Dexalgin Ampoules 25 mg/ml 2 ml 10 pcs.

Composition

1 ml: – dexketoprofen trometamol 36.9 mg, respectively. dexketoprofen content 25 mg

Auxiliary substances:

ethanol 96%,

sodium chloride,

sodium hydroxide,

d/i water.

Pharmacological action

Pharmaceutical Group: NSAIDs.

Pharmaceutical 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. The duration of the analgesic effect after administration at a dose of 50 mg is 4-8 hours.

When combined with opioid analgesics of dexketoprofen, trometamol significantly reduces the need for opioids (up to 30-45%).

Indications

— relief of the pain syndrome of different Genesis (including postoperative pain, pain in bone metastases, post-traumatic pain, pain in renal colic, algomenorrhea, sciatica, radiculitis, neuralgia, toothache);

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

Contraindications

-peptic ulcer of the stomach and duodenum— – history of gastrointestinal bleeding, other active bleeding (including suspected intracranial bleeding), anticoagulant therapy— – gastrointestinal diseases (Crohn’s disease, ulcerative colitis);- severe hepatic impairment (10-15 points on the Child-Pugh scale);- severe renal impairment (CC;- bronchial asthma (including in the anamnesis);— severe heart failure; – treatment of pain syndrome during coronary artery bypass grafting;- hemorrhagic diathesis or other coagulation disorders— – children’s age;— hypersensitivity to dexketoprofen or other NSAIDs or to any of the excipients that make up the drug Dexalgin.

It is contraindicated for epidural, subshell or intra-shell administration due to the ethanol contained in the preparation.

With caution, the drug should be used for a history of allergic conditions; disorders of the hematopoietic system; with SLE or mixed connective tissue diseases; simultaneously with other medications; in case of predisposition to hypovolemia; with coronary heart disease; in elderly patients (older than 65 years).

Side effects

Frequency of side effects: common (1-10%), infrequent (0.1-1%) rare (0.01-0.1%), very rare (less than 0.01%, including individual reports).

From the hematopoietic system: rarely-anemia; very rarely-neutropenia, thrombocytopenia.

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

From the sensory organs: infrequently-blurred vision; rarely-tinnitus.

From the cardiovascular system: infrequently-hypotension, fever, hyperemia of the skin; rarely-extrasystole, tachycardia, hypertension, peripheral edema, superficial thrombophlebitis.

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

From the digestive system: 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, increased activity of liver enzymes, jaundice; very rarely – pancreatic damage, liver damage.

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

From the side of the reproductive system: rarely – in women-a violation of the menstrual cycle, in men-a violation of the function of the prostate gland.

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

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

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

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

From the side of laboratory parameters: rarely-ketonuria, proteinuria.

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

Other: 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).

Interaction

Unwanted combinations:Concomitant 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 concomitantly with oral anticoagulants, heparin in doses exceeding the preventive ones, 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, and therefore this indicator should be monitored when prescribing, changing the dose, and after discontinuation of NSAIDs.

When used with methotrexate in high doses (15 mg / week. increased hematological toxicity of methotrexate occurs due to a decrease in its renal clearance during NSAID therapy.

When used concomitantly with hydantoins and sulfonamide preparations, there is a risk of increasing the toxic effect of these drugs.

Combinations that require caution:

If concomitant use with diuretics, ACE inhibitors is necessary, it should be taken into account that NSAID therapy is associated with the risk of acute renal failure in patients with dehydration (reduced glomerular filtration rate due to inhibition of prostaglandin synthesis). NSAIDs may reduce the antihypertensive effect of certain medications. When co-administered with diuretics, it is necessary to ensure that the patient’s water balance is adequate, and to monitor renal function before prescribing NSAIDs. When used concomitantly with methotrexate in low doses (less than 15 mg/week), it is possible to increase the hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. It is necessary to monitor the number of blood cells weekly 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.

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

When used concomitantly with zidovudine, there is a risk of increased toxic effects on red blood cells due to exposure to reticulocytes, with the development of severe anemia one week after the appointment of NSAIDs. All blood cells and reticulocytes should be monitored 1-2 weeks after starting NSAID therapy.

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

When used concomitantly with low-molecular-weight heparin preparations, the risk of bleeding increases. Combinations to take into account:

NSAIDs may reduce the antihypertensive 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, renal function should be monitored. When administered concomitantly 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 a dose adjustment of NSAIDs. NSAIDs can cause an increase in the concentration of cardiac glycosides in the blood plasma.

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

Data obtained in experimental animal studies indicate a high risk of convulsions when prescribing NSAIDs against the background of high-dose ciprofloxacin therapy.

Pharmaceutical interaction:

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

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

Dilute solution of Dexalgin® for infusions should not be mixed with promethazine or pentazocine. The dilute solution of Dexalgin® for infusions is compatible with the following solutions for injection: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

When dilute solutions of Dexalgin® for infusions are stored in plastic containers or when using infusion systems made of ethyl vinyl acetate, cellulose propionate, low-density polyethylene or polyvinyl chloride, the Active ingredient is not absorbed by the listed materials.

How to take, course of administration and dosage

exalgin® is intended for intravenous and intramuscular administration.

Recommended dose for adults: 50 mg every 8-12 hours. If necessary, repeated administration of the drug with a 6-hour interval is possible. The daily dose is 150 mg.

In elderly patients and patients with impaired liver and/or kidney function, Dexalgin therapy should be initiated at a lower dose; the daily dose is 50 mg.

Dexalgin® 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 analgesics for oral administration.

Rules for the preparation and administration of solutions

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

Overdose

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

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

Special instructions

In patients with a history of digestive disorders or gastrointestinal diseases, constant monitoring is necessary. If gastrointestinal bleeding or ulcerative lesions occur, Dexalgin therapy should be discontinued. Since all NSAIDs can inhibit platelet aggregation and increase bleeding time due to slowing prostaglandin synthesis, controlled clinical trials have studied the concomitant administration of dexketoprofen trometamol and low-molecular-weight heparin preparations in prophylactic doses in the postoperative period. No effect on coagulation parameters was observed. However, careful medical monitoring is necessary when Dexalgin is co-administered with other medications that affect blood clotting.

As with other NSAIDs, Dexalgin® can lead to an increase in plasma creatinine and nitrogen levels. Like other prostaglandin synthesis inhibitors, Dexalgin® 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. During therapy with Dexalgin®, as with other NSAIDs, there may be a slight transient increase in some liver parameters, as well as a significant increase in serum AST and ALT levels. At the same time, monitoring of liver and kidney functions is necessary in elderly patients. In case of a significant increase in the corresponding indicators, Dexalgin® should be discontinued. Like other NSAIDs, dexketoprofen trometamol may mask the symptoms of infectious diseases. If symptoms of bacterial infection appear or if you feel unwell during Dexalgin therapy, the patient should inform their doctor. Each ampoule of Dexalgin® contains 200 mg of ethanol.

Influence on the ability to drive motor vehicles and control mechanisms due to possible dizziness and drowsiness during treatment with Dexalgin®, the ability to concentrate attention and the speed of psychomotor reactions may decrease.

Active ingredient

Dexketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Purpose

For adults as directed by your doctor

Indications

Lumbago, Sciatica, Sciatica, Arthritis, Osteoarthritis, Osteochondrosis, Rheumatoid Arthritis, Trigeminal Neuralgia

Weight

Weight: 50 gr.