Diclofenac-Teva gel 1%, 40g

• Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica).

• Joint pain (finger joints, knee joints, etc.) osteoarthritis. Muscle pain (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).

• The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Outwardly.

To remove the protective membrane, use the screw cap as a key (groove on the outside of the cap). Align the indentation on the outside of the lid with the shaped protective membrane of the tube and twist. The membrane should separate from the tube.

Adults

The drug is applied in a thin layer to the painful area of ??the skin 3 times a day, lightly rubbing into the skin. The required amount of the drug depends on the size of the painful area. A single dose of the drug is 3 g (which in volume corresponds to the size of a cherry or walnut), sufficient to treat an area of ??400-800 cm2. The maximum daily dose is 9 g. If the hands are not a zone of localization of pain, then after applying the drug, they must be washed. Apply in the minimum effective doses for the shortest possible course. The course of treatment is no more than 14 days. The need for a longer use of the drug is determined by the doctor.

Children over 14 years old

The course of treatment is no more than 7 days. If, after 7 days of use, the therapeutic effect is not observed or the condition worsens, you should consult your doctor. The use of the drug in children under the age of 14 is not recommended.

100 g of the drug contain:

active substance: diclofenac sodium 1,000 g;

excipients: diisopropyl adipate 5,000 g; hyprolosis 2,000 g; lactic acid 90% 0.044 g; sodium disulfite 0.050 g; isopropanol 40,000 g; purified water 51.906 g.

• Hypersensitivity to diclofenac or other components of the drug, as well as to acetylsalicylic acid, other NSAIDs.

• The tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs.

• Pregnancy (III trimester).

• Children's age (up to 14 years old).

• Violation of the integrity of the skin at the intended site of application.

• Breastfeeding period.

  Carefully

• Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, bleeding disorders (including hemophilia, prolonged bleeding time, bleeding tendency), chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

Pharmacodynamics

The active ingredient diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties. By indiscriminately inhibiting cyclooxygenase of types 1 and 2, it disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins in the focus of inflammation. Diclofenac gel for external use is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.

Pharmokinetics

Suction.

The amount of diclofenac absorbed through the skin is proportional to the area of ??the treated surface and depends both on the total dose of the applied drug and on the degree of skin hydration. With the recommended method of application of the drug, no more than 6% of diclofenac is absorbed.

Distribution.

The concentration of diclofenac in plasma, synovial membrane and synovial fluid was measured when the drug was applied to the area of ??the affected joint. The maximum plasma concentrations were approximately 100 times lower than after oral administration of the same amount of diclofenac. The connection with plasma proteins is 99% (mainly with albumin). Diclofenac is predominantly distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in blood plasma. Biotransformation / Metabolism Diclofenac metabolism is carried out in part by glucuronidation of the unchanged molecule, but mainly through single and multiple hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates.Two phenolic metabolites are biologically active, but to a significantly lesser extent than diclofenac.

Excretion.

The total systemic plasma clearance of diclofenac is 263 ± 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 amounts to 1-3 hours. One of the metabolites (3'-hydroxy-4'-methoxydiclofenac) has a longer half-life, however, this metabolite is completely inactive. It is excreted by the kidneys (about 65%) and with bile (about 35%) in the form of inactive compounds with glucuronic acid.

Overdose

Due to the low systemic absorption of the active component of the drug when used externally, an overdose is unlikely. If used incorrectly or accidentally swallowed, it is possible to develop nausea, vomiting and systemic adverse reactions characteristic of NSAIDs. Symptoms: nausea, vomiting, epigastric pain, diarrhea. If you experience symptoms of an overdose, consult a doctor. If the drug is taken orally, in order to prevent the absorption of diclofenac as soon as possible, gastric lavage should be performed, followed by the use of activated charcoal, symptomatic therapy is indicated. Hemodialysis and forced diuresis for the elimination of diclofenac are not effective due to the high degree of binding of diclofenac to blood plasma proteins (about 99%).

Side effects

Infectious and parasitic diseases: very rarely - pustular eruptions. From the immune system: very rarely - generalized skin rash, allergic reactions (urticaria, hypersensitivity (including urticaria), angioedema). From the respiratory system: very rarely - bronchial asthma. On the part of the skin and subcutaneous tissue: often - erythema, dermatitis, (including contact dermatitis, itching, hyperemia, swelling of the treated skin area, papular vesicular rash, peeling); rarely, bullous dermatitis; very rarely - photosensitivity reactions. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Drug interactions

Diclofenac can increase the effect of drugs that cause photosensitization. No clinically significant interactions with other drugs have been described.