Dexalgin

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).

V/v, v/m.

Recommended dose for adults: 50 mg every 8-12 hours. If necessary, it is possible to re-administer the drug at intervals of 6 hours. The daily dose is 150 mg.

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

Dexalgin^® it is intended for short-term (no more than 2 days) use during acute pain syndrome. In the future, it is possible to transfer the patient to oral analgesics.

Technique of intravenous injection. The contents of 1 amp. (2 ml) are slowly injected deep into/m.

Technique of intravenous injection. If necessary, the contents of 1 amp. (2 ml) of the drug Dexalgin^® it can be administered by slow intravenous injection lasting at least 15 seconds.

The technique of the in/in infusion. The contents of 1 amp. (2 ml) are diluted in 30-100 ml of saline solution, glucose solution or Ringer's solution (lactate). The solution should be prepared under aseptic conditions and always protected from exposure to daylight. The dilute solution (should be transparent) is administered by slow intravenous infusion lasting 10-30 minutes.

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

peptic ulcer of the stomach and duodenum,

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

gastrointestinal diseases (Crohn's disease, ulcerative colitis),

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

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

bronchial asthma (including in the anamnesis),

severe heart failure,

treatment of pain syndrome in aortocoronary bypass surgery,

hemorrhagic diathesis or other coagulation disorders,

children's age.

Dexalgin^® it is contraindicated for non-araxial (epidural or subshell, intracellular) administration due to the ethanol that is part of the drug.

With caution: allergic conditions in the anamnesis, violation of the hematopoietic system, systemic lupus erythematosus or mixed connective tissue diseases, simultaneous therapy with other drugs (see "Interaction"), predisposition to hypovolemia, coronary heart disease, elderly age (over 65 years).

Possible side effects when using dexketoprofen trometamol, as with other dexketoprofen drugs, are listed below by descending frequency of occurrence: often (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 circulatory and lymphatic systems: rarely-anemia, very rarely-neutropenia, thrombocytopenia.

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

On the part of the senses: rarely, blurred vision, and rarely tinnitus.

From the CCC side: infrequently-arterial hypotension, feeling of heat, hyperemia of the skin, rarely-extrasystole, tachycardia, arterial hypertension, peripheral edema, superficial thrombophlebitis.

From the respiratory system: rarely-bradypnea, very rarely-bronchospasm, dyspnea.

From the gastrointestinal tract: often-nausea, vomiting, infrequently-abdominal pain, dyspepsia, diarrhea, constipation, hematemesis, dry mouth, rarely — erosive and ulcerative lesions of the gastrointestinal tract, including bleeding and perforation, anorexia, very rarely-pancreatic damage.

From the liver and gallbladder: rarely-increased activity of liver enzymes, jaundice, very rarely-liver damage.

From the urinary system: rarely-polyuria, renal colic, very rarely-nephritis or nephrotic syndrome.

On the part of the reproductive system: rarely-a violation of the menstrual cycle (in women), a violation of the function of the prostate gland (in men).

From the musculoskeletal system: rarely-muscle spasm, difficulty in movement in the joints.

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

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

On the part of laboratory parameters: rarely-ketonuria, proteinuria.

Local and general reactions: often-pain at the injection site, infrequently-inflammatory reaction, hematoma, hemorrhage at the injection site, feeling hot, chills, fatigue, rarely-back pain, fainting, fever, very rarely-anaphylactic shock, facial edema.

Other violations: 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, dialysis.

Dexketoprofen trometamol-the active substance of the drug Dexalgin^® - 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.

The analgesic effect occurs within 30 minutes after parenteral administration. The duration of the analgesic effect after administration at a dose of 50 mg is 4-8 hours.

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

Suction. C_max after intravenous administration of dexketoprofen, trometamol is achieved in an average of 20 minutes (10-45 minutes). The AUC after a single dose of 25-50 mg is proportional to the dose, both with intravenous and intravenous administration. The corresponding pharmacokinetic parameters are similar after a single and repeated I / m or I/v administration, which indicates the absence of 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-distribution time is about 0.35 h.

Output. The main route of elimination of dexketoprofen is its conjugation with glucuronic acid, followed by excretion through the kidneys. T_1/2 Dexketoprofen trometamol is about 1-2. 7 h. In the elderly, there is an elongation of T_1/2 (both after a single, and after repeated intravenous or intravenous administration), on average up to 48%, and a decrease in the total clearance of the drug.

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

Dexalgin^® do not mix in the same syringe with a solution of dopamine, promethazine, pentazocine, pethidine or hydroxyzine (a precipitate is formed).

Dexalgin^® it can be mixed in one syringe with a solution of heparin, lidocaine, morphine and theophylline.

Dexalgin^®, dilute solution for infusions, should not be mixed with promethazine or pentazocine.

Dexalgin^®, a dilute solution for infusions, is compatible with the following solutions for injection: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

When storing dilute solutions for infusions of the drug Dexalgin^® in plastic containers or when using infusion systems made of ethylvinyl acetate, cellulose propionate, LDPE or PVC, the absorption of the active substance by the listed materials does not occur.

The following interactions are typical for all NSAIDs.

Undesirable combinations

With other NSAIDs, including salicylates in high doses (more than 3 g / day): simultaneous administration 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 level of lithium in the blood, up to toxic, and therefore this indicator should be monitored when prescribing, 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 sulfonamide preparations: the risk of increasing the toxic effect of these drugs.

Combinations that require caution

With diuretics, ACE inhibitors: NSAID therapy is associated with the risk of acute renal failure in dehydrated patients (reduced glomerular filtration due to reduced PG synthesis). NSAIDs may reduce the antihypertensive effect of certain medications. When concomitantly prescribed with diuretics, it is necessary to make sure that the patient's water balance is adequate, and to monitor kidney function before prescribing NSAIDs.

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 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 count all blood cells and reticulocytes 1-2 weeks after the start of NSAID therapy.

With sulfonamide preparations: 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: plasma concentrations of NSAIDs may increase, which may be due to an inhibitory effect 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 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 ciprofloxacin: data obtained in experimental animal studies indicate a high risk of convulsions when NSAIDs are prescribed against the background of high-dose ciprofloxacin therapy.

In a 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.

Solution for intravenous and intramuscular administration, 25 mg / ml. 2 ml of the drug in ampoules of dark glass (type I) with a white dot in the upper part of the ampoule. 5 amp. in a contour plastic package (pallet) in a cardboard pack.

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

According to the recipe.

In patients with gastrointestinal disorders or a history of gastrointestinal diseases, constant monitoring is necessary. In the event of gastrointestinal bleeding or ulcers, therapy with Dexalgin^® it should be canceled.

Since all NSAIDs can inhibit platelet aggregation and increase bleeding time due to slowing down the synthesis of PG, in controlled clinical trials, the simultaneous administration of dexketoprofen trometamol and low-molecular-weight heparin drugs in prophylactic doses in the postoperative period was studied. No effect on the coagulation parameters was observed. However, with the simultaneous administration of the drug Dexalgin^® with other drugs that affect blood clotting, careful medical monitoring is necessary.

Like other NSAIDs, Dexalgin^® it can lead to an increase in the level of creatinine and nitrogen in the blood plasma. Like other PG synthesis inhibitors, Dexalgin^® it can 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^® there may be a slight transient increase in some hepatic parameters, as well as a significant increase in the level of AST and ALT in the blood serum. At the same time, monitoring of hepatic and renal functions is necessary in the elderly. In the case of a significant increase in the corresponding indicators of Dexalgin^® it should be canceled.

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

In each ampoule of the drug Dexalgin^® contains 200 mg of ethanol.

Influence on the ability to drive vehicles and manage mechanisms. Due to possible dizziness and drowsiness during the administration of Dexalgin^® the ability to concentration of attention and quickness of psychomotor reactions in patients may be reduced.

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

Transparent colorless solution with a characteristic smell of alcohol.