Dimexid® arterium

INSTRUCTIONS for medical use of the medicinal product DIMEXID® Arterium (DIMEXID Arterium)

Composition:

Active substance: dimethyl sulfoxide;

1 vial contains 50 ml of dimethyl sulfoxide.

Pharmaceutical form. Topical solution.

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 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 (transport capability).

Pharmacokinetics.

After topical application of the 90% solution of Dimexidum® Arterium to the skin, it appears in the blood within 5 minutes, reaching maximum concentration within 4–6 hours, with maintenance of an almost unchanged level 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, Bechterew's disease (ankylosing spondylitis), deforming osteoarthritis (in the presence of periarticular tissue involvement); for arthropathy, tendon strains, traumatic infiltrates, acute and chronic osteomyelitis, streptoderma, purulent wounds, and abscesses.

Also used in reconstructive plastic surgery—for the grafting of transplanted autologous and homologous skin grafts, as well as for the preservation of homologous skin grafts.

Contraindications.

Hypersensitivity to the drug. Cardiac and vascular insufficiency, marked 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 effects of ethanol (alcohol inhibits the elimination of the drug) and insulin, acetylsalicylic acid, butazone; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin), chloramphenicol, rifampicin, griseofulvin, and sensitizes the body to anesthetic agents. It should be noted that the drug enhances both the specific activity and the toxicity of medicinal agents. It may be used in combination with nonsteroidal anti-inflammatory agents in the complex treatment of deforming osteoarthritis and rheumatoid arthritis; in combination with locally acting antimicrobial agents (synthomycin liniment)—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 facial skin.

Prior to use, a sensitivity test must be performed. For this purpose, apply Dimexid® Arterium to the skin using a cotton swab moistened with Dimexid® Arterium. Intense redness and itching of the skin after application of Dimexid® Arterium 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 of 18 °C, crystallization of dimethyl sulfoxide may occur; 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 influence reaction rate when driving vehicles or operating machinery

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

Method of administration and dosage.

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

Gauze dressings moistened with Dimexidum® Arterium solution should be applied to affected areas, extending to adjacent healthy skin, once daily for 20–30 minutes. Cover the dressing with polyethylene film and then with cotton or linen cloth.

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

For skin pyoderma, apply a 40% solution.

In skin plastic surgery, apply dressings with a 10–20% solution of Dimexidum® Arterium to transplanted skin autografts and homografts immediately after surgery and during subsequent postoperative days until stable graft engraftment is achieved.

As a preservative for storage of skin homografts, use a 5% solution of the drug in Ringer's solution.

Recommendations 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, edema) and intensification of adverse reactions.

Treatment. Discontinuation of the drug, symptomatic therapy.

Side effects.

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

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

Gastrointestinal tract: nausea, vomiting, diarrhea.

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

Respiratory system: 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 in a bottle; 1 bottle per carton.

Availability. Over-the-counter.

Manufacturer: JSC "Galichpharm".

Manufacturer's address:

79024, Lviv, Opryshkivska St., 6/8, Ukraine.