Dexalgin, 25 mg/ml 2 ml 10 pcs

Pharmaceutical group: NSAIDs.

Pharmacological action: Dexalgin is a nonsteroidal anti-inflammatory drug (NSAID). It has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action is associated with inhibition of prostaglandin synthesis at the level of COX-1 and COX-2.

The analgesic effect occurs 30 minutes after parenteral administration. Duration of analgesic effect after administration of 50 mg is 4-8 hours.

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

Indications

– pain relief of different genesis (incl.ч. Postoperative pain, pain from bone metastases, post-traumatic pain, pain from renal colic, algodysmenorrhea, sciatica, radiculitis, neuralgia, toothache).including rheumatoid arthritis, spondyloarthritis, arthrosis, osteochondrosis).

Active ingredient

Composition

1 ml:
– dexketoprofen trometamol 36.9 mg, which corresponds to the content of dexketoprofen 25 mg

Auxiliary substances:

Ethanol 96%,

Sodium chloride,

Sodium hydroxide,

Water d/s.

How to take, the dosage

exalgin® is intended for intravenous and intramural administration.

The recommended dose for adults is 50 mg every 8-12 hours. If necessary, the drug may be administered again at 6-hour intervals. The daily dose is 150 mg.

In elderly patients and patients with hepatic and/or renal impairment therapy with Dexalgin® should be started at lower doses; the daily dose is 50 mg.

Dexalgin® is intended for short-term (not more than 2 days) use during acute pain syndrome. Later it is possible to transfer the patient to analgesics for oral administration.

Regulations for preparation and administration of solutions

The contents of one ampoule (2 ml) are slowly injected deep into the ampoule.
The contents of one ampoule (2 ml) are administered by slow intravenous injection for at least 15 seconds.
The contents of one ampoule (2 ml) are diluted in 30-100 ml of physiological solution, glucose or Ringer’s solution (lactate). The solution should be prepared under aseptic conditions and always protected from exposure to daylight. The diluted solution (should be clear) is administered by slow IV infusion lasting 10-30 minutes.

Interaction

Undesirable combinations:
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 synergistic action.

Concomitant use with oral anticoagulants, heparin in doses greater than prophylactic and ticlopidine increases the risk of bleeding due to inhibition of platelet aggregation and damage to the gastrointestinal mucosa.
NSAIDs increase the concentration of lithium in blood plasma, up to toxic, and therefore this indicator should be monitored when prescribing, changing doses and after discontinuation of NSAIDs.

When used with methotrexate at high doses (15 mg/week or more) there is an increase in hematological toxicity of methotrexate due to its decreased renal clearance with NSAID therapy.

When concomitant use with hydantoins and sulfonamides there is a risk of increased toxic effects of these drugs.

Combinations requiring caution:

When concomitant use with diuretics, ACE inhibitors is necessary, note that NSAID therapy is associated with the risk of 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. If concomitant administration with diuretics, it is necessary to ensure that the patient’s water balance is adequate and to monitor renal function before prescribing NSAIDs.
Concomitant use with methotrexate in low doses (less than 15 mg/week) may increase hematological toxicity of methotrexate due to its decreased renal clearance during NSAID therapy. It is necessary to monitor the blood cell count weekly during the first weeks of concomitant therapy. In case of renal dysfunction even in mild degree, as well as in elderly patients it is necessary to provide careful medical monitoring.

Simultaneous use with pentoxifylline increases the risk of bleeding. Intensive clinical monitoring and frequent monitoring of bleeding time (clotting time) is necessary.

In concomitant use with zidovudine there is a risk of increased toxic effects on red blood cells due to the effect on reticulocytes, with the development of severe anemia one week after administration of NSAIDs. Monitoring of all blood cells and reticulocytes 1-2 weeks after initiation of NSAID therapy is necessary.

It is possible to increase hypoglycemic action of sulfonylurea derivatives due to its displacement from binding sites with plasma proteins under the influence of NSAIDs.

Simultaneous use with preparations of low molecular weight heparin increases the risk of bleeding.
Combinations to be taken into account:

NSAIDs may decrease the hypotensive effect of beta-adrenoblockers due to inhibition of prostaglandin synthesis.
When concomitant use with cyclosporine and tacrolimus, NSAIDs may increase nephrotoxicity that is mediated by the action of renal prostaglandins. Renal function should be monitored during combination therapy.
Simultaneous use with thrombolytics increases the risk of bleeding.

Concomitant use with probenecid may increase plasma concentrations of NSAIDs, which may be due to inhibition of renal secretion and/or conjugation with glucuronic acid. This requires adjustment of the dose of NSAIDs.
NSAIDs may cause increased plasma concentrations of cardiac glycosides.

Because of the theoretical risk of prostaglandin inhibitors altering mifepristone’s effectiveness, NSAIDs should not be prescribed earlier than 8-12 days after mifepristone withdrawal.

The data obtained in experimental animal studies indicate a high risk of convulsions when NSAIDs are prescribed with high-dose ciprofloxacin therapy.

Pharmaceutical interactions:

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

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

Diluted solution of Dexalgin® for infusion must not be mixed with promethazine or pentazocine.
Diluted solution of Dexalgin® for infusion is compatible with the following solutions for injection: 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 of ethylvinyl acetate, propionate cellulose, low density polyethylene or polyvinyl chloride, there is no absorption of the active substance by the listed materials.

Special Instructions

In patients with a history of digestive system disorders or gastrointestinal diseases, continuous monitoring is necessary. In the case of gastrointestinal bleeding or ulcerative lesions, therapy with Dexalgin® should be stopped.
Since all NSAIDs may inhibit platelet aggregation and increase bleeding time due to inhibition of prostaglandin synthesis, in controlled clinical trials, simultaneous administration of Dexketoprofen trometamol and low molecular weight heparin drugs at preventive doses in the postoperative period was studied. No effect on coagulation parameters was observed. Nevertheless, careful medical monitoring is necessary while concomitant administration of Dexalgin® with other drugs influencing blood clotting.

Like other NSAIDs, Dexalgin® may increase plasma creatinine and nitrogen levels. Like other inhibitors of prostaglandin synthesis, Dexalgin® may have adverse effects on the urinary system, which may lead to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure.
During the therapy with Dexalgin®, like other NSAIDs, a slight transient increase in some liver parameters and significant increase in serum AST and ALT levels may be observed. In this case, monitoring of liver and kidney functions is necessary in elderly patients. In case of significant increase of the corresponding indicators Dexalgin® should be discontinued.
Like other NSAIDs, dexectoprofen trometamol may mask the symptoms of infectious diseases. If there are symptoms of bacterial infection or if there is a worsening of the condition during Dexalgin® therapy, the patient should inform the physician.
Each vial of Dexalgin® contains 200 mg of ethanol.

Influence on driving and operating ability
Due to possible dizziness and somnolence during treatment with Dexalgin® , the ability to concentrate and speed of psychomotor reactions may decrease.

Contraindications

– gastric and duodenal ulcer;
– gastrointestinal bleeding in the history, other active bleeding (including suspected intracranial bleeding;

Side effects

The frequency of side effects: frequently (1-10%), infrequently (0.1-1%) rarely (0.01-0.1%), very rarely (less than 0.01%, including individual reports).

Hematopoietic system: rare – anemia; very rare – neutropenia, thrombocytopenia.

CNS disorders: infrequent – headache, dizziness, insomnia, somnolence; rarely – paresthesia.

Sensory system disorders: infrequent blurred vision; rarely – tinnitus.

Cardiovascular system: infrequent arterial hypotension, fever, skin hyperemia; rarely – extrasystole, tachycardia, arterial hypertension, peripheral edema, superficial thrombophlebitis.

Respiratory system: rarely – bradypnoea; very rarely – bronchospasm, dyspnoea.

The digestive system: frequently – nausea, vomiting; infrequently – abdominal pain, dyspepsia, diarrhea, constipation, hematemesis, dry mouth; rarely – erosive-ulcerative lesions of the gastrointestinal tract, including bleeding and perforations, anorexia, increased liver enzyme activity, jaundice; very rarely – pancreatic lesions, liver damage.

As to the urinary system: rarely – polyuria, renal colic; very rarely – nephritis or nephrotic syndrome.

Reproductive system disorders: rare – in women – menstrual disorders, in men – disorders of prostate function.

Muscular system: rare – muscle spasm, difficulty with movement in the joints.

Dermatological reactions: sometimes – dermatitis, rash, sweating; rarely – acne; very rare – photosensitization.

Allergic reactions: rare – urticaria; very rare – severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome), angioedema, allergic dermatitis.

Metabolism disorders: rarely – hyperglycemia, hypoglycemia, hypertriglyceridemia.

Laboratory disorders: rarely – ketonuria, proteinuria.

Local and general reactions: often – pain at the injection site; infrequent – inflammatory reaction, hematoma, hemorrhages at the injection site, fever, fatigue; rarely – back pain, fainting, fever; very rare – anaphylactic shock, facial edema.

Other: aseptic meningitis, occurring mainly in patients with systemic lupus erythematosus or mixed connective tissue diseases, hematologic disorders (purpura, aplastic and hemolytic anemia, rarely – agranulocytosis and bone marrow hypoplasia).

Overdose

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

Treatment:symptomatic therapy; if necessary – gastric lavage, dialysis.

Similarities