Meladinine

Meladinine

methoxsalen

Manufacturer:

Laboratoires MACORS

Distributor:

Pacific Healthcare
Full Prescribing Info
Contents
Methoxsalen.
Description
Each tablet contains Methoxsalen 10 mg.
Excipients/Inactive Ingredients:
Tablet only: Lactose, Maize starch, Talc, Sucrose, Gum Arabic, Magnesium stearate.
Action
Pharmacology: Meladinine is found to increase the pigmentation of normal skin and induce re-pigmentation of idiopathic leucoderma. Idiopathic leucoderma or vitiligo is known to be a resistant skin disease that may affect the general condition of the patient. Meladinine can bring about a remission in the most serious leucodermic patients.
Meladinine concentrates in the melanocytes, where it absorbs ultraviolet energy, thus promoting the production of melanin and the pigmentary response of the vitiligenous areas.
Indications/Uses
Increase color intensity of patient's skin or helping to eliminate the outer layer of epidermis by treatment with Ultraviolet radiation (solar or artificial) or combination with photosensitizing agent: PSORIASIS, IDIOPATHIC VITILIGO.
Dosage/Direction for Use
Tablet: Patients should follow the doctor's prescription exactly. Oral methoxsalen may be administered as a single dose with milk or after a meal, or in 2 divided doses approximately 30 minutes apart, to minimize adverse GI effects.
Idiopathic Vitiligo: Children > 12 years and Adults: Oral 20 mg daily 2 - 4 hours before exposure to UVA light or sunlight. Therapy should be on alternate days and never on 2 consecutive days. Oral dosages greater than 0.6 mg/kg should not be used, since severe burns may result.
Psoriasis: Adults: Oral 10 - 70 mg. 1.5-2 hours before exposure to UVA light. Treatments may be administered 2 or 3 times weekly (at least 48 hours apart) or as necessary. The initial dose of methoxsalen is based on the patient's body weight according to the following schedule: See table.

Click on icon to see table/diagram/image

Paint: The paint should be applied daily or less frequently according to the tolerance of the patient and should be used at least 1 hr before the ultraviolet or solar irradiation or at night a few minutes before sleep, to be followed in the morning by irradiation. The paint should be applied to the leucodermic patch or bald area by means of a cotton wad or brush.
Refrain from applying paint to delicate areas (eg, eyelids and genitalia). The treated parts must be exposed with measure to sunlight or if it is not possible, to ultraviolet light, during the period strictly prescribed by the physician. Do not exceed half a minute for the first time.
During treatment, local reactions may develop on the depigmented areas. The usual reaction is a more or less intense reddishness; blistering may be noted if the radiation has been prolonged too much. Should the reaction be excessive, it is then necessary to stop the painting for a few days until disappearance. The treatment should be conducted under the supervision of a dermatologist. It has been observed clinically in the treatment of leucoderma that the best results are obtained by combining both oral and topical treatment together with solar or ultraviolet irradiation.
Contraindications
Tablet: Associated with Meladinine: Skin diseases aggravated by sunshine; Lupus erythematosus, porplyria; Hypertension, heart failure; Liver or kidney failure.
Associated with PUVA therapy: Cataract; History of skin cancer; Previous treatment with arsenic, ionizing radiation; Children.
Paint: Hepatic insufficiency and all other persons except healthy adults.
Special Precautions
All exposure to sunshine after treatment with Meladinine is associated with marked risk of burning.
The stipulated gradual increase in duration of exposure to UV radiation (sunlight or lamp) must be followed carefully.
After each treatment session, any further exposure to sunshine must be avoided by covering the skin.
Using sun block for explores areas of skin in order to avoid all risk of burning (topical therapy).
Use of dark glasses effective against UVA should be advised during treatment sessions and for 8-10 hours following treatment and in certain cases up to 24 hours.
In women of childbearing age, use of an effective form of contraception should be recommended during treatment.
Attention should be paid to the potential long-term risks of photochemotherapy, e.g. skin ageing, changes in pigmentation, a risk of basal cell epithelioma and risk of cataract, and patients should consequently be closely monitored.
Use In Pregnancy & Lactation
It is not known whether methoxsalen can cause fetal harm when administered orally to pregnant women. Methoxsalen should be used during pregnancy only when clearly needed. It is not known whether methoxsalen affects fertility in humans. Since it is not known whether methoxsalen is distributed into milk, the drug should be used with caution in nursing women.
Adverse Reactions
Tablet: Frequency not always defined: Cardiovascular: severe edema, hypotension.
Central nervous system: nervousness, vertigo, depression.
Dermatologic: painful blistering, burning, and peeling of skin; pruritus (10%), frecking, hypopigmentation, rash, cheilitis, erythema, itching.
Gastrointestinal: nausea (10%).
Neuromuscular & Skeletal: loss of muscle coordination.
Paint: Meladinine in therapeutic doses is completely free from toxicity.
Occasionally, there may be occur gastric discomforts, nausea, nervousess, insomnia or depressed mood. To minimize gastric effects, tablets may be taken with milk or meals.
Drug Interactions
In order to avoid any interactions between different medicines, the patient should always tell their doctor or pharmacist of any other medicines they are currently taking and in particular they should avoid concomitant use of all medication with potentially photosensitising effects (e.g., anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides [bacteriostatic soaps], sulfonamides, tetracyclines, thiazides, or certain organic staining dyes such as methylene blue, toluidine blue, rose Bengal and methyl orange). This concomitant therapy may produce additive photosensitizing effects.
Storage
Do not exceed the expiry date indicated on the external packaging.
ATC Classification
D05AD02 - methoxsalen ; Belongs to the class of topical psoralens used in the treatment of psoriasis.
D05BA02 - methoxsalen ; Belongs to the class of systemic psoralens used in the treatment of psoriasis.
Presentation/Packing
Tab 10 mg x 30's. Paint 0.75 % x 24 mL.
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