Dexalgin 25

relief of pain syndrome of various origins (including postoperative, post-traumatic pain, pain with bone metastases, renal colic, algodismenorrhea, sciatica, sciatica, neuralgia, toothache),

symptomatic treatment of acute and chronic inflammatory, inflammatory-degenerative and metabolic diseases of the musculoskeletal system (including rheumatoid arthritis, spondyloarthritis, osteoarthritis, osteochondrosis).

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of application.

Inside, while eating.

Depending on the intensity of the pain syndrome, the recommended dose for adults is 12.5 mg (1/2 table).) every 4-6 hours or 25 mg (1 table.) every 8 hours, the maximum daily dose is 75 mg.

In elderly patients and patients with impaired liver and/or kidney function, therapy with Dexalgin^® 25 should start with lower doses. The maximum daily dose is 50 mg.

Dexalgin^® 25 is not intended for long-term therapy, the course of treatment with the drug should not exceed 3-5 days.

hypersensitivity to dexketoprofen or other NSAIDs, or any of the excipients that make up the drug,

peptic ulcer of the stomach and duodenum in the acute phase,

a history of gastrointestinal bleeding, other active bleeding (including suspected intracranial bleeding), anticoagulant therapy,

inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase,

severe liver function disorders (10-15 points on the Child-Pugh scale),

moderate or severe renal impairment (Creatinine Cl <50 ml / min),

complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis),

severe heart failure,

the period after coronary artery bypass grafting,

hemorrhagic diathesis or other coagulation disorders,

age up to 18 years (there are no data on the effectiveness and safety of the drug).

With caution: allergic reactions in the anamnesis, violation of the blood clotting system, systemic lupus erythematosus or mixed connective tissue diseases, simultaneous therapy with other drugs (see "Interaction"), a state of severe hypovolemia, ischemic heart disease, cerebrovascular diseases, diabetes mellitus, hyperlipidemia, peripheral artery diseases, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, long-term use of NSAIDs, alcoholism, heavy smoking, elderly age (over 65 years).

Possible side effects when using Dexalgin^® 25, as with other dexketoprofen drugs, are listed below in descending order of occurrence: frequently (1-10% of patients), infrequently (0.1–1% of patients), rarely (0.01–0.1% of patients), very rarely (less than 0.01% of patients), including individual reports.

From the blood and lymphatic system: very rarely — neutropenia, thrombocytopenia.

From the nervous system: infrequently-headache, dizziness, insomnia, drowsiness, rarely-paresthesia.

On the part of the senses: rare noise in the ears, very rarely — blurred vision.

From the CCC side: infrequently-a feeling of heat, hyperemia of the skin, rarely-extrasystole, increased blood pressure, very rarely-tachycardia, decreased blood pressure.

From the respiratory system: rarely-bradypnea, very rarely-bronchospasm, shortness of breath.

From the gastrointestinal tract: often-nausea, vomiting, abdominal pain, dyspepsia, diarrhea, infrequently-constipation, dry mouth, flatulence, rarely-erosive and ulcerative lesions of the gastrointestinal tract, bleeding from an ulcer or its perforation, anorexia, very rarely-damage to the pancreas.

From the liver and biliary tract: rarely-increased activity of liver enzymes (including AST and ALT), jaundice, very rarely-liver damage.

From the kidneys and urinary tract: rarely-polyuria, very rarely-nephritis or nephrotic syndrome.

On the part of the reproductive system: rarely-a violation of the menstrual cycle (in women), transient disorders of the prostate gland with prolonged use (in men).

From the musculoskeletal system: rarely-back pain, muscle spasm, difficulty moving in the joints.

From the skin and subcutaneous tissues: infrequently-dermatitis, rash, rarely-urticaria, acne, sweating, very rarely-severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome), angioedema, allergic dermatitis, photosensitization.

From the side of metabolism: rarely-hyperglycemia, hypoglycemia, hypertriglyceridemia.

From the laboratory data side: rarely-ketonuria, proteinuria.

From the general status side: infrequently-fever, fatigue, very rarely-anaphylactic shock, facial edema.

Other violations: infrequently — aseptic meningitis, which occurs mainly in patients with systemic lupus erythematosus or mixed connective tissue diseases, hematological disorders (purpura, aplastic and hemolytic anemia), rarely — agranulocytosis and bone marrow hypoplasia.

Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.

Treatment: symptomatic therapy, if necessary — gastric lavage, hemodialysis.

Dexketoprofen trometamol-the active substance of the drug Dexalgin^® 25-NSAIDs that have analgesic, anti-inflammatory and antipyretic effects. The mechanism of action is associated with the inhibition of PG synthesis at the level of COX-1 and COX-2.

Analgesic effect occurs 30 minutes after oral administration, the duration of therapeutic action reaches 4-6 hours.

In combination therapy with opioid analgesics dexketoprofen trometamol significantly (up to 30-45 %) reduces the need for opioids.

Suction. C_max after oral administration of dexketoprofen, trometamol is achieved in an average of 30 minutes (15-60 minutes). Simultaneous food intake slows down the absorption of the drug. AUC after single and repeated doses are similar, indicating that there is no accumulation of the drug.

Distribution. Dexketoprofen trometamol is characterized by a high level of binding to plasma proteins (99%). Average value of V_d is less than 0.25 l / kg, the half-life is about 0.35 hours.

Output. The main route of excretion of dexketoprofen is its conjugation with glucuronic acid, followed by renal excretion. T_1/2 dexketoprofen trometamol is 1.65 h. In the elderly, there is an elongation of T_1/2, an average of up to 48%, and a decrease in the total clearance of the drug.

• Nonsteroidal anti-inflammatory drugs (NSAIDs) [NSAIDs-Propionic acid derivatives]

The following interactions are typical for all NSAIDs.

Undesirable combinations

With other NSAIDs, including salicylates in high doses (more than 3 g/day): the simultaneous use of several NSAIDs due to the synergistic effect increases the risk of gastrointestinal bleeding and ulcers.

With oral anticoagulants, heparin, in doses exceeding the preventive ones, and ticlopidine: increased risk of bleeding due to inhibition of platelet aggregation and damage to the gastrointestinal mucosa.

With lithium preparations: NSAIDs increase the concentration of lithium in the blood, up to toxic, and therefore this indicator should be monitored when using, changing the dose and after the withdrawal of NSAIDs.

With methotrexate in high doses (15 mg / week or more): increased hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy.

With hydantoin and sulfonamides: the risk of increased toxic effects of these drugs.

Combinations that require caution

With diuretics, ACE inhibitors: therapy of NSAIDs is associated with the risk of acute renal insufficiency in dehydrated patients (reduction in glomerular filtration rate due to reduced synthesis of PG). NSAIDs may reduce the antihypertensive effect of certain medications.

With methotrexate in low doses (less than 15 mg / week): increased hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. It is necessary to conduct a weekly count of blood cells in the first weeks of simultaneous therapy. In the presence of impaired renal function, even in a mild degree, as well as in the elderly, careful medical supervision is necessary.

With serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline), oral glucocorticoids: increased risk of gastrointestinal bleeding.

With pentoxifylline: increased risk of bleeding. Intensive clinical monitoring and frequent checking of the bleeding time (blood clotting time) is necessary.

With zidovudine: the risk of increased toxic effects on red blood cells due to exposure to reticulocytes, with the development of severe anemia a week after the appointment of NSAIDs. It is necessary to conduct a general blood test with a count of the number of reticulocytes 1-2 weeks after the start of NSAID therapy.

With sulfonylurea derivatives: NSAIDs may increase the hypoglycemic effect of sulfonylurea due to its displacement from the sites of binding to plasma proteins.

With low-molecular-weight heparin preparations: increased risk of bleeding.

Combinations to take into account

With beta-blockers: NSAIDs can reduce the hypotensive effect of beta-blockers, which is due to the inhibition of the synthesis of PG.

With cyclosporine and tacrolimus: NSAIDs can increase nephrotoxicity, which is mediated by the action of renal PG. During simultaneous therapy, it is necessary to monitor kidney function.

With with thrombolytic drugs: increased risk of bleeding.

With probenecid: The concentrations of NSAIDs in the blood plasma may increase, which may be due to the inhibitory effect of probenecid on renal tubular secretion and/or conjugation with glucuronic acid, which requires dose adjustment of NSAIDs.

With cardiac glycosides: NSAIDs can lead to an increase in the concentration of glycosides in the blood plasma.

With mifepristone: Due to the theoretical risk of changes in the effectiveness of mifepristone under the influence of PG synthesis inhibitors, NSAIDs should not be prescribed earlier than 8-12 days after mifepristone withdrawal.

With quinolones: The data obtained in experimental animal studies indicate a high risk of seizures when using NSAIDs against the background of high-dose quinolone therapy.

In a dry place, protected from light, at a temperature not exceeding 25 °C.

Keep out of reach of children.

Do not use after the expiration date indicated on the package.

Film-coated tablets, 25 mg. According to 10 tables. in a contour cell package (white opaque PVC film/aluminum foil). 1 blister pack in a cardboard box.

Application of the drug Dexalgin^® 25 during pregnancy and lactation is contraindicated.

According to the recipe.

For patients with disorders of the gastrointestinal tract or gastrointestinal diseases in the anamnesis should be carefully monitored. In the event of gastrointestinal bleeding or ulcers, therapy with Dexalgin^® 25 should be canceled.

It is clinically proven that the simultaneous use of dexketoprofen and low-molecular-weight heparin preparations in prophylactic doses in the postoperative period does not change the clotting parameters. However, with the simultaneous use of the drug Dexalgin^® Together with other drugs that affect blood clotting, careful medical monitoring of the blood clotting system is necessary.

Like other NSAIDs, Dexalgin^® 25 may lead to an increase in the concentration of creatinine and nitrogen in the blood plasma. Like other PG synthesis inhibitors, Dexalgin^® 25 may have a side effect on the urinary system, which can lead to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure.

As in the case of other NSAIDs, against the background of therapy with Dexalgin^® 25 there may be a slight transient increase in some hepatic parameters, as well as a significant increase in the activity of AST and ALT in the blood serum. At the same time, monitoring of liver and kidney function is necessary in the elderly. In the case of a significant increase in the corresponding indicators of Dexalgin^® 25 should be canceled.

Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases. In case of detection of signs of infection or deterioration of health during therapy with Dexalgin^® 25 the patient should immediately consult a doctor.

Influence on the ability to drive vehicles and manage mechanisms. Due to possible dizziness and drowsiness during the administration of Dexalgin^® the ability to concentrate and the speed of psychomotor reactions in patients may decrease in the first hour after taking the drug. Therefore, during treatment with Dexalgin^® 25 caution should be exercised when driving vehicles and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

M01AE17 Dexketoprofen

• C40. 9 Malignant neoplasm of bones and articular cartilage of the extremities of unspecified localization
• K08. 8. 0* Toothache
• M06. 9 Rheumatoid arthritis, unspecified
• M19. 9 Osteoarthritis, unspecified
• M42 Spinal osteochondrosis
• M48. 9 Spondylopathy, unspecified
• M54. 1 Radiculopathy
• M54. 3 Sciatica
• M54. 9 Dorsalgia, unspecified
• M79. 2 Neuralgia and neuritis, unspecified
• N23 Renal colic, unspecified
• N94. 6 Dysmenorrhea, unspecified
• R52. 1 Persistent, uncoopable pain
• R52. 2 Other persistent pain
• R52. 9 Pain, unspecified
• T14. 9 Unspecified injury
• T88. 9 Complication of surgical and therapeutic intervention, unspecified

Round biconvex tablets, covered with a white film coating, with a risk on both sides of the tablet.