Diclofenac-Teva gel 1%, 40g

Composition

100 g of gel contains:

• Active ingredient:
• diclofenac diethylamine 1.16 g, which corresponds to diclofenac sodium 1.00 g.
• Auxiliary substances:
• Isopropyl alcohol,
• carbopol 940,
• polysorbate 80,
• gasoline alcohol,
• sodium metabisulfite,
• 70% non-crystallizing sorbitol,
• triethanolamine,
• purified water.

Pharmacological action

of NSAIDs, a derivative of phenylacetic acid. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of arachidonic acid metabolism, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever.

The analgesic effect is caused by two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous systems).

Inhibits the synthesis of proteoglycan in cartilage.

In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase the volume of movement. Reduces post-traumatic and post-operative pain, as well as inflammatory edema.

Inhibits platelet aggregation. With prolonged use, it has a desensitizing effect.

When applied topically in ophthalmology, it reduces swelling and pain in inflammatory processes of non-infectious etiology.

Clinical pharmacology

Inhibiting cyclooxygenase 1 and 2, it affects the metabolism of arachidonic acid, reducing the amount of prostaglandins in the focus of inflammation.

The water-alcohol base additionally has a local anesthetic effect.

Indications

Joint syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, periarthropathies), post-traumatic inflammation of the soft tissues and musculoskeletal system (sprains, bruises). Pain in the spine, neuralgia, myalgia, arthralgia, pain and inflammation after operations and injuries, pain in gout, migraine, algodismenorrhea, pain in adnexitis, proctitis, colic (biliary and renal), pain in infectious and inflammatory diseases of ENT organs.

For topical application: inhibition of miosis during cataract surgery, prevention of cystoid macular edema associated with lens removal and implantation, non-infectious eye inflammation, post-traumatic inflammatory process in penetrating and non-penetrating eyeball wounds.

Contraindications

• Hypersensitivity.
  • Including other nonsteroidal anti-inflammatory drugs.
• Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase).
• “Aspirin” asthma.
• “Aspirin” triad (a combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid and pyrazolone drugs).
• Violation of hematopoiesis.
• Pregnancy (I and III trimesters).
• Children’s age (up to 6 years).
• Lactation period.
• Violation of the integrity of the skin.

Use the drug with caution when: :

• Induced acute hepatic porphyria.
• Severe liver and kidney function disorders.
• Heart failure.
• Pregnancy.

Side effects

• Itching.
• Hyperemia of the skin.
• A rash.
• Burning sensation.

With prolonged use and/or application on large surfaces – systemic side effects due to resorptive action:

• Generalized skin rash.
• Bronchospasm.
• Angioedema.
• Photosensitization.

Interaction

Concomitant use of antihypertensive drugs with diclofenac may weaken their effect.

There have been isolated reports of seizures in patients taking concomitant NSAIDs and quinolone-type antibacterial drugs.

When used concomitantly with corticosteroids, the risk of side effects from the digestive system increases.

Concomitant use of diuretics may reduce the diuretic effect. When used concomitantly with potassium-sparing diuretics, it is possible to increase the concentration of potassium in the blood.

Concomitant use with other NSAIDs may increase the risk of side effects.

Hypoglycaemia or hyperglycaemia have been reported in diabetic patients treated with diclofenac concomitantly with hypoglycaemic drugs.

When used concomitantly with acetylsalicylic acid, it is possible to reduce the concentration of diclofenac in blood plasma.

Although clinical studies have not established the effect of diclofenac on the action of anticoagulants, isolated cases of bleeding with simultaneous use of diclofenac and warfarin have been described.

With simultaneous use, it is possible to increase the concentration of digoxin, lithium and phenytoin in blood plasma.

Absorption of diclofenac from the gastrointestinal tract decreases with simultaneous use with colestyramine, to a lesser extent-with colestipol.

With simultaneous use, it is possible to increase the concentration of methotrexate in blood plasma and increase its toxicity.

Concomitant use of diclofenac may not affect the bioavailability of morphine, but the concentration of the active morphine metabolite may remain elevated in the presence of diclofenac, which increases the risk of side effects of the morphine metabolite, including respiratory depression.

When used concomitantly with pentazocin, a case of a large convulsive seizure has been described; with rifampicin, the concentration of diclofenac in blood plasma may decrease; with ceftriaxone, the excretion of ceftriaxone with bile increases; with cyclosporine, the nephrotoxicity of cyclosporine may increase.

How to take, course of use and dosage

Externally.

2-4 g of the drug (4-8 cm of gel displaced from the tube), depending on the area of the painful focus, is applied 3-4 times a day to the affected areas and gently rubbed (it can be used to enhance the effect together with other dosage forms of diclofenac).

Wash your hands after application.

Special instructions

With extreme caution, it is used for diseases of the liver, kidneys, gastrointestinal tract in the anamnesis, dyspeptic phenomena, bronchial asthma, arterial hypertension, heart failure, immediately after serious surgical interventions, as well as in elderly patients.

If a history of allergic reactions to NSAIDs and sulfites is indicated, diclofenac is used only in urgent cases. In the course of treatment, systematic monitoring of liver and kidney function, peripheral blood picture is necessary.

Rectal use is not recommended in patients with a history of anorectal diseases or anorectal bleeding. Externally, it should be applied only on undamaged areas of the skin.

Avoid contact with diclofenac in the eyes (with the exception of eye drops) or on the mucous membranes. Patients using contact lenses should apply eye drops no earlier than 5 minutes after removing the lenses.

It is not recommended for use in children under 6 years of age.

During the period of treatment with dosage forms for systemic use, alcohol consumption is not recommended.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, the rate of psychomotor reactions may decrease. If visual clarity is impaired after applying eye drops, do not drive a car or engage in other potentially dangerous activities.

Storage conditions

 In a dry place, protected from light, at a temperature not exceeding +25 ° C, in places inaccessible to children.

Shelf life

3 years

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

Pregnant women in the first and second trimester as prescribed by a doctor, Children over 12 years of age, For adults

Indications

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