Diclofenac-ACOS, gel 5% 50 g

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).

ATX code: M02AA15

Pharmacological properties

Pharmacodynamics
. The active ingredient diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are a major link in the development of inflammation. Diclofenac is used to eliminate pain syndrome, inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helps reduce pain and swelling associated with inflammation, increase joint mobility.

Pharmacokinetics
When 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 where it is applied, depending on the total dose of the drug and the degree of hydration of the skin. With the recommended method of application absorption is not more than 6%. Binding with blood plasma proteins is 99.7 %. It is excreted by the kidneys. When applied to the area of the affected joint the concentration in synovial fluid is higher than in plasma.

Indications

Post-traumatic inflammation of soft tissues, e.g. due to sprains, overstrain, contusions, injuries;
– rheumatic diseases and soft tissue swelling (tendovaginitis, bursitis, periarticular tissue lesions, wrist syndrome);
– joint pain (finger joints, knee joints, etc.) osteoarthritis.The preparation is aimed to be used for symptomatic therapy, pain and inflammation decrease at the moment of the usage. It has no influence on the disease progression.

Active ingredient

Composition

Active ingredient: diclofenac sodium – 5.0 g.

Auxiliary substances: ethanol (96 % alcohol), propylene glycol, hydroxyethylcellulose (hypotellose, sodium nitrosol), lavender oil, purified water.

How to take, the dosage

Outwards.
Adults and children over 12 years old apply the preparation with thin layer on the skin in the center of inflammation 2-3 times a day in the dose of 2 g (about 4 cm when the tube is completely open) and gently rub it in.
The single dose is 2 g.
The maximum daily dose should not exceed 6 g.
After the drug application the hands should be washed.
The course of treatment should not exceed 14 days. The necessity of longer application is determined by the doctor.
Use in minimal effective doses with minimal short course.
Diclofenac should be used only according to the indications, method of application and in such doses as specified in the instruction.

Interaction

Special Instructions

Use only externally. The gel should be applied only to intact skin, avoiding contact with open wounds.
Patients with gastric and duodenal ulcer disease, liver, kidney or hematopoietic system disorders, as well as patients with concomitant use of other NSAIDs should consult a physician when using the gel.

When using the drug together with other diclofenac dosage forms, the maximum daily dose should be considered.

In case of prolonged use and/or application to large surfaces development of systemic adverse reactions due to the resorptive action is possible.
Avoid contact of the drug with eyes, mucous membranes or open wounds.
The drug contains propylene glycol which may cause local skin irritation. Treatment should be discontinued if a skin rash develops after application of the drug.

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

Synopsis

Contraindications

– hypersensitivity to diclofenac or other components of the drug;
– complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, intolerance to salicylates or other NSAIDs (including anamnesis);
– pregnancy (III trimester);
– period of breastfeeding;
– childhood (under 12 years);
– violation of the integrity of the skin at the intended place of application.

With caution

Hepatic porphyria (exacerbation), gastrointestinal erosive and ulcerative lesions (including gastric and duodenal ulcers), severe liver and renal function disorders, chronic heart failure, blood clotting disorders (including hemophilia, prolonged bleeding time, tendency to bleed), bronchial asthma, advanced age, pregnancy I and II trimester.

Side effects

The incidence of adverse reactions is classified as follows: very common (≥1/10), common (≥1/100 to < 1/10), infrequent (≥1/1000 to < 1/100), rare (≥1/10000 to < 1/1000), very rare (< 1/10000), including individual reports.
Local reactions: infrequent – erythema multiforme (including Stevens-Johnson syndrome), eczema; rare – bullous dermatitis; very rare – contact dermatitis (itching, hyperemia, swelling of the treated skin area, pustular rash, papulose-vesicular rash, peeling).

If the gel is applied to large surfaces of the skin, over a long period of time, systemic side effects of diclofenac may develop.

Systemic reactions: rare – generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions), asthma, photosensitization; very rare – anaphylactic reactions (including shock).
If any of the above side effects worsen or if you notice any other, not specified in the instructions, inform your doctor.

Overdose

Because of the low systemic absorption by application of the gel, overdose is unlikely.
In case of accidental ingestion, systemic adverse reactions are possible.

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 blood plasma protein binding of diclofenac (about 99.7%).

Pregnancy use

Use in I and II trimesters is possible only after consultation with a physician if the expected benefits to the mother exceed the potential risk to the fetus.
There is no experience of using the drug during breast-feeding.

In the absence of data on penetration of the drug into the breast milk, it is not recommended to use the drug during breastfeeding. If use of the drug is still necessary, it should not be applied to the mammary glands or to a large area of skin and should not be used for prolonged periods.
If you are pregnant or anticipate that you might be pregnant or are planning a pregnancy, you should consult your doctor before using diclofenac.

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