Instructions Dimethyl sulfoxide gel 250 mg/g tube 30 g
Composition
active ingredient: dimethyl sulfoxide;
1 g of gel contains 250 or 500 mg of dimethyl sulfoxide.
Excipients: sodium carmellose, mint flavoring, purified water.
Dosage form
Gel.
Main physicochemical properties: colorless to light yellow gel with a specific odor.
Pharmacotherapeutic group
Topical agents for joint and muscle pain. ATX code M02AX03.
Pharmacological properties
Pharmacodynamics.
Anti-inflammatory drug for external use, inactivates hydroxyl radicals, improves the course of metabolic processes in the focus of inflammation. Has an anesthetic and analgesic effect. Has moderate antiseptic and fibrinolytic effects. When applied topically, it quickly and well penetrates biological membranes. It also performs a transport function, ensuring deep penetration of other drugs through the skin.
Pharmacokinetics.
After application to the skin and mucous membranes, it is rapidly and almost completely absorbed. Bioavailability is 60–70%, and the degree of bioavailability and depth of penetration are directly proportional to the concentration of dimethyl sulfoxide. When applied locally to the skin, it is detected in the blood serum already 10 minutes after application, the peak concentration is observed after 4–8 hours. It penetrates well into the cells of the tissues of all organs, except hair, nails and tooth enamel. It is metabolized by oxidation to methylsulfonylmethane, with subsequent reduction to dimethyl sulfide. Dimethyl sulfoxide and its metabolites are excreted in the urine and feces. Dimethyl sulfide can also be excreted through the skin and lungs, which is accompanied by a specific garlic odor. Cumulation of dimethyl sulfoxide and its metabolites in the body with prolonged use of the drug does not occur.
Indication
Use to relieve pain in the complex therapy of the following diseases and conditions:
· rheumatoid arthritis;
· deforming osteoarthritis;
· arthropathy;
· killing;
· ligament damage;
· traumatic infiltrates.
Contraindication
Hypersensitivity to dimethyl sulfoxide and other components of the drug, severe hepatic and/or renal failure, cardiovascular failure, angina pectoris, severe atherosclerosis, glaucoma, cataracts, myocardial infarction, stroke, coma, pregnancy, breastfeeding, age up to 12 years.
Interaction with other medicinal products and other types of interactions
Dimethyl sulfoxide enhances the effect of ethanol (alcohol inhibits the excretion of the drug) and insulin, acetylsalicylic acid, butadione; digitalis, quinidine, nitroglycerin drugs. Increases the level of absorption and enhances the effects of other local drugs applied simultaneously. Compatible with heparin, antibacterial drugs, nonsteroidal anti-inflammatory drugs. The drug DIMETHYL SULFOXIDE cannot be used with sulindac (nonsteroidal anti-inflammatory drug) due to the possibility of severe toxic reactions (peripheral neuropathy). Increases the sensitivity of microorganisms to aminoglycosides and beta-lactam antibiotics, chloramphenicol, rifampicin, griseofulvin. Sensitizes the body to the effects of drugs for general and local anesthesia.
Application features
Given the possibility of individual intolerance to the drug, it is recommended to conduct a drug test for tolerance. To do this, the gel is applied to a small area of skin on the back of the wrist. The appearance of sharp hyperemia and itching indicates hypersensitivity to the drug.
If a patient is hypersensitive, medications containing dimethyl sulfoxide should not be prescribed. If allergic reactions occur during treatment, the drug is discontinued.
Do not apply to damaged skin or skin with allergic manifestations. Do not apply to facial skin.
Avoid contact with mucous membranes and eyes. In case of accidental contact, rinse immediately with water.
It is prescribed with caution to patients with a severe allergic history, as well as to people suffering from ischemic heart disease.
Due to the fact that dimethyl sulfoxide can enhance not only the activity, but also the toxicity of some drugs, it should be prescribed with caution simultaneously with other topical agents.
Use during pregnancy or breastfeeding
Contraindicated during pregnancy or breastfeeding. Breastfeeding should be discontinued during treatment with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
It should be used with caution, taking into account the effects on the central nervous system, in particular the possibility of dizziness.
Method of administration and doses
The drug is for external use. Adults and children over 12 years of age apply a thin layer of gel to the affected area 1–2 times a day and rub in gently. For use on sensitive areas, use a gel with a dimethyl sulfoxide concentration of 250 mg/g. Duration of treatment is 10–14 days. Repeated courses can be carried out no earlier than after 10 days.
Children.
Do not use in children under 12 years of age.
Overdose
Overdose of the drug may cause increased side effects. In this case, it is necessary to stop using the drug, wash the treated area of skin. Treatment is symptomatic.
Adverse reactions
Dimethyl sulfoxide is usually well tolerated, but some patients may experience:
On the part of the immune system: allergic reactions, including dermatitis, skin rash, angioedema, increased skin pigmentation, itching, burning, skin hyperemia, erythema, dry skin.
Gastrointestinal: temporary garlic odor from the mouth (due to the action of dimethyl sulfide, a metabolite of dimethyl sulfoxide), nausea, vomiting, diarrhea.
From the side of the central and peripheral nervous system: headache, dizziness, insomnia, adynamia.
Respiratory system: bronchospasm.
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua
Expiration date
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 the reach of children.
Packaging
15 g or 30 g in a tube; 1 tube in a cardboard pack.
Vacation category
Without a prescription.
Producer
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Location of the manufacturer and address of its place of business.
21027, Ukraine, Vinnytsia, 600-anniversary St., 25.
