Diclofenac, 2% ointment 30 g

Phenylacetic acid derivative NSAID has anti-inflammatory and analgesic effects. By indiscriminately inhibiting COX 1 and COX 2, disrupts the metabolism of arachidonic acid, reduces the amount of Pg, including in the focus of inflammation.

Pharmacokinetics

In application systemic absorption is less than 6%. Protein binding is 99.7%. It is excreted by kidneys. When applied to the area of the affected joint the concentration in synovial fluid is higher than in plasma.

Indications

Inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis, rheumatic soft tissue lesions; gouty arthritis); trauma-induced inflammation of tendons, ligaments, muscles and joints (due to strains, stress and bruises).

Pain syndrome (lumbago, sciatica, neuralgia, myalgia, tendovaginitis, bursitis, rheumatic soft tissue lesions; degenerative diseases of the musculoskeletal system: deforming osteoarthritis, osteochondrosis).

Active ingredient

Composition

100 g of the ointment contains the active substance: diclofenac sodium – 2.0 g;

auxiliary substances: carbomer (arespol, polyacrylate sparsely crosslinked) – 1.0 g, sodium hydroxide – 0.37 g, benzyl benzoate (benzyl benzoate medical) – 6.0 g, polysorbate-80 (tween 80) – 1.0 g, methyl parahydroxy benzoate (nipagin) – 0.08 g, propyl parahydroxy benzoate (nipazol) – 0.02 g, purified water – to 100.0 g.

How to take, the dosage

Externally. The ointment – 2 to 4 g (1 g corresponds to about 2 cm of squeezed out strip of ointment) is applied in a thin layer, lightly rubbing into the skin, over the inflammation 2 – 3 times a day; after application, you should wash your hands, unless this area is subjected to treatment. The maximum daily dose is 8 g.

The course of treatment is 7 to 14 days.

The drug has an optimal combination of analgesic and anti-inflammatory effects and good tolerability. Therefore it can be used even for a long time if there are no contraindications.

The duration of the treatment depends on the indication and the effect noted (to increase the effect the drug can be used together with other diclofenac dosage forms with the approval of the physician).

Special Instructions

Apply only to intact areas of skin. No occlusive dressing should be applied after application.

Systemic side effects due to resorptive action may occur with prolonged use and/or application to large surfaces.

Contact of the product to eyes, mucous membranes or open wounds should be avoided.

Apply only topically.

The product does not affect driving and operating ability.

Synopsis

Contraindications

With caution

Hepatic porphyria (exacerbation), gastrointestinal erosive ulcers (in the phase of exacerbation), severe liver and renal function disorders, CHF; bronchial asthma, urticaria or acute rhinitis, triggered by taking ASA or other NSAIDs. NSAIDs; bleeding disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), elderly age, pregnancy (III trimester), breast-feeding period.

If you have any of the listed diseases or conditions, always consult your doctor before using the drug.

Side effects

Skin reactions: eczema, photosensitization, contact dermatitis (itching, hyperemia, swelling of the treated skin area, papular vesicular rash, peeling).

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

Overdose

Symptoms: Due to low systemic absorption during application of the ointment, overdose is unlikely. In case of accidental ingestion systemic adverse reactions are possible.

Treatment: gastric lavage, induction of vomiting, activated carbon, forced diuresis, symptomatic therapy. Dialysis is not effective due to high degree of binding to diclofenac proteins (about 99%).

Pregnancy use

Due to the lack of data on the use of the drug in pregnant women, the use of the drug during the I and II trimester of pregnancy is recommended only by prescription, comparing the benefit to the mother and the risk to the fetus.

The use of the drug is not recommended during breastfeeding. If use of the drug is still necessary, it should not be applied to the mammary glands or a large area of skin and should not be used for long periods of time.

Similarities