Diclofenac-Akrihin - instructions for use, dose, side effects, contraindications

active substance: diclofenac sodium in terms of 100% substance - 1 g; auxiliary substances: ethanol (rectified ethyl alcohol) - 25 g, propylene glycol - 5 g, carbomer 940 (carbopol 980) - 0.9 g, diethanolamine - 1 g, paraffin liquid (vaseline oil) 2.5 g, cocoa gel prilaprat 2.5 g macrogol cetostearate macrogol 20 cetostearyl ether 2 g, lavender oil 0.05 g, orange flower oil (neroli oil) 0.05 g, purified water up to 100 g.

Description:Gel from white to white with a yellowish or grayish hue of color, with a specific smell.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Nonsteroidal anti-inflammatory drug (NSAID), has a pronounced analgesic and anti-inflammatory effect. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

With rheumatic diseases reduces swelling, flushing and pain in rest and motion, morning stiffness and swelling of the joints, improving their functional capacity. With postoperative and traumatic injuries quickly suppresses pain and inflammation in the area of application, promotes resorption of post-traumatic hematoma. Water-ethanol base additionally has a local anesthetic effect.

Pharmacokinetics:

With external application diclofenac well penetrates through the skin, mainly concentrating in the focus of inflammation and synovial fluid. The amount of diclofenac that is absorbed through the skin, in proportion to the time of contact of the gel with the skin and the area of application, depends on the total dose of the drug and on the degree of hydration of the skin. With the recommended method of applying 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. The binding with plasma proteins (mainly with albumins) is 99%. Metabolised in the liver, mainly by hydroxylation,with the formation of several derivatives, two of which are pharmacologically active, but to a lesser extent than diclofenac. It is excreted by the kidneys (about 65%) and bile (about 35%) in the form of inactive compounds with glucuronic and sulfuric acids; less than 1% is excreted unchanged. The total systemic plasma clearance of diclofenac is, on average, 263 ml / min, the final elimination period is 1-2 hours.

Indications:

- inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis);

- rheumatic affections of soft tissues (tendovaginitis, bursitis, lesion of periarticular tissues);

- degenerative diseases of the musculoskeletal system (deforming osteoarthritis, osteochondrosis);

- post-traumatic inflammation of tendons, ligaments, muscles and joints (as a result of stretching, with load and bruises);

- pain syndrome and puffiness associated with diseases of the muscles and joints (lumbago, sciatica, neuralgia, myalgia).

Contraindications:Hypersensitivity to diclofenac or to other components of the drug; to acetylsalicylic acid, or to other NSAIDs.Erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation). Pregnancy (III trimester), lactation, children's age (up to 6 years), violation of the integrity of the skin.

Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, elderly age, bronchial asthma, pregnancy (I and II trimester).

Pregnancy and lactation:The drug should not be used in the III trimester of pregnancy. Experience in using the drug during lactation is not available. Use in I and II trimesters is possible only after consultation with a doctor.

Dosing and Administration:

Outwardly. Adults and children over 12 years of age, the drug is applied to the skin 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 is 2-4 g (which is comparable in volume to the size of a cherry or walnut, respectively).

Children from 6 to 12 years of age should not be used more than 2 times a day, a single dose of the drug up to 2 g. The duration of treatment depends on the indications and the effect observed. After 2 weeks of use, consult a physician.

Side effects:

Local reactions: eczema, contact dermatitis (itching, redness, swelling of the treated area of the skin, papules, vesicles, peeling).

Systemic reactions: generalized skin rash, allergic reactions (including bronchospasm, angioedema, edema), photosensitization.

Overdose:Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.

Interaction:The drug may enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.

Special instructions:

The drug should be applied only to undamaged skin areas, avoiding contact with open wounds, eyes and mucous membranes. After applying the drug, you should wash your hands if this area is not being treated. Avoid the application of an occlusive dressing.

Before use, patients with gastric ulcer and duodenal ulcer, bronchial asthma, rhinitis, polyps of the nasal mucosa, impaired liver, kidney or hematopoiesis, as well as with the use of other non-steroidal anti-inflammatory drugs, should consult a physician.

When using the drug together with other dosage forms of diclofenac, the maximum daily dose should be taken into account.

When applied to large areas of the skin for a long time, the risk of systemic side effects, characteristic of NSAIDs, increases.

Effect on the ability to drive transp. cf. and fur:Does not affect.

Form release / dosage:

Gel for external use 1%.

Packaging:For 40 or 50 g in an aluminum tube. Each tube together with instructions for use in a pack of cardboard.

Storage conditions:At a temperature of 15 to 25 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002395

Date of registration:22.12.2006

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Information update date: & nbsp11.03.2016

Illustrated instructions

Instructions

Diclofenac-Acrychin (Diclofenac-Akrihin)