Mastodon

Dimexid® (Solution, Gel, Concentrate) Instructions for Use

ATC Code

M02AX03 (Dimethyl sulfoxide)

Active Substance

Dimethyl sulfoxide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with anti-inflammatory and analgesic action for external use

Pharmacotherapeutic Group

Drugs for external use for muscle and joint pain; other drugs for external use for muscle and joint pain

Pharmacological Action

Anti-inflammatory agent for external use. The mechanism of action is associated with the inactivation of hydroxyl radicals and the improvement of metabolic processes in the focus of inflammation, as well as a decrease in the conduction rate of excitatory impulses in peripheral neurons.

It has a local anesthetic, local anti-inflammatory, analgesic, and antimicrobial effect; it possesses some fibrinolytic activity. It penetrates the skin and other biological membranes, increasing their permeability to medicinal substances.

Pharmacokinetics

When a solution of dimethyl sulfoxide is applied to the skin, it is detected in the blood within 5 minutes, with Cmax reached in 4-6 hours, maintaining an almost unchanged level for 1.5-3 days.

Dimethyl sulfoxide is excreted in urine and feces, both unchanged and in the form of dimethyl sulfone.

Indications

As part of complex therapy: diseases of the musculoskeletal system: rheumatoid arthritis, ankylosing spondylitis (Bekhterev’s disease), deforming osteoarthritis (with damage to periarticular tissues), reactive synovitis, limited scleroderma, erythema nodosum, discoid lupus erythematosus, foot mycoses, keloid scars, thrombophlebitis, alopecia, eczema, streptoderma, erysipelas; bruises, sprains, traumatic infiltrates; purulent wounds, burns, radiculitis, trophic ulcers, acne, furunculosis; in skin-plastic surgery – for the preservation of skin homografts.

ICD codes

ICD-10 code Indication
A46 Erysipelas
B35.3 Tinea pedis
I80 Phlebitis and thrombophlebitis
L02 Cutaneous abscess, furuncle and carbuncle
L08.0 Pyoderma
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L30.0 Nummular eczema
L52 Erythema nodosum
L63.9 Alopecia areata, unspecified
L64.9 Androgenic alopecia, unspecified
L70 Acne
L91.0 Hypertrophic scar
L93.0 Discoid lupus erythematosus
L94.0 Localized scleroderma [morphea]
L98.4 Chronic skin ulcer, not elsewhere classified
M05 Seropositive rheumatoid arthritis
M15 Polyosteoarthritis
M45 Ankylosing spondylitis
M54.1 Radiculopathy
M54.3 Sciatica
M54.4 Lumbago with sciatica
M65 Synovitis and tenosynovitis
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
1B70.0Z Erysipelas, unspecified
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1F28.2 Dermatophytosis of foot
8B93.Z Radiculopathy, unspecified
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
9A06.70 Atopic eczema of the eyelids
BD70.0 Superficial thrombophlebitis of lower extremities
BD70.Z Superficial thrombophlebitis, unspecified
BD71.4 Deep vein thrombosis of lower extremity
BD7Z Diseases of veins, unspecified
EA40 Tropical phagedenic ulcer
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA82 Nummular dermatitis
EA85.20 Atopic hand eczema
EB21 Pyoderma gangrenosum
EB31 Erythema nodosum
EB61.0 Localized scleroderma
ED70.1 Female pattern hair loss
ED70.2Z Alopecia areata, unspecified
ED80.Z Acne, unspecified
EE60.1 Hypertrophic scar
EF60 Ischemic ulceration of the skin
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
EL50.0 Postoperative keloid scar
EL50.1 Postoperative hypertrophic scar
EM0Z Unspecified skin disorder
FA05 Polyosteoarthritis
FA20.0 Seropositive rheumatoid arthritis
FA92.0Z Ankylosing spondylitis, unspecified
FB40.Z Tenosynovitis, unspecified
ME60.2 Ulcerative skin lesion of unspecified nature
ME84.20 Lumbago with sciatica
ME84.3 Sciatica
ND56.0 Superficial injury of unspecified body region
ND56.3 Dislocation, sprain or strain of unspecified body region
NE11 Burn of unspecified body region
NF0A.3 Posttraumatic wound infection, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution, Concentrate

For external use. In the form of applications and irrigations (washings). The concentration of the solution and the solvent are determined depending on the area of application. The duration of treatment is 10-15 days.

Gel

For external use.

Adults and children over 12 years: the drug is applied in a thin layer to the affected area 1-2 times/day and rubbed in lightly. The duration of treatment is 10-14 days. Repeated courses are recommended to be conducted no less than 10 days apart.

Adverse Reactions

Possible: allergic reactions, pruritic dermatitis, contact dermatitis, erythema, dry skin, mild burning sensation, pruritic dermatitis.

Rarely: bronchospasm.

Contraindications

Hypersensitivity to dimethyl sulfoxide; severe hepatic and/or renal failure, angina pectoris, severe atherosclerosis, glaucoma, cataract, stroke, coma, myocardial infarction; pregnancy; breastfeeding period; children under 12 years of age.

Use in Pregnancy and Lactation

Dimethyl sulfoxide is contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe hepatic failure.

Use in Renal Impairment

Contraindicated in severe renal failure.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

Dimethyl sulfoxide should be used with caution simultaneously with other medicinal products, as it may enhance their effect.

Before using dimethyl sulfoxide, it is recommended to perform a test for drug tolerance.

Drug Interactions

Dimethyl sulfoxide can be used in combination with heparin, antibiotics, and NSAIDs in dosage forms for external use.

It increases the absorption and enhances the effect of ethanol and insulin.

It increases the sensitivity of microorganisms to aminoglycoside and beta-lactam antibiotics, chloramphenicol, rifampicin, griseofulvin.

It sensitizes the body to agents for general anesthesia.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Scan Biotech LLC (India)

Dosage Form

Bottle Rx Icon Dimexid® Concentrate for solution for external use: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for solution for external use in the form of a colorless transparent liquid or colorless crystals, odorless or with a weak specific odor; hygroscopic.

100 ml
Dimethyl sulfoxide 99 g

50 ml – amber glass bottles (1) – cardboard packs.
100 ml – amber glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Biopharmaks, LLC (Russia)

Manufactured By

AVZ S-P. LLC (Russia)

Or

Pharmamed, LLC (Russia)

Contact Information

PHARMAMED LLC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Gel for external use 25%: tube 30 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use colorless or with a yellowish tint, transparent, homogeneous, with a weak specific odor; the presence of air bubbles is allowed.

100 g
Dimethyl sulfoxide 25 g

Excipients: methylparahydroxybenzoate, propylparahydroxybenzoate, carbomer, sodium hydroxide solution 5%, purified water.

30 g – laminated tubes (1) – cardboard packs.
50 g – laminated tubes (1) – cardboard packs.

Marketing Authorization Holder

Begrif, LLC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for solution for external use in the form of a colorless transparent liquid or colorless crystals, odorless or with a weak characteristic odor, hygroscopic.

1 ml
Dimethyl sulfoxide 1 ml

50 ml – amber glass bottles (1) – cardboard packs.
100 ml – amber glass bottles (1) – cardboard packs.
50 ml – amber glass dropper bottles (1) – cardboard packs.
100 ml – amber glass dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

West, LLC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use 99%: 50 ml or 100 ml fl.

Dosage Form, Packaging, and Composition

Concentrate for solution for external use in the form of a colorless transparent hygroscopic liquid or colorless crystals, odorless or with a weak specific odor.

100 ml
Dimethyl sulfoxide 99 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (70) – cardboard boxes (for hospitals).
100 ml – dark glass bottles (50) – cardboard boxes (for hospitals).
5 kg – polyethylene canisters (for hospitals).

Marketing Authorization Holder

Khimreaktivkomplekt Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Dimexid® Concentrate for solution for external use: fl. 50 ml or 100 ml, drum 20 kg

Dosage Form, Packaging, and Composition

Concentrate for solution for external use 100 ml
Dimethyl sulfoxide 99 g

50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use 99%: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for solution for external use in the form of a colorless, transparent liquid or colorless crystals, odorless or with a weak specific odor; hygroscopic.

1 fl.
Dimethyl sulfoxide 99%

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Kemerovo Pharmaceutical Factory JSC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use 99%: fl. 50 ml or 100 ml, dropper fl. 100 ml

Dosage Form, Packaging, and Composition

Concentrate for solution for external use in the form of a colorless, transparent liquid or colorless crystals, odorless or with a weak specific odor; hygroscopic.

100 ml
Dimethyl sulfoxide 99 g

50 ml – glass bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
100 ml – dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for solution for external use in the form of a colorless transparent liquid or colorless crystals, odorless or with a weak characteristic odor, hygroscopic.

100 ml
Dimethyl sulfoxide 100 ml

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
50 ml – polyethylene terephthalate bottles (1) – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) – cardboard packs.

Marketing Authorization Holder

Lekar, LLC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Solution for external use 25%: fl. 100 g, 150 g, 200 g, 250 g, 300 g, or 500 g

Dosage Form, Packaging, and Composition

Solution for external use colorless, transparent, odorless or with a faint specific odor.

1 fl.
Dimethyl sulfoxide 100 g, 150 g, 200 g, 250 g, 300 g, 500 g

100 g – bottles – carton packs.
150 g – bottles – carton packs.
200 g – bottles – carton packs.
250 g – bottles – carton packs.
300 g – bottles – carton packs.
500 g – bottles – carton packs.

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Dimexid® Concentrate for solution for external use 99%: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use 99% 100 ml
Dimethyl sulfoxide 99 g

50 ml – dark glass bottles (1) – carton packs.
100 ml – bottles (1) – carton packs.

Marketing Authorization Holder

Murom Instrument-Making Plant, FSUE (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use 99%: fl. 100 ml

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use 99% 100 ml
Dimethyl sulfoxide 99 g

100 ml – dark glass bottles (1) – carton packs.

Marketing Authorization Holder

Redkinsky Pilot Plant, PJSC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use 99%: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use 99% 100 ml
Dimethyl sulfoxide 99 g

50 ml – dark glass bottles (1) – carton packs.
100 ml – dark glass bottles (1) – carton packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use 99%: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use 99% 100 ml
Dimethyl sulfoxide 99 g

50 ml – dark glass bottles (1) – carton packs.
100 ml – bottles (1) – carton packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle Rx Icon Dimexid® Concentrate for solution for external use 99%: 50 ml or 100 ml fl.

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use 100 ml
Dimethyl sulfoxide 99 g

50 ml – bottles (1) – carton packs.
100 ml – bottles (1) – carton packs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for preparation of solution for external use: 50 ml or 100 ml bottle.

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use in the form of a colorless, transparent liquid or colorless crystals, odorless or with a faint specific odor, hygroscopic.

100 ml
Dimethyl sulfoxide 100 ml

50 ml – bottles (1) – carton packs.
100 ml – bottles (1) – carton packs.
50 ml – bottles (20) – carton boxes (for hospitals).
50 ml – bottles (40) – carton boxes (for hospitals).
50 ml – bottles (50) – carton boxes (for hospitals).
50 ml – bottles (60) – carton boxes (for hospitals).
50 ml – bottles (80) – carton boxes (for hospitals).
50 ml – bottles (100) – carton boxes (for hospitals).
50 ml – bottles (120) – carton boxes (for hospitals).
100 ml – bottles (20) – carton boxes (for hospitals).
100 ml – bottles (40) – carton boxes (for hospitals).
100 ml – bottles (50) – carton boxes (for hospitals).
100 ml – bottles (60) – carton boxes (for hospitals).

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for solution for external use 99%: fl. 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use – a colorless transparent liquid or colorless crystals, odorless or with a faint specific odor; hygroscopic.

100 ml
Dimethyl sulfoxide 99 ml

50 ml – bottles (1) – carton packs.
100 ml – bottles (1) – carton packs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Concentrate for preparation of solution for external use: 50 ml or 100 ml bottle.

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use in the form of a colorless transparent hygroscopic liquid or colorless crystals, odorless or with a faint specific odor.

100 ml
Dimethyl sulfoxide 100 g

50 ml – glass bottles (1) – carton packs.
100 ml – glass bottles (1) – carton packs.
50 ml – glass bottles (1) (from 4 to 100 pcs) – group packaging (for hospitals).
100 ml – glass bottles (1) (from 4 to 100 pcs) – group packaging (for hospitals).
1 L – canisters for hospitals.
1 L – canisters (2) – group packaging (for hospitals).
1 L – canisters (3) – group packaging (for hospitals).
1 L – canisters (4) – group packaging (for hospitals).
1 L – canisters (5) – group packaging (for hospitals).
1 L – canisters (6) – group packaging (for hospitals).
1 L – canisters (7) – group packaging (for hospitals).
1 L – canisters (8) – group packaging (for hospitals).
1 L – canisters (9) – group packaging (for hospitals).
1 L – canisters (10) – group packaging (for hospitals).
1 L – canisters (11) – group packaging (for hospitals).
1 L – canisters (12) – group packaging (for hospitals).
3 L – canisters for hospitals.
3 L – canisters (2) – group packaging (for hospitals).
3 L – canisters (3) – group packaging (for hospitals).
3 L – canisters (4) – group packaging (for hospitals).
3 L – canisters (5) – group packaging (for hospitals).
3 L – canisters (6) – group packaging (for hospitals).
3 L – canisters (7) – group packaging (for hospitals).
3 L – canisters (8) – group packaging (for hospitals).
3 L – canisters (9) – group packaging (for hospitals).
3 L – canisters (10) – group packaging (for hospitals).
3 L – canisters (11) – group packaging (for hospitals).
3 L – canisters (12) – group packaging (for hospitals).
5 L – canisters for hospitals.
5 L – canisters (2) – group packaging (for hospitals).
5 L – canisters (3) – group packaging (for hospitals).
5 L – canisters (4) – group packaging (for hospitals).
5 L – canisters (5) – group packaging (for hospitals).
5 L – canisters (6) – group packaging (for hospitals).
5 L – canisters (7) – group packaging (for hospitals).
5 L – canisters (8) – group packaging (for hospitals).
5 L – canisters (9) – group packaging (for hospitals).
5 L – canisters (10) – group packaging (for hospitals).
5 L – canisters (11) – group packaging (for hospitals).
5 L – canisters (12) – group packaging (for hospitals).

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Dimexid® Renewal Concentrate for solution for external use

Dosage Form, Packaging, and Composition

Concentrate for solution for external use

1 fl.
Dimethyl sulfoxide 100%

100 ml – bottles – carton packs – Over-the-Counter
50 ml – bottles – carton packs – Over-the-Counter

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Dimexid®-Tphf Gel for external use 25%

Dosage Form, Packaging, and Composition

Gel for external use

100 g
Dimethyl sulfoxide 25 g

30 g – tubes – carton packs – Over-the-Counter
40 g – tubes – carton packs – Over-the-Counter
50 g – tubes – carton packs – Over-the-Counter

Table of Contents

TABLE OF CONTENTS