Dexalgin coated pills 25mg N10
Condition: New product
998 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Dexketoprofen
Release form
Pills
Composition
1 ml: Dexketoprofen trometamol 36.9 mg, which corresponds to a dexketoprofen content of 25 mg. Adjuvants: ethanol 96% - 200 mg, sodium chloride - 8 mg, sodium hydroxide - to pH 7.4, water d / and - up to 2 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
AbsorptionAfter i / m administration of dexketoprofen trometamol Cmax in serum is reached on average after 20 minutes (10-45 minutes). AUC after a single injection in a dose of 25-50 mg is proportional to the dose, as with the / m, and with a / in the introduction. The corresponding pharmacokinetic parameters are similar after a single dose and repeated intramuscular or intravenous administration, which indicates the absence of drug cumulation. Distribution For dexketoprofen trometamol, a high level of plasma protein binding is observed (99%). The average value of Vd is less than 0.25 l / kg, the half-time is about 0.35 hours. IntroductionThe main way to eliminate dexketoprofen is its conjugation with glucuronic acid, followed by excretion by the kidneys. The T1 / 2 of dexketoprofen trometamol is about 1-2.7 hours. The pharmacokinetics in special clinical situations of the elderly is an increase in the duration of T1 / 2 (both after a single dose and after repeated intramuscular or intravenous administration) to an average of 48% and 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, sciatica, 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
- gastric ulcer and duodenal ulcer; - gastrointestinal bleeding in history, other active bleeding (including suspected intracranial bleeding), anticoagulant therapy; - gastrointestinal diseases (Crohn's disease, non-specific ulcerative colitis); - severe abnormal liver function (10-15 points on the Child-Pugh scale); - severe renal dysfunction (CK <50 ml / min); - bronchial asthma (including in history); - severe heart failure; - pain treatment syndrome with coronary artery bypass surgery - hemorrhoids ди diathesis or other coagulation disorders; - children’s age; - hypersensitivity to dexketoprin or other NSAIDs or to any of the excipients that make up the preparation. the drug should be used for allergic conditions in history; disorders of the hematopoietic system; with SLE or mixed connective tissue diseases; simultaneously with other drugs; in case of predisposition to hypovolemia; with CHD; in older patients (over 65 years).
Precautionary measures
Do not exceed recommended doses.
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
The incidence of side effects: often (1-10%), rarely (0.1-1%) rarely (0.01-0.1%), very rarely (less than 0.01%, including individual reports). From the hematopoietic system: rarely - anemia; very rarely - neutropenia, thrombocytopenia. For the central nervous system: infrequently - headache, dizziness, insomnia, drowsiness; rarely - paresthesia. For the senses: infrequently - blurred vision; rarely - tinnitus. From the side of the cardiovascular system: infrequently - arterial hypotension, feeling of heat, hyperemia of the skin; rarely - extrasystole, tachycardia, arterial hypertension, peripheral edema, superficial thrombophlebitis. On the part of 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 - damage to the pancreas, liver damage. From the urinary system: rarely - polyuria, renal colic; very rarely - nephritis or nephrotic syndrome. From the reproductive system: rarely - in women - menstrual disorders, in men - impaired prostate function. From the musculoskeletal system: rarely - muscle spasm, difficulty in movements 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. Metabolism: rarely - hyperglycemia, hypoglycemia, hypertriglyceridemia. From laboratory indicators: rarely - ketonuria, proteinuria. Local and general. : often - pain at the injection site; infrequently - inflammatory reaction, hematoma, hemorrhages at the injection site, feeling of heat, chills,fatigue; rarely back pain, fainting, fever; very rarely - anaphylactic shock, swelling of the face. Other: aseptic meningitis, occurring 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).
Overdose
Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia. Treatment: symptomatic therapy; if necessary, gastric lavage, dialysis.
Interaction with other drugs
The following drug interaction is typical for all NSAIDs, including Dexalgin. Unexpected combinations Simultaneous prescription of several NSAIDs, including salicylates in high doses (more than 3 g / day) increases the risk of gastrointestinal bleeding and ulcers due to synergism of action. When used simultaneously with oral anticoagulants, heparin in doses exceeding prophylactic and ticlopidine increases the risk of bleeding due to inhibition of platelet aggregation and lesions of mucus persistent gastrointestinal sheath. PNVEs increase lithium concentration in 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 or more) there is an increase in hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. When used simultaneously with hydantoins and sulfa drugs, there is a risk of an increase in the toxic effect of these drugs. Combines and those requiring caution. If necessary, they should be taken simultaneously with diuretics and ACE inhibitors, it should be noted that NSAID therapy is associated with the risk of acute renal failure in patients with dehydration (reduction of glomerular filtration caused by inhibition of prostaglandin synthesis). NSAIDs can reduce the hypotensive effect of certain drugs. With simultaneous appointment with diuretics, it is necessary to ensure that the patient's water balance is adequate, and to monitor kidney function before prescribing NSAIDs. When used simultaneously with methotrexate in low doses (less than 15 mg / week), hematologic toxicity of methotrexate may increase due to a decrease in its renal clearance during NSAID therapy.It is necessary to monitor the number of blood cells in the first weeks of simultaneous therapy weekly. In the presence of impaired renal function, even in a mild degree, as well as in the elderly, careful medical observation is necessary. If used simultaneously with pentoxifylline, the risk of bleeding increases. Intensive clinical monitoring and frequent monitoring of bleeding time (clotting time) is necessary. If used simultaneously with zidovudine, there is a risk of increased toxic effect on erythrocytes caused by exposure to reticulocytes, with the development of severe anemia a week after NSAID is prescribed. The control of all blood cells and reticulocytes in 1-2 weeks is necessary. after initiation of NSAID therapy. The hypoglycemic effect of sulfonylurea derivatives may be increased due to its displacement from plasma protein binding sites under the influence of NSAIDs. When used simultaneously with low-molecular-weight heparin preparations, the risk of bleeding increases. Combinations that need to be taken into account by NSAIDs can reduce the effect. , which is due to inhibition of prostaglandin synthesis. When used simultaneously with cyclosporine and tacrolimus, NSAIDs could ut enhance nephrotoxicity, which is mediated by the action of renal prostaglandins. During combination therapy, kidney function must be monitored. If administered concurrently with thrombolytics, the risk of bleeding increases. If used simultaneously 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. PNVPs can cause an increase in the concentration of cardiac glycosides in the blood plasma. Due to the theoretical risk of changing the efficacy of mifepristone under the influence of prostaglandin synthesis inhibitors, NSAIDs should not be prescribed earlier than 8-12 days after the abolition of mifepristone. in experimental animal studies indicate a high risk of convulsions when prescribing NSAIDs during therapy with ciprofloxacin in high doses. Pharmaceutical interaction Dexalgin is not possible with mix in one syringe with a solution of dopamine, promethazine, pentazocine, petidine or hydroxyzine (a precipitate forms). Dexalgin can be mixed in one syringe with a solution of heparin, lidocaine,morphine and theophylline. Diluted solution of the drug Dexalgin for infusions should not be mixed with promethazine or pentazocine. for infusions in plastic containers or when using infusion systems made of ethyl vinyl acetate, cellulose propionate, low density polyethylene or polyvine lhlorida, absorption of the active substance occurs not listed materials.
special instructions
In patients with disorders of the digestive system or gastrointestinal diseases in history, constant monitoring is necessary. In the case of gastrointestinal bleeding or ulceration, treatment with Dexalgin should be discontinued. all NSAIDs can inhibit platelet aggregation and increase bleeding time due to slower prostaglandin synthesis; controlled clinical studies have studied the simultaneous administration of dexketoprofen trometamol and low-molecular-weight heparin drugs in prophylactic doses in the 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 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. Against the background of therapy with Dexalgin, like other NSAIDs, there may be a slight renal failure. a transient increase in certain hepatic parameters, as well as a significant increase in serum AST and ALT levels. At the same time, the control of liver and kidney functions is necessary in elderly patients.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 symptoms of bacterial infection or deterioration of health during therapy with Dexalgin, the patient should report this to the doctor. Each ampoule of Dexalgin contains 200 mg of ethanol. Dexalgin may decrease the ability to concentrate and speed psychomotor reactions.