Dexalgin sachet granules oral. solution 25 mg package No. 10

Contraindications

• hypersensitivity to dexketoprofen, any other NSAID (NSAID) or to the excipients of the drug;
• if substances of similar action, for example acetylsalicylic acid or other NSAIDs, provoke the development of asthma attacks, bronchospasm, acute rhinitis or cause the development of nasal polyps, urticaria or angioedema;
• if photoallergic and phototoxic reactions were known during treatment with ketoprofen or fibrates;
• history of gastrointestinal bleeding or perforation associated with previous NSAID therapy;
• active phase of peptic ulcer/gastrointestinal bleeding or gastrointestinal bleeding, peptic ulcer, history of perforation;
• chronic dyspepsia;
• other bleeding in the active phase or increased bleeding;
• Crohn's disease or ulcerative colitis;
• severe heart failure;
• moderate to severe renal impairment (creatinine clearance ≤ 59 ml/min);
• severe liver dysfunction (10-15 points on the Child-Pugh scale);
• with hemorrhagic diathesis and other blood clotting disorders;
• for severe dehydration caused by vomiting, diarrhea, or insufficient fluid intake;
• III trimester of pregnancy and lactation.

Use of the drug Dexalgin injection

Injected deeply intramuscularly, intravenously in a slow stream (duration of administration - at least 15 s) or intravenously by drip over 10-30 minutes. To prepare a solution of the drug Dexalgin Inject for intravenous infusion, use 30–100 ml of isotonic sodium chloride solution, glucose solution or Ringer's solution. The finished solution should be transparent and colorless; it must be protected from exposure to daylight. Adults The recommended dosage regimen is 50 mg of the drug every 8–12 hours. If necessary, a repeat dose can be administered at 6-hour intervals. The daily dose should not exceed 150 mg. Dexalgin Injection is intended for short-term use, and treatment should be limited to the period of acute symptoms (no more than 2 days). If possible, patients should be switched to an oral dosage form of the drug. Elderly patients Dose adjustment for this age category of patients is usually not required, however, due to the physiological age-related decline in renal function, it is recommended to prescribe the drug in lower doses in the presence of mild renal failure: the total daily dose in this case should not exceed 50 mg. Liver dysfunction: In patients with mild to moderate liver dysfunction (Child-Pugh score 5–9), the total daily dose should be reduced to 50 mg and liver function tests should be monitored frequently. Dexalgin Injection should not be prescribed to patients with severe liver dysfunction. Renal impairment For patients with mild renal impairment (creatinine clearance 50–80 ml/min), the daily dose is reduced to 50 mg. Dexalgin Injection should not be prescribed to patients with moderate or severe renal failure (creatinine clearance ≤50 ml/min). The diluted solution of the drug Dexalgin Inject is chemically stable for 24 hours, provided it is stored at a temperature of 25 ° C in a place protected from light. The solution of the drug must be used immediately after preparation. However, if it is not used immediately, medical personnel are responsible for the time and conditions of its storage until use. Typically, such a solution is stored for no more than 24 hours at a temperature of 2–8 ° C in a place protected from light, provided that the dilution was carried out under controlled and validated aseptic conditions. When storing diluted solutions of the drug Dexalgin Inject in plastic containers or when using infusion systems made of ethyl vinyl acetate, cellulose propionate, low-density polyethylene or polyvinyl chloride, absorption of the active component by these materials does not occur.

Mode of application

The recommended dose for adults is 25 mg every 8 hours. The maximum daily dose should not exceed 75 mg. Side effects can be reduced by using the lowest effective dose for the shortest time required to achieve improvement.

Before use, dissolve the entire contents of 1 packet in 1 glass of water and mix well for better dissolution. The resulting solution should be taken immediately after preparation.

The drug Dexa-Zdorovye is intended only for short-term use necessary to eliminate symptoms.

Use along with food slows down absorption, so for acute pain it is recommended to take the drug at least 15 minutes before meals.

Side effects of the drug Dexalgin injection

Possible side effects from the use of the drug, grouped by organ system and frequency of occurrence (common - 1-10%, infrequent - 0.1-1%, rare - 0.01-0.1%, very rare - ≤0.01% ), are given in the table:

The following side effects are also possible, as they are described for other NSAIDs, and may be associated with inhibition of prostaglandin synthesis: aseptic meningitis, occurring mainly in patients with systemic lupus erythematosus or connective tissue diseases; hematological disorders (thrombocytopenic purpura, aplastic anemia and rarely - agranulocytosis and bone marrow hypoplasia).

Interaction

Other NSAIDs, including selective cyclooxygenase-2 inhibitors and salicylates in high doses (≥3 g/day). With the simultaneous use of several NSAIDs, the risk of ulcers in the digestive tract and gastrointestinal bleeding increases due to their mutual enhancement of action.

Anticoagulants NSAIDs enhance the effect of anticoagulants, such as warfarin, due to the high degree of binding of dexketoprofen to plasma proteins, as well as inhibition of platelet function and damage to the mucous membrane of the stomach and duodenum. If simultaneous use is necessary, it should be under medical supervision and monitoring of appropriate laboratory parameters.

Heparin increases the risk of bleeding (inhibition of platelet function and damage to the mucous membrane of the stomach and duodenum). If simultaneous use is necessary, it should be carried out under medical supervision with monitoring of appropriate laboratory parameters.

Pharmacological properties of the drug Dexalgin injection

Dexketoprofen trometamol is the trometamol salt of S-(+)-2-(3-benzoylphenyl)propionic acid. The drug has analgesic, anti-inflammatory and antipyretic properties, the mechanism of which is associated with a decrease in the synthesis of prostaglandins due to inhibition of COX. Dexketoprofen trometamol has an inhibitory effect on the activity of COX-1 and COX-2. Studies performed on several pain models have demonstrated its effective analgesic effect. The analgesic effectiveness of dexketoprofen trometamol with intramuscular and intravenous administration was studied to control moderate and intense pain after abdominal surgery, as well as in orthopedic and gynecological practice, for acute pain associated with pathology of the musculoskeletal system and pain in renal colic. . In the studies conducted, a rapid onset of analgesic action was noted, with the maximum effect achieved within 45 minutes. The duration of the analgesic effect after administration of dexketoprofen at a dose of 50 mg was, as a rule, 8 hours. The use of the drug in combination with opioid analgesics made it possible to significantly reduce the need for the latter. In a postoperative pain management study in which patients received morphine using a self-monitoring analgesia device, administration of dexketoprofen resulted in a significant reduction in morphine requirements (30–45%) compared with placebo. With intramuscular administration of dexketoprofen trometamol, the maximum plasma concentration is achieved on average after 20 minutes (range 10–45 minutes). The AUC value after a single dose of 25–50 mg remains proportional to the dose for both IM and IV administration. The results of pharmacokinetic studies with repeated administration indicate that the AUC and maximum concentration after the last injection did not differ from the values ​​​​obtained with a single dose, indicating the absence of accumulation of the drug. Similar to other drugs with a high (99%) level of binding to plasma proteins, the average volume of distribution is ≤0.25 l/kg body weight. The half-life of distribution is approximately 0.35 hours, the half-life is 1–2.7 hours. The main route of elimination of dexketoprofen is its conjugation with glucuronic acid with further excretion by the kidneys. After excretion of dexketoprofen trometamol, only the S (+) enantiomer is detected in the urine, indicating the absence of conversion to the R (–) enantiomer in the human body. In elderly people, the average half-life after single and repeated administrations is increased (up to 48%), and the overall clearance of the drug is reduced.

Note!

Description of the drug Dexalgin sachet granules d/oral. solution 25 mg package No. 10 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.

Special instructions for the use of Dexalgin injection

Dexalgin Injection cannot be administered neuraxially, epidurally, or into the intrathecal space due to its ethanol content. The drug should be prescribed with caution to patients with a history of allergies. Persons with symptoms of gastrointestinal disorders or a history of gastrointestinal diseases require medical supervision, especially in case of gastrointestinal bleeding. In those isolated cases when gastrointestinal bleeding develops in patients taking dexketoprofen, the drug is immediately discontinued. NSAIDs can inhibit platelet aggregation and increase bleeding time. The simultaneous use of dexketoprofen and low molecular weight heparin drugs in prophylactic doses in the postoperative period was studied during clinical trials. No effect on coagulation parameters was detected. Despite this, careful monitoring of patients who simultaneously take Dexalgin Inject and other drugs that affect blood clotting is necessary. Like other NSAIDs, Dexalgin Inject can cause an increase in the level of creatinine and nitrogen in the blood plasma, have a negative effect on the urinary system, leading to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. As with the use of other NSAIDs, there may be a slight transient increase in the parameters of some liver tests, a significant increase in the activity of glutamino-oxaloacetic and glutaminopyruvic transaminases in the blood serum. Dexalgin Injection should be prescribed with caution to patients with hematopoietic disorders, patients with systemic lupus erythematosus or other connective tissue diseases. Like other NSAIDs, Dexalgin Inject can mask the symptoms of infectious diseases. Isolated cases of exacerbation of infectious processes localized in soft tissues have been reported when using NSAIDs. Therefore, medical supervision is required for patients with signs of bacterial infection or worsening of their condition during treatment with dexketoprofen. Caution should be exercised when prescribing the drug to patients with impaired liver, kidney, heart function or with conditions that may cause fluid retention in the body. In these patients, the use of NSAIDs can lead to worsening of the condition and fluid retention in the body. Caution should also be exercised when prescribing dexketoprofen to patients using diuretics or predisposed to hypovolemia, since they have an increased risk of developing nephrotoxicity. Caution is necessary when prescribing the drug to elderly people, as they are more likely to experience adverse reactions, such as gastrointestinal bleeding or intestinal perforation. The risk of developing these reactions depends on the dose of the drug; they can occur at any stage of treatment, often in a more severe form without warning symptoms and without a history of such disorders. Elderly patients are more likely to have impaired renal, liver or cardiovascular function, so their condition must be regularly monitored. Due to possible dizziness and drowsiness, dexketoprofen may impair the ability to drive vehicles and operate machinery. The effectiveness and safety of dexketoprofen in children has not been studied, so it should not be prescribed to children.