Composition, form of production and packaging
Capsules 1 caps.
methoxalene 10 mg
Excipients: Macrogol 400-515 mg, propylene glycol 15 mg.
The composition of the capsule shell: gelatin - 157-184.31 mg, glycerol 85% - 65.58-76.99 mg, anhydrizor 85/70 (sorbitol, sorbitan oleate, mannitol, glycerol 85%) - 50.68-59.49 mg, titanium dioxide - 3.97-4.67 mg.
10 pieces. - blisters (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Photosensitizing drug. When the drug is taken orally under the influence of long-wave (320-400 nm) UV irradiation as a result of the interaction of methoxalene with DNA, the proliferation rate of epidermal cells decreases, as well as the intensification of melanogenesis processes.
PHARMACOKINETICS
Suction and distribution
After taking the drug inside metoksalen well and quickly absorbed from the digestive tract.
C max is achieved in 1-3 hours after administration. Binding to plasma proteins is reversible.
Metabolism and excretion
Metoxalene accumulates in the epidermal cells and is metabolized fairly quickly.
T 1/2 is about 2 hours. It is excreted mainly in the form of metabolites by the kidneys during the day.
INDICATIONS
As a photosensitizing agent for photochemotherapy (PUVA):
- psoriasis;
- red flat lichen;
- Lymphoma (mushroom mycosis);
- vitiligo.
DOSING MODE
The drug is taken orally, concomitantly with the use of milk or lean food. The dose is determined from the calculation of approximately 0.6 mg per kg of body weight of the patient at one time. The drug is taken for 1.5-2 h before UV irradiation.
Doses of Oxorelane depending on the body weight of the patient are shown in the table.
Body Weight Dose Oxsoralen
Less than 30 kg of 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
Over 115 kg of 70 mg
The PUVA procedures start with a dose of UVA of 0.25-0.5 J / cm 2 (depending on skin type) with a gradual increase in the dose by 0.25-1.0 J / cm 2 .
The maximum single dose is 18-20 J / cm 2 . The procedures are carried out 2-4 times a week. The duration of therapy is from 2 weeks to 2 months.
SIDE EFFECT
From the side of the central nervous system: dizziness, nervousness, insomnia, depression.
From the digestive system: nausea, vomiting, decreased appetite.
Dermatological reactions: skin hyperemia, itching, burns (with excessive UV exposure exposure).
With prolonged use in high doses: symptoms of skin aging, cataracts, skin cancer.
CONTRAINDICATIONS
- Blood diseases;
- malignant and benign tumors, melanoma (including in the anamnesis);
- liver failure;
- kidney failure;
- diabetes;
- increased photosensitivity (with systemic lupus erythematosus, hepatoporphyria, pigment xeroderma, albinism);
- eye diseases;
- aphakia;
- children's age till 12 years;
- lactation (breastfeeding);
- Pregnancy;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in liver failure.
SPECIAL INSTRUCTIONS
The patient should be warned that you should not take sun baths 24 hours prior to taking Oxoralen and subsequent phototherapy; after taking the drug is recommended to wear sunglasses for 8 hours (to prevent the development of cataracts) and avoid exposure to sunlight.
During the PUVA therapy session, the patient should also be in sunglasses. Only 1/3 of the prescribed dose of radiation should work on the skin of the abdomen, breast, genitals.
Soft gelatin capsules and hard gelatin capsules containing methoxalene are not interchangeable, and the dosing regimen is tailored individually.
OVERDOSE
Symptoms : may increase the described side effects.
DRUG INTERACTION
The drug should not be taken simultaneously with other drugs that have a photosensitizing effect - anthralin, tar and its derivatives, griseofulvin, phenothiazines, nalidixic acid, quinolones, fluoroquinolones, halogenated salicylates (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, organic dyes methylene blue, toluidine blue).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 В° C.
