DIMEXID-LUBNIFARM

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIMEXIDE-LUBNYPHARM

Composition:

Active substance: dimethyl sulfoxide;

1 g of gel contains dimethyl sulfoxide – 500 mg;

Excipients: carbomer, triethanolamine, levomenthol, purified water.

Pharmaceutical form. Topical gel.

Main physicochemical properties: colorless or yellowish gel with a characteristic odor. Opalescence and presence of air bubbles are permissible.

Pharmacotherapeutic group. Topical agents for joint and muscle pain. ATC code M02AX03.

Pharmacological Properties.

Pharmacodynamics.

An anti-inflammatory medicinal product for topical use, inactivates hydroxyl radicals, improves the course of metabolic processes at the site of inflammation. Exerts local anesthetic, analgesic, and antimicrobial effects; has moderate fibrinolytic activity. Penetrates through the skin, mucous membranes, microbial cell membranes (increasing their sensitivity to antibiotics), and other biological membranes, enhancing their permeability for medicinal agents.

Pharmacokinetics.

After application of the medicinal product, dimethyl sulfoxide is detected in blood serum within 8–15 minutes, with maximum concentrations observed within 2–8 hours. Typically, dimethyl sulfoxide is no longer detectable in blood serum after 30–36 hours.

Dimethyl sulfoxide does not accumulate. When applied topically, dimethyl sulfoxide penetrates into the joint cavity and becomes bound to proteins in blood and tissues.

Dimethyl sulfoxide is excreted from the body via the kidneys in unchanged form and as oxidation metabolites—dimethyl sulfone and dimethyl sulfate; additionally, it is excreted in the expired air as a reduction product (dimethyl sulfide).

Clinical characteristics.

Indications.

To be used as part of combination therapy for rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (in the presence of periarticular tissue involvement); in arthropathy, tendon strain due to trauma, traumatic infiltrates, acute and chronic osteomyelitis, streptoderma, purulent wounds, and abscesses.

Contraindications.

Hypersensitivity to dimethyl sulfoxide or other components of the medicinal product. Cardiovascular insufficiency, severe atherosclerosis, angina pectoris, renal or hepatic dysfunction, stroke, myocardial infarction, comatose states, glaucoma, cataract.

Concomitant use with medicinal products containing sulindac.

Pregnancy, breastfeeding period, children under 12 years of age.

Interaction with other medicinal products and other forms of interaction.

The medicinal product increases absorption and enhances the effects of ethanol (alcohol inhibits drug elimination), insulin (during prolonged use of the medicinal product, plasma glucose levels should be monitored), acetylsalicylic acid, phenylbutazone; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin), chloramphenicol, rifampicin, griseofulvin, and increases organism sensitivity to anesthetics. Enhanced specific activity and toxicity of medicinal products due to dimethyl sulfoxide should be taken into account.

Dimexid-Lubnifarm must not be used concomitantly with sulindac (nonsteroidal anti-inflammatory drug) due to the risk of severe toxic reactions (peripheral neuropathy).

Compatible with heparin, antibacterial agents, and nonsteroidal anti-inflammatory drugs.

In case of taking any other medicinal products, it is mandatory to consult a physician regarding the possibility of using the medicinal product Dimexid-Lubnifarm.

Special precautions for use

Do not apply to damaged skin or skin with signs of allergy. Do not apply to facial skin. Some patients may experience a garlic-like odor in exhaled air during treatment.

Due to the possibility of individual intolerance, a tolerance test should be performed before application. For this purpose, apply a thin layer of the gel to the skin of the elbow crease; the appearance of hyperemia and pronounced itching indicates hypersensitivity.

If allergic reactions occur during treatment, discontinue use of the medicinal product and administer H1-histamine receptor blockers.

Elderly patients may use the product after prior consultation with a physician.

Avoid contact of the gel with mucous membranes and eyes. In case of accidental contact with eyes, immediately rinse thoroughly with running water.

Application of dimethyl sulfoxide may cause photosensitization. Therefore, exposure to sunbathing and solarium use should be avoided during treatment with Dimexid-Lubnifarm gel.

Use during pregnancy or breastfeeding

There have been reports of potential teratogenic effects of dimethyl sulfoxide in animals.

There is currently insufficient experience with the use of dimethyl sulfoxide in pregnant women; therefore, the use of the medicinal product Dimexid-Lubnifarm during pregnancy is contraindicated.

Dimethyl sulfoxide penetrates into breast milk; therefore, the use of the medicinal product Dimexid-Lubnifarm during breastfeeding is contraindicated.

Ability to influence reaction rate when driving or operating machinery

The medicinal product should be used with caution due to its potential effects on the central nervous system, particularly considering the possibility of dizziness.

Dosage and Administration.

Apply the gel as a thin layer to the affected area, gently rubbing it in, 1–2 times daily. Treatment duration is 10–14 days. A repeat course is recommended no sooner than after 10 days.

Children.

Not recommended for children under 12 years of age.

Overdose.

Symptoms: allergic reactions (urticaria, swelling) and increased incidence of adverse drug reactions may occur, requiring discontinuation of the drug.

Treatment: symptomatic.

Side effects.

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

Immune system disorders: allergic reactions, including dermatitis, skin rash, angioedema, itching, burning, skin hyperemia, erythema, dryness of the skin.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

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

Respiratory system disorders: bronchospasm.

Skin disorders: photosensitivity reactions.

Reporting of adverse reactions following marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

40 g in tubes; 1 tube per cardboard box.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

JSC «Lubnipharm».

Manufacturer's address and location of its business operations.

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