Diklak
Diklak: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Diclac
ATX code: M02AA15
Active ingredient: diclofenac (diclofenac)
Producer: Salutas Pharma (Germany), RubiePharm Arzneimittel GmbH (Germany)
Description and photo updated: 2019-27-08
Prices in pharmacies: from 160 rubles.
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Diclac is a non-steroidal anti-inflammatory drug with antipyretic and analgesic effects.
Release form and composition
Dosage forms:
- Solution for intramuscular (i / m) administration: colorless or yellowish transparent liquid without foreign inclusions (3 ml each in colorless glass ampoules, 5 ampoules in a cardboard box);
- Rectal suppositories: torpedo-shaped with a smooth surface from white to cream in color, odorless, with a longitudinal section - a homogeneous structure without inclusions (5 pcs. In a strip, in a cardboard box 2, 6 or 10 strips);
- Prolonged-release tablets: round flat form with a smooth surface of two layers of pink and white, bevel on both sides (10 pcs. In blisters, in a cardboard box 1, 2, 5 or 10 blisters);
- Gel for external use 5%: colorless or slightly yellow transparent homogeneous consistency with a characteristic smell of isopropyl alcohol, does not contain bubbles (50 or 100 g in an aluminum tube, in a cardboard box 1 tube).
Each pack also contains instructions for the use of Diklak.
The active ingredient is diclofenac sodium:
- 1 ampoule - 75 mg;
- 1 suppository - 50 mg, 100 mg;
- 1 tablet - 75 mg, 150 mg;
- 1 g of gel - 50 mg.
Auxiliary components:
- Solution for i / m administration: benzyl alcohol, N-acetylcysteine, mannitol, propylene glycol, sodium hydroxide, water for injection;
- Suppositories: solid fat base;
- Tablets: magnesium stearate, methylhydroxypropylcellulose, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, calcium hydrogen phosphate dihydrate, colloidal silicon dioxide, corn starch, iron oxide red;
- Gel: macrogol-7-glyceryl cocoate, aromatic oil, isopropyl alcohol, hypromellose, purified water.
Pharmacological properties
Pharmacodynamics
Diclofenac - the active substance of Diclac, has anti-inflammatory, analgesic and antipyretic effects, is a non-steroidal anti-inflammatory agent. Indiscriminately inhibits COX-1 and COX-2 (cyclooxygenase-1 and -2), reduces the number of prostaglandins in the focus of inflammation, disrupts the metabolism of arachidonic acid.
The analgesic and anti-inflammatory effect of diclofenac in rheumatic diseases helps to reduce the severity of pain, swelling of the joints, morning stiffness. This leads to an improvement in the functional state of the joint. In the postoperative period and in trauma, diclofenac reduces inflammatory edema and pain.
Pharmacokinetics
Suction:
- Injection solution: after i / m administration of 75 mg of diclofenac, C max (maximum concentration of the substance) in blood plasma is in the range from 1.9 to 4.8 μg / ml (on average - 2.7 μg / ml) and is achieved in 15 -30 minutes. Plasma concentration 3 hours after administration is on average 10% of C max;
- Rectal suppositories: after administration of 50 mg of diclofenac, C max in blood plasma is 1 μg / ml and is reached in 30–40 minutes;
- Tablets: after oral administration, diclofenac is absorbed quickly and completely, food slows down the absorption rate for 1–2 hours and halves the value of C max. The time to reach C max in case of taking Diclac with food is on average 5–6 hours;
- Gel: no information available.
The substance binds to plasma proteins at a level of more than 99% (most of the dose is bound to albumin). V d (volume of distribution) is 550 ml / kg.
Diclofenac penetrates into the synovial fluid. In synovial fluid, C max is reached 2–4 hours later than in plasma. T 1/2 (half-life) from the synovial fluid is 3–6 hours (4–6 hours after administration, the concentration of the substance in the synovial fluid is higher than the plasma concentration and remains higher for another 12 hours). The relationship between the concentration of Diclac in the synovial fluid and its clinical efficacy has not been identified.
Against the background of repeated administration, a change in the pharmacokinetic parameters of diclofenac is not observed, it is not cumulated in the body. The substance is excreted in breast milk.
1/2 dose of diclofenac is metabolized during the first passage through the liver. Metabolism is carried out by single or multiple conjugation and hydroxylation with glucuronic acid. The isoenzyme CYP2C9 takes part in the metabolism of the substance. Metabolites in comparison with diclofenac have a lower pharmacological activity.
T 1/2 from plasma is 2 hours. Systemic clearance - 350 ml / min. Excretion of 65% of the administered dose occurs by the kidneys in the form of metabolites, up to 1% is excreted as an unchanged substance, the rest of the dose is excreted with bile in the form of metabolites.
With severe renal failure in patients with creatinine clearance less than 10 ml / min, the excretion of metabolites in the bile increases, while an increase in their concentration in the blood is not observed.
Indications for use
The use of Diklak in the form of a solution (for short-term therapy of pain syndrome), suppositories and tablets is shown:
- Diseases of the musculoskeletal system: psoriatic, juvenile chronic arthritis, rheumatoid arthritis, ankylosing spondylitis; rheumatic lesions of soft tissues, gouty arthritis, osteoarthritis of the spine and peripheral joints, including those with radicular syndrome, bursitis, tendovaginitis;
- Mild or moderate pain syndrome with neuralgia, myalgia, lumboischialgia, algodismenorrhea, adnexitis, proctitis, migraine, headache and toothache, with pain after surgery, with post-traumatic pain syndrome that occurs with inflammation;
- Febrile syndrome;
- As part of the complex treatment of tonsillitis, pharyngitis, otitis media and other infectious and inflammatory diseases of the upper respiratory tract with severe pain.
Application of Diklak gel is shown:
- Diseases of the musculoskeletal system, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine;
- Rheumatic lesions of soft tissues;
- Muscle pains of non-rheumatic and rheumatic genesis;
- Traumatic soft tissue injuries.
Contraindications
- Aspirin bronchial asthma;
- Breastfeeding period;
- Hypersensitivity to the components of Diclac;
- Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
In addition, a contraindication to the use of Diclac in the form of a solution, suppositories and tablets are:
- Exacerbation of erosive and ulcerative lesions of the gastrointestinal tract (GIT);
- Bleeding from the gastrointestinal tract;
- Hematopoietic disorders;
- Hemophilia, and other disorders of hemostasis;
- Pregnancy period;
- Age up to 15 years - suppositories 50 mg;
- Age up to 18 years - solution for intramuscular injection, suppositories 100 mg, tablets.
The use of suppositories for hemorrhoids, rectal bleeding, inflammation or trauma of the rectum is prohibited.
Diklac should be prescribed with caution to patients with hepatic and renal failure, anemia, congestive heart failure, with edema syndrome, arterial hypertension, bronchial asthma, inflammatory bowel diseases, erosive and ulcerative lesions of the gastrointestinal tract during remission, with diabetes mellitus, diverticulitis, induced porphyria systemic diseases of the connective tissue, with alcoholism, condition after extensive surgical interventions, in elderly patients.
The use of Diklak gel is contraindicated in case of violation of the integrity of the skin, in the third trimester of pregnancy, for children under 6 years of age.
It is recommended to use Diclac gel with caution in chronic heart failure, exacerbation of hepatic porphyria, erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, in bronchial asthma, in the I and II trimesters of pregnancy, in elderly patients.
Diklak, instructions for use: method and dosage
- Solution for intramuscular injection: injected deeply in a single dose of 75 mg (1 ampoule). If necessary, re-introduction is possible only after 12 hours. IM injections are carried out for no more than 2 days. If necessary, therapy should be continued with the use of diclofenac in the form of suppositories or tablets;
- Suppositories: used rectally after bowel movement. Adults and adolescents aged 15 to 18 years, suppositories of 50 mg are prescribed 1 pc. 2-3 times a day. Suppositories of 100 mg are prescribed for adults 1 pc. Once a day. The course of treatment is no more than 7 days. The maximum daily dose is 150 mg. In the case of simultaneous use with diclofenac in the form of tablets, suppositories of 50-100 mg, it is advisable to apply once before bedtime, excluding the evening intake of the drug inside;
- Tablets: taken orally, without chewing, during or after meals, with a little water. Dosage - 75 mg Diklak tablets are prescribed 1-2 times a day, 150 mg - 1 time per day. The maximum daily dose of the drug is 150 mg;
- Gel: applied externally, applying to the skin of painful areas of the body and rubbing with light movements, the procedure is carried out 2-3 times a day. A single dose of Diclac should not exceed 2 g, which corresponds to 4 cm of the squeezed out gel from the completely open mouth of the tube. The treatment period depends on the clinical indications and the therapeutic effect. If it is necessary to extend treatment after 2 weeks of therapy, the patient should consult with the attending physician. It is recommended to wash your hands thoroughly after each application of the gel.
Side effects
The use of Diclac in the form of a gel, suppositories and tablets can cause side effects (> 1% - often, <1% - infrequently):
- From the digestive system: often - nausea, abdominal pain, flatulence, diarrhea or constipation, increased activity of hepatic transaminases, peptic ulcer with possible complications such as bleeding, perforation, bleeding in the gastrointestinal tract; infrequently - vomiting, dry mucous membranes (including the mouth), aphthous stomatitis, impaired appetite, jaundice, lesions of the esophagus, blood in the stool, melena, hepatitis (can occur in fulminant form), liver necrosis, cirrhosis, hepatorenal syndrome, colitis, pancreatitis, cholecystopancreatitis;
- From the side of the cardiovascular system: infrequently - extrasystole, increased blood pressure, chest pain, congestive heart failure;
- From the side of the nervous system: often - dizziness, headache; infrequently - sleep disturbance, nightmares, drowsiness, depression, irritability, aseptic meningitis (more often in patients with systemic connective tissue diseases, including systemic lupus erythematosus (SLE)), convulsions, disorientation, weakness, fear;
- From the urinary system: often - fluid retention; infrequently - interstitial nephritis, nephrotic syndrome, oliguria, proteinuria, hematuria, acute renal failure, papillary necrosis, azotemia;
- From the senses: often - tinnitus; infrequently - taste disturbance, diplopia, blurred vision, hearing loss (temporary or irreversible), scotoma;
- From the hematopoietic system: infrequently - leukopenia, anemia (including aplastic and hemolytic), thrombocytopenia, thrombocytopenic purpura, eosinophilia, agranulocytosis;
- Dermatological reactions: often - itching, rash; infrequently - urticaria, alopecia, eczema, punctate hemorrhages, toxic dermatitis, Lyell's syndrome (toxic epidermal necrolysis), exudative erythema multiforme (including Stevens-Johnson syndrome); photosensitivity;
- From the respiratory system: infrequently - cough, laryngeal edema, bronchospasm, pneumonitis;
- Allergic reactions: infrequently - anaphylactoid reactions, swelling of the lips and tongue, anaphylactic shock (usually developing rapidly), allergic vasculitis;
- Others: infrequently - the development of necrotizing fasciitis caused by a worsening of infectious processes.
The undesirable effects of using Diclac in the form of a gel can be:
- Systemic reactions: allergic reactions in the form of urticaria, angioedema, bronchospastic reactions; generalized skin rash;
- Local reactions: eczema; contact dermatitis (redness, itching, swelling of the body area at the site of application of the gel, vesicles, papules, peeling); photosensitivity.
Overdose
Tablets, solution, suppositories
The main symptoms: blurred consciousness, vomiting, headache, dizziness, shortness of breath; in children - myoclonic convulsions, abdominal pain, nausea, impaired renal and liver function, bleeding.
Therapy: gastric lavage, intake of activated charcoal, symptomatic treatment, forced diuresis. Hemodialysis is ineffective.
Gel
Overdose with external use of diclofenac is almost impossible, which is associated with extremely low systemic absorption.
special instructions
During the period of use of suppositories and Diklac tablets, it is recommended to carry out systematic monitoring of liver and kidney function, peripheral blood patterns, and feces for the presence of blood.
When taking Diclac, alcohol should be excluded.
Application of the gel is allowed only on intact skin areas; it is not recommended to use an occlusive dressing. Avoid contact of the gel on open wounds and mucous surfaces of the body.
Influence on the ability to drive vehicles and complex mechanisms
During the period of using Diklak in the form of a solution, suppositories, tablets, patients need to refrain from those activities, the implementation of which requires quick psychomotor reactions and increased concentration of attention.
Application during pregnancy and lactation
- pregnancy: solution, suppositories, tablets - Diklac is contraindicated; gel - in the third trimester of pregnancy, therapy is contraindicated, in I and II - it is possible to use it under medical supervision;
- lactation period: Diclac in all dosage forms is contraindicated.
Pediatric use
Contraindication:
- gel - up to 6 years;
- suppositories of 50 mg - up to 15 years;
- solution for intramuscular injection, suppositories of 100 mg, tablets - up to 18 years.
With impaired renal function
In severe renal impairment (renal failure), Diclac should be used with caution.
For violations of liver function
In case of exacerbation of hepatic porphyria and severe impairment of hepatic function, Diclac should be used with caution.
Use in the elderly
Diclac therapy in elderly patients should be carried out under medical supervision.
Drug interactions
Clinically significant interaction with other drugs refers to Diklac in the form of a solution, suppositories and tablets.
Taking Diclac increases the plasma concentration of methotrexate, digoxin, cyclosporine and lithium preparations.
Reduces the effect of diuretic, hypoglycemic, antihypertensive and hypnotics.
When using Diclac against the background of anticoagulants and thrombolytic agents, bleeding may occur, more often from the gastrointestinal tract.
Diclac increases the likelihood of developing side effects of other non-steroidal anti-inflammatory drugs and glucocorticosteroids (GCS) (bleeding from the gastrointestinal tract), nephrotoxicity of cyclosporine, toxicity of methotrexate.
When combined with acetylsalicylic acid, the concentration of diclofenac in the blood decreases.
While taking Diklak:
- Potassium-sparing diuretics - increase the risk of hyperkalemia;
- Paracetamol - increases the risk of nephrotoxic effects of diclofenac;
- Cefoperazone, cefamandol, cefotetan, plikamycin and valproic acid - increase the likelihood of developing hypoprothrombinemia;
- Gold preparations and cyclosporine - increase nephrotoxicity;
- Drugs that block tubular secretion - increase the level of concentration in the blood plasma of diclofenac, increasing its toxicity;
- Ethanol, colchicine, corticotropin and St. John's wort preparations increase the risk of gastrointestinal bleeding.
The use of all dosage forms of Diclac enhances the effect of drugs that cause photosensitivity.
Analogs
Diclofenac's analogs are: Diclofenac, Dicloran, Diclofenac, Diclofenac Retard, Diclofenac-Akos, Diclofenac-Eskom, Diclofenac-Altpharm, Voltaren, Voltaren Emulgel, Ortofen,
Terms and conditions of storage
Store at temperatures up to 25 ° C, solution and suppositories protected from light. Keep out of the reach of children.
Shelf life: solution for intramuscular injection, 50 mg suppositories, tablets, gel - 3 years; suppositories of 100 mg - 5 years.
Terms of dispensing from pharmacies
Tablets, solution, and suppositories are available with a prescription. The gel is sold without a prescription.
Reviews about Diklak
According to reviews, Diklak is an effective pain reliever and anti-inflammatory agent. The development of side effects is rarely reported. The gel is most often characterized as a drug that has a quick effect. Its disadvantages include a short and / or insufficient effect, an unpleasant odor, and the fact that the gel rolls off the skin.
Diklak price in pharmacies
The approximate price for Diklak is: gel (1 tube of 50 or 100 g) - 208-260 or 333-356 rubles, rectal suppositories (10 pcs. 50 mg each) - 58-70 rubles, tablets (10 pcs.) - 52-73 rubles.
Diklak: prices in online pharmacies
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Drug name Price Pharmacy |
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Diclac 5% gel for external use 50 g 1 pc. RUB 160 Buy |
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Diklak gel 5% 50g 279 r Buy |
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Diclac 5% gel for external use 100 g 1 pc. 344 r Buy |
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Diklak gel 5% 100g 351 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
