Diclak solution, tablets and gel: instructions for use, reviews, price

Compound

One Diclac enteric tablet contains 50 mg of diclofenac sodium and a number of auxiliary ingredients.
One ampoule of Diclak solution for intramuscular injection contains 75 mg of diclofenac sodium and excipients:

n-acetylcysteine;
benzyl alcohol;
mannitol (E421);
sodium hydroxide;
propylene glycol;
water for injections.

One modified-release Diclak tablet may contain 75 or 150 mg of active substance + a number of excipients.

The composition of 1 gram of gel for external use Diclak includes 50 mg of diclofenac sodium , as well as isopropyl alcohol, purified water, macrogol-7-glycerol cocoate, hypromellose, flavoring oil “Bouquet” WN 4507 as auxiliary components.

One rectal suppository Diklak contains 50 mg of diclofenac sodium , as well as 1,2-propylene glycol, witepsol and aerosil as auxiliary components.

Use of the drug Diclak

The dose of the drug is determined individually, depending on the patient’s age and the severity of the disease. The duration of the course should not exceed 3 weeks. Recommended doses for adults and adolescents over 15 years of age are 50–150 mg/day in 1–3 divided doses. The maximum daily dose of the drug is 150 mg. Diclak tablets should be taken after meals, without chewing and with a sufficient amount of liquid (1/2–1 glass of water). Adults are prescribed 1 tablet of Diclac ID modified release (75 or 150 mg) once a day. The modified-release tablet should be taken after or during meals without chewing, with sufficient liquid (1/2 to 1 glass of water). In acute conditions or exacerbations of chronic processes, adults are prescribed IM at a dose of 75 mg once a day, and in some cases administration is allowed 2 times a day. If the symptoms of the disease are most pronounced during the night or in the morning, Diclak ID should be used in the evening.

Release form

The drug Diklak has several dosage forms:

enteric tablets No. 20;
solution for intramuscular injection, produced in ampoules with a capacity of 3 ml, No. 5;
tablets with modified release of diclofenac sodium 75 mg, No. 20 and No. 100;
tablets with modified release of diclofenac sodium 150 mg, No. 20 and No. 100;
gel 5% in tubes with a capacity of 50 g;
gel 5% in tubes with a capacity of 100 g;
rectal suppositories 50 mg, No. 10.

Pharmacodynamics and pharmacokinetics

The composition of the drug Diclak includes diclofenac sodium - a drug with a non-sterile structure, which is a derivative of phenylacetic (alpha-toluic) acid and has the ability to have a pronounced:

anti-inflammatory;
anesthetic;
antirheumatic;
antipyretic effect.

The mechanism of action of diclofenac comes down to:

suppression of the activity of the cyclooxygenase (COX) enzyme involved in the synthesis of prostanoids and the cascade of metabolic reactions of arachidonic acid;
suppression of prostaglandin , which play a leading role in the development of inflammatory processes, pain and febrile conditions;
capillary permeability ;
stabilization of lysosome ;
suppression of platelet , which is provoked by the nucleotide adenosine diphosphate and fibrillar protein collagen ;

The use of diclofenac sodium improves the motor ability of joints , helps to increase the range of motion in them, as well as reduce the intensity of pain at rest and during movement.

In vitro experiments on the use of diclofenac sodium in doses equivalent to those used to treat patients have shown that the drug does not suppress the processes of biosynthesis of proteoglycans (carbohydrate-protein components) of cartilage tissue .

In patients whose pain and inflammation are the result of injury or surgery, Diklak:

quickly and effectively relieves pain (both spontaneously occurring and pain that makes itself felt when moving);
reduces the severity of edema caused by the inflammatory process;
reduces the symptoms of morning stiffness.

A significant analgesic effect of the drug is also observed when treating patients with symptoms of moderate and severe pain syndrome of non-rheumatic origin .

The positive therapeutic effect after injection of Diklak develops within about half an hour (and sometimes after 15 minutes). In addition, Diklak injections significantly alleviate the condition of patients suffering from migraine .

The drug is also able to relieve symptoms of pain and reduce the severity of blood loss in women with dysmenorrhea .

In cases where diclofenac is prescribed in combination with opioid analgesics to relieve pain in the postoperative period, the need for narcotic painkillers is significantly reduced.

A solution for intramuscular injection is recommended in the initial stages of treatment of rheumatic diseases of a degenerative and inflammatory nature, as well as for relieving pain that accompanies inflammatory diseases of non-rheumatic origin .

Diclak gel is a non-steroidal anti-inflammatory drug for external use from the group of alpha-toluic acid derivatives.

The drug is characterized by the ability to have a local antirheumatic , analgesic and anti-inflammatory effect diclofenac sodium, which is part of it, to suppress the biosynthesis of prostaglandins , which are mediators of pain and the inflammatory process.

Application of Diklak ointment:

relieves the intensity of pain in the affected joints and muscles (both at rest and in motion);
improves motor activity of joints affected by the pathological process.

After oral administration of the drug in the form of enteric tablets, diclofenac sodium is quickly and completely absorbed from the stomach and intestinal tract . Food affects the rate of absorption, slowing it down, however, the amount of substance absorbed remains unchanged.

After intramuscular administration of Diclac in a dose equivalent to 75 mg of diclofenac sodium, the process of absorption of the active substance begins immediately. The maximum plasma concentration of the drug, 2.5 μg/ml (or 8 μmol/l), is observed within twenty minutes after injection.

There is a linear relationship between the amount of absorbed substance and the dose of the drug.

The pharmacokinetic parameter AUC, which displays the area under the “concentration of the active substance - time” curve, after injection into the muscle or intravenous administration of Diclak is approximately twice as high as the same indicator after administration of the drug orally or rectally.

This is due to the fact that in the latter case, about 50% of the active substance undergoes metabolization processes already during the first passage through the liver .

After repeated administration of diclofenac sodium, its pharmacokinetic parameters remain unchanged. If the dosing intervals recommended by the instructions are followed, no accumulation of the active substance in the body is observed.

A characteristic feature of Diklak ID tablets is that a sixth of the active ingredient diclofenac sodium is released quickly, and the remaining ⅚ of its total amount is released gradually.

Thanks to this combination of pharmacological effects in one two-layer tablet, the following is provided:

rapid onset of action of the drug;
prolonged circulation of diclofenac sodium in the systemic circulation and, as a consequence, a long-term therapeutic effect, which is observed throughout the day.

After using the Diclak ID tablet per os, diclofenac is completely absorbed from the intestinal tract . The maximum plasma concentration is observed in the range from 1 to 16 hours after taking the drug (on average, this indicator reaches its maximum values two or three hours after administration).

There is a linear relationship between the amount of absorbed substance and the dose of the drug.

Once in the body, diclofenac is almost 100% (or, more precisely, 99.7%) bound to plasma proteins , mainly albumin . The volume of distribution of the substance ranges from 120 to 170 ml/kg.

The concentration of diclofenac in the synovial fluid after taking Diclak orally in the form of tablets is observed after three to six hours, and after injection of the drug - after two to four hours.

The half-life of the substance from synovial fluid varies from three to six hours.

Two hours after the plasma concentration reaches its maximum, the level of diclofenac in the synovial fluid becomes higher than its plasma level, and this effect persists for the next twelve hours.

After taking Diclak tablet, approximately 50% of a single dose of diclofenac sodium is metabolized during the first passage through the liver and only 35 to 70% of the absorbed substance reaches the posthepatic circulation in unchanged form.

Diclofenac is partially biotransformed through glucuronidation of the original molecule, however, to a greater extent due to the hydroxylation reaction and the methoxylation reaction.

As a result of these processes, several phenolic metabolites are formed, of which only two have biological activity, which, however, is less than the activity of the parent substance.

The half-life of diclofenac from the body is from one to two hours, and it is not affected by indicators of the functional activity of the kidneys and/or liver .

The systemic clearance of the substance in the blood plasma ranges from 207 to 319 ml/min.

Most of the diclofenac (about 60%) is excreted by the kidneys in the form of metabolites, slightly less than 1% of the substance is excreted in unchanged form, the remainder is excreted in the form of metabolites along with bile .

When prescribing Diclak solution for the treatment of patients from special groups, no differences in the pharmacokinetic characteristics of the drug were identified (including any difference in the age dependence of absorption, metabolism and excretion of the active substance from the body).

In some elderly patients, after a 15-minute injection of the solution into a vein, the plasma concentration of diclofenac sodium increased by approximately 50% compared to young healthy people.

renal function, if the dosage regimen recommended by the instructions was followed, there was no accumulation of diclofenac sodium .

When treating patients with chronic liver cirrhosis or hepatitis of diclofenac were the same as when it came to treating patients with a healthy liver .

After using Diclac in gel form, diclofenac sodium is slowly and only partially absorbed on the surface of the skin. The plasma concentration reaches its maximum after six to nine hours.

The average retention time of the active substance in systemic circulation is approximately nine hours, which significantly exceeds the same figure after internal use of the drug, which is one to two hours.

After external use, the processes of metabolization and elimination of diclofenac from the body are identical to those after systemic administration of the drug. The binding rate of diclofenac to plasma proteins is 99%.

After rapid metabolization in the liver by hydroxylation and binding to glucuronic acid, approximately ⅔ of the substance is excreted by the kidneys , the rest along with bile .

Pharmachologic effect:

Diclak (diclofenac sodium) is a non-steroidal anti-inflammatory drug, a derivative of phenylacetic acid. It has antipyretic, antirheumatic, analgesic and anti-inflammatory effects. The mechanism of action is due to inhibition of the formation of kinins, prostaglandins and other mediators of inflammation and pain. It also has a stabilizing effect on lysosome membranes and an anti-edematous effect by reducing capillary permeability. Able to inhibit platelet aggregation, which is caused by collagen and adenosine diphosphate. In vitro experiments have shown that when used in therapeutic doses it does not suppress the processes of biosynthesis of cartilage tissue proteoglycans.

Diclac enteric tablets are quickly and completely absorbed from the intestine after internal administration. Cmax in blood plasma is observed after 1-16 hours (average number - 2-3 hours). After parenteral administration (into the muscle), the maximum concentration is achieved within 10-20 minutes. High concentrations of diclofenac sodium are observed in the myocardium, bile, blood, liver, kidneys and lungs. In the synovial fluid, the drug content is 30% less than in the blood, but the maximum concentration is determined longer than the plasma concentration.

After absorption, it is also determined in breast milk and other tissues of the body. The volume of distribution of diclofenac sodium is 0.2-0.55 l/kg.

The drug is subject to intense first-pass metabolism. Only 35-70% of unchanged diclofenac sodium, which is absorbed from the intestine, enters the systemic circulation. The half-life is 2 hours and is independent of renal and liver function. The half-life from synovial fluid is 3-6 hours. Metabolism takes place in the liver due to conjugation and hydroxylation. Approximately 70% of the drug is eliminated by the kidneys in the form of pharmacologically inactive metabolites. 30% is excreted in feces. 99% of diclofenac sodium is bound to plasma proteins.

The release form of "Diklak ID" is tablets characterized by a combination of rapid release (1/6 of the total amount) with gradual release (5/6 of the total amount of diclofenac sodium administered). This combination of action ensures long-term circulation of the active substance in the blood and a rapid onset of action. The therapeutic effect of Diklak ID lasts 24 hours.

Indications for use

Indications for the use of Diclak enteric tablets are:

rheumatic diseases of a degenerative and inflammatory nature (for example, rheumatoid arthritis or osteoarthritis );
symptoms of pain localized in the spine;
soft tissue rheumatism ( extra-articular rheumatism );
attacks of acute gouty arthritis ;
pain syndrome accompanied by inflammation and swelling of tissues after injury or surgery (including pain syndrome developing after orthopedic or dental intervention);
gynecological diseases that are accompanied by symptoms of inflammation and pain (for example, adnexitis or primary dysmenorrhea
diseases of the ENT organs occurring in a severe form , accompanied by pain (the drug is prescribed as an adjuvant).

Diclak solution is prescribed for intramuscular administration to patients with:

rheumatic diseases of a degenerative and inflammatory nature (for example, rheumatoid arthritis or osteoarthritis );
attacks of acute gouty arthritis ;
biliary pain;
renal colic;
accompanied by inflammation and swelling of tissues and post-traumatic pain syndrome ;
pain syndrome developing in the postoperative period;
severe migraine .

It is advisable to prescribe intravenous administration of the drug for the treatment and prevention of postoperative pain syndrome .

Diklak ID tablets are prescribed:

for rheumatism ;
to relieve symptoms of postoperative and post-traumatic pain syndrome ;
for painful conditions that accompany certain gynecological diseases.

Rectal suppositories are recommended for use:

with inflammatory, as well as degenerative forms of rheumatism (for example, with chronic polyarthritis neuritis or neuralgia );
for soft tissue lesions of rheumatic origin ;
with post-traumatic or postoperative pain syndrome , which is accompanied by painful swelling of tissues and the development of an inflammatory process in them;
for inflammatory pain conditions of non-rheumatic origin.

Diclak gel is used for the symptomatic treatment of pain, relieving symptoms of inflammation and eliminating tissue swelling in case of:

various types of traumatic injuries of soft tissues ( tendon sprains , muscles , dislocations , hematomas , etc.);
localized forms of inflammatory diseases of a rheumatic nature (for example, with tendinitis or periarthropathy );
with localized forms of rheumatism , accompanied by the development of degenerative processes (for example, with osteoarthritis of peripheral joints or osteoarthritis of the spine ).

Contraindications

Contraindications to the use of Diclak in the form of tablets, solution and suppositories are:

increased individual sensitivity to diclofenac or any of the components included in each of these forms of the drug;
acute peptic ulcer of the stomach or intestines ;
gastrointestinal bleeding;
perforation of the stomach or intestines ;
renal , cardiac or liver failure in severe form;
disruption of hematopoietic processes of unknown origin;
last trimester of pregnancy ;
lactation.

Diclak is not prescribed to patients who, as a response to treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, develop attacks of bronchial asthma , symptoms of acute rhinitis and urticaria .

A contraindication to the prescription of Diclak tablets is age under 15 years. Diclak solution is contraindicated in patients under 18 years of age. The instructions prohibit the use of rectal suppositories for children under 12 years of age, as well as for patients with symptoms of proctitis ( inflammation of the rectum ).

Contraindications to the use of Diclak gel are:

increased individual sensitivity to diclofenac or any of the excipients of the drug;
the patient has a history of attacks of bronchial asthma , urticaria or acute rhinitis
nasal polyps (including a history);
history of angioedema ;
increased individual sensitivity to painkillers and, in particular, to antirheumatic drugs;
last trimester of pregnancy .

Special instructions for the use of Diclak

Diclofenac can be used only after a thorough assessment of the risk/benefit ratio in the following cases: in the first and second trimesters of pregnancy, with porphyria, systemic lupus erythematosus, collagenosis. Careful medical observation is necessary in case of a history of gastrointestinal disorders, peptic ulcers or inflammatory bowel diseases (ulcerative colitis, Crohn's disease); hypertension (arterial hypertension) and/or heart failure; history of kidney disease; severe liver dysfunction; in elderly patients; immediately after major surgical interventions; in patients with coagulation disorders; in patients with fever, nasal polyps or COPD, as well as hypersensitivity to other NSAIDs. Since the use of diclofenac sodium may cause side effects from the central nervous system, in particular weakness and dizziness, the drug may have an adverse effect on the ability to drive a car and work with potentially dangerous equipment. This is especially pronounced when taking alcohol at the same time. 1 tablet contains less than 0.01 metabolic carbohydrate units.

Side effects

Dosage forms of Diclac intended for oral administration can provoke:

Impaired function of the circulatory and lymphatic systems , which are expressed in the form of various forms of anemia , including aplastic and hemolytic, a decrease in the number of leukocytes , platelets and neutrophil granulocytes (all of these phenomena are classified as very rare).
Immune system disorders , expressed in the form of hypersensitivity reactions, anaphylactoid reactions , angioedema (rare).
In very rare cases - mental disorders , expressed in the form of disorientation in space, the occurrence of depressive states , nightmares , increased irritability , and various types of psychotic disorders.
Nervous system dysfunction : often - headaches , dizziness ; in rare cases - increased drowsiness ; in very rare cases - sensitivity disorders, taste disorders, memory impairment, aseptic meningitis , the appearance of tremor cerebral circulation disorders , the appearance of nightmares, increased irritability.
In rare cases - visual impairment , blurred , double vision .
Hearing impairment , which is expressed: often - in the form of vertigo ; extremely rarely - in the form of hearing disorders, ringing in the ears .
Cardiac dysfunction : palpitations , chest pain, symptoms of heart failure , myocardial infarction (all of these phenomena are very rare).
Vascular system disorders : arterial hypertension , vasculitis (very rare).
Respiratory system dysfunction : rarely - asthmatic attacks (including shortness of breath) and the appearance of symptoms of bronchospastic syndrome ; very rarely - damage to the alveolar walls and/or interstitial tissue of the lungs , accompanied by fibrosis .
Disorders of the digestive system , stomach and intestinal tract : most often - attacks of nausea , vomiting , dyspeptic disorders , abdominal pain, increased flatulence , signs of anorexia ; in rare cases - gastritis , gastrointestinal bleeding , the appearance of blood impurities in the vomit, bloody diarrhea , melena , development of gastric and/or intestinal (and the ulcer may be accompanied by bleeding and/or perforation); in very rare cases - colitis , including ulcerative and hemorrhagic colitis , constipation , development of stomatitis , the appearance of diaphragm-like strictures in the intestine , various types of disorders of the esophagus, pancreatitis .
Disorders of the hepatobiliary system : increased levels of intracellular enzymes ALT and AST ( transaminases ); rarely - the appearance of symptoms of hepatitis and liver ; very rarely - development of fulminant (ultra-fast) hepatitis , death of liver tissue ( hepatonecrosis ), development of liver failure .
Disorders of the urinary system : in very rare cases - the development of symptoms of acute renal failure , necrotizing papillitis , the appearance of blood impurities in the urine, increased protein content in the urine, the development of symptoms of nephrotic syndrome , interstitial nephritis .

In rare cases, taking the drug may cause swelling .

During treatment with Diclak solution, the possibility of developing an abscess at the injection site (very rare) cannot be ruled out; hardening of the injection site and its pain (often); swelling and necrotic processes at the site of drug administration (rare).

Some patients may experience symptoms of aseptic meningitis , including neck tension, fever , and decreased consciousness . These symptoms mainly affect patients with autoimmune diseases .

The use of Diclak gel can cause:

Skin reactions: infrequently - sensations of itching , burning , the appearance of vesicles , papules and pustules , increased dryness of the skin and their peeling, the appearance of signs of contact dermatitis at the site of application of the drug; rarely - the appearance of symptoms of bullous dermatitis ; extremely rarely - increased photosensitivity, the appearance of generalized skin rashes, eczema .
Impaired immune system : development of hypersensitivity reactions (in particular, angioedema ) and the appearance of shortness of breath (which, however, are observed in rare cases).
Attacks of bronchial asthma (in very rare cases).

Reactions from the stomach and intestinal tract after topical use of diclofenac sodium are considered extremely rare.

When using high doses of Diclak gel, as well as after applying it to too large areas of the body, the possibility of systemic adverse reactions and hypersensitivity reactions, which are expressed in the form of angioedema or dyspnea .

Diclak injection solution - instructions, composition, dosage, side effects of use

Diclak injection solution

Diclac solution for injection (Solutio Diclac pro injectionibus)

General characteristics:

international and chemical name: diclofenac; sodium salt of [2-(2,6-dichlorophenyl)-amino]-phenylacetic acid;

Basic physical and chemical characteristics : colorless, transparent solution;

Compound. 1 ml of solution includes 25 mg of diclofenac sodium);

other ingredients: benzyl alcohol, N-acetylcysteine, mannitol, sodium hydroxide, propylene glycol, purified water.

Release form of the medicine. Injection.

Pharmacotherapeutic group. Nonsteroidal anti-inflammatory and antirheumatic drugs. ATC code M01A B05.

Action of the medicine.

Pharmacodynamics. Diclak is a non-steroidal anti-inflammatory drug of the group of phenylacetic acid derivatives, which has pronounced antirheumatic, antipyretic, analgesic and anti-inflammatory properties due to the suppression of the synthesis of prostaglandins - mediators of pain and inflammation. The use of diclofenac helps to increase the range of motion in the affected joints, reduce pain at rest and during movement. In in vitro studies, at concentrations equivalent to those achieved in the treatment of patients, it does not inhibit the biosynthesis of cartilage tissue proteoglycans. Inhibits platelet aggregation.

Pharmacokinetics. After intramuscular administration, maximum plasma concentrations are reached within 10 to 20 minutes. High concentrations of the drug are observed in the blood, bile, liver, heart, lungs and kidneys; a small amount of the drug is excreted in mother's milk. In synovial fluid, the concentration of diclofenac is 30% lower than in plasma, but is determined longer than in plasma. The volume of distribution is 0.2 - 0.55 l/kg. Metabolized in the liver. Approximately 70% is excreted in the urine as pharmacologically inactive metabolites and almost 30% in the feces. Binding to blood proteins is almost 99%. The half-life is approximately 2 hours.

Indications for use. Inflammatory and degenerative diseases of the joints and spine: rheumatoid arthritis, ankylosing spondylitis (ankylosing spondylitis), osteoarthritis, spondyloarthrosis; rheumatic diseases of periarticular soft tissues; acute gouty arthritis; post-traumatic and postoperative pain and inflammation; symptomatic treatment of non-rheumatic inflammatory conditions that are accompanied by pain (primary dysmenorrhea or adnexitis; renal, intestinal and biliary colic).

Method of use and dose. For the treatment of acute conditions or relief of exacerbation of a chronic process, adults are prescribed 3 ml (which corresponds to 75 mg of diclofenac sodium) intramuscularly once a day, in some cases it is allowed 2 times a day. Subsequent therapy is continued using oral or rectal dosage forms. In this case, you should not exceed the maximum daily dose of diclofenac sodium (150 mg), even on the day of drug injection.

RAMIMED, Medochemie Ltd., Cyprus, Europe description and instructions for use of the drug.

Side effect. With regard to the following side effects, it should be taken into account that they are mainly dose-dependent and have significant differences in individuals. The risk of gastrointestinal bleeding (gastritis, erosion, ulcers) especially depends on the dose range and duration of use.

Pancreas. In some cases, the development of pancreatitis has been reported. Blood/blood vessels. In isolated cases, disturbances in the hematopoietic system (anemia, leukopenia, agranulocytosis, thrombocytopenia) may occur. The first symptoms may be: diarrhea, sore throat, flu-like symptoms, feeling of exhaustion, nosebleeds, skin hemorrhages. In some cases, the development of allergic vasculitis and hemolytic anemia was observed.

Gastrointestinal tract. Gastrointestinal disturbances, including nausea, vomiting, diarrhea and gastrointestinal bleeding, which in some cases may lead to anemia, are very likely. In some cases, manifestations of dyspepsia, abdominal cramps, anorexia, as well as the development of gastrointestinal ulcers (with the possibility of bleeding and perforation) are possible; Melena or bloody diarrhea is occasionally observed. The patient should be informed of the need to suspend treatment and immediately consult a doctor if the above manifestations occur. There are isolated reports about the development of stomatitis, glossitis, damage to the esophagus, disorders of the lower intestinal tract (including manifestations of Crohn's disease/ulcerative colitis), constipation, and the development of diaphragmatic-intestinal structures.

Leather. Rarely, hypersensitivity reactions may occur, including skin rash and itching, urticaria or alopecia. In some cases, bullous exanthema, eczema, erythema, photosensitivity, purpura (including allergic purpura) and severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) may occur.

The cardiovascular system. In some cases, the development of tachycardia, chest pain and increased or decreased blood pressure has been reported.

Liver. Rarely, increased levels of serum transaminases may occur. In some cases, liver damage is possible (hepatitis with or without jaundice, sometimes with a fulminant course, even without prodromal symptoms). Therefore, liver function indicators should be monitored during long-term use.

Respiratory system. Isolated cases of allergic pneumonia and pulmonitis were observed.

Nervous system. Rarely, disorders of the central nervous system may develop, including headache, agitation, irritability, weakness, drowsiness and dizziness. It is also possible to develop disturbances in sensitivity, including tactile or taste, visual function (blurred vision or diplopia), the appearance of ringing in the ears and reversible hearing impairment, memory impairment, disorientation, muscle twitching. Anxiety, nightmares, tremors, depression and other psychotic reactions have been observed.

Avil Retard - instructions, composition, dosage, side effects of use

Urinary system. Rarely, peripheral edema may occur, especially in patients with high blood pressure or impaired renal function. Also, rarely, damage to kidney tissue (interstitial nephritis, papillary necrosis) may occur, possibly with manifestations of acute renal failure, proteinaria and/or hematuria. In some cases, nephrotic syndrome may develop.

Allergic reactions. Severe allergic reactions may develop. They can manifest as swelling of the face, tongue and inner surface of the larynx with spasm of the respiratory tract, impaired respiratory function, and, among other things, asthmatic attacks, tachycardia, drops in blood pressure with a lightning-fast shock reaction. If one of these symptoms appears, which is always possible on first use, immediate medical attention should be given.

Other. In some cases, symptoms of aseptic meningitis may occur, including neck muscle tension, diarrhea, or confusion. Patients with autoimmune diseases (lupus erythematosus, mixed collagenosis) are prone to such reactions. At the injection site there is a sterile abscess and necrosis of subcutaneous fat.

Restrictions and contraindications in the use of the drug. Diclofenac sodium is contraindicated in cases of known hypersensitivity to the active ingredient or to any of the excipients; with existing disorders of the hematopoietic system; stomach or intestinal ulcers; with severe impairment of liver and kidney function; in the third trimester of pregnancy and during lactation; children and adolescents under 18 years of age.

Exceeding the permissible dose of the drug (overdose).

Symptoms. Symptoms of overdose may include disorders of the central nervous system: headache, dizziness, drowsiness and fainting. Abdominal pain, nausea and vomiting, gastrointestinal bleeding, and impaired liver and kidney function may also occur.

Treatment. A specific antidote is unknown. Treatment is symptomatic.

Features of use. Diclofenac can be used only with a thorough analysis of the risk/benefit comparison in the following cases: in the first and other trimesters of pregnancy, with advanced porphyria, in the presence of systemic lupus erythematosus (SLE) and mixed collagenoses (mixed connective tissue diseases).

Particularly careful medical observation is necessary in the case of gastrointestinal disorders and signs of gastric or intestinal ulcers or inflammatory processes in the intestines (ulcerative colitis, Crohn's disease) in the anamnesis; high blood pressure and/or heart failure; prior kidney damage; severe liver dysfunction; in older patients; immediately after major surgical interventions; in patients with coagulation disorders; in patients with symptoms of fever, nasal polyps or chronic obstructive pulmonary diseases, as well as in patients with hypersensitivity to other non-steroidal anti-inflammatory drugs. During treatment, especially long-term treatment, it is necessary to monitor liver and kidney function indicators, blood glucose levels (especially in patients with diabetes), and the condition of peripheral blood.

Fexofast - instructions, composition, dosage, side effects of use

Since the use of diclofenac sodium may cause side effects from the central nervous system, including weakness and dizziness, the ability to drive a car and operate machinery may be impaired in some cases. This is especially true when taking alcohol concomitantly.

Interaction with other drugs. Diclofenac sodium may reduce the effectiveness of ACE inhibitors. In addition, their combined use may increase the risk of developing renal dysfunction.

Medicines that contain probenecid may slow down the excretion of diclofenac sodium.

Concomitant use of diclofenac sodium and digoxin, phenytoin or lithium preparations may increase plasma concentrations of these drugs.

Diclofenac sodium may reduce the effectiveness of diuretics or antihypertensive drugs.

Concomitant use of diclofenac sodium and potassium-sparing diuretics may lead to hyperkalemia; in such cases, monitoring of plasma potassium levels is necessary.

The combined use of diclofenac sodium and other non-steroidal anti-inflammatory drugs or glucocorticoids increases the risk of side effects from the gastrointestinal tract.

The use of diclofenac sodium within 24 hours before or after taking methotrexate may lead to increased concentrations of methotrexate and, accordingly, its toxic effects.

Nonsteroidal antirheumatic drugs may increase the renal toxicity of cyclosporine.

In some cases, after using diclofenac sodium, changes in blood sugar levels are observed, which requires a corresponding adjustment of the dose of antidiabetic drugs. In general, appropriate monitoring of blood sugar is recommended when they are used concomitantly.

Features of conditions, shelf life and sales. . Keep out of the reach of children, in a dark place at a temperature of 15 to 25°C. Shelf life: 5 years.

Instructions for use of Diclak (Method and dose)

When treating with Diclak in any of its dosage forms, it is recommended to select the dose individually, using the lowest dose at which a positive clinical effect will be observed. In this case, the duration of the therapeutic course should be as short as possible.

Diclak in the form of enteric-soluble (gastro-resistant) tablets is prescribed to adults and adolescents over 15 years of age. The optimal daily dose in the initial stages of treatment is from 100 to 150 mg of diclofenac sodium.

If the clinical picture of the disease is characterized as mild, as well as in cases where long-term treatment with the drug is expected, a daily dose of 75 to 100 mg is considered sufficient. It is usually divided into two or three doses.

If it is necessary to take Diclac in a dose equivalent to 75 mg of diclofenac , the drug should be used with the appropriate dosage. The maximum permissible daily dose is equivalent to 150 mg of diclofenac .

For women with dysmenorrhea , Diclak is prescribed in a dose equivalent to 50-150 mg of diclofenac . In this case, the dose at the initial stages of treatment can vary from 50 to 100 mg. In cases where this is necessary, it can be increased over several menstrual cycles , but it should not exceed 200 mg per day.

It is recommended to start taking the drug when the first symptoms of pain . The duration of the therapeutic course depends entirely on the severity of clinical manifestations and usually lasts up to several days.

Enteric-soluble tablets are taken before meals, without chewing and with at least a glass of liquid.

Patients with minor and moderately severe impairment of the functional activity of the kidneys and/or liver do not require dose adjustment.

Diclak injection solution is prescribed in an individually selected dosage based on the characteristics of the course of the disease. The course of treatment should be as short as possible, and the dose should be the minimum effective.

Intramuscular injections of the drug are recommended for no more than two days in a row. pain relief is necessary, treatment is continued with Diclak tablets.

The daily dose of diclofenac sodium in the form of a solution for intramuscular injection is 75 mg (or one ampoule of Diclak). Injections should be done by inserting a needle deeply into the upper outer sector of the gluteal muscle .

In especially severe cases, characterized by severe pain, it is allowed to double the daily dose of the drug. An interval of at least several hours must be maintained between injections; the solution is injected alternately into the right and left gluteal muscles .

An alternative treatment regimen is also allowed, when instead of the second injection the patient is prescribed diclofenac sodium in some other dosage form. The dose is calculated so that it does not exceed 150 mg per day in total.

During migraine , it is recommended to inject Diclac as early as possible in a dose equivalent to 75 mg of diclofenac . Also on the same day, the drug can be used in the form of rectal suppositories (100 mg per day). The optimal dose on the first day of treatment with Diclak according to this regimen should not exceed 175 mg of diclofenac sodium per day.

Infusion use of Diclac involves administering the drug by bolus method. Depending on the duration of the procedure, the contents of one ampoule of the drug are mixed with a 9% sodium chloride solution or a 5% glucose solution, buffered with an 8.4% solution for infusion (sodium bicarbonate solution).

Typically, for these purposes, take from 100 to 500 ml of sodium chloride or glucose. Only clear solutions may be used.

For the treatment of moderate to severe postoperative pain, it is recommended to administer 75 mg of diclofenac sodium . The duration of the infusion is from half an hour to two hours.

If necessary, the procedure is repeated after a few hours, not forgetting that the maximum permissible dose of diclofenac sodium should not exceed 150 mg per day.

For preventive purposes after surgery, 15-60 minutes after surgery, the patient is administered 25 to 50 mg of diclofenac (the so-called loading dose of the drug). After this, a continuous infusion is prescribed (the rate should not exceed 5 mg/h) until a dose equivalent to 150 mg of diclofenac sodium .

The recommended dose of diclofenac in the form of Diclak ID modified-release tablets in the initial stages of treatment is from 75 to 150 mg per day (one or two tablets, depending on the intensity of pain).

If long-term treatment is intended, a daily dose equivalent to 75 mg of diclofenac .

For patients whose symptoms of the disease are more pronounced at night and in the morning, Diclak ID is prescribed to be taken in the evening, before bedtime.

The maximum permissible dose is 150 mg per day. The duration of the therapeutic course should not exceed two weeks. The decision on the duration of taking Diklak tablets is made by the attending physician, taking into account the severity of the clinical picture and the general condition of the patient.

The tablets are swallowed whole, without crushing first, and washed down with at least a glass of liquid. It is best to take them at the same time as meals.

Suppositories are prescribed for use in adult patients:

once a day in a dose equal to 100 mg of diclofenac ;
twice a day 50 mg;
three to four times a day, 25 mg.

The maximum permissible dose should not exceed 150 mg per day.

For adolescents over twelve years of age, the recommended dose of diclofenac in the form of suppositories is:

50-100 mg per day in one or two doses;
75 mg in two or three doses.

Diclak gel is intended for the treatment of adults and children over twelve years of age. It is recommended to apply the ointment twice or thrice a day in the amount necessary to treat the area affected by the pathological process.

For example, two to four grams of the drug (the volume of a cherry or a small walnut) is a sufficient dose to treat a skin area of 0.4 to 0.8 square meters. m). The gel should be applied in a thin layer, lightly rubbing into the skin.

After applying the drug, it is recommended to wash your hands thoroughly with soap. The exception is cases when this particular part of the hands is subject to treatment.

In accordance with the instructions for use, Diclak gel can be used simultaneously with the iontophoresis procedure (introduction of the drug into the body using direct galvanic current).

Thanks to this method of administration, the gel penetrates through the skin into much deeper layers and has a more pronounced therapeutic effect. The drug is applied under a negatively charged electrode.

The duration of the therapeutic course is determined based on data on the effectiveness of treatment. Usually it ranges from ten to fourteen days. Depending on the patient’s health condition, a decision may be made to repeat treatment (but not earlier than two weeks after the end of the first course).

In case of damage to soft tissues (including rheumatic origin), the drug is recommended to be used for no more than two weeks. The duration of treatment for patients whose pain is a consequence of arthritis is three weeks, unless otherwise determined by the attending physician.

In situations where the drug is used without a doctor’s prescription, and after seven days of treatment the patient does not experience any improvement in his condition, he should seek help from a medical facility.

Overdose

The typical picture of an overdose of diclofenac has not been described. If the dose recommended by the instructions is exceeded, the possibility cannot be excluded:

vomiting;
bleeding from the gastrointestinal tract ;
bowel disorders (in particular, diarrhea );
dizziness;
development of convulsive seizures;
headaches;
involuntary muscle contractions and twitching (so-called myoclonic spasms; this symptom is most often observed in children).

Diclofenac intoxication may cause symptoms of acute renal failure and liver .

As in cases of poisoning with other drugs from the group of non-steroidal anti-inflammatory drugs, treatment for diclofenac involves the appointment of a complex of supportive and symptomatic measures.

Such measures are necessary in cases where the patient:

blood pressure levels decrease ;
of renal failure occur ;
Various types of disorders of the gastrointestinal tract ;
respiratory function is weakened.

Specific measures involving the administration of detoxification therapy (for example, forced diuresis or hemosorption ) are considered inappropriate, since the active components of non-steroidal anti-inflammatory drugs are characterized by the ability to significantly bind to plasma proteins and undergo intensive metabolization.

When treated with Diclak gel, intoxication is considered an unlikely event, which is due to the low rates of systemic absorption of diclofenac after topical use of the drug.

In cases where the patient inadvertently swallowed a certain amount of gel, symptomatic treatment is prescribed, which involves taking sorbents, gastric and prescribing a set of measures used in the treatment of symptoms of poisoning with non-steroidal anti-inflammatory drugs.

Side effects of the drug Diclak gel

local side effects: skin reactions are sometimes noted (itching, hyperemia, exanthema, burning sensation, dry skin, urticaria). Systemic side effects may occur when the gel is used in high doses or applied to large areas of the skin. Isolated cases of gastrointestinal disorders, generalized exanthema, hypersensitivity reactions in the form of facial edema (angioedema) and dyspnea, as well as photosensitivity have been reported.

Interaction

The simultaneous administration of the drug Diclak with Digoxin , the antiepileptic drug Phenytoin , as well as with lithium preparations, can provoke an increase in the plasma concentrations of these drugs.

When Diclak is prescribed simultaneously with diuretics, a decrease in the therapeutic effectiveness of these drugs is observed.

When taking diclofenac with potassium-sparing diuretics, hyperkalemia may develop .

Simultaneous use with acetylsalicylic acid provokes a decrease in the plasma concentration of diclofenac . In addition, such a combination significantly increases the risk of developing unwanted side reactions.

Under the influence of diclofenac, the toxic effect on the kidneys of the antidepressant Cyclosporine .

Treatment with diclofenac can lead to the appearance of symptoms of hypo- or hyperglycemia , therefore, if it is necessary to prescribe them in combination with hypoglycemic agents, blood glucose levels should be constantly monitored .

When taking the cytostatic drug Methotrexate within 24 hours before or after taking diclofenac , it can lead to an increase in the plasma concentration of Methotrexate and an increase in the severity of its toxic effect.

If simultaneous administration with anticoagulants blood clotting parameters should be regularly monitored .

Diclak in gel form does not interact with other drugs (or this interaction is so insignificant that it is not taken into account). This is due to the fact that after topical use of the drug, its systemic absorption rates are characterized as extremely low.

Note!

The description of the drug Diklak on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use. Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug).

Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Reviews

For the most part, reviews of Diclak gel and other forms of this drug are similar to each other: almost all patients note the high effectiveness of the drug. However, after stopping the course of treatment, the symptoms of the disease often return again. Therefore, like its analogues, Diklak is considered primarily as a means for symptomatic therapy.

To completely eliminate the disease, the patient usually requires a thorough examination and elimination of the cause that provoked the development of the pathological process.

Price, where to buy

The price of Diklak gel is approximately 200 rubles per 50 gram tube. The price of ointment for a tube with a capacity of 100 grams averages 290-300 rubles.

The cost of the drug in the form of rectal suppositories is from 90 to 100 rubles. The price of Diklak tablets starts at approximately 65 rubles per pack of 10 pieces.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine

ZdravCity

Diklak gel 5% 50g Salutas Pharma GmbH
RUB 271 order
Diclak gel 5% 100gSalutas Pharma GmbH
RUR 386 order

Pharmacy Dialogue

Diclak gel (tube 5% 50g)Salutas Pharma GmbH
RUB 273 order
Diclak gel (tube 5% 100g)Salutas Pharma GmbH
RUB 404 order
Diclak gel (tube 5% 100g)Salutas Pharma GmbH
RUR 378 order
Diclak gel (tube 5% 50g)Salutas Pharma GmbH
RUB 263 order

Pharmacy24

Diklak 5% 100 g gel Salutas Pharma GmbH, Nimechchina
200 UAH.order
Diklak ID 150 mg N20 tablets Salutas Pharma GmbH, Nimecchina / Lek S.A. Poland
158 UAH order
Diclak 75 mg/3 ml N5 injection solution Lek pharmaceutical company d.d., Slovenia
90 UAH order
Diklak ID 75 mg No. 20 tablets Salutas Pharma GmbH, Nimechchina
98 UAH order
Diklak ID 150 mg No. 100 tablets Salutas Pharma GmbH, Nimecchina / Lek S.A. Poland
746 UAH order