Pharmacological properties

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Diklofen-gel at topical administration expressed anti-inflammatory, analgeziruyushchy, antiedematous and antiagregantny effects that is connected with oppression of biosynthesis of prostaglandins, kinin and other mediators of inflammation. medicine reduces permeability of a vascular wall of capillaries, stabilizes membranes of lysosomes, reduces temperature in the inflammation center.

Menthol which is a part of medicine has fast analgetic effect at the expense of the cooling effect, enhancing analgetic effect of diclofenac.

Diklofen-gel promotes reduction of hypostasis of joints and circumarticular fabrics, reduces severity of a rest pain and at the movement, reduces morning constraint, increases the volume of movements in joints, their functional and motive capacity. Reducing aggregation ability of platelets, medicine improves local microcirculation.

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Amount of the diclofenac getting through skin is proportional to time of contact of Diklofen-gelya and the area of skin to which it is applied and also depends on a dose of medicine and extent of hydration of skin. After drawing on the surface of skin of Diklofen-gelya the absorption of diclofenac is about 6%. The occlusive bandage can raise a diclofenac resorption several times. After topical administration, diclofenac is defined in blood plasma, a synovial membrane and synovial fluid of joints. Diclofenac contacts proteins of blood plasma for 99%. Metabolism of diclofenac happens mainly by hydroxylation to formation of several derivatives, two of which pharmacological are active, but in much smaller degree, than diclofenac. Diclofenac and its metabolites are removed mainly with urine in the form of glucuronides.

At patients with diseases of kidneys of cumulation of diclofenac and its metabolites it is noted p.

At patients with chronic hepatitis or the compensated cirrhosis the indicators of pharmacokinetics and metabolism of diclofenac do not change.

Indication

Topical administration in complex therapy of inflammatory processes, a pain syndrome at:

• localized forms of inflammatory and degenerative diseases of joints and a backbone, including osteoarthrites, osteoarthroses of peripheral joints and a backbone;
• rheumatic diseases of soft tissues (including a tendovaginitis, a syndrome "shoulder brush", a bursitis, a periarthritis, periartropatiya);
• posttraumatic inflammations of soft tissues, sinews, ligaments, muscles and joints (stretching, dislocations, overstrain, bruises, hypostases).

Use

Drug is used outwardly. 1 g of diklofen-gel (strip of gel 2.5-3 cm long) is applied a uniform thin layer to skin and slightly rubbed within 1–2 min. after putting medicine it is necessary to wash up hands (except those cases when applique is carried out on area of hands). the procedure is repeated by 2–4 times a day. the average daily dose for adults makes 4–5 g of gel that corresponds to 120-150 mg of diclofenac of sodium.

Duration of treatment of Diklofen-gelem at posttraumatic inflammations of soft tissues or at rheumatic diseases of soft tissues — 10–14 days, at treatment of osteoarthrites — up to 4 weeks

In need of simultaneous application of Diklofen-gelya with diclofenac tablets the daily dose of the last should not exceed 50 mg.

Contraindication

• Hypersensitivity to diclofenac, menthol or other components of medicine; existence in the anamnesis of attacks oh, small tortoiseshells, sharp rhinitis or other allergic reactions caused by intake of acetylsalicylic acid or others npvp; period of pregnancy and feeding by a breast; children's age up to 15 years.

Side effects

In this dosage form diklofen-gel is well transferred by

. at some patients at non-compliance with rules of application or at overdose can note the phenomena of local irritation of skin: seldom — allergic or contact dermatitis with formation of papules, bulls or skin desquamation; separate cases of a photosensitization, formation of infiltrate, abscess, necrosis of fatty tissue are possible.

Emergence of system side effects after topical administration of Diklofen-gelya is improbable

. Considering a possibility of prolonged use, putting medicine on extensive sites of skin, probability of application of the doses exceeding the recommended, simultaneous use of the medicines which are also containing diclofenac or other NPVP can note such side reactions (more characteristic of the injection and tableted diclofenac forms):

from a GIT: heartburn, loss of appetite, nausea, vomiting, a lock or diarrhea, pain in epigastric area, enterospasms, a meteorism; seldom — ulcerogenic action with or without bleeding or perforation; development of nonspecific hemorrhagic colitis, aphthous stomatitis, glossitis, damage of a gullet, pancreatitis, exacerbation of hemorrhoids is in some cases possible;

from kidneys: hypostases, in some cases — a sharp renal failure, a hamaturia, a proteinuria, interstitial nephrite, a nephrotic syndrome, a necrotizing papillitis;

from a liver: development of toxic hepatitis is possible;

from central nervous system: dizziness, a headache, is extremely rare — increased fatigue, in some cases — paresthesia, memory violations, a disorientation, insomnia, irritability, concern, a depression, dreadful dreams, a tremor, psychotic reactions, spasms, aseptic meningitis, disorders of vision (diplopia), a hearing disorder (sonitus), violations of taste;

from a cardiovascular system: tachycardia, pain in a breast, increase in the ABP, the phenomenon of heart failure;

allergic reactions: in some cases — generalized skin rash, bullous rashes, eczema, a polymorphic erythema, purple, urticaria, an erythrosis, Stephens's syndrome — Johnson, a Lyell's disease (toxic epidermal necrolysis), a bronchospasm;

change of laboratory indicators: anemia, a leukopenia, thrombocytopenia, the Agranulocytosis, decrease or increase in level of glucose and potassium in blood, increase in activity of serumal aminotransferases is possible.

Emergence of above-mentioned symptoms demands medicament withdrawal of Diklofen-gel and purpose of symptomatic treatment.

Special instructions

apply

Diklofen-gel only outwardly.

needs to apply Drug to

on the intact sites of skin. Not to allow hit of medicine in eyes and on other mucous membranes, and at hit it is necessary to wash out them enough flowing water. It is not necessary to apply gel under the bandages which are doing not pass air (occlusal) it is necessary to avoid thermal procedures, insolation (including artificial) on sites of skin with the applied gel.

not to apply

along with sunblock, cosmetic creams, with repellents or other local means in zones of drawing Diklofen-gelya.

can Put on not earlier than in 10 min. after putting medicine, to take the shower/bathroom not earlier than in 1 h after gel applique.

it is obligatory for p to wash up hands after the procedure of drawing (except those cases when applique is carried out on the site of hands).

Considering possible prolonged use of medicine and/or drawing on the big square, with care appoint (taking into account the increased risk of adverse effects) to the people of advanced age weakened with low body weight, with erosive and ulcer gastrointestinal diseases in the anamnesis, with OH, violations of blood formation, AG, heart failure, a serious illness of a liver, kidneys.

should not be applied along with other medicines containing diclofenac.

periodic control of a blood count and functions of a liver, kidneys, monitoring of the ABP, the analysis a calla on the occult blood is necessary for

At prolonged use.

Alcohol intake, smoking increases risk of gastrointestinal bleeding.

Use during pregnancy and feeding by a breast. Use of medicine during pregnancy is contraindicated. In need of use of medicine during feeding by a breast during a course of treatment the breastfeeding is recommended to be stopped.

Children. There is no experience of application for children aged up to 15 years.

Ability to influence speed of response at control of vehicles or work with other mechanisms. There are no data on ability of the medicine Diklofen-gel to influence speed of response at control of vehicles or work with other mechanisms.

When using diklofen-gel the possibility of interaction with other medicines is minimum

Interaction

. however considering a possibility of prolonged use, uses of the doses exceeding recommended, putting medicine on extensive sites of skin, in case of simultaneous use of other medicines of diclofenac or others npvp it is impossible to exclude a possibility of such interactions:

• with anticoagulants, antitrombotichesky means the risk of developing bleedings increases;
efficiency of antihypertensive therapy by inhibitors of an angiotensin-converting factor can reduce
• Diklofen-gel;
• with acetylsalicylic acid or other NPVP the risk of emergence of side effects increases;
• with glucocorticoids, alcohol the ulcerogenic action amplifies;
application of Diklofen-gelya with digoxin, Phenytoinum, medicines of lithium, a hinolonama can lead
• to increase in concentration of these medicines in blood plasma;
efficiency of diuretic medicines can reduce
• Diklofen-gel, when assigning with kaliysberegayushchy diuretics the development of a hyperpotassemia is possible;
application of Diklofen-gelya during 24 h to or after reception of a methotrexate can lead
• to increase in concentration of a methotrexate in blood plasma and, respectively, to manifestation of its toxic effects;
at a combination to oral glucose-lowering medicaments the development both hypo - and a hyperglycemia is possible
• ;
nephrotoxicity of cyclosporine can strengthen
• Diklofen-gel.

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Overdose

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About cases of overdose it was not reported. considering a route of administration, when performing the mode of dosing and owing to low system absorption of diclofenac, the overdose of diklofen-gel is improbable. but at prolonged use of medicine in the doses exceeding recommended and/or when drawing on the big area of leather there can be above-mentioned system side effects owing to resorptive action.

Treatment. To remove or wash away the remained gel from skin. There is no specific antidote. Symptomatic therapy. The artificial diuresis is ineffective in view of high extent of linking of diclofenac with proteins of blood plasma.

Storage conditions

At a temperature not above 25 °C.