Instruction for use: Oxoralen

Active substance Methoxsalen

ATX code D05BA02 Methoxsalen

Pharmacological group

dermotropic means

Nosological classification (ICD-10)

C84.0 Mushroom mycosis

Mycosis mushroom, Fungoid granuloma

L40 Psoriasis

Chronic psoriasis with diffuse plaques, Generalized psoriasis, Psoriasis of the scalp, Psoriasis of the scalp, Generalized form of psoriasis, Psoriasis dermatitis, Psoriasis complicated by erythroderma, Invalidative psoriasis, Isolated psoriatic plaque, Exfoliative psoriasis, Psoriatic Erythroderma, Psoriasis with eczematosis, Hyperkeratosis in psoriasis,Inverse psoriasis,Psoriasis eczematous, Dermatosis of psoriasis, Psoriasis of the genitals, Psoriasis with lesions of hairy areas of skin, Erythrodermal psoriasis, Chronic psoriasis of the scalp, Chronic psoriasis, Ordinary psoriasis, Refractory psoriasis, Kebner phenomenon, Scaly lichen

L43 Red Leaf Flat

Lishay Wilson, Erosive-ulcerative form of red flat lichen, Warty forms of red lichen, Red lichen, Flat lichen, Kebner phenomenon

L80 Vitiligo

Hypomelanoz, Depigmentation of focal, Leather, pie

Composition and form of release

Capsules 1 caps.

methoxalene 10 mg

auxiliary substances: polyethylene glycol 400; propylene glycol; gelatin; titanium dioxide; glycerin 85% (glycerol); anhydrizor 85/70 (sorbitol, sorbitan oleate, mannitol, glycerol)

in a planar cell pack of 10; in a pack of cardboard 5 packages.

Description of dosage form

Soft gelatin capsules are white, oval in shape, containing a colorless or yellowish liquid.

pharmachologic effect

Pharmacological action - photosensitizing.

Pharmacodynamics

When administered under the influence of long-wave (320-400 nm) UV rays, as a result of the interaction of methoxalene with epidermal DNA, the proliferation rate of the epidermal cells decreases, as well as the intensification of melanogenesis processes.

Pharmacokinetics

Good and quickly absorbed from the digestive tract. Cmax is reached within 1-3 hours. Reversibly binds to plasma proteins. T1 / 2 - about 2 hours. It accumulates in the epidermal cells and is rapidly metabolized. It is excreted mainly in the form of metabolites by the kidneys during the day.

Indication

As a photosensitizing agent for photochemotherapy (PUVA):

psoriasis;

red flat lichen;

lymphoma (mushroom mycosis);

vitiligo.

Contraindications

hypersensitivity;

blood diseases;

malignant and benign tumors; melanoma (including in the anamnesis);

hepatic and / or renal insufficiency;

diabetes;

increased photosensitivity (systemic lupus erythematosus, hepatoporphyria, pigment xeroderma, albinism);

eye diseases; aphakia;

pregnancy;

the period of breastfeeding;

children under 12 years.

pregnancy and lactation

Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.

Side effects

Dizziness, nausea, vomiting, decreased appetite, skin flushing, itching, burns (with excessive exposure to UV radiation), nervousness, insomnia, depression. With prolonged use in high doses, symptoms of skin aging, cataracts, skin cancer are possible.

Interaction

Incompatible with other drugs that have a photosensitizing effect, such as anthralin, tar and its derivatives, griseofulvin, phenothiazines, nalidixic acid, quinolones and fluoroquinolones, halogenated salicylates (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, organic dyes (methylene blue, toluidine blue and etc.).

Dosing and Administration

Inside, with milk or low-fat food, for 1.5-2 hours before UV irradiation, approximately at the rate of 0.6 mg / kg per 1 reception.

The PUVA procedures are prescribed with a dose of long-wave UV rays, depending on skin type, with 0.25-0.5 J / cm2 with a gradual increase in the dose by 0.25-1 J / cm2.

The maximum single dose is 18-20 J / cm2. The frequency of the procedures is 2-4 times a week. Duration of treatment - from 2-3 weeks to 2 months.

special instructions

Do not take sun baths for 24 hours before taking Oxoralen and subsequent phototherapy. After taking the drug, it is recommended to wear sunglasses for 8 hours (to prevent the development of cataracts) and to avoid exposure to sunlight. During the session the patient should be in sunglasses. Only 1/3 of the prescribed radiation dose should affect the skin of the abdomen, chest, genitals.

Soft gelatin capsules and hard gelatin capsules containing methoxalene are not interchangeable and are selected individually.

storage Conditions

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.