Photoditasin® (Fotoditazin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspconcentrate for solution for infusion
Composition:

1 ml of concentrate contains:

active substance: photoditazine (N-dimethylglucamine salt of chlorine E6) - 5 mg;

atExcipients: water for injections

Description:The solution is dark green with a yellowish tinge.
Pharmacotherapeutic group:photosensitizing agent
ATX: & nbsp
  • Drugs used in photodynamic and radiation therapy
    • Pharmacodynamics:

    Photoditazin® is a second-generation photosensitizer intended for fluorescent diagnosis (FD) and photodynamic therapy (PDT) of malignant tumors.

    The drug selectively accumulates in malignant neoplasms. With subsequent irradiation with monochromatic light at a wavelength of 661-662 nm of the tumor focus, a photosensitizing effect occurs, consisting in generation of active oxygen species (singlet oxygen) and other free radical particles in the tumor tissue, leading to the development of biochemical and structural-functional changes in tumor cells and their deaths.

    The high photocytotoxicity of Photoditasin ® is characteristic for various types of tumor cells. It is a highly informative diagnostic tool for spectrophluorescence methods of investigation.

    An important feature of the preparation of Photoditazin is the practical absence of dark cytotoxicity, rapid elimination (24-28 hours) from the body, primarily from the skin and mucous membranes, high tropicity (ie, the ratio of drug concentrations in the tumor and normal tissue), reaching , depending on the type of tumors, the maximum values ​​above 20. These features of the drug virtually eliminate the damaging effect in the conduct of PDT of healthy organs and tissues, as well as light trauma to the skin.

    Pharmacokinetics:

    After intravenous administration of Photoditazine, the maximum concentration in the tumor is reached after 1.5-2.5 hours from the time of administration (depending on the nosological type of tumor). After 4-5 hours, the concentration of Photoditazine in the tumor gradually decreases. The half-life of the drug is 12 hours. After 28 hours after intravenous administration, trace amounts of the drug are found in the blood.

    The maximum contrast ratio of the drug accumulation (tumor / normal tissue) depends on the nosological type of tumor and can vary from 3.0 to 24. The drug is actively metabolized in the liver (over 95%).The connection with plasma proteins is 92-96%.

    Indications:

    Fluorescent diagnosis of skin cancer and lung cancer.

    Photodynamic therapy of skin cancer (squamous, basal cell), lung cancer (only in cases of contraindications to surgical treatment).

    Contraindications:

    Hypersensitivity to the drug.

    Pronounced renal or hepatic insufficiency.

    Cardiovascular disease in the phase of decompensation.

    Pregnancy and lactation.

    Childhood.

    Dosing and Administration:
    The drug is administered once in the form of intravenous drip infusion for 30 minutes at a dose of 0.7-1.4 mg / kg body weight of the patient. 2-3 hours after the administration of the drug, a local irradiation session of the tumor is carried out at a dose of 150-600 J /cm2 at a power density of 150-300 mW /cm2.
    The dose and power of the light flux is determined depending on the location of the tumor, tumor volume, nosological species.
    The irradiation session is carried out with the help of laser devices providing generation of radiation with a wavelength of 661-662 nm.
    Preparation of a solution for intravenous infusion
    The calculated dose of Photoditazin ® is dissolved in 100 ml of 0.9% sodium chloride solution.
    Side effects:

    An increase in body temperature (37-38 ° C) for 30 minutes and pain in the irradiation zone, which are stopped by the introduction of analgesics, antihistamines.

    Increase in blood pressure in patients with concomitant diseases of the cardiovascular system.

    Overdose:

    Symptoms: shortness of breath, tachycardia, increased blood pressure, agitation, followed by oppression, hypothermia.

    Treatment: symptomatic therapy (there is no specific antidote).

    Interaction:

    Possible joint use with analgesics.

    It is not recommended to use local anesthetics (infiltration anesthesia).

    Special instructions:

    Within 24 hours after the administration of the drug, the patient must strictly adhere to the light regime (irradiation with direct sunlight, viewing of television programs, etc.).

    Beginning with the first day of Photoditasin ® application, open body surfaces should be treated with a photoprotective cream.

    Form release / dosage:Concentrate for the preparation of solution for infusion, 5 mg / ml.
    Packaging:

    50 mg / 10 ml (5 mg / ml) in bottles of dark brown glass.

    One bottle in a cardboard pack together with instructions for use.

    Storage conditions:

    At a temperature not exceeding 10 ° C, in a place protected from light and inaccessible to children.

    Shelf life:

    1 year.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001246
    Date of registration:18.05.2012
    The owner of the registration certificate:Veta Grand, OOOVeta Grand, OOO
    Manufacturer: & nbsp
    Information update date: & nbsp07.03.2016
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