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Diklopharm 5% 50g of the gel for topical application




The instruction for medical use of DIKLOFARM medicine the Trade name Diklopharm the International unlicensed name Sodium Diclofenac the Dosage form Gel for external use of 5% Structure of 100 g of gel contains active agent – diclofenac of sodium of 5.0 g, excipients: carbomer, isopropyl alcohol, propylene glycol, methylparahydroxybenzoate, water purified. Description Uniform gel of almost white color. Pharmacotherapeutic Musculoskeletal system group. Drugs for topical administration in articulate and muscular pain. Anti-inflammatory drugs, nonsteroid, for topical administration. Diclofenac. The ATX M02AA15 code the Pharmacological Pharmacokinetics Absorption Quantity properties of the diclofenac which is soaking up through skin in proportion to the area of the processed surface also depends both on a total dose of the applied drug, and on extent of hydration of skin. For the 7th day the relative bioavailability of drug (AUC relation) is 4.5% (for an equivalent dose of sodium salt of diclofenac). When carrying a moisture-permeable bandage the absorption did not change. Concentration of diclofenac was measured in plasma, a synovial membrane and synovial fluid when putting drug on area of the affected joint: the maximum concentration (Cmax) in plasma was about 100 times lower, than after oral introduction of the same amount of diclofenac. Distribution of 99.7% of diclofenac contacts proteins of plasma, mainly albumine (99.4%). Diclofenac mainly is distributed and late in the fabrics subject to inflammation, such as joints where its concentration is 20 times higher, than in plasma. Metabolism Metabolism of diclofenac is carried out partially by a glyukuronization of not changed molecule, but mainly by means of single and repeated hydroxylation that leads to formation of several phenolic metabolites, the majority of which turns into glyukuronidny conjugates. Two phenolic metabolites are biologically active, but in much smaller degree, than diclofenac. Removal the General system plasma clearance of diclofenac makes 263±56 ml/min. Bólshaya a part of diclofenac and its metabolites is removed by kidneys. Final elimination half-life (T1/2) makes 1–2 Parts T1/2 of metabolites, including two pharmacological active, is also short and makes 1–3 h. One of metabolites (3 ‘-hydroxies-4 ‘-metoksidiklofenak) has longer elimination half-life, however this metabolite is inactive. A pharmacodynamics Diclofenac – non-steroidal anti-inflammatory drug (NPVP), derivative phenylacetic acid, possessing the significant anti-inflammatory, analgeziruyushchy and febrifugal action. Not selectively oppressing cyclooxygenase 1 (TsOG1) and cyclooxygenase 2 (TsOG2), breaks metabolism of arachidonic acid, reduces amount of prostaglandins in the center of inflammation which are the main link in inflammation development. It is applied to elimination of a pain syndrome and inflammation in joints, muscles and a linking of traumatic or rheumatic origin, promoting reduction of the pain and puffiness connected with inflammatory process, increasing mobility of joints. Indications – dorsodynias in inflammatory and degenerative diseases of a backbone (sciatica, an osteoarthrosis, a lumbago, a sciatica), – joint pains (joints of fingers of hands, knee, etc.) in an osteoarthrosis, – muscle pains (owing to stretchings, retension, bruises, injuries), – inflammation and puffiness of soft tissues and joints owing to injuries and in rheumatic diseases (a tendovaginitis, a bursitis, defeats of periartikulyarny fabrics, a radiocarpal syndrome). Intended for symptomatic therapy, reduction of pain and inflammation at the time of use. Does not influence progressing of a disease. The route of administration and doses Gel is applied outwardly. To adults and children 12 years drug are more senior apply a thin layer to skin over the center the inflammation/place of an injury 2-3 times a day, slightly rubbing in skin. The necessary amount of drug depends on the size of a painful zone. A single dose of drug – up to 2 g (about 4 cm at completely open mouth of a tuba). Maximum daily dose of 6 g. If hands are not a zone of localization of pain, then after putting drug they need to be washed up. Duration of treatment depends on indications and noted effect. It is not necessary to use drug more than 14 days without the recommendation of the doctor. If in 7 days of use the therapeutic effect is not observed or the state worsens, it is necessary to see a doctor. Diklopharm should be applied in minimum effective doses minimum short course. Side effects Undesirable reactions are generally characterized by the moderate and taking place skin manifestations in the site of application of gel. Development of allergic reactions is seldom or never possible. Frequency of emergence of side reactions is determined according to classifications of World Health Organization: very often – more than 1/10, it is frequent – more than 1/100, but less than 1/10, infrequently – more than 1/1000, but less than 1/100, is rare – more than 1/10000, but less than 1/1000, is very rare – less than 1/10000. From the immune system: seldom – reactions of hypersensitivity (including a small tortoiseshell), a Quincke’s disease, bronkhospastichesky reactions very seldom – anaphylactic reactions (including shock) from airways, a thorax and mediastinum: very seldom – asthma from skin and hypodermic fabric: often – contact dermatitis (an itching, hyperaemia, puffiness of the processed site of skin, pustulous rash, papular and vesicular rashes, peelings), a multiformny exudative erythema (including Stephens-Johnson’s syndrome), eczema seldom – bullous dermatitis very seldom – the Contraindication photosensitization – hypersensitivity to diclofenac or other components of drug – tendency to emergence of attacks of bronchial asthma, skin rashes or acute rhinitises at use of acetylsalicylic acid or other NPVP – disturbance of integrity of integuments in the expected site of application – pregnancy (III trimester) – children’s age (up to 12 years) Medicinal interactions Diclofenac can strengthen effect of the medicines causing a photosensitization. Clinically significant interaction with other medicines is not described. The special instructions Drug should be applied only to the uninjured skin, avoiding hit on open wounds. It is not necessary to allow hits of drug in a mouth, in eyes and on mucous membranes. After putting drug the imposing of a bintovy bandage is allowed, however it is not necessary to apply air-tight occlusive bandages. In case of development after putting drug of skin rash, its use needs to be stopped. Pregnancy and the period of a lactation Due to the lack of data on use of diclofenac in the form of gel at pregnant women, use of drug during the I and II trimesters of pregnancy is possible only on doctor’s orders, comparing advantage for mother and risk for a fruit. Drug is contraindicated in the III trimester of pregnancy in connection with a possibility of lowering of a tone of a uterus, a fruit renal failure with the subsequent development of an oligoamnios and/or premature closing of an arterial channel of a fruit. Due to the lack of data on penetration of diclofenac in the form of gel in breast milk, use of drug during breastfeeding is not recommended. If nevertheless use of drug is necessary, then it should not be applied on mammary glands or on the big surface of skin and not to apply is long. The feature of influence of medicine on ability of driving or potentially dangerous mechanisms does not influence ability to run vehicles, mechanisms and to be engaged in other types of activity demanding the increased concentration of attention. The overdose In view of low system absorption at at topical administration of gel overdose is improbable. Symptoms: At accidental intake the development of system undesirable reactions is possible. Treatment: gastric lavage, vomiting indution, intake of activated carbon, symptomatic therapy. The hemodialysis is inefficient in view of high extent of linking of diclofenac with proteins of blood plasma (about 99%). The form of release and packing On 30 g or 50 g of drug place in a tuba aluminum with internal varnish coating, the lithographed external surface, a membrane and a packing ring and with the screw-on lid from polyethylene. 1 tuba together with the instruction for medical use in the state and Russian languages is placed in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! Period of storage 3 years. The use period after the first opening of packing no more than 30 days. Not to apply after an expiration date! Prescription status Without prescription VETPROM Producer of the ABP, Bulgaria 2400, Mr. Radomir, Father Paisius St., 26 the Owner of the registration certificate of “DANSON-BG” of OOD, Bulgaria 2400, Mr. Radomir, Father Paisius St., 26 the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan accepting claims (offer) on quality of medicines from consumers, responsible for post-registration observation of safety of medicine Address: Republic of Kazakhstan, Almaty, Itev St. 46-18 Ph. / fax: +7 (727) 395 91 13 Mobile phone number: +7 (701) 718 25 92
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