Photoditazin
Photoditazin: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Fotoditazin
ATX code: L01XD
Active ingredient: dimeglumine chlorin E6 (Dimeglumine chlorin E6)
Producer: gel-penetrator of light radiation - LLC "VETA-GRAND" (Russia), concentrate for preparation of solution for infusion - LLC "company DEKO" (Russia)
Description and photo updated: 2020-19-03
Photoditazine is a drug used for photodynamic therapy (PDT) and fluorescence diagnostics (PD) of malignant tumors.
Release form and composition
Photoditazin is available in the following dosage forms:
- concentrate for the preparation of solution for infusion: liquid of dark green color with a yellow tint (10 ml each in a vial of light-shielding or dark brown glass, sealed with a rubber stopper and rolled in an aluminum / combined cap; in a cardboard box, 1 bottle);
- gel-penetrator of light radiation (for external use): greenish polymer gel (0.5; 1 or 2 ml in a disposable injection syringe with a capacity of 2 ml, with a plastic cap; in a sterile package 1 syringe).
Each pack also contains instructions for the use of Photoditazin.
1 ml of concentrate contains:
- active substance: chlorin E6 dimeglumin (photoditazine) - 5 mg;
- additional component: water for injection - up to 1 ml.
1 ml of gel contains:
- active substance: photoditazine - 5 mg;
- additional components: methylhydroxyethylcellulose ethers.
Pharmacological properties
Pharmacodynamics
Photoditazin belongs to the second generation photosensitizers and is intended for PD and PDT of malignant neoplasms. The active substance selectively accumulates in malignant tumors, and with further local exposure to monochromatic light with a wavelength of 661–662 nm on the tumor focus, it provides a photosensitizing effect. The latter consists in damage to tumor tissue by generating oxygen in it in forms with higher energy (singlet oxygen) and other free radicals that cause biochemical and structural-functional changes in tumor cells and the subsequent death of these cells. The gel has maximum efficiency at a light wavelength of 662 nm.
The active substance is characterized by high photocytotoxicity in relation to various types of tumor cells. When performing spectrofluorescent research methods, the drug manifests itself as a highly informative diagnostic tool. Specifically important qualities of a medicinal product are as follows:
- fast (within 24–28 hours) elimination from the body, primarily from the skin and mucous membranes;
- virtually no dark cytotoxicity;
- the presence of high tropism, that is, the ratio of the content of the agent in the tumor and normal tissue, reaching, taking into account the type of tumor, maximum values of more than 20.
These properties of Photoditazin during PDT almost completely eliminate the damaging effect on healthy organs and tissues, as well as injury to the skin by light.
Pharmacokinetics
With intravenous (iv) administration, the maximum concentration of the active substance in the tumor is recorded 1.5–2 hours after the injection (depending on the nosological form of the tumor), then after 4–5 hours its content gradually decreases. The half-life (T 1/2) of the drug is 12 hours, after intravenous administration, 28 hours later, trace amounts of Photoditazin are detected in the blood.
The maximum contrast ratio of the agent accumulation (tumor / normal tissue) can be from 3 to 24, this indicator is influenced by the nosological form of the tumor. The active process of biotransformation of the drug occurs in the liver (more than 95%), it binds to plasma proteins by 92–96%.
Indications for use
A concentrate for the preparation of a solution for infusion Photoditazin is recommended for use in the following cases:
- PD of lung cancer and skin cancer;
- PDT for skin cancer (basal cell, squamous cell), lung cancer (only if there are contraindications to surgical treatment).
Gel Photoditazin is recommended for use to enhance the penetrating effect of a light energy source used in phototherapy, including PDT against the background of various types of light exposure.
The gel is used for the following diseases / conditions:
- basal cell, squamous cell carcinoma and skin keratoses;
- background and precancerous lesions of the vagina, cervix, external genitalia;
- purulent long-term non-healing trophic ulcers and wounds;
- psoriasis and skin dermatoses;
- arthrosis and arthritis;
- periodontal disease;
- chronic rhinitis and rhinosinusopathy;
- acne vulgaris.
Also, Photoditazin gel is used in ophthalmology and cosmetology in the implementation of photodynamic rejuvenation of the facial skin.
Contraindications
The use of Photoditazin is contraindicated in the presence of hypersensitivity to its components.
Additional contraindications for the concentrate:
- cardiovascular lesions in the decompensation phase;
- severe renal and / or hepatic impairment;
- the period of pregnancy and lactation;
- childhood.
Photoditazin, instructions for use: method and dosage
Concentrate for solution for infusion
The solution prepared from the Photoditazin concentrate is administered as an intravenous drip infusion. It is necessary to use the drug in a darkened room.
The recommended dosage regimen: 1 time per day at a dose of 0.7-1.4 mg / kg, for 30 minutes.
A session of local tumor irradiation at a dose varying from 150 to 600 J / cm² at a power density of 150-300 mW / cm² is performed 2-3 hours after the intravenous infusion of the solution. The power and dose and luminous flux are determined taking into account the localization and volume of the tumor, as well as its nosological type. During the irradiation session, laser devices are used to ensure the generation of radiation with a wavelength of 661–662 nm.
The solution for intravenous infusion is prepared by diluting the required dose of the concentrate in a 0.9% sodium chloride solution in a volume of 100 ml.
Light Penetrator Gel
Gel Photoditazin is used externally.
The drug is applied as an application to the mucous membrane or skin 15-30 minutes before exposure to light. The recommended dose is 1 ml of the product per 3-5 cm² of the treated surface area.
After 15-30 minutes, the gel is removed from the affected area using a cotton swab moistened with distilled water, and light exposure is performed in accordance with approved medical technologies.
Side effects
Against the background of intravenous administration of the drug, the following undesirable effects may be observed:
- vascular disorders: increase in blood pressure (BP) in patients with concomitant lesions of the cardiovascular system;
- general disorders and disorders at the injection site: pain in the irradiation zone (removed by antihistamines and analgesics), an increase in body temperature (37–38 ° C) for 30 minutes; mild systemic phototoxicity.
No negative side effects were observed with external application of Photoditazin.
Overdose
Possible symptoms of an overdose of Photoditazine during infusion use of the drug: hypothermia, shortness of breath, increased blood pressure, tachycardia, agitation, turning into depression.
The specific antidote is unknown; if necessary, symptomatic treatment is carried out.
special instructions
During the period of infusion therapy with Photoditazine, it is recommended to use antioxidants that promote rapid epithelialization of the wound surface, reduce the severity of pain and the growth of connective tissue.
During application of the product, one should beware of solar and ultraviolet (UV) radiation.
For 28 hours after the infusion of the infusion solution, strict adherence to the light regime is necessary - it is required to exclude direct sunlight, watching television programs, etc. In case of violation of the light regime during this period, the risk of hyperemia and edema of the open surfaces of the skin is aggravated (without pigmentation).
From the first day of treatment with the drug, a photoprotective cream should be applied to open body surfaces.
Influence on the ability to drive vehicles and complex mechanisms
The drug does not affect the ability to drive a car and other complex moving mechanisms.
Application during pregnancy and lactation
The use of Photoditazin in the form of a concentrate is contraindicated for pregnant and breastfeeding women.
Pediatric use
The concentrate for the preparation of solution for infusion is not used in pediatric practice.
With impaired renal function
In severe renal failure, infusion of the drug is contraindicated.
For violations of liver function
In case of severe violations of liver function, injecting an infusion solution is contraindicated.
Drug interactions
With the systemic use of photoditazine:
- local anesthetic drugs (infiltration anesthesia): combined use is not recommended;
- analgesics: combined use is allowed.
Analogs
The analogues of Photoditazin are Photoran E6, Alasens, Radakhlorin, Photolon.
Terms and conditions of storage
Store in a place inaccessible to children, protected from light penetration, gel at a temperature of 15-25 ° C, concentrate - not higher than 10 ° C.
Shelf life:
- light radiation gel penetrator - 2 years;
- concentrate for preparation of solution for infusion - 1 year.
Terms of dispensing from pharmacies
Gel-penetrator of light radiation is dispensed without a prescription, the concentrate for the preparation of solution for infusion is available with a prescription.
Reviews about Photoditazin
Patients in the few reviews of Photoditazin mainly note positive dynamics after a course of drug treatment. They indicate the efficacy of PDT with the use of the drug in the treatment of basal cell skin cancer and the lowest risk of recurrence in this case compared with other methods of treatment. An improvement in the condition is also noted when using the drug for the treatment of lung cancer, the drug helps to get rid of shortness of breath and stridor breathing, and helps to restore the lumen of the bronchi.
There are no complaints about the development of adverse reactions.
Price for Photoditazin in pharmacies
The price for Photoditazin can be:
- concentrate for the preparation of solution for infusion (5 mg / ml) - 18 800-21 000 rubles. for 1 bottle, 10 ml;
- gel-penetrator of light radiation (5 mg / ml) - 3800–3950 rubles. for 1 syringe containing 1 ml.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
