Diclofenac, gel 1%, 40g

Composition

>of 1 g of gel contains the Active ingredient Diclofenac diethylamine 11.60 mg (respectively diclofenac sodium 10 mg); Excipients: Isopropanol Carbomer 940 Polysorbate 80 Benzyl Alcohol Sodium disulfite Sorbitoltrolamine Purified water

Pharmacological action

A nonsteroidal anti-inflammatory drug derived from phenylacetic acid, it has an anti-inflammatory and analgesic effect. Selectively inhibiting cyclooxygenase 1 (COX 1) and cyclooxygenase 2 (COX 2), it affects the metabolism of arachidonic acid, reduces the amount of prostaglandins (Pg) in the inflammatory focus. Pharmacokinetics: When applied topically, it is partially absorbed through the skin, with a bioavailability of 6%. Binding to plasma proteins is 99.7%. It is excreted by the kidneys. In patients with polyarthritis who receive local therapy (in the area of an inflamed joint), the concentration in synovial fluid and tissue is higher than the concentration in plasma.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis; rheumatic soft tissue lesions; gouty arthritis); traumatic inflammation of tendons, ligaments, muscles and joints (as a result of sprains, stress and bruises).

Contraindications

Hypersensitivity to diclofenac or other components of the drug, acetylsalicylic acid or other NSAIDs. Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (in the anamnesis). Pregnancy (third trimester), lactation period, children’s age (up to 12 years), violation of the integrity of the skin. With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), severe liver and kidney function disorders, chronic heart failure, blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed); bronchial asthma, elderly age, pregnancy I and II trimester.

Side effects

From the side of the skin:  

eczema, photosensitivity, contact dermatitis (itching, hyperemia, swelling of the treated skin area, papular-vesicular rashes, peeling).

Allergic reactions

(itching and burning of the skin, erythematous skin rash, urticaria, angioedema, systemic anaphylactic reactions (including shock).

Interaction

Concomitant use of Diclofenac with digoxin, phenytoin or lithium preparations may increase the plasma concentrations of these drugs; with diuretics and antihypertensive

agents, the effect of these drugs may decrease; with potassium-sparing diuretics, hyperkalemia may develop; with acetysalicylic acid, a decrease in the concentration of diclofenac in blood plasma and an increased risk of side effects.

Diclofenac may increase the toxic effect of cyclosporine on the kidneys.

Diclofenac can cause hypo – or hyperglycemia, so when used concomitantly with hypoglycemic agents, monitoring of blood glucose concentration is required.

When using methotrexate for 24 hours before or after taking Diclofenac, it is possible to increase the concentration of methotrexate and increase its toxic effect.

When used concomitantly with anticoagulants, regular monitoring of blood clotting parameters is necessary.

How to take, course of use and dosage

Externally.

For adults and children over 12 years of age, the drug is applied in a thin layer over the focus of inflammation 3-4 times a day and lightly rubbed.

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 large cherry).

After applying the drug, wash your hands.

The duration of treatment depends on the indications and therapeutic effect.

After 2 weeks of using the drug, you should consult your doctor.

Special instructions

The gel is applied only to undamaged areas of the skin. After applying, do not apply an occlusive dressing. When applied to large areas of the skin for a long time, the risk of developing systemic side effects increases. Avoid contact with eyes, mucous membranes, or open wounds. Use only as an external remedy.

Form of production

Gel for external use 1%.

40 g of gel in an aluminum tube, capped with a screw cap made of plastic.

The tube opening is protected by an aluminum membrane.

The lid is a monolithic structure that includes a device for piercing the membrane.

The tube together with the instructions for use is placed in a cardboard pack.

Storage conditions

At a temperature of 15 to 25°C. Keep out of reach of children!

Shelf

life is 3 years.

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

Children over 6 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, For adults

Indications

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