Description
Release form
solution for infusion pronounced analgesic, anti-inflammatory and antipyretic properties. Indirectly inhibiting types 1 and 2 cyclooxygenase, it violates the metabolism of arachidonic acid and the formation of pro-inflammatory prostaglandins in the focus of inflammation. Diclofenac is used to eliminate pain and inflammation in charters, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.
Pharmacokinetics: The amount of dclofenac absorbed through the skin is proportional to the area of ​​the treated surface and depends on the total dose of the drug applied and on the degree of skin hydration.
The concentration of diclofenac in plasma, synovial membrane and synovial fluid was measured when the drug was applied to the affected joint. Maximum plasma concentrations were approximately 100 times lower than after oral administration of the same amount of diclofenac. 99.7% of diclofenac binds to plasma proteins, mainly with albumin (99.4%). Diclofenac is predominantly distributed and retained deep in the tissues, susceptible to inflammation, such as joints, where its concentration is 20 times higher than in blood plasma.
Diclofenac metabolism is carried out in part by glucuronidation of an unchanged molecule, mainly by single and multiple hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted into glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac. The total systemic plasma clearance of diclofenac is 263 В± 56 ml / min. The final half-life is 1-2 hours. The half-life of metabolites, including two pharmacologically active ones, is also short and is 1-3 hours. One of the metabolites (3′-hydroxy-4′-methoxydiclofenac) has a longer half-life, however, this metabolite is completely inactive. Most diclofenac and its metabolites are excreted in the urine.
Indications
– back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica)
– pain in the joints (joints of the fingers, knees, etc.) with rheumatoid arthritis, osteoarthritis
– pain in the muscles (due to sprains, strains, bruises, injuries)
– inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues, wrist syndrome).
Contraindications
Hypersensitivity to diclofenac or other components of the drug, a tendency to occur asthma attacks, skin rashes or acute rhinitis with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs pregnancy (III trimester), maternal infancy (up to 12 years) skin in the intended place of application.
Precautions: Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe hepatic and renal dysfunctions, bleeding disorders (including hemophilia, prolonged bleeding time, tendency to bleedings), chronic heart failure, bronchial asthma, advanced age, pregnancy (I and II trimester )
Special instructions
Diclofenac-Teva should only be applied to intact skin, avoiding contact with m open wounds. Do not allow the drug to enter the mouth, eyes, or mucous membranes. After applying the drug, a bandage bandage is allowed, however, airtight occlusive dressings should not be applied. If skin rash develops after application of the drug, its use must be discontinued.
Impact on the ability to drive transp. Wed and fur.: The drug does not affect the ability to perform potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions (driving, working with moving mechanisms).
Dosage and administration
Applied externally.
For adults and children over 12 years of age, the drug is applied to the skin 2 times a day (every 12 hours: preferably in the morning and evening), rubbing slightly into the skin.
The required amount of the drug depends on the size of the painful area. A single dose of the drug – 2 to 4 g (which is comparable in volume to the size of cherries or walnuts, respectively) is sufficient to treat an area of 400-800 cm2. If the hands are not a localized area of pain, then after applying the drug they must be washed. The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days with post-traumatic inflammation and rheumatic diseases of the soft tissues without the recommendation of a doctor. If after 7 days of use the therapeutic effect is not observed or the condition worsens, you should consult the rook.
To remove the protective membrane, use a screw cap as a key (recess with protrusions on the outside of the cap). Align the recess on the outside of the cap with the curly protective membrane of the tube and rotate. The membrane should separate from the tube.
Side effects
The frequency of side effects is classified according to the recommendations of the World Health Organization: very often (> 1/10) often (> 1/100, but <1/10) infrequently (> 1/1000, but <1/100 ) rarely (> 1/10000, but <1/1000) very rarely (<1/10000), including individual messages, the frequency is unknown - the frequency cannot be estimated from the available data. Infectious and parasitic diseases: very rarely – pustular rashes. On the part of the immune system: very rarely – generalized skin rash, allergic reactions (urticaria, hypersensitivity, angioedema). From the respiratory system and organs of the chest and mediastinum: very rarely – asthma attacks, bronchospastic reactions. From the skin: often – erythema, dermatitis, including contact dermatitis (symptoms: eczema, itching, swelling of the treated area of ​​the skin, rash, papules, vesicles, peeling) rarely – bullous dermatitis is very rare – photosensitivity reactions. Overdose Due to the low systemic absorption during application of the gel, an overdose is unlikely. With random ingestion, the development of systemic adverse reactions is possible. Treatment of overdose with accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to blood plasma proteins (about 99%). Storage conditions At a temperature not exceeding 25 ° С. Keep out of the reach of children! Expiration 4 years. After opening the tube, the drug is suitable for use within 1 year. Do not use after the expiration date! Deystvuyuschee substances Diclofenac Terms and conditions Without a prescription Dosage form gel for external use
