Diclofenac-Teva gel 1%, 100g

Composition

100 g of the drug contains: Active ingredient: diclofenac sodium 1,000 g; excipients: diisopropyladipinate 5,000 g; hyprolose 2,000 g; lactic acid 90% 0.044 g; sodium disulfite 0.050 g;isopropaiol 40,000 g; purified water 51,906 g.

Pharmacological action

Gel for external use, the active component of which is diclofenac-a non-steroidal anti-inflammatory drug with pronounced analgesic, anti-inflammatory and antipyretic properties. Indiscriminately inhibiting cyclooxygenase types 1 and 2, it disrupts 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 joints, 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 dpclofenac absorbed through the skin is proportional to the area of the treated surface and depends both on the total dose of the drug applied and on the degree of hydration of the skin. The concentration of diclofenac in plasma, synovial membrane and synovial fluid was measured when the drug was applied to the affected joint area. Maximum plasma concentrations were approximately 100 times lower than after oral use of the same amount of diclofenac. 99.7% of diclofenac binds to plasma proteins, mainly albumins (99.4%). Diclofenac is mainly distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in blood plasma. The metabolism of diclofenac is carried out partly by glucuronidation of the unchanged molecule, but mainly by 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 much lesser extent than diclofenac. 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 is 1-3 hours. One of the metabolites (3′-hydroxy-4′-methoxydiclofenac) has a longer half-life, however, this metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.

Indications

-back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);- joint pain (finger joints, knee joints, etc. ) in rheumatoid arthritis, osteoarthritis;- muscle pain (due to sprains, overexertion, 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 develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs; pregnancy (III trimester), breastfeeding; children (up to 12 years); violation of the integrity of the skin at the intended site of application. With caution: Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney function disorders, blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

Side effects

the Frequency of side effects is classified in accordance with the recommendations of the world health organization: very often (> 1/10); often (> 1/100, but < 1/10); infrequently (> 1/1000, but < 1/100); rare (> 1/10000, but < 1/1000); very rare (< 1/10000), including individual messages; frequency unknown – frequency cannot be estimated from the available data. Infectious and parasitic diseases: very rarely – pustular rashes. From the immune system: very rarely – generalized skin rash, allergic reactions (urticaria, hypersensitivity, angioedema). From the respiratory system, chest and mediastinal organs: very rarely – attacks of suffocation, bronchospastic reactions. From the skin: often-erythema, dermatitis, including contact dermatitis (symptoms: eczema, itching, swelling of the treated skin area, rash, papules, vesicles, peeling); rarely-bullous dermatitis; very rarely-photosensitization reactions.

Interaction

The drug may enhance the effect of drugs that cause photosensitization. No clinically significant interactions with other medicinal products have been described.

How to take, course of use and dosage

It is 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), 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 – 2-4 g (which is comparable in volume to the size of a cherry or walnut, respectively) is enough to treat an area of 400-800 cm 2. If the hands are not a zone of pain localization, 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 for post-traumatic inflammation and rheumatic soft tissue diseases without a doctor’s recommendation. If after 7 days of use the therapeutic effect is not observed or the condition worsens, you should contact the rook. To remove the protective membrane, use a screw-on cover as a key (a recess with protrusions on the outside of the cover). Align the recess on the outside of the lid with the shaped protective membrane of the tube and rotate. The membrane must separate from the tube.

Overdose

Due to the low systemic absorption when applying the gel, overdose is unlikely. If accidentally ingested, systemic adverse reactions may occur. Treatment of accidental oral overdose: 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 plasma proteins (about 99%).

Special instructions

Diclofenac-Teva should only be applied to undamaged skin, avoiding contact with open wounds. Do not allow the drug to enter the mouth, eyes and mucous membranes. After applying the drug, it is allowed to apply a bandage, but do not apply airtight occlusive dressings. If a skin rash develops after applying the drug, its use should be discontinued. Influence on the ability to drive vehicles and mechanisms: The drug does not affect the ability to perform potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (driving vehicles, working with moving mechanisms).

Form of production

Gel for external use 1%.100 g of the drug in an aluminum tube, tightened with aluminum foil to control the first opening, with a screw-on lid. 1 tube together with the instructions for use is placed in a cardboard box.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children!

Shelf

life is 4 years. After opening the tube, the drug is suitable for use for 1 year. Do not use after the expiration date!

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

For adults

Indications

Osteoarthritis, Arthritis, Lumbago, Sciatica, Tendon Inflammation, Osteoarthritis, Rheumatoid Arthritis, Swelling after injuries and Operations, Bursitis, Periarthritis, Gout