DIMETHYLSULFOXIDE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIMETHYLSULFOXIDE (DIMETHYLSULFOXID)

Composition:

Active substance: dimethylsulfoxide;

1 vial contains dimethylsulfoxide 50 ml or 100 ml.

Pharmaceutical form. Liquid for external use.

Main physicochemical properties: colorless liquid or colorless crystals. Hygroscopic.

Pharmacotherapeutic group.

Topical agents for joint and muscle pain.

ATC code M02AX03.

Pharmacological properties.

Pharmacodynamics.

Dimethyl sulfoxide has the ability to penetrate biological membranes, including skin barriers, thereby exerting its specific effects, which include anti-inflammatory, antipyretic, analgesic, antiseptic, and moderate fibrinolytic actions. The drug enhances the penetration through intact skin and mucous membranes of medicinal agents (transporting ability).

Pharmacokinetics.

After topical application of a 90% dimethyl sulfoxide 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 as dimethyl sulfone.

Clinical characteristics.

Indications.

To be used as part of complex therapy for 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 strain due to trauma, traumatic infiltrates, acute and chronic osteomyelitis, streptoderma, purulent wounds, abscesses.

Also used in plastic surgery—for the grafting of transplanted skin autografts and homografts, as well as for the preservation of skin homografts.

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

Dimethyl sulfoxide enhances the effects of ethanol (alcohol inhibits drug elimination) and insulin, acetylsalicylic acid, butadione; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin, etc.), chloramphenicol, rifampicin, griseofulvin, and increases organism sensitivity to anesthetic agents. Enhanced specific activity as well as toxicity of medicinal agents due to the drug should be taken into account. May be used in combination with nonsteroidal anti-inflammatory agents in complex therapy of deforming osteoarthritis and rheumatoid arthritis; in combination with topical antimicrobial agents (synthomycin ointment)—for the treatment of streptoderma.

Special precautions for use.

Do not apply to damaged skin or skin with signs of allergy. Do not apply to the facial skin.

Before using the medicinal product, a sensitivity test must be performed. For this purpose, a small amount of the solution should be applied to the skin using a cotton swab. A sharp redness and itching of the skin after application of dimethyl sulfoxide indicate individual hypersensitivity to the drug.

Elderly patients may use the drug 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 them 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 vial containing the drug 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 medicinal product is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment with dimethyl sulfoxide.

Ability to influence reaction rate when driving or operating machinery.

Use with caution, considering the effect on the central nervous system, including the possibility of dizziness.

Method of administration and dosage.

Used as aqueous solutions (30–50% concentration) for compresses and tampons.

Gauze pads moistened with dimethyl sulfoxide solution are applied to affected areas, including adjacent healthy skin areas, for 20–30 minutes once daily. Over the pad, a polyethylene film is placed, followed by cotton or linen fabric.

For diffuse streptoderma, compresses with 40–90% dimethyl sulfoxide solution are recommended.

For purulent skin diseases, a 40% solution is used.

In dermato-plastic surgery, dressings with 10–20% solution of the drug are applied to transplanted skin autografts and homografts immediately after surgery and during subsequent postoperative days until stable graft take.

A 5% dimethyl sulfoxide solution in Ringer's solution is used as a preserving agent for storage of skin homografts.

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

Children.

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

Overdose.

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

Adverse reactions.

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

Immune system side effects: allergic reactions including dermatitis, skin rash, angioneurotic edema, itching, burning, skin hyperemia, erythema, skin dryness.

Gastrointestinal tract side effects: nausea, vomiting, diarrhea.

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

Respiratory system side effects: bronchospasm.

Shelf life. 3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

50 ml or 100 ml in glass or polymer bottles.

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

Manufacturer.

LLC "MEDLEV".

Manufacturer's address and place of business.

171 Bohdana Khmelnytskoho St., Bldg. B-1, K-1, Dnipro, 49000, Ukraine.