Diclofenac-ACOS gel for external use 5%, 50g

Composition

Active ingredient: diclofenac sodium – 5.0 g.

Excipients: ethanol (96% alcohol), propylene glycol, hydroxyethylcellulose (hyethellose, natrosol), lavender oil, purified water.

Pharmacological action

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

ATX code: M 02 AA 15

Pharmacological properties

Pharmacodynamics The active ingredient 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, inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helps to reduce pain and swelling associated with the inflammatory process, and increase 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 gel 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 application method, the absorption is not more than 6%. Binding to plasma proteins is 99.7%. It is excreted by the kidneys. When applied to the affected joint area, the concentration in synovial fluid is higher than in plasma.

Indications

– post-traumatic inflammation of soft tissue, for example, due to a sprain, strain, bruises, and injuries;– rheumatism and swelling of the soft tissues (tenosynovitis, bursitis, the defeat of the periarticular tissues, wrist syndrome);– pain in the joints (joints of the fingers, knee, etc. ) in osteoarthritis;– back pain in inflammatory and degenerative diseases of the spine (osteoarthritis, sciatica, lumbago, sciatica). The drug 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. 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. There is no experience of using the drug during breastfeeding.

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. If you are pregnant or believe that you might be pregnant, or are planning to become pregnant, you should consult your doctor before using diclofenac.

Contraindications

– hypersensitivity to diclofenac or other components of the drug;– complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, intolerance to salicylates or other NSAIDs (including in the anamnesis);– pregnancy (III trimester);– the period of breastfeeding;– children’s age (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 (including peptic ulcer of the stomach and duodenum), severe liver and kidney function disorders, chronic heart failure, blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), bronchial asthma, old age, pregnancy I and II trimester.

Side effects

The frequency of adverse reactions is classified as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (Local reactions: infrequently-erythema multiforme (including Stevens-Johnson syndrome), eczema; rarely-bullous dermatitis; very rarely-contact dermatitis (pruritus, hyperemia, swelling of the treated skin area, pustular rash, papular-vesicular rashes, peeling).

When the gel is applied 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), asthma, photosensitization; very rarely – anaphylactic reactions (including shock). If any of these side effects get worse or you notice any other side effects that are not listed in the instructions, tell your doctor.

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 drug is applied in a thin layer to the skin in the focus of inflammation 2-3 times a day in a dose of 2 g (about 4 cm with the tube neck fully open) and lightly rubbed. A single dose of the drug is 2 g. The maximum daily dose of the drug should not exceed 6 g. After applying the drug, your hands should be washed. The course of treatment is no more than 14 days. The need for a longer application is determined by the doctor. Use in minimally effective doses in a minimally short course. Use diclofenac only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

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

Symptoms: nausea and vomiting.

Treatment: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Hemodialysis and forced diuresis are not effective due to the degree of binding of diclofenac to plasma proteins (about 99.7%).

Description

Homogeneous, colorless or yellowish transparent gel with a specific smell. Opalescence and air bubbles are allowed.

Special instructions

Apply only externally. The gel should only be applied to undamaged skin, avoiding contact with open wounds. After applying the gel, do not apply an occlusive dressing. When used in patients with peptic ulcer of the stomach and duodenum, impaired liver, kidney or hematopoietic system, as well as when using other NSAIDs at the same time, it is necessary to consult a doctor.

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 to large surfaces, systemic adverse reactions may develop due to resorptive action. Avoid contact with eyes, mucous membranes, or open wounds. The drug contains propylene glycol, which can cause local skin irritation. Treatment should be discontinued if a skin rash develops after application of the drug.

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

Form of production

Gel for external use 5%.30 g,50 g,100 g in aluminum tubes with screwed polymer bushons or in laminate tubes with screwed polymer bushons. Each tube with instructions for medical use is placed in a cardboard box.

Storage conditions

At a temperature of 15 to 25 °C. Freezing is not allowed. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Diclofenac

Dosage form

gel for external use