Dexalgin® 25 (Dexalgin® 25)

Contraindications

• hypersensitivity to the active substance or to any other NSAID (NSAID), or to any of the excipients;
• use in patients in whom substances with a similar mechanism of action, for example acetylsalicylic acid and other NSAIDs, cause attacks of bronchial asthma, bronchospasm, acute rhinitis or lead to the development of nasal polyps, urticaria or angioedema;
• known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates;
• a history of bleeding or perforation in the digestive tract associated with taking NSAIDs;
• active phase of peptic ulcer/bleeding in the digestive tract, recurrent course of peptic ulcer/bleeding in the digestive tract in the anamnesis;
• chronic dyspepsia;
• bleeding in the active phase or increased bleeding;
• Crohn's disease or ulcerative colitis;
• severe heart failure;
• moderate or severe renal impairment (creatinine clearance ≤ 59 ml/minute);
• severe liver dysfunction (10-15 points on the Child-Pugh scale);
• hemorrhagic diathesis or other bleeding disorders;
• severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake);
• III trimester of pregnancy and breastfeeding period.

Dexalgin

The following drug interactions are typical for all NSAIDs, including Dexalgin®.

Undesirable combinations

The simultaneous administration of several NSAIDs, including salicylates in high doses (more than 3 g / day), increases the risk of gastrointestinal bleeding and ulcers due to the synergy of action.

When used simultaneously with oral anticoagulants, heparin in doses exceeding prophylactic doses, and ticlopidine, the risk of bleeding increases due to inhibition of platelet aggregation and damage to the gastrointestinal mucosa.

NSAIDs increase the concentration of lithium in the blood plasma, up to toxic levels, and therefore this indicator must be monitored when prescribing, changing the dose and after discontinuation of NSAIDs.

When used with methotrexate in high doses (15 mg/week or more), the hematological toxicity of methotrexate increases due to a decrease in its renal clearance during NSAID therapy.

When used simultaneously with hydantoins and sulfonamide drugs, there is a risk of increased toxic effects of these drugs.

Combinations requiring caution

If simultaneous use with diuretics and ACE inhibitors is necessary, it should be taken into account that NSAID therapy is associated with the risk of developing acute renal failure in patients with dehydration (decreased glomerular filtration due to inhibition of prostaglandin synthesis). NSAIDs may reduce the hypotensive effect of some drugs. When coadministered with diuretics, ensure that the patient's fluid balance is adequate and monitor renal function before prescribing NSAIDs.

When used simultaneously with methotrexate in low doses (less than 15 mg/week), the hematological toxicity of methotrexate may increase due to a decrease in its renal clearance during NSAID therapy. Blood cell counts should be monitored weekly during the first weeks of concomitant therapy. In the presence of even mild renal dysfunction, as well as in elderly people, careful medical supervision is necessary.

When used simultaneously with pentoxifylline, the risk of bleeding increases. Intensive clinical monitoring and frequent monitoring of bleeding time (blood clotting time) is necessary.

When used concomitantly with zidovudine, there is a risk of increased toxicity to red blood cells due to effects on reticulocytes, with the development of severe anemia one week after administration of NSAIDs. It is necessary to control all blood cells and reticulocytes after 1-2 weeks. after starting NSAID therapy.

It is possible that the hypoglycemic effect of sulfonylurea derivatives may be enhanced due to its displacement from sites of binding to plasma proteins under the influence of NSAIDs.

When used simultaneously with low molecular weight heparin drugs, the risk of bleeding increases.

Combinations to consider

NSAIDs may reduce the hypotensive effect of beta-blockers due to inhibition of prostaglandin synthesis.

When used concomitantly with cyclosporine and tacrolimus, NSAIDs may increase nephrotoxicity, which is mediated by the action of renal prostaglandins. During combination therapy, it is necessary to monitor renal function.

When prescribed simultaneously with thrombolytics, the risk of bleeding increases.

When used concomitantly with probenecid, plasma concentrations of NSAIDs may increase, which may be due to inhibition of renal secretion and/or conjugation with glucuronic acid. This requires NSAID dose adjustment.

NSAIDs can cause an increase in the concentration of cardiac glycosides in the blood plasma.

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

Data obtained from experimental studies in animals indicate a high risk of developing convulsions when NSAIDs are prescribed during therapy with high doses of ciprofloxacin.

Pharmaceutical interactions

Dexalgin® should not be mixed in the same syringe with a solution of dopamine, promethazine, pentazocine, pethidine or hydroxyzine (a precipitate will form).

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

A diluted solution of Dexalgin® for infusion should not be mixed with promethazine or pentazocine.

A diluted solution of Dexalgin® for infusion is compatible with the following injection solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

When diluted solutions of Dexalgin® for infusion are stored in plastic containers or when using infusion systems made from ethyl vinyl acetate, cellulose propionate, low-density polyethylene or polyvinyl chloride, absorption of the active substance by the listed materials does not occur.

Mode of application

Depending on the type and intensity of pain, the recommended dose is 12.5 mg (1/2 film-coated tablet) every 4-6 hours or 25 mg (one film-coated tablet) every 8 hours. The daily dose should not exceed 75 mg.

Undesirable effects of the drug can be minimized by using the minimum effective dose for the shortest possible period of time necessary to eliminate symptoms. The drug "Dexalgin®" is not intended for long-term therapy; treatment continues as long as symptoms persist.

It is recommended to take the tablets with a sufficient amount of liquid (for example, a glass of water). Concomitant use with food slows down the absorption of the drug, so in case of acute pain it is recommended to take the drug at least 30 minutes before meals.

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.

Features of application

Pregnant

Prescribing dexketoprofen in the first and second trimesters of pregnancy is possible only in cases of extreme necessity.

Like all other NSAIDs, dexketoprofen trometamol can reduce female fertility and is therefore not recommended for use by women planning pregnancy. Women who have problems conceiving or are undergoing infertility evaluation should consider discontinuing the drug.

If dexketoprofen is used by a woman who is trying to become pregnant, or during the first and second trimester of pregnancy, the minimum effective dose should be used for the shortest possible period of time.

Children

The use of the drug in children has not been studied, therefore safety and effectiveness for children and adolescents have not been established; the drug should not be prescribed to children and adolescents.

Drivers

When using Dexalgin® tablets, side effects may occur, such as dizziness, blurred vision or drowsiness, which reduces reaction speed, the ability to drive vehicles and operate other mechanisms.

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.

Overdose

Overdose symptoms are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, vertigo, disorientation, headache).

In case of accidental overdose, symptomatic therapy should be started immediately in accordance with the patient's clinical condition. If an adult patient or child has taken a dose of 5 mg/kg body weight within one hour, activated charcoal must be taken. Hemodialysis can be used to remove dexketoprofen.

Note!

Description of the drug Dexalgin table. p/o 25 mg 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.