Diclofenac-ACOS ointment for external use 1%, 30g

Composition

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of 100 g of ointment contains: Active ingredient: diclofenac sodium-1,0 g; Excipients: Dimethyl sulfoxide (dimexide), macrogol 400 (polyethylene glycol 400), macrogol 4000 (polyethylene glycol 4000), propylene glycol, methyl parahydroxybenzoate (methylparaben, nipagin), propyl parahydroxybenzoate (propylparaben, nipazole).

Pharmacological action

Pharmacotherapy group: nonsteroidal anti-inflammatory drug (NSAID).

ATX code: MO 2 AA 15

Pharmacological properties

Pharmacodynamics The active component of diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase 1 and 2 types, it disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development 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.

PharmacokineticsWhen applied externally, diclofenac penetrates well through the skin, mainly concentrating in the focus of inflammation and synovial fluid. The amount of diclofenac that is absorbed through the skin is proportional to the time of contact of the ointment with the skin and the area of its application, depends on the total dose of the drug and on the degree of hydration of the skin. With the recommended method of application of the drug, no more than 6% of diclofenac is absorbed. The use of an occlusive dressing for 10 hours leads to a 3-fold increase in the resorption of diclofenac.

Indications

-back pain in inflammatory and degenerative diseases of the spine (osteoarthritis, sciatica, lumbago, sciatica);- joint pain (finger joints, knee joints, etc. ) in osteoarthritis;- muscle pain; – inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases;- pain and swelling associated with diseases of the muscles and joints (lumbago, sciatica, neuralgia, myalgia, tendinitis);- degenerative diseases of the musculoskeletal system (deforming osteoarthritis, osteochondrosis). It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Use during pregnancy and lactation

The drug should not be used in the third trimester of pregnancy. Due to the lack of data on the penetration of the drug into breast milk, it is not recommended to use it during breastfeeding. If you still need to use the drug, then do not apply it to the mammary glands or on a large surface of the skin and do not use it for a long time. Use in the first and second trimesters is possible only after consultation with a doctor, if the expected benefit to the mother exceeds the potential risk to the fetus.

Contraindications

Hypersensitivity to diclofenac. Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis). Pregnancy (third trimester), breast-feeding period, children’s age (up to 12 years). Violation of the integrity of the skin in the intended place of application.

With caution

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney function disorders, chronic heart failure, blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), old age, pregnancy of the first and second trimester.

Side effects

The frequency of side effects is classified according to the World Health Organization guidelines: very common – ≥1/10; common – ≥1/100 to <1/10; uncommon – ≥1/1000 to <1/100; rare – ≥1/10000 to <1/1000; very rare (including isolated reports) –

Local reactions: infrequently-erythema multiforme (including Stevens-Johnson syndrome), eczema, very rarely contact dermatitis (pruritus, hyperemia, swelling of the treated skin area, papular-vesicular rashes, peeling). When applying the ointment to large areas of the skin, for a long period of time, it is possible to develop systemic side effects of diclofenac.

Systemic reactions: rarely-generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions), rarely-photosensitization, very rarely-anaphylactic reactions (including shock).

Interaction

It is not recommended to use the drug with other NSAIDs. Diclofenac may increase 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

Externally. For adults and children over 12 years of age, the ointment is applied to the skin 2 times a day (every 12 hours, preferably in the morning and evening), in a dose of 2-4 g. Apply a thin layer on the skin above the focus of inflammation and rub lightly. The maximum daily dose of the ointment should not exceed 8 g. The course of treatment should not exceed 14 days. If there is no effect from the use of the drug after 7 days, you should consult a doctor. If the hands are not the area of pain localization, then after applying the ointment, they must be washed. Use in minimally effective doses in a minimally short course.

Overdose

Due to the low systemic absorption when applying the ointment, overdose is unlikely. If accidentally ingested, systemic adverse reactions may occur.

Symptoms: nausea and vomiting.

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

Description

The ointment is white or almost white in color, with a faint specific smell.

Special instructions

Apply only externally. The ointment can only be applied to undamaged areas of the skin. After applying the ointment, do not apply an occlusive dressing. Patients with peptic ulcer of the stomach and duodenum, impaired liver, kidney or hematopoietic system, as well as with the simultaneous use of other NSAIDs should consult a doctor before using. When using the drug together with other dosage forms of diclofenac, the maximum daily dose should be taken into account.

With prolonged use and/or application on large surfaces, systemic side effects may develop due to resorptive action. Avoid contact with eyes, mucous membranes, or open wounds.

Influence on the ability to drive vehicles and mechanismsThe drug does not affect the ability to drive vehicles and other mechanisms.

Form of production

Ointment for external use 1%.30 g each in aluminum tubes. Each tube with instructions for use is placed in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 ° C. Freezing is not allowed. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Diclofenac

Dosage form

ointment