoriasis, the mechanism is assumed to be decrease in cell proliferation by DNA photodamage.

Pharmacokinetics:
Following oral administration, absorption is rapid. Methoxsalen reaches peak drug levels in the blood between 0.5-4 hours.
The drug half-life is approximately 2 hours.
Methoxsalen is reversibly bound to serum albumin & is also preferentially taken up by epidermal cells. Approximately 95% of the drug is excreted as a series of metabolites in the urine within 24 hours.

Indications:
Ultra-medanine with UV radiation is indicated for the symptomatic control of severe recalcitrant, disabling psoriasis, vitiligo and skin manifestations of cutaneous T-cell lymphoma in persons who have not been responsive to other forms of treatment.

Contraindications:
Ultra-medanine is contraindicated in:
•    Patients with hypersensitivity to Methoxsalen or psoralen compounds.
•    Patients with specific history of light sensitive disease states including lupus erythematosus, albinism, porphyria, cutanea tarda, erythropoietic protoporphyria, variegate porphyria and xeroderma pigmentosum.
•    In patients exhibiting melanoma, squamous cell carcinoma or aphakia.

Warnings & Drug interactions:
•    Patients with hepatic insufficiency should be treated with caution since hepatic biotransformation is necessary for drug urinary excretion.
•    Special care should be exercised in treating patients who are receiving concomitant therapy with known photosensitizing agent such as griseofulvin, coal tar, phenothiazines, sulfonamides, anthralin, nalidixic acid, tetracyclines, halogenated salicylanilides (bacteriostatic soap), thiazides, methylene blue, toluidine blue, rose bengal or methyl orange.
•    Exposure to sunlight and/or UV radiation may result in premature aging of the skin.
•    Patients with cardiac diseases or others who may be unable to tolerate prolonged standing or exposure to heat stress should not be treated in a vertical UVA chamber.
•    Patients having multiple basal cell carcinomas, history of previous x-ray therapy or grenz ray therapy, history of previous arsenic therapy should be diligently observed and treated.
•    If the lens is exposed to UVA during the time Ultra-medanine is present in the lens, photochemical action may lead to irreversible binding of methoxsalen to proteins and the DNA components of the lens.

Precautions:
1-    Patients must not sunbathe during the 24 hours prior to Methoxsalen ingestion and UV exposure.
2-    UVA absorbing wrap around sunglasses should be worn during daylight for 24 hours after Ultra-medanine ingestion.
3-    Abdominal skin, breast and other sensitive areas (male genitalia) should be protected from the light.
4-    The patient should wear protective devices such as a hat and gloves and/or apply sunscreens to all areas that might be exposed to the sun (including lips). Sunscreens should not be applied to areas affected by psoriasis until after the patients has been treated in the UVA chamber.
5-    Patients should not sunbathe for 48 hours after therapy.
6-    In vitiligo therapy, the dosage of Ultra-medanine should not be increased above 0.6 mg/kg, since overdosage may result in serious burning of the skin.

Pregnancy:
Ultra-medanine should be used in pregnant women if clearly needed.

Nursing mothers:
Caution should be exercised when Ultra-medanine should be given to nursing mothers.
Either Ultra-medanine ingestion or nursing should be discontinued.

Pediatric use:
Safety in children has not been established.

Side effects:

The most common side effects are nausea, pruritis, mild or transient erythema.
Other adverse reactions: dizziness, headache, depression, insomnia, nervousness, leg cramps &hypotension.  

Overdosage:
In case of overdosage, induce emesis &keep the patients in a darkened room for at least 24 hours.

Dosage and administration:

Psoriasis therapy:
Ultra-medanine capsule should be taken 2 hours before UV exposure with some low fat food or milk according to the following table:

Patient's weight (kg) Dose (mg)
<30
30-50
51-65
66-80
81-90
91-115
>115
10
20
30
40
50
60
70

Vitiligo therapy:
1-    Drug dosage: Two capsules (10 mg each ) in one dose taken with milk or in food two to four hours before ultraviolet light exposure.
2-    Light exposure: The exposure time to sunlight should comply with the following guide:

Light exposure  Basic skin color
 Light Medium Dark
Initial exposure
Second exposure
Third exposure
Fourth exposure
15 min
20 min
25 min
30 min
20 min
25 min
30 min
35 min
25 min
30 min
35 min
40 min

•    Subsequent exposure: Gradually increase exposure based on erythema & tenderness of the amelanotic skin.
•    Therapy should be on alternate days & never two consecutive days.

Therapeutic category: dermatological drug

Legal Category: Prescription only medicine.
Storage: Store in a dry place at a temperature below 30° C, protect from light.

Package: Box containing 20 capsules.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.