Project Description

Dimexid

Dimexidum

international nonproprietary name

Dimethyl sulfoxide

Ref

BP-0038

Pharmacotherapeutic group

Preparations for external appliance for control of pain syndrome in case of osteomuscular system diseases. Preparations for treating dermal diseases.

Composition of the preparation

100 g of gel contain 25 g or 50 g of dimethyl sulfoxide; excipients: carbopol 980NF – 0.5 g, menthol – 0.15 g, triethanolamine -0.35 g, purified water – to 100 g.

Pharmacological action

Pharmacodynamics

The anti-inflammatory preparation for external appliance activates hydroxyl radicals, improves the metabolic processes in the inflammation foci. It exerts local anesthetic and analgesic effects. It possesses a moderate antiseptic and fibrinolytic effects. Being applied locally it passes through the biologic membranes well and quickly including skin, mucous membranes, microbial cells membranes (it increases their sensitivity to antibiotics). It performs a transport function as well providing a deep penetration of other medicines through skin and mucous membranes.

Pharmacokinetics

Being applied on skin and mucous membranes it is absorbed quickly and practically completely. The bioavailability is 60 – 70 %, the bioavailability degree and the penetration depth depend directly proportionally on the dimethyl sulfoxide concentration. Being applied on skin the preparation is found in the blood serum in 10 minutes after the application, the peak concentration is observed in 5 – 8 hours. It penetrates well in the tissues cells of each organ excluding hair, nails and tooth enamel.  It is metabolized through oxidation into methyl sulfonil methane subsequently restoring to dimethyl sulfide. Dimethyl sulfoxide and its metabolites are eliminated with urine and feces. Dimethyl sulfide can eliminate through skin and lungs as well the process being accompanied by a garlic odor. No accumulation of dimethyl sulfoxide or its metabolites in the body is observed in case of a long time appliance.

Indications 

Complex therapy for rheumatoid arthritis, Behterev’s disease, osteoarthrosis (in case the periarticular tissues changes are present), radiculitis, scleroderma, nodal erythema, erysipelatous inflammation; contusions, strained ligaments, inflammatory edema; infiltrates (including traumatic ones); purulent wounds, burns, trophic ulcers, thrombophlebitis, eczema, acne, complex therapy for pyoderma, furunculosis; in dermal plastic surgery – skin auto- and homotransplantations, skin grafts preservation; in stomatology – inflammatory diseases of maxillofacial area, of salivary glands, parodontitis, pulpitis, periodontitis, arthritis and osteoarthrosis of temporomandibular joint.

special indication

Not established

special warning

Considering that the individual intolerance of the preparation is possible the preparation should be tested for tolerance. For the test performance dimexidum gel is applied on a small area of the wrist back. An acute hyperemia and pruritus appearance evidences about an increased sensitivity to the preparation.

Dosage and method of administration

The preparation is applied on skin in form of applications. A thin layer of dimexidum gel 50% is applied on the skin areas damaged (for the skin of face and other especially sensitive parts of the body as well as on the mucous membrane dimexidum gel 25% should be applied) and is rubbed carefully.

The applications are made 2 – 3 times a day for 10 – 15 days.

In case of eczema, diffuse streptoderma and for local anesthesia for pain syndrome applications of gel 50% are allowed in form of compresses on the areas damaged 2 – 3 times a day.

In case of thrombophlebitis the preparation is prescribed in combination with heparin ointment 100 U or heparin gel 1000 U as simultaneous applications 2 – 3 times a day for 10 – 15 days.

In dermal plastic surgery dimexidum gel 25% bandages are applied on the skin auto- or homografts transplanted immediately after the operations and during the following days of the postoperative period for providing the graft stable adhesion.

overdosage

No cases of the preparation overdosing applied locally in the recommended doses were described.

safety measures

The preparation should be prescribed with care to patients having allergy in the anamnesis and to persons suffering from coronary disease.

Side effects

The preparation is usually well tolerated though itching dermatitis, erythema, xeroderma may develop in some patients. Bronchospasm occur rarely. Some patients don’t like the preparation odor, it’s appliance may be accompanied by nausea, vomituraton.

Contraindications

The preparation is contraindicated in case of hypersensitivity, severe hepatic and/or renal failure, stenocardia, pronounced atherosclerosis, glaucoma, cataract, myocardial infarction, insult, coma, pregnancy and lactation (for the period of treatment the breast feeding should be stopped).

Interactions with other medicinal preparations

It enhances the ethanol, insulin absorption and effect. It increases the absorption and effect of the other medicines applied simultaneously. It is compatible with heparin, antibacterial preparations, non steroid anti-inflammatory drugs. It enhances microorganisms sensitivity to aminoglycosides and beta-lactam antibiotics, chloramphenicol, rifampycin, griseofulvin. It sensitivizes the organism to medicines for general and local anesthesia effect.

The form of release

Aluminium tubes 40 g in each; each tube accompanied by the appliance instruction is inserted into a pack.