Instructions for Nimedar gel 10 mg/g tube 30 g
Composition
active ingredient: nimesulide;
1 g of gel contains nimesulide 10 mg;
excipients: dimethyl sulfoxide, propylene glycol, levomenthol, macrogol 400, carbomer 980, trometamol, purified water.
Dosage form
Gel.
Main physicochemical properties: yellow or yellow with a greenish tint, almost transparent gel, with a faint specific odor. It should be homogeneous in appearance.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs for topical use.
ATX code M02A A26.
Pharmacological properties
Pharmacodynamics
Nimedar is a nonsteroidal anti-inflammatory drug (NSAID), a selective inhibitor of cyclooxygenase-2. In terms of anti-inflammatory activity, nimesulide in equimolar concentration at the initial stage of inflammation is comparable to indomethacin and piroxicam. Inhibiting the synthesis of prostaglandins in the area of inflammation, nimesulide has practically no effect on the synthesis of regulatory prostaglandins in the stomach wall and kidneys. It suppresses the activity of platelet activation factor, tumor necrosis factor α, proteinases, histamine and the formation of free oxygen radicals. When applied externally, it causes a decrease or disappearance of pain in the area of application, including joint pain, at rest and during movement, reduces morning stiffness and swelling of the joints, and helps increase the volume of movements.
Pharmacokinetics
When Nimedar is applied to the skin, a gradual transdermal infusion of nimesulide into the subcutaneous tissue and synovial fluid of the joint is observed. The drug practically does not penetrate into the systemic bloodstream, which explains the absence of significant systemic effects.
Indication
Local treatment of pathological conditions of the musculoskeletal system characterized by pain, inflammation and stiffness of movements, such as osteoarthritis, periarthritis, post-traumatic tendonitis, tendosynovitis, muscle strains, heavy physical exertion on the joints.
Contraindication
Hypersensitivity to nimesulide or to other components of the drug.
Dermatitis and infectious skin diseases. Epidermal damage. Do not use in patients in whom acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis cause allergic reactions (rhinitis, urticaria or bronchospasm).
Interaction with other medicinal products and other types of interactions
When applied topically, the drug has not been found to interact with other drugs. However, it should be taken into account that if it enters the systemic circulation, nimesulide may enhance the effectiveness and toxicity of many drugs as a result of displacement from plasma protein binding sites and, thus, an increase in their free fraction in the blood. Based on this, the drug should be prescribed with caution simultaneously with anticoagulants, digoxin, phenytoin, lithium preparations, diuretics, antihypertensive drugs, other nonsteroidal anti-inflammatory drugs, cyclosporine, methotrexate, and oral hypoglycemic agents.
With simultaneous topical use of several NSAIDs, local irritation in the form of urticaria, redness of the skin, and peeling may develop.
Glucocorticoids and antirheumatic drugs (gold preparations, aminoquinolones) enhance the anti-inflammatory effect of Nimedar.
Application features
Physician supervision is required when prescribing the drug to elderly patients with impaired renal or hepatic function, or congestive heart failure. Patients with gastroduodenal bleeding, ulcers in the acute stage, or severe blood clotting disorders should use the drug under physician supervision.
Should not be used simultaneously with other topical medications.
It is recommended to apply the gel only to intact skin areas, avoiding contact with open wounds. Avoid contact with eyes and mucous membranes. Do not apply the gel under airtight dressings.
To reduce the risk of adverse reactions, the minimum effective dose should be used for the shortest possible duration of treatment. If the patient's condition does not improve, he should definitely consult a doctor.
Should not be used in patients with known hypersensitivity to NSAIDs. If hypersensitivity reactions develop, treatment should be discontinued.
During treatment with the drug, photosensitivity reactions may develop. To reduce the risk of photosensitivity, patients should avoid UV radiation and visiting a solarium.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The duration of the course of therapy is determined individually, depending on the effectiveness of the therapy, and is no more than 4 weeks.
Children
Do not use on children.
Overdose
When applying the gel to large areas of skin or when exceeding the recommended doses, systemic side effects typical of nimesulide and other nonsteroidal anti-inflammatory drugs are possible: dyspepsia, headache, dizziness, epigastric pain.
Treatment: Dose reduction or discontinuation of the drug, symptomatic therapy.
Adverse reactions
Local skin irritation of mild to moderate severity: erythema, rash, peeling, itching, allergic reactions. Rarely, anaphylactic reactions such as angioedema, vasomotor rhinitis, wheezing, bronchospasm have occurred in sensitive patients.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
30 g in a tube; 1 tube in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
