Oxsoralen (Capsules) Instructions for Use

Marketing Authorization Holder

Gerot Pharmazeutika, GmbH (Austria)

Manufactured By

R.P. Scherer, GmbH & Co. KG (Germany)

Packaged By

G.L. PHARMA, GmbH (Austria)

Quality Control Release

GEROT PHARMAZEUTIKA, GmbH (Austria)

ATC Code

D05BA02 (Methoxsalen)

Active Substance

Methoxsalen (BAN)

Dosage Form

Oxsoralen

Capsules 10 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Excipients: macrogol 400 – 515 mg, propylene glycol – 15 mg.

Capsule shell composition: gelatin – 157-184.31 mg, glycerol 85% – 65.58-76.99 mg, anidrisorb 85/70 (sorbitol, sorbitan oleate, mannitol, glycerol 85%) – 50.68-59.49 mg, titanium dioxide – 3.97-4.67 mg.

10 pcs. – blisters (5) – cardboard packs.

Clinical-Pharmacological Group

Photosensitizing drug

Pharmacotherapeutic Group

Photosensitizing agent

Pharmacological Action

Photosensitizing drug. When the drug is taken orally under the influence of long-wave (320-400 nm) UV radiation, as a result of the interaction of methoxsalen with DNA, the rate of proliferation of epidermal cells decreases, and the processes of melanogenesis are enhanced.

Pharmacokinetics

Absorption and Distribution

After oral administration, Methoxsalen is well and rapidly absorbed from the gastrointestinal tract.

C_max is reached 1-3 hours after administration. Binding to plasma proteins is reversible.

Metabolism and Excretion

Methoxsalen accumulates in epidermal cells and is metabolized fairly rapidly.

T_1/2 is about 2 hours. It is excreted mainly in the form of metabolites by the kidneys within 24 hours.

Indications

As a photosensitizing agent for photochemotherapy (PUVA) of:

• Psoriasis;
• Lichen planus;
• Lymphomas (mycosis fungoides);
• Vitiligo.

ICD codes

Dosage Regimen

The drug is taken orally, simultaneously with milk or low-fat food. The dose is determined at the rate of approximately 0.6 mg per kg of the patient’s body weight per dose. The drug is taken 1.5-2 hours before UV irradiation.

Doses of Oxsoralen depending on the patient’s body weight are given in the table.

PUVA procedures start with a UVA dose of 0.25-0.5 J/cm² (depending on skin type) with a gradual increase in dose by 0.25-1.0 J/cm².

The maximum single dose is 18-20 J/cm². Procedures are performed 2-4 times a week. The duration of therapy is from 2 weeks to 2 months.

Adverse Reactions

From 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).

With long-term use in high doses: symptoms of skin aging, cataract, skin cancer.

Contraindications

• Blood diseases;
• Malignant and benign tumors, melanoma (including history);
• Hepatic insufficiency;
• Renal insufficiency;
• Diabetes mellitus;
• Increased photosensitivity (in systemic lupus erythematosus, hepatoporphyria, xeroderma pigmentosum, albinism);
• Eye diseases;
• Aphakia;
• Children under 12 years of age;
• Lactation (breastfeeding);
• Pregnancy;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Special Precautions

The patient should be warned not to sunbathe for 24 hours before taking Oxsoralen and subsequent phototherapy; after taking the drug, it is recommended to wear sunglasses for 8 hours (to prevent the development of cataracts) and avoid exposure to sunlight.

During a PUVA therapy session, the patient must also wear sunglasses. Only 1/3 of the prescribed radiation dose should affect the skin of the abdomen, chest, and genitals.

Soft gelatin capsules and hard gelatin capsules containing Methoxsalen are not interchangeable, and the dosage regimen is selected individually.

Overdose

Symptoms: possible intensification of the described adverse reactions.

Drug Interactions

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, halogen-containing salicylates (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, organic dyes (including methylene blue, toluidine blue).

Storage Conditions

List B. The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.