Dexalgin solution for v.v, vm injecting 25mg ml 2ml N10
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Active ingredients
Dexketoprofen
Release form
Solution
Composition
1 ampoule (2 ml) contains: Active ingredient: Dexketoprofen trometamol - 36.9 mg (which corresponds to 25.0 mg of dexketoprofen). Additional substances: ethanol (96%) - 200.0 mg, sodium chloride - 8.0 mg , sodium hydroxide to pH 7.4, water for injection up to 2.0 ml.
Pharmacological effect
Nonsteroidal anti-inflammatory drug (NSAIDs). It has an analgesic, anti-inflammatory and antipyretic effect. The mechanism of action is associated with inhibition of the synthesis of prostaglandins 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 in a dose of 50 mg is 4-8 hours. In combination therapy with opioid analgesics dexketoprofen trometamol significantly (up to 30-45%) reduces the need for opioids.
Pharmacokinetics
Suction. The maximum concentration in serum (Cmax) after intramuscular administration of dexketoprofen trometamol is reached on average after 20 minutes (10-45 minutes). The area under the concentration-time curve (AUC) after a single dose at a dose of 25-50 mg is proportional to the dose, both for intramuscular and intravenous administration. The corresponding pharmacokinetic parameters are similar after single and repeated intramuscular or intravenous administration, which indicates the absence of drug cumulation. Distribution. Dexketoprofen trometamol is characterized by a high level of binding to plasma proteins (99%). The mean value of the volume of distribution (Vd) is less than 0.25 l / kg, the half-time is about 0.35 h. Injection. The main way to dexketoprofen is to conjugate it with glucuronic acid, followed by excretion through the kidneys. The elimination half-life (T1 / 2) of dexketoprofen trometamol is about 1-2.7 hours. In elderly people, there is a prolongation of the half-life (both after a single dose and after repeated intramuscular or intravenous administration) to an average of 48% and a decrease in the total clearance of the drug .
Indications
- Relief of pain syndrome of various genesis (including postoperative pain, pain in bone metastases, post-traumatic pain, pain in renal colic, algomenorrhea, ischalgia, sciatica, neuralgia, toothache); - symptomatic treatment of acute and chronic inflammatory, inflammatory - degenerative and metabolic diseases of the musculoskeletal system (includingrheumatoid arthritis, spondylitis, arthrosis, osteochondrosis).
Contraindications
- Hypersensitivity to dexketoprofen or other NSAIDs or to any of the excipients that make up the drug (see. Composition); - gastric ulcer and duodenal ulcer; - a history of gastrointestinal bleeding, other active bleeding (including suspected intracranial bleeding), anticoagulant therapy; - gastrointestinal diseases (Crohn's disease, ulcerative colitis); - severe liver dysfunction (10-15 points on the Child-Pugh scale); - severe renal dysfunction (creatinine clearance <50 ml / min); - bronchial asthma (including a history); - severe heart failure; - treatment of pain syndrome in coronary artery bypass surgery; - hemorrhagic diathesis or other coagulation disorders; - Children's age. Dexalgin is contraindicated for neuraxial (epidural or intrashell) intradishell administration due to ethanol contained in the preparation
Precautionary measures
Allergic conditions in history; violation of the blood system; systemic lupus erythematosus or mixed diseases of connective tissue; simultaneous therapy with other drugs (see Interaction with other drugs); predisposition to hypovolemia; coronary heart disease; old age (over 65).
Use during pregnancy and lactation
The use of the drug Dexalgin during pregnancy and lactation is contraindicated.
Dosage and administration
Dexalgin is intended for intravenous and intravenous infusion. The recommended dose for adults: 50 mg every 8-12 hours. If necessary, repeated administration of the drug is possible at 6-hour intervals. The daily dose is 150 mg. In elderly patients and patients with impaired liver and / or kidney function, treatment with Dexalgin should be started with lower doses; the daily dose is 50 mg. Dexalgin is intended for short-term (no more than 2 days) use during the period of acute pain syndrome. In the future, it is possible to transfer the patient to analgesics for oral administration. The rules for preparing and administering solutions The content of one ampoule (2 ml) is slowly injected deep into the oil. The content of one ampoule (2 ml) is administered by slow intravenous injection of at least 15 seconds. one ampoule (2 ml) is diluted in 30-100 ml of physiological saline, glucose solution 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 intravenous infusion lasting 10-30 minutes.
Side effects
Possible side effects when using dexketoprofen trometamol, as with other dexketoprofen preparations, are listed below in descending frequency of occurrence: often (1-10% of patients), infrequently (0.1-1% of patients) rarely (0.01-0, 1% of patients), very rarely (less than 0.01% of patients), including individual messages. From the side of the circulatory and lymphatic systems. Rare: anemia. Very rare: neutropenia, thrombocytopenia. From the central nervous system. Not often: headache, dizziness, insomnia, drowsiness .Redko: paresthesia.So stor Sensory organs: Infrequently: blurred vision. Rarely: tinnitus. On the side of the cardiovascular system. Often: hypotension, feeling of heat, hyperemia of the skin. bradypnea. Very rare: bronchospasm, dyspnea. From the gastrointestinal tract. Frequently: nausea, vomiting. Frequent: abdominal pain, dyspepsia, diarrhea, constipation, hematemesis, dry mouth. Rarely: erosive and ulcerative lesions Gastrointestinal organs, including bleeding and perforation, anorexia. Very rare: damage to the pancreas. From the side of the liver and gall bladder. Rare: increased activity of liver enzymes, jaundice. Very rare: damage to the liver. From the urinary system. Rare: polyuria, renal colic. Very rare: nephritis or nephrotic syndrome. From the side of the reproductive system. Rarely: in women - menstrual disorders, in men - impaired prostate function. From the musculoskeletal system. Rare: muscular spasm, difficulty of movement in the joints. On the skin side. Infrequently: dermatitis, rash, sweating. Rarely: urticaria, acne. Very rare: severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome), angioedema, allergic dermatitis, substancesRedko: hyperglycemia, hypoglycemia,hypertriglyceridemia. From the side of laboratory parameters. Rarely: ketonuria, proteinuria. Local and general reactions. Frequently: pain at the injection site. Infrequently: inflammatory reaction, hematoma, hemorrhages at the injection site; Feeling hot, chills, fatigue. Rarely: back pain, fainting, fever. Very rare: anaphylactic shock, swelling of the face. Other disorders: aseptic meningitis that occurs mainly in patients with systemic lupus erythematosus or mixed diseases of connective tissue, hematological 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.
Interaction with other drugs
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 the same syringe with heparin, lidocaine, morphine and theophylline solution. Dexalgin - diluted infusion solution cannot be mixed with promethasine or promethazine. Dexalgin - diluted solution for infusions is compatible with the following solutions for injections: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline. When stored, dexalgin - dilute solution Pores for infusions in plastic containers or when using infusion systems made from ethyl vinyl acetate, cellulose propionate, low density polyethylene or polyvinyl chloride, the active substance is not absorbed by the listed materials. The following interactions are characteristic of all NSAIDs. Undesirable combinations With other NSAIDs, including salicylates in high doses (more than 3 g / day): the simultaneous appointment of several NSAIDs due to a synergistic effect increases the risk of gastrointestinal bleeding and ulcers. With oral anticoagulants, heparin in doses exceeding prophylactic, and ticlopidine: increased risk of bleeding due to inhibition of platelet aggregation and damage to the mucous membrane of the gastrointestinal tract. With lithium preparations: NSAIDs increase the lithium level in the blood, up to toxic, and therefore this indicator should be monitored upon appointment,changes in dose and after discontinuation of NSAIDs. With high-dose methotrexate (15 mg / week or more): increased hematological toxicity of methotrexate due to a decrease in its renal clearance during therapy with NSAIDs. With hydantoins and sulfa drugs: the risk of an increase in the toxic effect of these drugs. Combinations that require caution With diuretics, angiotensin-converting enzyme inhibitors: NSAID therapy is associated with the risk of developing acute renal failure in dehydrated patients (reduced glomerular filtration, buslovenny reduced prostaglandin synthesis). NSAIDs can reduce the hypotensive effect of certain drugs. With simultaneous appointment with diuretics, it is necessary to make sure that the patient's water balance is adequate and to monitor kidney function before prescribing NSAIDs. With methotrexate in low doses (less than 15 mg / week): hematological toxicity of methotrexate is increased due to a decrease in its renal clearance background of NSAID therapy. It is necessary to conduct a weekly count of blood cells 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 observation is necessary. With pentoxifylline: an increased risk of bleeding. Intensive clinical monitoring and frequent check-up of bleeding time (clotting time) is required. With zidovudine: the risk of increased toxic effect on erythrocytes due to the effect on reticulocytes, with the development of severe anemia a week after the appointment of NSAIDs. It is necessary to count all blood cells and reticulocytes in 1-2 weeks after the start of NSAID therapy. With sulfa drugs: NSAIDs can increase the hypoglycemic effect of sulfonylurea due to its displacement from plasma binding sites. With drugs of low molecular weight heparin: an increased risk of bleeding. Combinations which need to be taken into account With β-adrenergic blockers: NSAIDs can reduce the hypotensive effect of β-adrenergic blockers due to inhibition of prostaglandin synthesis With cyclosporine and tacrolimus: NSAIDs can increase nephrotoxicity, which is mediated by the action of renal prostaglandins.During simultaneous therapy, kidney function must be monitored. With thrombolytic agents: an increased risk of bleeding. With probenecid: NSAID concentrations in plasma may increase, which may be due to the inhibitory effect on renal tubular secretion and / or conjugation with glucuronic acid, which requires dose adjustment NSAIDs. With cardiac glycosides: NSAIDs can lead to an increase in the concentration of glycosides in the plasma. With mifepristone: due to the theoretical risk of changing the effectiveness of mifepristone under iyaniem inhibitors of prostaglandin synthesis, NSAIDs should not be administered earlier than 8-12 days after discontinuation of ciprofloxacin mifepristona.S: data from experimental animal studies indicate a high risk of convulsions in the appointment of NSAIDs during therapy with ciprofloxacin at high doses.
special instructions
Patients with disorders of the gastrointestinal tract or gastrointestinal diseases in the history requires constant monitoring. In the event of gastrointestinal bleeding or ulcers, treatment with Dexalgin should be discontinued. Since all NSAIDs can inhibit platelet aggregation and increase bleeding time due to slower prostaglandin synthesis, in controlled clinical studies, the simultaneous administration of decompotroprofen trometamol and low-molecular heparin preparations was studied in a controlled clinical study, and a low-level heparin should be used to treat the low molecular weight heparin. postoperative period. No effect on coagulation parameters was observed. However, while prescribing the drug Dexalgin with other drugs that affect blood clotting, careful medical monitoring is required. Like other NSAIDs, Dexalgin can lead to an increase in plasma creatinine and nitrogen levels. Like other prostaglandin synthesis inhibitors, Dexalgin 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, the drug can be treated with Dexalgin a slight transient increase in some hepatic parameters, as well as a significant increase in the level of aspartic and alanine transaminases (AST and AlT) in the blood serum. At the same time, control of hepatic and renal functions is necessary in elderly people.In the case of a significant increase in relevant indicators, dexalgin should be canceled. Like other NSAIDs, dexketoprofen trometamol may mask the symptoms of infectious diseases. In case of signs of bacterial infection or deterioration of health during therapy with Dexalgin, the patient should immediately consult a doctor. Each ampoule of Dexalgin contains 200 mg of ethanol. Effects on the ability to drive and control mechanisms. Dexalgin ability to concentrate and the speed of psychomotor reactions in patients may decrease.