Voltaren Emulgel for back pain, muscles and joints, gel 1% 75g

Compound

Voltaren 1% gel contains 11.6 mg of diethylamine diclofenac (10 mg diclofenac sodium ) per 1 gram as an active ingredient.
Additionally: carbomer , polyethylene glycol cetostearyl ether, cocoyl caprylocaprate, propylene glycol, isopropyl alcohol, diethylamine, mineral oil, flavor 45 (including benzyl benzoate), purified water.

of diethylamine diclofenac (20 mg diclofenac sodium as an active ingredient .

Additionally: carbomer, polyethylene glycol cetostearyl ether, cocoyl caprylocaprate, propylene glycol, isopropyl alcohol, diethylamine, mineral oil, oleyl alcohol, butylated hydroxytoluene (E 321), eucalyptus flavor, purified water.

Pharmacodynamics and pharmacokinetics

Voltaren Emulgel (Voltaren Emulgel) in its regular and “Forte” form includes an active ingredient from the NSAID - diclofenac , which is a medicinal drug with characteristically pronounced analgesic , antipyretic and anti-inflammatory effectiveness. The effect of diclofenac is manifested due to its indiscriminate inhibition of COX-1 and COX-2, which leads to disruption of the conversion of arachidonic acid .

Gel Voltaren Emulgel is indicated for use to relieve the patient from the inflammatory process and pain syndrome observed in muscle tissue, joints, ligaments and of a rheumatic or traumatic nature. The effects of the drug help reduce or completely relieve swelling and pain associated with the ongoing inflammatory process, as well as increase the mobility of joints that have been subjected to negative external or internal influences.

The amount of diclofenac absorbed through the skin corresponds to the surface area of ​​the skin to which the drug is applied and depends on the degree of skin hydration and the total dosage of the medicinal product used. After 2 times applying Voltaren Forte (23.2 mg) to a skin surface area of ​​400 cm², the plasma concentration of its active ingredient corresponds to that after 4 times using regular Voltaren gel (11.6 mg). On the seventh day of use, the relative bioavailability of this medicinal drug is 4.5% (for an equivalent dose of diclofenac sodium). There was no change in suction when using a moisture-permeable dressing.

When Voltaren was applied to the affected joint area, the concentration of its active ingredient in the synovial fluid, membrane, and plasma was measured. Serum Cmax in this case was approximately 100 times lower than with oral administration of the same dosage of diclofenac tablets or capsules.

Diclofenac bound to plasma proteins, of which 99.4% of the drug is bound to albumin . The predominant distribution of diclofenac is observed deep in inflamed tissues, for example, in the joints, where its content is 20 times higher than the plasma concentration.

Metabolic transformations of diclofenac occur partly through glucuronidation of its untransformed molecule, but mainly through hydroxylation (single and multiple), which leads to the release of several phenolic metabolic , most of which are converted to the form of glucuronide conjugates. metabolites of diclofenac are biologically active , but to a much lesser extent than their original active ingredient.

The systemic cumulative plasma clearance of diclofenac is 263 ± 56 ml/min. The final T1/2 takes 60-120 minutes. T1/2 of metabolic products (including two pharmacologically active metabolites) is also short and varies between 60-180 minutes. One of the completely inactive metabolites (3′-hydroxy-4′-methoxydiclofenac) is characterized by a longer T1/2, but this is not of fundamental importance. The main part of the active ingredient and its metabolic products are excreted by the kidneys.

Voltaren Emulgel gel for external use 2% 50g

Compound

Active substance: diclofenac sodium - 2 g.
Excipients: carbomers * - 1.1-1.7 g, cetostearomacrogol - 2 g, cocoyl caprylocaprate - 2.5 g, diethylamine * - 0.89-1.37 g, isopropanol - 17.5 g, liquid paraffin - 2.5 g, oleyl alcohol - 0.75 g, eucalyptus flavor - 0.1 g, propylene glycol - 5 g, butylated hydroxytoluene - 0.02 g, purified water* - 64.22-65.32 g.

* when using different production equipment and different batch sizes (1000 kg and 2500 kg), the amounts of carbomers, diethyleneamine and purified water may be slightly adjusted within the indicated figures.

Pharmacokinetics

Suction

The amount of diclofenac absorbed through the skin is proportional to the area of ​​the treated surface and depends on both the total dose of the drug applied and the degree of skin hydration. After applying Voltaren® Emulgel®, gel for external use 2% (2 applications per day) to a skin surface area of ​​400 cm2, the concentration of the active substance in plasma corresponds to its concentration when using 1% diclofenac gel (4 applications per day). On day 7, the relative bioavailability of the drug (AUC ratio) is 4.5% (for an equivalent dose of diclofenac sodium salt). When wearing a moisture-permeable dressing, suction did not change.

Distribution

When applying the drug to the area of ​​the affected joint, the concentration of diclofenac in plasma, synovial membrane and synovial fluid was determined. Cmax in plasma was approximately 100 times lower than after oral administration of the same amount of diclofenac.

The binding of diclofenac to plasma proteins is 99.7%, mainly with albumin (99.4%).

Diclofenac is preferentially distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in plasma.

Metabolism

The metabolism of diclofenac is carried out partly by glucuronidation of the unchanged molecule, but mainly through single and multiple hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Removal

The total systemic plasma clearance of diclofenac is 263±56 ml/min.

The final T1/2 is 1-2 hours. The T1/2 of metabolites, including two pharmacologically active ones, is also short-lived and is 1-3 hours. One of the metabolites (3′-hydroxy-4′-methoxydiclofenac) has a longer T1/2, however, this metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.

Indications for use

• back pain due to inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);
• pain in the joints (including finger joints, knees) due to rheumatoid arthritis, osteoarthritis;
• muscle pain (due to sprains, strains, bruises, injuries);
• inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tenosynovitis, bursitis, lesions of periarticular tissues, wrist syndrome).

Contraindications

• hypersensitivity to diclofenac or other components of the drug;
• tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs;
• violation of the integrity of the skin at the intended site of application;
• III trimester of pregnancy;
• lactation period (breastfeeding);
• children's age up to 12 years.

Carefully

the drug should be prescribed for hepatic porphyria (in the acute phase), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, chronic heart failure, bronchial asthma, as well as in the first and second trimesters of pregnancy and elderly patients.

Directions for use and doses

For adults and children over 12 years of age, the drug is applied to the skin 2 times a day (every 12 hours: preferably morning and evening), lightly rubbing into the skin.

The required amount of the drug depends on the size of the painful area. A single dose of the drug - 2-4 g (which is comparable in volume to the size of a cherry or walnut) - is enough to treat an area of ​​400-800 cm2.

If your hands are not the area where pain is localized, then after applying the drug they should be washed.

The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days for post-traumatic inflammation and rheumatic diseases of soft tissues without a doctor’s recommendation. If after 7 days of use the therapeutic effect is not observed or the condition worsens, the patient should consult a doctor.

To remove the protective membrane, use the screw cap as a key (the recess with protrusions on the outside of the cap). Align the indentation on the outside of the cap with the shaped protective membrane of the tube and turn. The membrane should separate from the tube.

The tubes can have either a regular cap (round shape) or an innovative cap (triangular shape), which is especially convenient for use when the mobility of the hand joints is limited due to osteoarthritis or other joint diseases or injuries.

Storage conditions

Store out of the reach of children at a temperature not exceeding 30 °C.

Best before date

3 years. The drug should not be used after the expiration date indicated on the package.

special instructions

Voltaren® Emulgel® should be applied only to intact skin, avoiding contact with open wounds.

The drug should not come into contact with the eyes and mucous membranes.

After applying the gel for external use 1%, you should not apply an occlusive dressing.

After applying the gel for external use 2%, a bandage may be applied, but airtight occlusive dressings should not be applied.

If a skin rash develops after application of the drug, its use should be discontinued.

This medicine contains propylene glycol, which may cause mild local irritation in some people. It also contains butylated hydroxytoluene, which may cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

Description

NSAIDs for external use.

Dosage form

Gel for external use 2% is homogeneous, creamy, white to white with a yellowish tint.

Use in children

Contraindicated: children under 12 years of age.

Pharmacodynamics

NSAIDs for external use. Diclofenac has a pronounced analgesic, anti-inflammatory and antipyretic effect. By indiscriminately inhibiting COX-1 and COX-2, it disrupts the metabolism of arachidonic acid. Voltaren® Emulgel® is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.

Thanks to its hydroalcoholic base, Voltaren® Emulgel® has a calming and cooling effect.

Side effects

Determination of the frequency of adverse reactions: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10,000, <1 /1000), very rarely (<1/10,000), including isolated reports.

Infectious and parasitic diseases: very rarely: pustular rash.

From the immune system: very rarely - hypersensitivity reactions (including urticaria), angioedema.

From the respiratory system: very rarely - asthma.

From the skin and subcutaneous tissues: often - dermatitis (including contact dermatitis), rash, erythema, eczema, itching; rarely - bullous dermatitis; very rarely - photosensitivity reactions.

If any of the above adverse reactions worsen, or the patient notices any other adverse reactions, the doctor should be informed.

Use during pregnancy and breastfeeding

Due to the lack of data on the use of the drug Voltaren® Emulgel® during pregnancy, the use of the drug in the first and second trimesters of pregnancy is recommended only as prescribed by a doctor, weighing the benefits for the mother and the risk for the fetus.

The drug is contraindicated in the third trimester of pregnancy due to the possibility of decreased uterine tone, impaired fetal renal function with subsequent development of oligohydramnios and/or premature closure of the fetal ductus arteriosus.

Due to the lack of data on the release of the active substance of Voltaren® Emulgel® into breast milk, the drug is not recommended for use during breastfeeding. If it is still necessary to use the drug, it should not be applied to the mammary glands or large surface areas of the skin and should not be used for a long time.

There are no data on the effect of the drug on fertility.

Interaction

Voltaren® Emulgel® may enhance the effect of drugs that cause photosensitivity.

Clinically significant interactions with other drugs have not been described.

Overdose

Due to the extremely low systemic absorption when applying the gel, overdose is unlikely.

Symptoms: accidental ingestion may cause systemic adverse reactions.

Treatment of overdose due to accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

Impact on the ability to drive vehicles and operate machinery

Does not affect.

Indications for use

Doctors recommend resorting to treatment with external preparations Voltaren for:

• back pain felt due to degenerative and inflammatory pathologies of the spine ( sciatica , osteoarthritis , radiculitis , lumbago );
• joint pain (joints of the knees, fingers, etc.), observed with osteoarthritis , rheumatoid arthritis , etc.;
• swelling and inflammation occurring in joints and soft tissues due to injury or due to rheumatic diseases ( wrist syndrome , tenosynovitis , inflammation of periarticular tissues, bursitis , etc.);
• muscle pain noted due to overexertion, sprain , injury, bruises ).

Voltaren as a standard NSAID in modern rheumatology

The NSAID class includes a large number of drugs that are characterized by common and distinctive features. They differ from each other in the severity of analgesic and anti-inflammatory activity, the range of adverse events, routes of administration of the drug into the body, area of ​​application and category of cyclooxygenase (COX) inhibition - the main mechanism of action of these pharmacological agents. Thus, according to the severity of inhibition of two COX isoforms, they are all divided into drugs with selective inhibition of COX-1, COX-2 non-selective, COX-2 selective and COX-2 specific. The range of adverse events when taking NSAIDs is largely associated with the preferential inhibition of one or another COX isoform. The most studied COX-2 non-selective NSAID is Voltaren (diclofenac sodium), which is most often used compared to other drugs in this group of drugs [2,3]. Despite the significant advances in modern anti-inflammatory therapy for rheumatic diseases, some drugs that were introduced into clinical practice in the 20–30s have not lost their importance. last century and later - in the 60–70s. As is known, gold salts, D-penicillamine and aminoquinoline derivatives were proposed for the treatment of rheumatoid arthritis long before the need for basic or slow-acting therapy for this disease was justified. Later, NSAIDs were developed and became widely used, which are now considered “standard” or “classic”. These drugs include, first of all, Voltaren. The history of Voltaren began in 1964, when the Geigy company synthesized a new NSAID, codenamed GP 45840. Subsequent preclinical studies revealed high therapeutic efficacy and good tolerability of GP 45840, named Voltaren. Since 1974, the widespread introduction of this drug into clinical practice began. Already in 1976, the results of 166 clinical trials in 21 countries were summarized, clearly showing the high effectiveness of Voltaren with relatively rare and mild adverse reactions. In the same year, domestic rheumatologists presented the results of testing Voltaren for rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and rheumatism, noting its fairly high therapeutic potential and quite satisfactory tolerability [4]. Voltaren (diclofenac sodium) is a phenylacetic acid derivative. 95.7% of the drug binds to serum proteins. The peculiarities of its pharmacodynamics include a short half-life, which, in turn, helps reduce the number of undesirable effects due to rapid elimination from the body. The maximum concentration of Voltaren in plasma reaches 1180 ng/ml. In the body, it is transformed into inactive metabolites, which are excreted in urine and bile [5]. It does not accumulate with prolonged use. A positive property of Voltaren is its sufficient full compatibility with a number of drugs. However, it should be borne in mind that when combined with oral anticoagulants, it can lead to prolongation of prothrombin time and an increased risk of bleeding, and with hypoglycemic drugs - to the development of hypo- or hyperglycemia [6]. In some patients, Voltaren increases the toxicity of methotrexate due to prolongation of its half-life, which leads to a decrease in the excretion of methotrexate and endogenous creatinine. However, this phenomenon occurs when prescribing medium and high doses of methotrexate, and when prescribing 7.5–10 mg/week. Impairment of renal excretory function is usually not observed. When Voltaren is taken orally, its absorption occurs in the duodenum, since the tablets are produced with a coating resistant to the action of gastric juice. This coating helps reduce the frequency and severity of gastrointestinal toxicity. After 30 min. after administration, the maximum level of Voltaren in plasma is reached. Adsorption of Voltaren and its distribution in the body do not depend on food intake. There is no significant difference in its content between young and elderly people [5]. All NSAIDs are conventionally divided into short- and long-lived. However, there is no clear relationship between the half-life of the drug and its clinical effectiveness. Short-lived drugs can accumulate in high concentrations at the site of inflammation. In Voltaren, although it is a short-lived drug, the duration of the anti-inflammatory effect exceeds the circulation time in the blood plasma due to its redistribution and accumulation in inflamed tissues. When taken orally, its half-life does not exceed 2 hours and is approximately the same as that of ketoprofen and ibuprofen, while for many other NSAIDs (in particular, indomethacin and ketorolac) this period is 2.5–3 times more. Naturally, medications with a short half-life pose less risk to patients due to their rapid elimination from the body. In synovial fluid, the maximum concentration of Voltaren after a single intramuscular injection appears after 4 hours, and its half-life from joint tissue is 8 hours. Thus, the drug persists significantly longer in the synovium and joint fluid than in plasma, while the concentration in tissues is 4–5 times higher than the concentration in blood [7]. These data are of great importance for the treatment of rheumatic diseases in general and, in particular, joint diseases. The main mechanism of action of Voltaren (diclofenac sodium), like other NSAIDs, is inhibition of cyclooxygenase (COX) activity [8]. This enzyme is involved in the synthesis of prostaglandins, including PGE2. Prostaglandins are of great importance for the development of inflammation, pain and fever (Table 1). As is known, blockade of COX-2 plays a decisive role in the fight against inflammation and pain. One of the powerful COX-2 inhibitors is Voltaren [9,10,11]. It was shown that five days after the start of therapy with Voltaren at a dose of 150 mg/day. blockade of PGE2, by which one can judge the inhibition of COX-2, is 93.9%, while with the use of other NSAIDs (ibuprofen, naproxen, rofecoxib, meloxicam) this figure ranges from 66.7 to 77.0%. Suppression of PGE2 in synovial fluid lasts from 8 to 12 hours after administration of a single dose. Voltaren inhibits the release of intracellular arachidonic acid without affecting the expression of lipoxygenase [11]. The experiment established that it is a potential inhibitor of platelet aggregation. However, in clinical settings, its effect on platelet aggregation and adhesion, as well as on the activation of prothrombin time, has not been revealed [5]. The pharmacological activity of Voltaren is not limited only to the suppression of prostaglandin synthesis. In addition, it inhibits the synthesis of leukotrienes, the formation of superoxide radicals and the release of lysosomal enzymes, affects the activation of cell membranes, the aggregation and adhesion of neutrophils, and the functions of lymphocytes. When choosing an NSAID, the following factors must be taken into account: the severity of the anti-inflammatory and analgesic effect, the presence and nature of risk factors for adverse events, as well as their possible spectrum, the presence of concomitant diseases, the nature of interactions with other drugs and, of course, cost. According to these parameters, Voltaren (diclofenac sodium) has established itself as one of the most acceptable NSAIDs and continues to be considered as the “gold standard” for inflammatory and degenerative diseases of the joints and spine, especially since it is superior to most NSAIDs in its anti-inflammatory and analgesic activity [12 ]. In the treatment of rheumatoid arthritis, Voltaren (diclofenac) is considered the drug of choice. According to a double-blind study that compared Voltaren and indomethacin in patients with rheumatoid arthritis, it turned out that both drugs significantly reduced the number of inflamed joints and increased hand grip strength [13]. However, such a significant indicator of a truly anti-inflammatory effect as the dynamics of the total circumference of the proximal interphalangeal joints reliably underwent reverse dynamics only during treatment with Voltaren. It is believed that anti-inflammatory therapy for rheumatoid arthritis should begin with the prescription of Voltaren, because it has a significant anti-inflammatory effect [14]. In the presence of high activity of the inflammatory process, accompanied by severe pain, it is advisable to prescribe Voltaren in the form of intramuscular injections, which accelerates the onset of the therapeutic effect. Parenteral or rectal administration of the drug significantly reduces the risk of gastroenterological complications, but does not eliminate them completely. Voltaren is no less important in the treatment of ankylosing spondylitis (Bechterew's disease). Symptom-modifying therapy for this disease primarily includes NSAIDs, which are considered first-line drugs and a necessary component of combination therapy for ankylosing spondylitis. Patients with this diagnosis take NSAIDs almost continuously for many months and even years. These drugs are the basis of drug therapy, especially since in case of ankylosing spondylitis, effective basic therapy is limited only to sulfasalazine, which has a positive effect on the manifestations of peripheral arthritis and has virtually no effect on the symptoms of spondylitis. As for NSAIDs, they are effective not only in suppressing the inflammatory process in the joints, but also in the axial skeleton, while they significantly reduce the intensity of pain in the spine and its mobility, as well as the severity and duration of morning rigidity. Phenylbutazone and indomethacin have long been considered as the most effective NSAIDs in the treatment of ankylosing spondylitis. However, this point of view is not obvious. In controlled double-blind studies, diclofenac showed the same effectiveness as these drugs, with better tolerability of the latter. In another randomized controlled trial of piroxicam, naproxen, and Voltaren at equivalent doses, they were found to have approximately the same symptom-modifying effect. However, when assessing adverse events, the majority of patients preferred Voltaren [15]. The possibility of an active influence of NSAIDs on the prognosis of ankylosing spondylitis requires clarification. For a long time it was generally accepted that they have only a symptomatic effect in this disease, without controlling the progression of structural changes in the spine, including those patients who have a clear clinical (anti-inflammatory) effect. However, there have been recent reports implicating NSAIDs as agents that may reduce the rate of radiographic progression of ankylosing spondylitis. In this regard, they can be considered as disease-modifying agents [16]. The clear positive effect of NSAIDs on the symptoms of spondylitis during the first 48 hours after their administration is considered as one of the diagnostic criteria for ankylosing spondylitis. In a study of 741 patients with spinal pain, it turned out that this symptom occurred in the vast majority of patients with ankylosing spondylitis and only in 15% of spinal pain caused by other pathological conditions [17]. In ankylosing spondylitis, the sensitivity of this symptom is 77% and the specificity is 85%. Interestingly, if the intensity of back pain does not decrease from taking NSAIDs in the first 48 hours of treatment, then the probability of this disease is only 3%. The presented data emphasize the importance of this group of drugs in the treatment of ankylosing spondylitis. Another indication for Voltaren is acute gouty arthritis. To suppress it, not only NSAIDs are used, but colchicine, corticosteroids and some other drugs. The bright and rapid (within 48 hours) effect of colchicine was considered as one of the diagnostic signs of this disease. However, the effectiveness of NSAIDs and colchicine appears to be similar. These drugs can prevent the further development of an acute attack of gout if they are prescribed in a timely manner, i.e. for 30–60 minutes. from the start of the attack. In Europe, rheumatologists prefer to use colchicine or a combination of colchicine and NSAIDs, while in North America they prefer NSAIDs. NSAIDs are used for gout not only to relieve an acute attack, but also to treat chronic arthritis. Among NSAIDs, preference is given to indomethacin and Voltaren. Controlled studies have not revealed a higher effectiveness of traditional NSAIDs compared to selective COX-2 inhibitors (for example, coxibs). Carrying out effective therapy for osteoarthritis is a difficult task, which is associated with its chronic and steadily progressing course, which is so typical for this disease. One of the most important areas of drug therapy for osteoarthritis is the suppression of persistent inflammation of joint tissues with its localization in cartilage, bone, entheses and synovium. This effect involves the prescription of anti-inflammatory therapy, and primarily NSAIDs. As is known, NSAIDs occupy a central place among symptom-modifying drugs for osteoarthritis. For this disease, NSAIDs are prescribed, predominantly rapidly absorbed and short-lived, with a pronounced analgesic effect. At the same time, these drugs should not have a chondronegative effect in the prescribed doses. The effect of NSAIDs on cartilage metabolism appears to be multifaceted. Some NSAIDs have a negative effect on the synthesis of the cartilage matrix and thereby contribute to the progression of osteoarthritis, others have a chondroneutral effect, and others have a chondroprotective effect. Thus, indomethacin inhibits the synthesis of proteoglycans, type II collagen and hyaluronic acid by chondrocytes, and also promotes premature death of chondrocytes [18]. Huskisson EC et al. in a randomized controlled trial, joint space width was assessed in 812 patients with knee osteoarthritis [19]. While taking indomethacin, narrowing of the gap was observed in 47% of patients and only in 22% on placebo. There are observations that the use of indomethacin in patients with osteoarthritis leads to rapid and significant impairment of the function of the hip joint and its subsequent replacement compared to those patients who were treated only with simple analgesics. However, not all NSAIDs contribute to the progression of osteoarthritis. It has been shown that some of them stimulate the anabolic function of cartilage tissue by inhibiting the production of interleukin (IL)-1 and the expression of the receptor for this cytokine, promote the intensification of the synthesis of growth factors, including transforming growth factor-1, inhibit the degradation of aggrecan, inhibit the catabolism of cartilage, and neutralize the action of metalloproteinases and reduce the intensity of chondrocyte apoptosis [20]. Such drugs include diclofenac, meloxicam, ketoprofen, aceclofenac. It has been shown that diclofenac in vitro does not suppress the biosynthesis of proteoglycans at concentrations equivalent to those in humans, and in vivo it suppresses the activity of costal cartilage chondrocytes, but stimulates articular cartilage chondrocytes [21]. Great importance is attached to NSAIDs in the treatment of a large group of diseases accompanied by pain in the lower back. The literature presents the results of studying the effect of NSAIDs on the central mechanisms of pain that are not associated with inhibition of prostaglandin synthesis, although inhibition of their production seems to be one of the main mechanisms of analgesic action. In this regard, of particular interest are data on the presence of dissociation between the anti-inflammatory (COX-dependent) and analgesic (antinoceptive) effects of NSAIDs [1]. Activation of prostaglandin synthesis in the central nervous system (including the spinal cord) occurs with any peripheral stimulus and inflammation. Voltaren, by suppressing the activity of COX-2, promotes the development of a pronounced analgesic effect, which is of pathogenetic significance for pain in the lower back. When managing such patients, Voltaren is first prescribed parenterally, and only when the pain subsides should one switch to taking this drug orally. The doctor has a large number of different forms of Voltaren at his disposal. It can be used as oral tablets, suppositories, parenteral solution, topical gel and eye drops. The drug is available in various concentrations, which creates certain convenience in the treatment of patients. The maximum daily dose of Voltaren is 0.15 g. This dose is divided into 2–4 doses. Voltaren Emulgel is a means for external use. It gives a high concentration of the drug in subcutaneously located target tissues, which is of particular value to improve the tolerance of the drug. Thus, the concentration of diclofenac in the affected structures of the joint and periarticular tissues after the re -use of Voltaren Emulgel is 770 ng/ml (110–2960) in the synovial fluid, and only 27.6 ng/ml in plasma. These new dosage forms contain special modifications of diclofenac. The tolerance of Voltaren (sodium diclofenac) was studied in a large number of controlled studies, in which it was compared with other non -election and selective TSOG -2 inhibitors. In terms of tolerance, Voltaren surpasses most non -election NSAIDs and takes 2nd place after Ibuprofen. Voltaren and Indomethacin showed the same therapeutic potential in patients with rheumatoid arthritis of 36 months. study [22]. However, the best tolerance was observed in the treatment of Voltaren. In particular, after 12 months. Treatment in the Indomethacin group ceased to treat 41% of patients, and only 19% in the voltaren group. The risk of developing the undesirable phenomena of Voltaren is inaccurately higher than when taking placebo [23]. In general, the manifestations of drug intolerance to this drug are close to similar manifestations of other NSAIDs. However, it should be borne in mind that the frequency of the occurrence of undesirable phenomena and their severity is reliably distinguished by Voltaren and numerous generics, and this applies not only to complaints that are actively presented to patients, or complaints identified during questioning, but also objective symptoms of drug intolerance. So, according to the Institute of Rheumatology, for 2002–2005, in patients taking voltaren, the frequency of detection of single erosions was 7.1% and multiple erosions and ulcers - 11.1%, while the treatment with generics of diclofenac 13, 3 and 14.9%, respectively. A comparative study of the effectiveness and tolerance of Voltaren (diclofenac) and selective TSOG -2 inhibitors, for example, rofecoxib and celloxib, showed that in patients with osteoarthritis, diclofenac was more effective, while there were no reliable differences in the frequency of unwanted reactions. An interesting study is RL Dreiser C COVAVT. (2000). The authors reported the results of a randomized double blind study, in which they evaluated the tolerance of sodium diclofenac 150 mg/day. and two doses of meloxicam - 7.5 and 15 mg/day. In 489 patients with acute pain in the lower back. The duration of therapy was 14 days. According to the doctors, the good and satisfactory tolerance of the selective inhibitor of the COO -2 and the diclofenac, which is not such, turned out to be the same and corresponded to 96 and 95%. Similar assessment was received according to patients. In another placebo -controlled, randomized, double blind examination, 150 mg/day diclofenac was compared in patients with osteoarthritis. (1 group) and celloxib 200 mg/day. (Group 2) [24]. Gastrointestinal complications were often found in patients of group 1, as well as an increase in serum aminotransferases and anemia. In the 2nd group, on the contrary, peripheral edema was 2 times more likely, also almost 2 times - dizziness, 3 times - infection of the upper respiratory tract, 5 times - pain in the lower back. In general, it can be noted that Voltaren demonstrates good tolerance with fairly high doses (150 mg) and prolonged use (up to 8 months or more). Thus, Diclofenac at the beginning of the 21st century did not lose its relevance and continues to be considered as a standard in the treatment of joint diseases and spine. It has an optimal combination of anti -inflammatory and analgesic effects, has a large arsenal of various dosage forms, allows optimizing therapy and conducting effective monitoring of treatment safety.

Literature 1. Nasonov E.L. Non-steroidal anti-inflammatory drugs. M, 2000, 143 p. 2. Thompson PW et al. Rheumatology 2005; 44:1308–1310. 3. Zeider H et al. Rheumatology 2006; 45:494–496. 4. Nasonova V.A. RMJ 2004; 6: 392– 395. 5. Brogden RN, Heel R, Pakes GE et al. Drugs 1980; 20: 24. 6. Liauw HL, Moscaritola JD, Bucher J. Diclofenac sodium (Voltaren). New York, Marcel Dekker, 1987. 7. Abberger H, Korbonits M. Das Markewzeichen in der Rheumatherapie aus Novartis. 2000, 2. 8. Ku EC, Lee W, Kohari HV et al. Semin Arthritis Rheum 1985; 15: 36. 9. Patrignari P, Panara VR, Sciulli VG et al. J Physiol Pharmacol 1997; 48:623–631. 10. Gottesdiener K, Schnitzer T, Fisher C. et al. Arthritis Rheum 1999; 42 (Suppl 9): 144. 11. Schwartz JI, Van Hecken A, De Leperieri I et al. Ann Rheum Dis 1999; 206: abstract 857. 12. Nasonova V.A. Difficult Patient 2004; 2 (3): 6–10. 13. Tsvetkova E.S. Ter. archive 1978; 9:26–30. 14. Sididin Ya.A., Guseva N.G., Ivanova M.M. Diffuse connective tissue diseases. M., 2004, 638 p. 15. Calin A, Eastmond JJ Rheumatol 1990; 17:801–803. 16. Wanders A et al. Arthritis Rheum 2005;52:1756–1765. 17. Dougados M., Dijrmans B., Khan M. et al. Ann. Rheum. Dis. 2002; 61(Suppl III): 40–50. 18. Ding C. Inflammation 2002; 26: 139. 19. Huskinsson EC, Berry P, Gishen P. J Rheumatol 1995; 22: 1941–1946. 20. HenrotinY, Reginster T. Osteoarthritis Cartilage 1999; 7: 355–357. 21. Knokher VA, Jasani MK, Dandona P. Clin Sci 1993; 84(3). 13P, abstract 46. 22. Wyjnand SM, van Riel P et al. J Rheumatol 1991; 18: 184–187. 23. Maeda T, Yoshida A. et al. Jap J Inalammation 1990. 10, 213–226. 24. Mc Kenna F., Borenstein D., Wendt H. et al. Scand. J. Rheumatol, 2001; 30: 11–18.

Contraindications

External use of Voltaren gel is contraindicated for:

• breastfeeding;
• damage to the skin in the area required for application of the drug;
• III trimester of pregnancy ;
• the patient's tendency to develop attacks of asthma ( bronchial asthma ), acute rhinitis or rashes observed when using medications from the NSAID ;
• under the age of 12;
• personal hypersensitivity of the patient to the ingredients of the emulgel ( diclofenac or additional components).

The gel should be used with caution when:

• exacerbation of hepatic porphyria ;
• I and II trimester of pregnancy;
• erosive and ulcerative painful conditions of the gastrointestinal tract;
• bronchial asthma;
• serious liver/kidney pathologies ;
• heart failure;
• bleeding disorders (including frequent and prolonged bleeding , hemophilia );
• in old age.

Drug analogues

Voltaren is quite expensive, but has cheaper analogues. They contain the same active substance or are as similar as possible in action and components. List of Voltaren gel analogs that are cheaper:

There are other NSAIDs on sale in the form of ointments based on ibuprofen, meloxicam, ketorolac and other components that work in a similar way.

Voltaren or Diclofenac: which is better?

The drug under the trade name “Diclofenac” is produced by many companies, “Biosintez”, “Teva”, “Altfarm”, “Akrikhin” and others. Its price is the least expensive - you can buy a tube of cream or gel for 30-80 rubles. The ointment contains 1-3% diclofenac sodium, a powerful anti-inflammatory component.

Additional substances depend on the specific brand of the drug - macrogol, preservatives, propylene glycol, a number of drugs contain dimethyl sulfox.

Some doctors believe that Diclofenac and Voltaren are completely identical. But this is not entirely true. Of course, they have the same active ingredient - diclofenac sodium. Some side components also coincide, for example, both drugs contain talc, starch and microcrystalline cellulose, carbopol, propylene glycol, ethyl alcohol, trolamine. They create the consistency characteristic of both drugs.

However, Voltaren contains macrogol cetostearate, an isopropyl alcohol. Together they help penetrate the skin faster, but can also provoke allergies. Because of this, it is recommended to buy Voltarene only after consulting with your doctor. But a negative reaction can also occur from Diclofenac: it contains lavender oil, to which not all patients react positively.

The volume of the drug and the concentration of the active substance in them are the same. But Voltaren’s packaging is more convenient, and it also has a special protective box. But Diclofenac has a dosage of 5 and 10 ampoules, while Voltaren has only 5. Of course, the dosage can be selected depending on specific instructions.

So you need to focus only on research data on the quality of medicines. It is known that the algorithms of Voltaren’s action have been studied as much as possible, so the list of contraindications has not been supplemented for a long time. But there is no confirmed information about the use of Diclofenac in children. Accordingly, the more preferable drug is Voltaren, but if a specialist suggests using its analogue, it is better to listen to his position.

Diklak as an analogue of Voltaren

Gel Diclak is another well-known product based on diclofenac, a complete structural analogue of Voltaren. . the medicine differs from others in its high concentration of the active substance, 5%, that is, it works much more effectively than the drug in question. Despite this, when used according to the instructions, the same 6% of the product is absorbed into the blood, no more. Therefore, you should not be afraid of pronounced side effects.

Due to its high effectiveness, the drug is recommended for diseases that cause severe pain:

• soft tissue rheumatism;
• rheumatoid arthritis;
• psoriatic arthritis;
• acute infectious arthritis;
• bursitis;
• lumbago;
• disc herniation in the spine.

The drug is prohibited under 6 years of age, during pregnancy (3rd trimester), and lactation. In old age, use with caution. Adverse reactions sometimes include contact dermatitis, papules, vesicles, and skin peeling.

Aertal is a powerful tool

Airtal is based on aceclofenac, a derivative of acetic acid, and provides a strong analgesic and anti-inflammatory effect. The cream releases. After application to the problem area, aceclofenac inhibits the production of prostaglandins and leukotrienes, suppressing COX 1,2.

A distinctive property of Airtal is its sufficient tolerability in the main groups of patients.

Due to its strong action, Airtal is recommended for use after painful injuries, sprains, fractures, and for inflammatory diseases of the joints and soft tissues.

It accumulates in the absorption zone, therefore it has a prolonged effect, and the risk of affecting the gastrointestinal tract is minimized. Airtal is used only by adults over 18 years of age; it is prohibited in the presence of the Varicella-Zoster virus in the body, since during the development of this viral infection it can cause complications in the soft tissues. One application requires 1.5-2 g of cream, so its consumption is more economical than that of Voltaren.

Side effects

Negative side effects when using Voltaren emulgel externally are mainly manifested by passing and moderately expressed local skin reactions observed in the area where the drug is applied. Occasionally (with personal hypersensitivity ), the formation of allergic phenomena .

The most common side effects are recognized: erythema and various dermatitis , including contact dermatitis , characterized by itching , eczema , swelling at the site of application of the gel, the formation of rashes , vesicles, papules and peeling .

Also, in some rare cases, doctors observed: pustular rashes , generalized rash , bronchospastic reactions, bullous dermatitis , allergic phenomena ( angioedema , urticaria ), asthma attacks, photosensitivity .

Voltaren emulgel 12 hours with triangular cap 2% 100g

Voltaren® Emulgel® is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.

Voltaren - for the treatment of acute joint pain. Thanks to the active ingredient - diclofenac - Voltaren immediately penetrates deep into the joint and accumulates, helping to relieve pain and inflammation. It is enough to apply Voltaren every 12 hours: morning and evening.

pharmachologic effect

NSAIDs for external use. Diclofenac has a pronounced analgesic, anti-inflammatory and antipyretic effect. By not selectively inhibiting COX-1 and COX-2, it disrupts the metabolism of arachidonic acid. Voltaren® Emulgel® is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.

Thanks to its hydroalcoholic base, Voltaren® Emulgel® has a calming and cooling effect.

Dosage regimen

The drug is used externally.

Gel for external use 1%

For 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).

After applying the drug, hands must be washed. The duration of treatment depends on the indications and the observed effect (to enhance the effect, the gel can be used together with other dosage forms of the drug Voltaren®).

If there is no therapeutic effect after 2 weeks, you should consult your doctor.

Laminated tubes: To remove the protective membrane, use the screw cap as a key (the ridged recess on the outside of the cap). Align the recess on the outside of the lid with the shaped protective membrane of the tube and turn. The membrane should separate from the tube.

Laminated tubes can have either a regular cap (round shape) or an innovative cap (triangular shape), which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries, as well as an applicator cap.

Before use, consultation with a specialist is required. The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. Storage mode, interactions and side effects are indicated in the instructions.

Side effect

• Infectious and parasitic diseases: very rarely: pustular rash.
• From the immune system: very rarely - hypersensitivity reactions (including urticaria), angioedema.
• From the respiratory system: very rarely - asthma.
• From the skin and subcutaneous tissues: often - dermatitis (including contact dermatitis), rash, erythema, eczema, itching; rarely - bullous dermatitis; very rarely - photosensitivity reactions.
• If any of the above adverse reactions worsen, or the patient notices any other adverse reactions, the doctor should be informed.

Contraindications for use

• hypersensitivity to diclofenac or other components of the drug;
• tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs;
• violation of the integrity of the skin at the intended site of application;
• III trimester of pregnancy;
• lactation period (breastfeeding);
• children's age up to 12 years.
• The drug should be prescribed with caution for hepatic porphyria (in the acute phase), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, chronic heart failure, bronchial asthma, as well as in the first and second trimesters of pregnancy and elderly patients.

Use during pregnancy and breastfeeding

• Due to the lack of data on the use of the drug Voltaren® Emulgel® during pregnancy, the use of the drug in the first and second trimesters of pregnancy is recommended only as prescribed by a doctor, weighing the benefits for the mother and the risk for the fetus.
• The drug is contraindicated in the third trimester of pregnancy due to the possibility of decreased uterine tone, impaired fetal renal function with subsequent development of oligohydramnios and/or premature closure of the fetal ductus arteriosus.

Instructions for use of Voltaren Emulgel gel

External preparations Voltaren are produced by the manufacturer, both in aluminum and laminated tubes.

Before using the drug from an aluminum tube for the first time, the patient must pierce its protective membrane using a special protrusion located at the top of the screw cap.

To remove a similar protective membrane from a laminated tube, the patient should use its screw cap as a kind of key. To do this, it is necessary to combine the recesses present at the top of the lid with the protective membrane and turn the lid itself, which will lead to the separation of the membrane from the tube. Also, for the convenience of manipulation by patients with limited joint mobility of the hands (injuries, osteoarthritis, other joint pathologies), laminated tubes, in addition to the standard round cap, can be equipped with an innovative triangular cap, which is also used in other similar dosage forms (ointment, cream).

Instructions for use of Voltaren Emulgel ointment imply exclusively external use of this medicinal product.

Patients who have reached the age of 12 years are recommended to apply the emulgel to the skin over the problem area 3-4 times every 24 hours (for the “Forte” drug, 2 times in the morning and in the evening), rubbing lightly. The amount of gel used depends on the size of the affected area. A single dose of the remedy varies between 2 (the size of a cherry) or 4 (the size of a walnut) grams. This amount of the drug will be enough to apply to problem areas of 400 cm2 and, accordingly, 800 cm2.

If the patient's hands are not the treated area, they must be thoroughly washed after applying the emulgel.

The duration of such local therapy depends on the disease observed and the patient's response to treatment (efficacy). For rheumatic pathologies and post-traumatic inflammation, doctors do not recommend using external forms of Voltaren for more than 14 days in a row. If there is no effect or the condition worsens after 7 days of treatment, the patient should seek clarification from his doctor.

Voltaren 1 or 2 percent: which is better?

The differences between different concentrations of Voltaren are obvious. So, a 1 percent product works slightly slower than a 2 percent product. This is due to the fact that the body receives less active substance, and accordingly, the bones are restored more slowly. A medicine with a concentration of 1 percent has a higher consumption, since it is taken longer. Also, a 1 percent product is applied at least 3-4 times a day, but the exact dosage depends on the decision of the attending physician.

Well, Voltaren at 2 percent works for 12 hours, so you can save on buying additional tubes. This is due to the fact that 2% diclofenac sodium has a more prolonged and powerful effect. Some reviews note that the product is absorbed 2 percent faster. But the manufacturers claim that the absorption time of both drugs is completely the same.

special instructions

External preparations Voltaren can only be applied to skin with an intact structure, avoiding contact of the emulgel on open wound surfaces.

It is necessary to exclude the possibility of the medication getting into the mouth, nose, eyes and other mucous membranes of the body.

After applying the gel, bandage dressings can be applied to the areas of its application, but the use of occlusive (airtight) dressings is not allowed.

rash is detected in the area where the emulgel is applied, further use of the drug should be stopped immediately.

In some people, the propylene glycol can cause local irritation, and butylated hydroxytoluene can lead to irritation of the eyes and mucous membranes or local negative effects on the skin (for example, contact dermatitis ).

Analogs

Level 4 ATC code matches:
Ultrafastin

Indomethacin

Dicloran

Dicloran Plus

Dolgit

Nise

Ketonal

Ketorol

Febrofeed

Fastum gel

Diclofenac

Finalgel

Bystrumgel

Deep Relief

Butadion

Diklovit

Artrosilene

Olfen

Fanigan Fast

Below are external analogues of Voltaren gel (gels, solutions, creams, ointments), the use of which is advisable for indications typical of drugs from the NSAID .

• Artrosilene;
• Butadion;
• Artrum;
• Dicloran Plus;
• Dolgit;
• Deep Relief;
• Ibalgin;
• Indobene;
• Indomethacin;
• Indovazin;
• Ketonal;
• Nise;
• Ketoprofen;
• Nimulid;
• Fastum;
• Finalgel , etc.

During pregnancy (and lactation)

Voltaren gel is contraindicated during pregnancy in the third trimester , as this can lead to a decrease in uterine tone and/or premature blockage of the ductus arteriosus in the fetus.

In the first and second trimesters, the doctor considers the possibility of external use of Voltaren individually, comparing the expected benefits for the mother with the potential risk for the fetus.

At this time, the degree of penetration of the active ingredient Voltaren Emulgel into the milk of a nursing mother is unknown. For this reason, combining breastfeeding and therapy is not recommended. In case of extreme need to use Voltaren emulgel, its application is possible only in minimal quantities and in small areas, bypassing the area of ​​the mammary glands .

Voltaren - what kind of remedy, indications

Gel for external use Voltaren Emulgel is a popular remedy for osteochondrosis and joint pain. The drug is produced by Glaxo Smith Klein (Switzerland) and is available in different volumes - 20, 50, 75 and even 100-150 ml. The cost of the largest package of 150 ml is 720 rubles. In a minimum package of 20 ml the product costs 230 rubles.

The active substance in the emulgel is diclofenac 1-2%, a representative of NSAIDs.

Diclofenac belongs to phenylacetic acid derivatives and is present in the gel in the form of a sodium salt. The gel is liquid, but resembles an emulsion, which is why it received a unique name (emulgel). It is white, yellowish in appearance, and has an indistinct odor. The medicine in local form helps relieve inflammation and has a pronounced analgesic property. It inhibits COX 1-2 - enzymes that cause the production of pain mediators. Therefore, the gel can be used to relieve pain and swelling caused by inflammation.

Thanks to the composition, the product penetrates better into the tissues and gives a soothing, cooling effect. Only 6% of the active substance is absorbed into the blood, but when applied to the joints, a high concentration of diclofenac accumulates in their cavities. In inflamed tissues, its amount is almost twenty times greater than in healthy tissues, which increases the effectiveness of use.

How much and what are the indications for using the gel? Here they are:

• osteochondrosis and other diseases of the spine;
• radiculitis, sciatica, lumbago;
• osteoarthritis and other joint diseases;
• tendonitis, tendovaginitis, pain in soft tissues.

The drug is widely used after injuries that lead to pain - bruises, sprains; Voltaren is popular among athletes for overexertion.

Reviews of Voltaren Emulgel

Reviews of Voltaren gel indicate that for most patients, this external remedy really helps relieve inflammation and local pain Also, patients using this drug note its rapid absorption, absence of odor and color.

Other patients for whom, due to some circumstances, Voltaren gel is not suitable, can be advised to use diclofenac in other external dosage forms (cream, ointment, etc.) or switch to other local drugs from the NSAID .

Price Voltaren Emulgel, where to buy

The price of Voltaren gel 1% in Russian pharmacies ranges from 450-500 rubles (2% - 650-700 rubles) per 100 grams.

Let us remind you that this external medicinal product is currently produced only in the form of a gel (emulgel), and therefore a search for “price of Voltaren ointment” will most likely lead to incorrect results.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Voltaren Emulgel gel d/nar.
  approx. 1% 100gGSK Consumer Healthcare S.A. RUR 579 order
• Voltaren Emulgel gel d/nar. approx. 1% 50gNovartis Consumer Health SA

  RUB 391 order

• Voltaren Emulgel gel d/nar. approx. 2% 150gGSK Consumer Healthcare S.A.

  RUB 1,064 order

• Voltaren Emulgel gel d/nar. approx. 2% 30gGSK Consumer Healthcare S.A. CH

  RUB 349 order

Pharmacy Dialogue

• Voltaren Emulgel for back pain, muscles and joints, gel 1% 50gNovartis

  RUR 398 order

• Voltaren Emulgel for back pain, muscles and joints, gel 1% 100gNovartis

  RUR 567 order

• Voltaren Emulgel for back pain, muscles and joints, gel 1% 20gNovartis

  RUB 224 order

• Voltaren emulgel for joint pain tube 2% 100g triangular capNovartis

  RUR 778 order

• Voltaren Emulgel for back pain, muscles and joints, gel 1% 75gNovartis

  RUR 494 order

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Pharmacy24

• Voltaren emulgel 1% 100 ml
  179 UAH. order
• Voltaren emulgel 1% 20 g gel

  72 UAH order

• Voltaren emulgel 50 g gel Novartis Consumer Health S.A., Switzerland / Novartis Pharma Products GmbH, Germany

  121 UAH order

PaniPharmacy

• Voltaren emulgel gel Voltaren emulgel 1% 20g Germany, Novartis Pharma Production

  79 UAH order

• Voltaren emulgel gel Voltaren emulgel 1% 50g Germany, Novartis Pharma Production

  136 UAH order

• Voltaren emulgel gel Voltaren emulgel 1% 100ml Switzerland, Novartis Consumer Health

  211 UAH order

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Voltaren Emulgel for back pain, muscles and joints, gel 1% 100g

A country

Switzerland
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Diclofenac

Description

Voltaren Emulgel 100g - intended for pain in the joints, back, muscles, as well as inflammation and swelling of soft tissues and joints.
Voltaren Emulgel has a triple effect! 1: against pain 2: against inflammation* 3: to speed up recovery** The active substance diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties, penetrates deep into the skin, acting on both pain and its cause - inflammation. * * Instructions for medical use, RU No. P N016030/01 dated 09.09.2009 ** Limit. Musculoskeletal disorders. 2013, 14:250. Compared to using placebo.

Compound

100 g of the drug contains: Active ingredient: 1.16 g of diclofenac diethylamine, which corresponds to 1 g of diclofenac sodium. Excipients: carbomers (carbopol 974 R) 1.20 g, macrogol cetostearate (cetomacrogol 1000) 2.00 g, cocoyl caprylocaprate (cetiol LC) 2.50 g, diethylamine 0.90 g, isopropanol 20.00 g, liquid paraffin 2.50 g, aromatic cream 45 (contains benzyl benzoate) 0.10 g, propylene glycol 5.00 g, water 64.64 g.

Product description

Homogeneous, creamy gel, color from white to yellowish.

pharmachologic effect

The active component diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic, anti-inflammatory and antipyretic properties.
By indiscriminately inhibiting cyclooxygenase types 1 and 2, it disrupts the metabolism of arachidonic acid. Voltaren Emulgel is used to eliminate pain and reduce swelling associated with the inflammatory process. Thanks to its water-alcohol base, Voltaren Emulgel has a calming and cooling effect. Pharmacokinetics Absorption The amount of diclofenac absorbed through the skin is proportional to the area of ​​the treated surface and depends both on the total dose of the drug applied and on the degree of skin hydration. After applying 2.5 g of Voltaren Emulgel to a skin area of ​​500 cm2, absorption is about 6% of the applied dose of diclofenac compared to Voltaren tablets. Distribution: 99.7% of diclofenac is bound to plasma proteins, mainly albumin (99.4%). The concentration of diclofenac in plasma, synovial membrane and synovial fluid was measured when the drug was applied to the area of ​​the affected joint. Maximum plasma concentrations were approximately 100 times lower than after oral administration of the same amount of diclofenac. Diclofenac accumulates in the skin, which plays the role of a reservoir that releases the active substance into the tissue. When applied to the area of ​​the affected joint, the concentration of synovial fluid is higher than in plasma. Diclofenac is preferentially distributed and retained deep in tissues prone to inflammation (such as joints) rather than in the bloodstream. The concentration of diclofenac in tissues is up to 20 times higher than in plasma. Metabolism The metabolism of diclofenac is carried out partly by glucuronidation of the unchanged molecule, but mainly through single and multiple hydroxylation. Excretion Most of diclofenac and its metabolites are excreted in the urine. The total systemic plasma clearance of diclofenac is 263±56 ml/min. The terminal half-life is 1-2 hours. The half-life of metabolites, including two pharmacologically active ones, is also short and amounts to 1-3 hours. One of the metabolites (3'-hydroxy-4'-methoxydiclofenac) has a longer half-life, however , this metabolite is completely inactive. Patients with renal and hepatic impairment Accumulation of diclofenac and its metabolites is not expected in patients suffering from renal impairment. In patients with chronic hepatitis or uncompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease

Indications for use

Back pain due to inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica), - joint pain (joints of the fingers, knees, etc.) with osteoarthritis, - muscle pain (due to sprains, strains, bruises, injuries) , - inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tenosynovitis, bursitis, lesions of periarticular tissues)

Contraindications

Hypersensitivity to diclofenac or other components of the drug; a tendency to develop attacks of bronchial asthma, Quincke's edema, urticaria or acute rhinitis when using acetylsalicylic acid or other NSAIDs; pregnancy (III trimester), breastfeeding; children's age (up to 12 years); violation of the integrity of the skin at the intended site of application.

Carefully

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe dysfunction of the liver and kidneys, chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

Use during pregnancy and lactation

Due to the lack of data on the use of Voltaren Emulgel in pregnant women, the use of the drug during the first and second trimester of pregnancy is recommended only as prescribed by a doctor, weighing the benefits for the mother and the risk for the fetus. The drug is contraindicated in the third trimester of pregnancy due to the possibility of decreased uterine tone, impaired fetal renal function with subsequent development of oligohydramnios and/or premature closure of the fetal ductus arteriosus. Due to the lack of data on the penetration of Voltaren Emulgel into breast milk, the use of the drug during breastfeeding is recommended only as prescribed by a doctor, weighing the benefits for the mother and the risk to the fetus. If it is still necessary to use the drug, it should not be applied to the mammary glands or large surface areas of the skin and should not be used for a long time. There are no data on the use of Voltaren Emulgel and its effect on fertility in humans.

Directions for use and doses

Externally. For 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 - 2-4 g (which is comparable in volume to the size of a cherry or walnut, respectively) is sufficient to treat an area of ​​400-800 cm2. If your hands are not the area where pain is localized, your hands should be washed after applying the drug. The duration of treatment depends on the indications and the observed effect (to enhance the effect, the gel can be used together with other dosage forms of Voltaren). If after 7 days of use the therapeutic effect is not observed or the condition worsens, you should consult a doctor. The product should not be used for more than 14 days for post-traumatic inflammation and rheumatic diseases of soft tissues. Laminated tubes: To remove the protective membrane, use the screw cap as a key (the recess with ridges on the outside of the cap). Align the indentation on the outside of the cap with the shaped protective membrane of the tube and turn. The membrane should separate from the tube. Laminated tubes can have either a regular cap (round shape) or an innovative cap (triangular shape), which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries, as well as an applicator cap. Aluminum tubes: Before first use, the protective membrane of the tube must be pierced using the special protrusion on the outside of the polypropylene screw cap. Aluminum bottles: The drug is applied to the skin 3-4 times a day. Spray on the painful area for 3-6 seconds, lightly rub into the skin until the solution is completely absorbed. The required amount of the drug depends on the size of the painful area. If your hands are not the area where pain is localized, your hands should be washed after applying the drug.

Side effect

Classification of the frequency of occurrence of adverse reactions: very often (≥1/10); often (≥1/100, Infectious and parasitic diseases: Very rare: pustular rash. Immune system disorders: Very rare: hypersensitivity reactions (including urticaria), angioedema. Respiratory, thoracic and mediastinal disorders: Very rare: bronchial asthma Disorders of the skin and subcutaneous tissues: Common: dermatitis (including contact dermatitis), rash, erythema, eczema, itching Rare: bullous dermatitis Very rare: photosensitivity reactions If any of the side effects indicated in the instructions are aggravated , or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

The extremely low systemic absorption of the active components of the drug when used externally makes overdose almost impossible. However, with accidental ingestion of 100 g of gel, equivalent to 1 g of diclofenac sodium, systemic adverse reactions may develop. Treatment for accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Hemodialysis is ineffective due to the high degree of protein binding of diclofenac (about 99%)

Interaction with other drugs

Voltaren Emulgel may enhance the effect of drugs that cause photosensitivity. Clinically significant interactions with other drugs have not been described.

special instructions

Voltaren Emulgel should be applied only to intact skin, avoiding contact with open wounds. After application, do not apply an occlusive dressing. Do not allow the drug to come into contact with the eyes or mucous membranes, and do not swallow. The drug contains propylene glycol and benzyl benzoate, which in some cases may cause mild local skin irritation. Treatment should be discontinued if a skin rash develops after application of the drug. The possibility of systemic adverse reactions (associated with the use of systemic forms of diclofenac) should be considered if diclofenac for external use is used at a higher dose or for a longer time than recommended.

Release form

Gel for external use 1%. 100 g each in an aluminum tube equipped with a protective aluminum membrane, with a screw-on plastic cap (white or blue) with a protrusion for perforating the membrane from the outside. The tube along with instructions for use are placed in a cardboard box. 100 g in a laminated tube (low-density polyethylene, aluminum, high-density polyethylene) with a shoulder and a one-piece shaped protective membrane made of high-density polyethylene and a polypropylene screw cap (white or blue), round or triangular, or with a screw-on applicator cap with transparent protective cap. The cover on the outside is equipped with a key (a recess with protrusions) for opening the protective membrane of the tube. The tube along with instructions for use are placed in a cardboard box. 100 ml in a pressurized aluminum bottle (about 73 g and 97 g, respectively), with a plastic pump dispenser on a polyethylene ring and a protective cap. The bottle along with instructions for use is placed in a cardboard box. Secondary packaging is allowed to have a first-opening control.

Storage conditions

At a temperature not exceeding 30 C, out of the reach of children.

Best before date

3 years. The drug should not be used after the expiration date indicated on the package.