DIMEXID-JFF

INSTRUCTIONS for medical use of the medicinal product DIMEKSID-ZHF (DIMEXID)

Composition:

Active substance: dimethyl sulfoxide;

1 vial contains dimethyl sulfoxide 50 ml or 100 ml.

Pharmaceutical form. Solution for external use.

Main physico-chemical properties: colorless liquid or colorless crystals. Hygroscopic.

Pharmacotherapeutic group. Topical preparations for joint and muscle pain. ATC code M02AX03.

Pharmacological properties.

Pharmacodynamics.

Dimethyl sulfoxide penetrates through biological membranes, including skin barriers, thereby exerting its specific effects, which include anti-inflammatory, antipyretic, analgesic, antiseptic, and moderate fibrinolytic activities. The drug enhances penetration through intact skin and mucous membranes of medicinal agents (transport capability).

Pharmacokinetics.

After topical application of a 90% dimexidum solution to the skin, it appears in the blood within 5 minutes, reaching maximum concentration within 4–6 hours, with maintenance of almost unchanged levels for 1.5–3 days. Dimethyl sulfoxide is excreted in urine and feces both unchanged and in the form of dimethyl sulfone.

Clinical characteristics.

Indications.

In complex therapy of inflammatory diseases of the musculoskeletal system: rheumatoid arthritis, Bechterew's disease (ankylosing spondylitis), deforming osteoarthritis (in the presence of periarticular tissue involvement); in arthropathy, tendon strains due to contusion, traumatic infiltrates, acute and chronic osteomyelitis, streptoderma, purulent wounds, abscesses.

Also used in skin-plastic surgery – for the engraftment of transplanted autologous and homologous skin grafts, as well as for the preservation of homologous skin grafts.

Contraindications.

Hypersensitivity to the drug. Cardiovascular insufficiency, severe atherosclerosis, angina pectoris, impaired kidney or liver function, stroke, myocardial infarction, comatose states, glaucoma, cataract.

Interaction with other medicinal products and other types of interactions.

Dimethyl sulfoxide enhances the effect of ethanol (alcohol inhibits drug elimination) and insulin, acetylsalicylic acid, butadione; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin), chloramphenicol, rifampicin, griseofulvin; it also sensitizes the body to anesthetic agents. One should take into account the enhancement by the drug of both the specific activity and the toxicity of medicinal agents.

It may be used in combination with nonsteroidal anti-inflammatory agents in complex therapy of deforming osteoarthritis and rheumatoid arthritis; in combination with locally acting antimicrobial agents (synthomycin ointment) – for the treatment of streptoderma.

If taking any other medicinal products, it is mandatory to consult a physician regarding the possibility of using the drug.

Special precautions for use.

Do not apply to damaged skin or skin exhibiting allergic reactions. Do not apply to facial skin.

Prior to use, a sensitivity test must be performed. For this purpose, apply the drug to the skin using a cotton swab moistened with Dimexidum-JFF. Sharp redness and itching of the skin indicate individual hypersensitivity to the drug.

Elderly patients may use the drug only after prior consultation with a physician.

Avoid contact of the drug with mucous membranes and eyes. In case of accidental contact with eyes, immediately rinse thoroughly with running water.

At temperatures below 18 °C, dimethyl sulfoxide may crystallize; this does not affect the quality of the drug. To dissolve the crystals, carefully warm the drug vial in a water bath (water temperature approximately 60 °C). Do not boil!

Do not violate the instructions for use of the medicinal product, as this may harm health.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment with dimethyl sulfoxide.

Ability to influence reaction speed when driving or operating machinery.

Use with caution, taking into account the effect on the central nervous system, particularly the possibility of dizziness occurring.

Method of administration and dosing.

Use as aqueous solutions (30–50% concentration) for compresses and tampons. Apply gauze pads moistened with dimexidum solution to affected areas, including adjacent healthy skin areas, once daily for 20–30 minutes. Cover the gauze pad with polyethylene film and then with cotton or linen cloth.

For diffuse streptoderma, compresses with a 40–90% solution of Dimexidum-JFF are recommended.

For skin pyodermas, use a 40% solution.

In skin plastic surgery, apply dressings with a 10–20% solution of the drug to auto- and homotransplants immediately after surgery and during subsequent days until stable graft take.

As a preserving agent for storage of skin homotransplants, use a 5% solution of the drug in Ringer's solution.

Instructions for preparing aqueous solutions of the drug at the specified concentrations:

Children.

Do not use the medication in children under 12 years of age.

Overdose.

Overdose of the medication may cause allergic reactions (urticaria, edema) and intensification of adverse effects, requiring discontinuation of the medication and administration of symptomatic therapy.

Side effects.

Dimethyl sulfoxide is generally well tolerated, but in some patients the following adverse reactions may occur:

Immune system disorders: allergic reactions, including dermatitis, skin rash, angioedema, itching, burning sensation, skin hyperemia, erythema, dry skin.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

Central and peripheral nervous system disorders: headache, dizziness, insomnia, adynamia.

Respiratory system disorders: bronchospasm.

Shelf life.

3 years.

Storage conditions. Store at 15–25 °C in a dry, dark place, protected from light and inaccessible to children.

Packaging.

50 ml or 100 ml in bottles.

Supply category. Over-the-counter (without prescription).

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business.

4 Korolyova St., Stanishevska Village, Zhytomyr District, Zhytomyr Oblast, 12430, Ukraine.