Dex solution for intravenous and intramuscular injection 50mg/2ml №5×1

Name:
Dex solution for IV and IM injection/conc-t for injection/addition solution for inf.50mg/2ml in cell pack No.5×1
Description:
Transparent colorless solution The main active ingredient Dexketoprofen Release form Solution for intravenous and intramuscular injection / concentrate for solution for infusion. Dosage 50mg/2ml Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Indications for use Symptomatic treatment of acute pain of moderate to severe intensity in cases where oral administration of the drug is inappropriate, for example, with postoperative pain, renal colic and pain in the lower back (lower back). Dosage and administration Dexketoprofen-LF is intended for intravenous and intramuscular administration. Recommended adult dose: 50 mg every 8 to 12 hours. If necessary, it is possible to re-administer the drug with a 6-hour interval. The maximum daily dose is 150 mg. Dexketoprofen-LF 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 oral analgesics. Intramuscular administration The contents of one ampoule (2 ml) are slowly injected deep intramuscularly. Intravenous administration If necessary, the contents of one ampoule (2 ml) can be administered by slow intravenous injection for at least 15 seconds. Intravenous infusion The contents of one ampoule (2 ml) are diluted in 30-100 ml of 0.9% sodium chloride solution, dextrose solution (glucose) or Ringer’s solution (lactate). The solution should be prepared under aseptic conditions and always protected from exposure to daylight. The prepared solution is administered by slow intravenous infusion lasting 10-30 minutes (the prepared solution should be clear). Elderly patients Dose adjustment for elderly patients is usually not required. However, due to the physiological decline in renal function, a lower dose of the drug is recommended: a total daily dose of 50 mg for mild renal impairment in elderly patients. Patients with impaired liver function For patients with mild to moderate liver disease (Child-Pugh score 5-9), reduce the total daily dose to 50 mg and carefully monitor liver function. Dexketoprofen-LF is contraindicated in patients with severe liver dysfunction (Child-Pugh score 10-15). Patients with impaired renal function For patients with mild renal impairment (creatinine clearance 50-80 ml / min), the total daily dose should be reduced to 50 mg. Dexketoprofen-LF is contraindicated in patients with moderate to severe renal insufficiency (creatinine clearance < 50 ml/min). Children and adolescents The efficacy and safety of the drug in children and adolescents has not been studied, so the drug should not be used in this category of patients. Use during pregnancy and lactation The use of the drug during pregnancy is contraindicated. There are no data on the excretion of dexketoprofen into breast milk. Dexketoprofen-LF is not recommended for use during breastfeeding. Use in children It is not recommended to prescribe the drug to children under 18 years of age due to the lack of data on the efficacy and safety of use in children. Influence on the ability to drive vehicles and control mechanisms Care must be taken when driving vehicles and working with mechanisms (risk of dizziness and drowsiness). Precautions and special instructionsWith caution: old age (over 65 years), a tendency to allergic reactions, systemic lupus erythematosus (SLE) and other systemic connective tissue diseases, bone marrow hematopoiesis suppression, coronary heart disease (CHD), chronic heart failure (CHF) , arterial hypertension, hypovolemia, dyslipidemia, diabetes mellitus, smoking, cerebrovascular diseases, simultaneous therapy with other drugs: glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including ASA, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), impaired renal and / or liver function. Use with caution in patients with a history of allergic conditions. Avoid using the drug in combination with other NSAIDs, including selective COX-2 inhibitors. The severity of side effects can be reduced by using the minimum effective dose for the minimum time necessary to improve the condition. Gastrointestinal bleeding, formation or perforation of an ulcer, in some cases with a fatal outcome, were noted for all NSAIDs at different stages of treatment, regardless of the presence of precursor symptoms or a history of serious gastrointestinal pathology. With the development of gastrointestinal bleeding, the use of the drug should be discontinued. The risk of gastrointestinal bleeding, ulcer formation or perforation increases with increasing dose of NSAIDs in patients with a history of ulcer, especially complicated by bleeding or perforation, as well as in elderly patients. In this group of patients, the frequency of side effects of NSAIDs, especially gastrointestinal bleeding and perforation, sometimes fatal, is increased. Treatment of such patients should begin with the lowest possible dose. NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since there is a risk of their exacerbation. Before starting the use of dexketoprofen trometamol, patients with a history of esophagitis, gastritis and / or peptic ulcer should confirm the presence of remission of these diseases. In patients with symptoms of gastrointestinal pathology or with a history of gastrointestinal disease, it is necessary to monitor the state of the gastrointestinal tract for possible disorders, especially with regard to gastrointestinal bleeding. For such patients, as well as patients using aspirin or other drugs that increase the risk of adverse reactions from the gastrointestinal tract, combination therapy with protective drugs, such as misoprostol or proton pump inhibitors, should be considered. Patients, especially the elderly, with a history of adverse reactions from the gastrointestinal tract, it is necessary to inform the doctor about all unusual symptoms associated with the gastrointestinal tract, in particular gastrointestinal bleeding, especially in the initial stages of treatment. With caution, the drug is prescribed to patients who are simultaneously using drugs that may increase the risk of ulcers or bleeding: oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin. Non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by inhibiting prostaglandin synthesis. The simultaneous use of dexketoprofen trometamol and low molecular weight heparin in prophylactic doses in the postoperative period was studied in controlled clinical trials, no effect on coagulation parameters was found. However, patients who use dexketoprofen trometamol concomitantly with drugs that affect hemostasis, such as warfarin, other coumarins or heparins, need careful medical supervision. Patients with arterial hypertension (AH) and / or congestive heart failure of mild or moderate severity require careful medical supervision, since the use of NSAIDs may cause fluid retention in the body and the appearance of edema. According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially at high doses and for a long time, may be accompanied by a slight increase in the risk of developing conditions caused by arterial thrombosis, such as myocardial infarction or stroke. There are not enough data to exclude such a risk when using dexketoprofen trometamol. In uncontrolled hypertension, congestive heart failure, confirmed coronary artery disease, diseases of the peripheral arteries and / or cerebral vessels, dexketoprofen trometamol is prescribed only after a thorough assessment of the patient's condition. This also applies to patients with risk factors for cardiovascular disease, such as hypertension, hyperlipidemia, diabetes mellitus, smoking, before starting long-term therapy. Very rare cases of serious skin reactions (some fatal) have been reported with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Patients are probably most at risk at the beginning of treatment: in most patients, these reactions developed in the first month of therapy. If a skin rash, signs of mucosal damage or other symptoms of hypersensitivity appear, the drug should be discontinued. Like all NSAIDs, the drug is able to increase the level of urea nitrogen and creatinine in blood plasma. Like other inhibitors of prostaglandin synthesis, its use may be accompanied by adverse reactions from the kidneys, which can lead to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Similar to other NSAIDs, the drug may cause a temporary and slight increase in certain liver tests, as well as a significant increase in the levels of AST and ALT. With a corresponding increase in these indicators, therapy should be discontinued. With caution, the drug is prescribed to patients with impaired liver and / or kidney function, as well as to patients with hypertension and / or congestive heart failure, since they may experience deterioration in kidney function, fluid retention in the body and edema during the use of NSAIDs. In view of the increased risk of nephrotoxicity, the drug is used with caution in the treatment of diuretics, as well as in patients who may develop hypovolemia. Particular care must be taken when treating patients with a history of heart disease, in particular with previous episodes of heart failure, since the risk of developing heart failure increases with the use of the drug. Most of all violations of the function of the kidneys, cardiovascular system and liver are detected in elderly patients. Dexketoprofen-LF is used with caution in patients with hematopoietic disorders, systemic lupus erythematosus and mixed connective tissue diseases. Like other NSAIDs, Dexketoprofen-LF is able to mask the symptoms of infectious processes. Separate cases of activation of infectious processes localized in soft tissues during the use of NSAIDs are described. Thus, if symptoms of a bacterial infection occur or worsen during therapy, the patient is advised to consult a doctor immediately. Like all NSAIDs, dexketoprofen can reduce fertility in women, so it is not recommended for women planning a pregnancy. In women undergoing evaluation or treatment for infertility, discontinuation of the drug should be considered. Appointment of the drug in the first trimester of pregnancy is possible only in case of emergency. Each ampoule of the drug contains 200 mg of ethanol, which corresponds to 5 ml of beer or 2.08 of wine. The drug may adversely affect persons suffering from alcoholism. The ethanol content should be taken into account when prescribing the drug during pregnancy and lactation, children and patients at risk, for example, with liver diseases, as well as those suffering from epilepsy. Interaction with other drugs Dexketoprofen-LF should not be mixed in the same syringe with a solution of dopamine, promethazine, pentosycin, pethidine or hydroxyzine (a precipitate forms). Dexketoprofen-LF can be mixed in one syringe with a solution of heparin, lidocaine, morphine and theophylline. Dexketoprofen-LF - prepared solution for infusion should not be mixed with promethazine or pentazocine. Dexketoprofen-LF - prepared solution for infusion is compatible with the following injection solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline. When storing the drug Dexketoprofen-LF - prepared solutions for infusion in plastic containers or when using infusion systems made of ethyl vinyl acetate, cellulose propionate, low density polyethylene or polyvinyl chloride, absorption of the active substance by the listed materials does not occur. The following interactions are typical for all NSAIDs: Undesirable combinations With other NSAIDs, including salicylates in high doses (more than 3 g / day), including selective inhibitors of cyclooxygenase-2 (COX-2): the simultaneous use of several NSAIDs due to a synergistic effect increases the risk of gastrointestinal -intestinal bleeding and ulcers. With oral anticoagulants, heparin in doses exceeding prophylactic doses, 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 concentration of lithium in the blood, up to toxic, and therefore this indicator must be monitored when prescribing, changing the dose and after discontinuing NSAIDs. With methotrexate in high doses (15 mg / week or more): an increase in hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. With hydantoins and sulfa drugs: risk of increased toxic effects of these drugs. Combinations requiring caution: With diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, antibacterial drugs (aminoglycosides): NSAID therapy is associated with a risk of developing acute renal failure in dehydrated patients (decrease in glomerular filtration due to reduced prostaglandin synthesis). NSAIDs may reduce the antihypertensive effect of some drugs. When co-administered with diuretics, it is necessary to ensure that the patient's fluid and electrolyte balance is adequate and to monitor renal function before prescribing NSAIDs. With methotrexate at low doses (less than 15 mg / week): an increase in hematological toxicity of methotrexate due to a decrease in renal clearance during NSAID therapy. It is necessary to carry out a weekly count of blood cells in the first weeks of simultaneous therapy. In case of impaired renal function, even mild, as well as in elderly patients, careful medical supervision is necessary. With pentoxifylline: increased risk of bleeding. Intensive clinical monitoring and frequent monitoring of bleeding time (blood clotting time) is required. With zidovudine: risk of increased toxic effect on erythrocytes due to exposure to reticulocytes, with the development of severe anemia one week after the appointment of NSAIDs. It is necessary to count all blood cells and reticulocytes 1-2 weeks after the start of NSAID therapy. With hypoglycemic drugs for oral administration: NSAIDs may enhance the hypoglycemic effect of these drugs due to its displacement from its binding sites with blood plasma proteins. With heparins (low molecular weight): increased risk of bleeding. With corticosteroids: increased risk of ulcers and gastrointestinal bleeding. With antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding. Combinations to be considered: With beta-blockers: NSAIDs may reduce the antihypertensive effect of beta-blockers, due to inhibition of prostaglandin synthesis. With cyclosporine and tacrolimus: NSAIDs may increase nephrotoxicity, which is mediated by the action of renal prostaglandins. During simultaneous therapy, it is necessary to monitor renal function. With thrombolytics: increased risk of bleeding. With probenecid: plasma concentrations of NSAIDs may increase, which may be due to an inhibitory effect on renal tubular secretion and / or conjugation with glucuronic acid, which requires dose adjustment of NSAIDs. With cardiac glycosides: NSAIDs can lead to an increase in the concentration of glycosides in the blood plasma. With mifepristone: due to the possible risk of changing the effectiveness of mifepristone under the influence of inhibitors of prostaglandin synthesis, NSAIDs should not be prescribed earlier than 8-12 days after discontinuation of mifepristone. With quinolone: data from experimental animal studies indicate a high risk of convulsions when NSAIDs are prescribed during high-dose quinolone therapy. Contraindications Hypersensitivity to dexketoprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), as well as to any of the excipients that make up the drug; acute (including suspected) and chronic diseases of the gastrointestinal tract (including history): Crohn's disease, ulcerative colitis, peptic ulcer of the stomach and duodenum; bleeding (including gastrointestinal) and a tendency to them; simultaneous use of anticoagulants; bronchial asthma (including history); chronic heart failure in the stage of decompensation; complete and an incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid (ASA) or other NSAIDs (including history); the period after coronary artery bypass grafting; severe renal failure (creatinine clearance (CC) less than 30 ml / min.); progressive kidney disease; severe liver failure (10- 15 points on the Child-Pugh scale); hyperkalemia; inflammatory bowel disease; pregnancy, lactation; age up to 18 years (efficacy and safety have not been established); Due to the ethanol content, the drug is contraindicated for neuraxial (intrathecal or epidural) administration. Composition One ampoule (2 ml) contains: Active ingredient: dexketoprofen 50.0 mg (as dexketoprofen trometamol). Excipients: ethanol, sodium chloride, 1 M sodium hydroxide solution, water for injection. Overdose Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia. Treatment: symptomatic therapy; if necessary: gastric lavage, dialysis. Adverse reactions are classified according to the frequency of occurrence as follows: Often (? 1/100 to < 1/10) Infrequently (? 1/1000 to < 1/100) Rarely (? 1/10.000 to < 1/1.000) Very rarely (< 1/10.000) Frequency unknown (cannot be calculated from the available data) From the side of the blood and lymphatic system: infrequently: anemia; very rarely: neutropenia, thrombocytopenia. From the immune system: rarely: swelling of the larynx; very rarely: anaphylactic reactions, including anaphylactic shock. From the side of metabolism and nutrition: rarely: hyperglycemia, hypoglycemia, hypertriglyceridemia, anorexia. Mental disorders: infrequently: insomnia. From the nervous system: infrequently: headache, dizziness, drowsiness; rarely: paresthesia, syncope. On the part of the organs of vision: infrequently: blurred vision. On the part of the ear and labyrinth: rarely: ringing in the ears. From the side of the heart: rarely: extrasystole, tachycardia. From the vascular system: infrequently: arterial hypotension, redness of the face and neck; rarely: arterial hypertension, thrombophlebitis of superficial veins. On the part of the respiratory tract, chest and mediastinal organs: rarely: bradypnea; very rarely: bronchospasm, shortness of breath. From the gastrointestinal tract: often: nausea, vomiting. infrequently: abdominal pain, dyspepsia, diarrhea, constipation, hematemesis, dry mouth. rarely: peptic ulcer, bleeding or perforation. very rare: pancreatitis. From the biliary tract: rarely: hepatitis, jaundice. very rarely: hepatocellular pathology. From the skin and subcutaneous adipose tissue: infrequently: dermatitis, itching, rash, increased sweating. rarely: urticaria, acne. very rarely: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), angioedema, facial edema, photosensitivity. From the musculoskeletal system and connective tissue: rarely: muscle stiffness, stiffness in the joints, muscle cramps, back pain. From the side of the kidneys and urinary system: rarely: acute renal failure, polyuria, renal colic, ketonuria, proteinuria; very rarely: nephritis, nephrotic syndrome. On the part of the reproductive system and mammary glands: rarely: menstrual irregularities, dysfunction of the prostate gland. General and local reactions: often: pain at the injection site, reaction at the injection site, including inflammation, hematoma, bleeding. infrequently: fever, fatigue, pain, chills. rarely: trembling, peripheral edema. Additional research methods: deviations in liver tests. The most common side effects are from the gastrointestinal tract. Thus, it is possible to develop peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients. According to available data, against the background of the use of the drug, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease may occur. Rarely noted gastritis. Edema, hypertension and heart failure were also detected. As with other NSAIDs, the following adverse reactions are possible: aseptic meningitis, which occurs in patients with systemic lupus erythematosus or mixed connective tissue diseases, and blood reactions (purpura, hypoplastic and hemolytic anemia, rarely agranulocytosis and bone marrow hypoplasia) . Bullous reactions are possible, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely). According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially at high doses and for a long time, may be accompanied by a slight increase in the risk of developing pathologies caused by arterial thrombosis, such as myocardial infarction and stroke. Storage conditions In a place protected from light at a temperature not exceeding 25? Keep out of the reach of children. The prepared solution for infusion is stored for 24 hours at a temperature of 2 ° - 8 ° C in a place protected from light. The prepared solution should be clear and colorless. /in and in/m injections 50mg/2ml №5х1