Deksalgin injection 25mg / ml 2 ml ampoules 10 pcs

Description

Composition
Active substance:
1 ampoule (2 ml) contains: dexketoprofen trometamol – 73.8 mg (corresponding to 50,0 mg of dexketoprofen).
Excipients:
Ethanol (96%) – 200.0 mg of sodium chloride – 8.0 mg Sodium hydroxide to pH 7.4 water for injection to 2.0 ml.
Product form:
Solution for intravenous or intramuscular injection and 25 mg / ml.
2 ml of the product in dark glass vials (type I) with a white dot in the upper part of the ampoule.
5 ampoules per contoured plastic packaging (pallet), together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to deksketoprofenu or other NSAIDs, or any of the excipients included in the formulation (see Structure.); gastric ulcer and duodenal ulcer; gastrointestinal bleeding history, other active bleeding (including suspected intracranial bleeding), anticoagulant therapy; gastro-intestinal disorders (Crohn’s disease, ulcerative colitis); severe liver function abnormalities (10-15 points on a scale Child-Pugh); severe renal dysfunction (creatinine clearance
Deksalgin® contraindicated for nevraksialnogo (intrathecal or epidural, intrathecal) administration due to the incoming of the ethanol preparation.
Precautions: allergic conditions in history; hemodyscrasia system; systemic lupus erythematosus or mixed connective tissue disease; simultaneous treatment with other drugs (see interaction with other drugs.); predisposition to hypovolemia; coronary artery disease; advanced age (over 65 years).
Indications
Relief of pain of various origins (including post-operative pain, pain of bone metastases, post-traumatic pain, pain of renal colic, tuberculosis, ischialgia, sciatica, neuralgia, toothache); symptomatic treatment of acute and chronic inflammatory, inflammatory and degenerative and metabolic diseases of the musculoskeletal system (including rheumatoid arthritis, spondylitis, osteoarthritis, low back pain).
Interaction with other drugs
Deksalgin® not be mixed in the same syringe with a solution of dopamine, promethazine, pentazocine, pethidine or hydroxyzine (precipitate formed).
Deksalgin® may be mixed in the same syringe with a solution of heparin, lidocaine, morphine and theophylline.
Deksalgin® – diluted infusion solution should not be mixed with promethazine or pentazocine.
Deksalgin® – diluted infusion solution suitable for solutions for injection: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.
When storing Deksalgin® – dilute solutions for infusion in plastic containers or by using infusion systems made from ethyl vinyl acetate, cellulose propionate, low density polyethylene or polyvinyl chloride, the absorption of the active substance occurs not listed materials.
The following interactions are common to all NSAIDs.
undesirable combinations
With other NSAIDs, salicylates including high doses (greater than 3 g / d) co-administration of several NSAIDs due to the synergistic effect increases the risk of gastrointestinal bleeding and ulceration.
With oral anticoagulants, heparin in doses exceeding preventive and ticlopidine: increased risk of bleeding due to platelet aggregation inhibition and mucosal lesions of the gastrointestinal tract.
With lithium preparations: NSAIDs increase the level of lithium in the blood up to the toxic, and therefore the active component is necessary to control the appointment, changing dose and then cancel NSAIDs.
With high-dose methotrexate (15 mg / week or more): improving hematological toxicity of methotrexate in connection with a reduction in its renal clearance background NSAID therapy.
With hydantoin and sulfanilamidnymi drugs: risk of increased toxic effect of these drugs.
Combinations requiring caution
With diuretics, angiotensin-converting enzyme: NSAID therapy is associated with the risk of acute renal failure in dehydrated patients (decreased glomerular filtration rate caused by decreased synthesis of prostaglandins). NSAIDs can reduce the hypotensive effect of certain drugs. When concomitant administration of diuretics is necessary to make sure that the water balance of the patient is adequate, and to conduct monitoring of renal function before prescribing NSAIDs.
With methotrexate at low doses (less than 15 mg / week): to hematological toxicity of methotrexate in connection with a reduction in its renal clearance amid NSAID therapy. Should be carried out weekly blood count during the first weeks of therapy simultaneously. In the presence of impaired renal function, even in mild as well as in elderly patients requires careful medical supervision.
Pentoxifylline: increased risk of bleeding. Needs intensive clinical monitoring and frequent checks bleeding time (time clotting).
With Zidovudine: risk of increased toxic effects on red blood cells caused by exposure to reticulocytes, with severe anemia in a week after the appointment of NSAIDs. Necessary to count all blood cells and reticulocytes in 1-2 weeks after initiation of therapy NSAIDs.
With sulfanilamide preparations: NSAIDs may enhance the hypoglycemic effect of sulfonylurea result of the displacement of its binding sites to plasma proteins.
With low molecular weight heparin drugs: increased risk of bleeding.
Combinations to be taken into account
With beta-blockers: NSAIDs may reduce the hypotensive effect of beta-blockers that due to the inhibition of prostaglandin synthesis.
Since cyclosporin and tacrolimus: NSAIDs may increase nephrotoxicity that is mediated by the action of renal prostaglandins. At the time of concurrent therapy is necessary to monitor kidney function.
With thrombolytics: increased risk of bleeding.
With probenecid: NSAID concentration in plasma may increase, which may be due to an inhibitory effect on renal tubular secretion and / or conjugation with glucuronic acid, which requires correction dose NSAIDs.
With cardiac glycosides: NSAIDs may lead to an increase in the plasma concentration of glycosides.
Since mifepristone: in relation to a theoretical risk of mifepristone efficiency change under the influence of inhibitors of prostaglandin synthesis, NSAIDs should not be administered earlier than 8-12 days after withdrawal of mifepristone.
With ciprofloxacin: data from experimental animal studies indicate a high risk of convulsions in the appointment of NSAIDs during therapy with ciprofloxacin at high doses.
Overdose
Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.
Treatment: symptomatic therapy; if necessary – gastric lavage, dialysis.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drugs (NSAIDs).
Pharmacodynamics:
Dexketoprofen trometamol – Deksalgin® active ingredient of the drug – a non-steroidal anti-inflammatory agent, has analgesic, anti-inflammatory and antipyretic action. The mechanism of action is related to the inhibition of prostaglandin synthesis at the level of cyclooxygenase 1 and 2.
Analgesic effect occurs within 30 minutes following parenteral administration. The duration of analgesic effect after administration of a dose of 50 mg is 4-8 hours.
In combination therapy with an opioid analgesic number dexketoprofen trometamol significantly (30-45%) reduces the need to opioids.
Pharmacokinetics:
Suction. The maximum concentration in serum (Cmax) following intramuscular administration of dexketoprofen trometamol achieved on average after 20 min (10-45 min). The area under the curve “concentration-time» (AUC), after single administration at a dose of 25-50 mg proportional to dose, both intramuscular and intravenous administration. Relevant pharmacokinetic parameters were similar after single and repeated intramuscular or intravenous administration, indicating the absence of drug accumulation.
Distribution. For dexketoprofen trometamol characterized by a high level of binding to plasma proteins (99%). The mean value of the distribution volume (Vd) is less than 0.25 L / kg, poluraspredeleniya time is about 0.35 hours.
Withdrawal. The main route of excretion is dexketoprofen its conjugation with glucuronic acid and subsequent isolation through the kidneys. The half-life (T1 / 2) of dexketoprofen trometamol is about 1-2,7 hours. In the elderly observed half-life period of elongation (both after single and after repeated intramuscular or intravenous administration) to an average of 48% reduction in total drug clearance .
Pregnancy and breast-feeding
Use of the drug Deksalgin® during pregnancy and lactation is contraindicated.
Conditions of supply of pharmacies
On prescription.
side effects
Possible side effects when using dexketoprofen trometamol as the use of other drugs dexketoprofen, are listed below in descending frequency of occurrence: frequent (1-10% of patients), rare (0.1-1% of patients), rare (0,01-0, one% of patients), very rare (less than 0.01% of patients), including individual messages.
On the part of the circulatory and lymphatic systems
Rarely anemia.
Very rare: neutropenia, thrombocytopenia.
On the part of the central nervous system
Uncommon: headache, dizziness, insomnia, somnolence.
Rare: paresthesia.
From the senses
Uncommon: blurred vision.
Rare: tinnitus.
Cardio-vascular system
Uncommon: hypotension, hot flashes, flushing of the skin.
Rarely: arrythmia, tachycardia, hypertension, peripheral edema, superficial thrombophlebitis.
The respiratory system
Rare: bradypnea.
Very rare: bronchospasm, dyspnea.
On the part of the gastrointestinal tract
Common: nausea, vomiting.
Uncommon: abdominal pain, dyspepsia, diarrhea, constipation, hematemesis, dry mouth.
Rare: erosive and ulcerative lesions of the gastrointestinal tract, including bleeding and perforation, anorexia.
Very rare: pancreatic lesion.
Of the liver and gall bladder
Rare: elevated liver enzymes, jaundice.
Very rare: liver damage.
From the urinary system
Rare: polyuria, renal colic.
Very rare: nephritis or nephrotic syndrome.
Reproductive system
Rare: in women – menstrual disorders, men – a violation of the prostate gland.
On the part of the musculoskeletal system
Rare: muscle spasms, difficulty of movement in the joints.
For the skin
Infrequent: dermatitis, rash, sweating.
Rare: rash, acne.
Very rarely severe skin reactions (Stevens-Johnson syndrome, Lyell’s syndrome), angioedema, allergic dermatitis, photosensitivity.
From a metabolism
Rare: hyperglycemia, hypoglycemia, hypertriglyceridemia.
From the laboratory parameters
Rare: ketonuria, proteinuria.
Local and general reactions
Common: pain at the injection site.
Uncommon: inflammatory reaction, hematoma, hemorrhage at the injection site; feeling of fever, chills, fatigue.
Rare: back pain, fainting, fever.
Very rare: anaphylactic shock, swelling of the face.
Other disorders: aseptic meningitis that occurs primarily in patients with systemic lupus erythematosus and mixed connective tissue disease, haematological disorders (purpura, aplastic and hemolytic anemias, rarely – agranulocytosis and hypoplasia of the bone marrow).
special instructions
In patients with disorders of the gastrointestinal tract or gastro-intestinal diseases in history requires constant monitoring. In case of gastrointestinal bleeding or ulcer therapy with Deksalgin® should be abolished.
Since all NSAIDs may inhibit platelet aggregation and increase bleeding time, due to the deceleration of prostaglandin synthesis, in controlled clinical trials have been studied co-administration of dexketoprofen trometamol and low molecular weight heparin preparations in prophylactic doses postoperatively. No effect on coagulation parameters was observed. However, while the appointment Deksalgin® drug with other drugs that affect blood clotting, careful medical supervision.
Like other NSAIDs, Deksalgin® may lead to increased levels of nitrogen and creatinine in blood plasma. As with other inhibitors of prostaglandin synthesis, Deksalgin® can have side effects on the urinary system, which can lead to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure.
As with other NSAIDs, on the background of therapy with Deksalgin® may be a slight transient increase in some liver parameters, and also a significant increase in aspartic acid and alanine transaminase (ALT and AST) in serum. With this control hepatic and renal function is necessary in the elderly. In the event of a significant increase in relevant indicators Deksalgin® should be abolished.
Like other NSAIDs, dexketoprofen trometamol may mask the symptoms of infectious diseases. In case of a bacterial infection or signs of deterioration of health on background therapy with Deksalgin® patient should immediately contact a physician.
Each ampoule Deksalgin® preparation contains 200 mg of ethanol.
Effects on ability to drive vehicles and management mechanisms
In connection with possible dizziness and sleepiness during ingestion Deksalgin® the ability to focus and speed of psychomotor reactions may decline in patients.
Storage conditions
At temperatures above 25 ° C, protected from light.
After dilution the solution is stored for 24 hours at 2 to 8 ° C, protected from light.
Drug store out of reach of children !.
Dosing and Administration
Deksalgin® intended for intravenous and intramuscular administration.
The recommended dose for adults is 50 mg every 8-12 hours, if necessary possibly repeated administration of the drug with a 6-hour intervals.. The daily dose is 150 mg.
Elderly patients and patients with impaired liver function and / or renal Deksalgin® drug therapy should be initiated with lower doses; daily dose is 50 mg.
Deksalgin® for short (no more than 2 days) during the application of acute pain. In the future, possible transfer of the patient to oral analgesics.
Technique of intramuscular injection
The contents of one ampoule (2 ml) was slowly injected by deep intramuscular injection.
Technique of intravenous injection
If necessary, the contents of one ampoule (2 ml) Deksalgin® drug can be introduced by slow intravenous injection of at least 15 seconds.
Technique of intravenous infusion
The contents of one ampoule (2 ml) was diluted in 30-100 ml saline, glucose solution or Ringer’s solution (lactate). The solution should be prepared under aseptic conditions and always be protected from exposure to daylight. The diluted solution (to be transparent) is administered by slow intravenous infusion lasting 10-30 min.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist