Dimexid

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIMEXID (DIMEXIDE)

Composition:

Active substance: dimexid;

1 vial contains dimexid (dimethyl sulfoxide) 40 ml, 50 ml or 100 ml.

Pharmaceutical form. Solution for external use.

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

Pharmacotherapeutic group.
Topical preparations 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 (carrying capacity).

Pharmacokinetics.

After topical application of a 90% dimexide 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.

As part of complex therapy for inflammatory diseases of the musculoskeletal system: rheumatoid arthritis, ankylosing spondylitis, deforming osteoarthritis (in the presence of periarticular tissue involvement); for arthropathy, tendon strain due to trauma, traumatic infiltrates, acute and chronic osteomyelitis, streptoderma, purulent wounds, abscesses.

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

Contraindications.

Hypersensitivity to the drug. Cardiac and vascular insufficiency, marked 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, butazone; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin, etc.), chloramphenicol, rifampicin, griseofulvin, and increases organism sensitivity to anesthetic agents. Enhanced specific activity and toxicity of medicinal products 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 locally-acting antimicrobial agents (synthomycin ointment)—for the treatment of streptoderma.

Special precautions.

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

Prior to using the medicinal product, a sensitivity test must be performed. For this purpose, a small amount of the solution is applied to the skin using a cotton swab. Sharp redness and itching of the skin after application of Dimexidum 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 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 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 affect reaction speed when driving vehicles or operating machinery.

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

Administration and Dosage

Dimexide is used in the form of aqueous solutions (30–50% concentration) for compresses and tampons.

Gauze dressings moistened with dimexide solution are applied once daily to affected areas, including adjacent healthy skin, for 20–30 minutes. The gauze dressing is covered with polyethylene film, followed by cotton or linen cloth.

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

For skin pyoderma, a 40% solution is used.

In skin-plastic surgery, dressings with a 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 is achieved.

A 5% solution of the drug in Ringer's solution is used as a preservative for the storage of skin homografts.

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

Children.

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

Overdose.

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

Side effects.

Dimethyl sulfoxide is usually well tolerated, but in some patients burning sensation, skin hyperemia, erythema, dryness of the skin, dizziness, headache, insomnia, adynamia, nausea, vomiting, diarrhea, hypersensitivity reactions including dermatitis, skin rashes, angioneurotic edema, pruritus, bronchospasm are possible.

Shelf life. 3 years.

Storage conditions.

Store in original packaging at a temperature from 15 ºC to 25 ºC.

Keep out of reach of children.

Packaging.

40 ml, 50 ml or 100 ml in glass bottles.

40 ml, 50 ml or 100 ml in a glass bottle; 1 bottle in a cardboard pack.

Prescription status. Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's location and address of business activity.

16, Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.