Oksoralen (Oxoralen)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceMetoksalenMetoksalen
Similar drugsTo uncover
  • Oksoralen
    capsules inwards 
    Geroth Pharmacetica GmbH     Greece
    • Dosage form: & nbspcapsules
    Composition:
    1 capsule contains active substance: methoxalene 10.0 mg;
    Excipients: macrogol 400 515.0 mg, propylene glycol 15.0 mg; capsule shell: gelatin 157.0 - 184.31 mg, glycerol 85% 65.58-76, 99 mg, anhydrisorb 85/70 (sorbitol, sorbitan oleate, mannitol, glycerol 85%) 50.68 - 59.49 mg, titanium dioxide 3.97-4.67 mg.
    Description:Soft oval gelatin capsules in white. The contents of capsules are liquid from colorless to slightly yellowish in color.
    Pharmacotherapeutic group:Photosensitizing agent
    ATX: & nbsp

    D.05.B.A   Psoralens for systemic use

    D.05.B.A.02   Metoksalen

    Pharmacodynamics:Photosensitizing agent. When administered under the influence of long-wave ultraviolet (UV) rays of the A band (wavelength 320-400 nm) (which is summarized as UFA), as a result of the interaction of methoxalene with the DNA of the epidermal cells, the proliferation rate of the epidermal cells decreases, and the melanogenesis processes increase.
    Pharmacokinetics:Good and quickly absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached within 1-3 hours after ingestion and remains up to 8 hours. Reversibly binds to blood serum albumin and accumulates in the epidermal cells. The elimination half-life is about 2 hours, the oxoral is rapidly metabolized.It is excreted in the main (about 95%) in the form of metabolites by the kidneys during the day.
    Indications:
    As a photosensitizing agent in photochemotherapy for symptomatic treatment of severe, non-treatable by other means of disabling psoriasis (after confirming the diagnosis by biopsy).
    For repigmentation with idiopathic vitiligo.
    Contraindications:
    Hypersensitivity, blood diseases, malignant and benign tumors, melanoma (including history), hepatic and / or renal insufficiency, diabetes mellitus, increased photosensitivity (systemic lupus erythematosus, late cutaneous porphyria, erythropoietic porphyria, mixed porphyria, pigmentary xerodermia , albinism), eye diseases, aphakia, lactation period, pregnancy, children's age (safety in children has not been studied).
    Carefully:Use with caution in diseases of the liver and diseases of the cardiovascular system, in patients who have undergone previous radiation therapy or treatment with arsenic compounds.
    Pregnancy and lactation:The use of the drug during pregnancy and during breastfeeding is contraindicated.
    Dosing and Administration:

    Treatment of psoriasis:

    Doses: the drug is taken orally - with milk or low-fat food, 1.5-2 hours before UVA-irradiation at the rate of approximately 0.6 mg per 1 kg of body weight at one time.

    Dose is Oxoral depending on body weight.

    Body mass

    Dose Oxsoralen

    Less than 30 kg

    10 mg

    30-45 kg

    20 mg

    46-65 kg

    30 mg

    66-80 kg

    40 mg

    81-90 kg

    50 mg

    91-115 kg

    60 mg

    more than 115 kg

    70 mg

    UVA-irradiation: Photochemotherapy procedures are prescribed with a dose of UVA, depending on skin type, with 0.25-0.5 J / cm2 with a gradual increase in the dose by 0.25-1.0 J / cm2. The maximum single dose is 18-20 J / cm2. Frequency of procedures 2-4 times a week. The duration of the course of treatment is from 2-3 weeks to 2 months. When changing body weight during treatment, a change in the dose of the drug is usually not required. After 15 procedures with a slight effect, the dose of the drug can be increased by 10 mg.

    Treatment of vitiligo:

    Doses: the drug is taken orally - with milk or low-fat food, 2-4 hours before irradiation with sunlight 2 capsules (20 mg) at one time.

    Irradiation with sunlight: in accordance with the following table


    Primary skin coloring


    Light

    Average

    Dark

    The first exposition

    15 minutes

    20 minutes

    25 min

    The second exposition

    20 minutes

    25 min

    30 min

    The third exposition

    25 min

    30 min

    35 min

    The fourth exposition

    30 min

    35 min

    40 min

    Further exposures should be gradually increased, based on erythema and soreness of the depigmented skin. The procedures are carried out every other day.

    Side effects:
    From the skin: burns (with excessive UVA exposure), itchy skin, vesicular, bullous, herpetic and nonspecific skin rash, urticaria, sweating, folliculitis, hypopigmentation of the skin, spread of psoriasis. With long-term admission in high doses, symptoms of skin aging, cataracts, skin cancer (flaky cell and basal cell), melanoma are possible.
    From the digestive system: nausea, vomiting, decreased appetite.
    From the central nervous system: dizziness, headache, nervousness, insomnia, depression.
    Other: malaise, swelling, leg muscle cramps, lowering blood pressure; at long reception of high doses - a cataract.
    Overdose:In case of an overdose of Oxoralen, vomiting and rinsing of the stomach should be made (if after taking the drug it took no more than 2-3 hours), then the patient should be in a darkened room for at least 24 hours.
    Interaction:Incompatible with other drugs that have a photosensitizing effect - dithranol, tar and its derivatives, griseofulvin, phenothiazine derivatives, nalidixic acid, quinolones, including fluoroquinolones, halogenated salicylates (bacteriostatic soaps), sulfonamides, tetracyclines, thiazide derivatives, organic dyes (methylene blue, toluidine blue, Bengal pink, methyl orange).
    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 24 hours (to prevent the development of cataracts) and to avoid exposure to sunlight for 8 hours. 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. After a photochemotherapy session, the patient should also wear sunglasses for 24 hours and avoid exposure to sunlight for 48 hours.
    Soft gelatin capsules and hard gelatin capsules containing metoksalen, are not interchangeable and are selected individually.
    Effect on the ability to drive transp. cf. and fur:
    The drug does not affect the ability to drive and work with potentially dangerous mechanisms, however, it must be taken into account that in rare cases, dizziness and weakness may occur when taking the drug.
    Form release / dosage:Capsules, 10 mg.
    Packaging:
    For 10 capsules in a contour mesh package of PVC / PVDC / Al (blister). For 5 blisters together with instructions for use in a cardboard box.
    Storage conditions:
    In a dry place at a temperature of no higher than 30 ° C. Keep out of the reach of children.
    Shelf life:
    5 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001142
    Date of registration:14.12.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Geroth Pharmacetica GmbHGeroth Pharmacetica GmbH Greece
    Manufacturer: & nbsp
    Representation: & nbspHEROTH PHARMACOUTICS GmbHHEROTH PHARMACOUTICS GmbHRussia
    Information update date: & nbsp26.05.2017
    Illustrated instructions
      Instructions
      Up