Directions for use and doses
Installed individually.
The average recommended single dose is 12.5 mg (1/2 tablet) 1 to 6 times/day every 4-6 hours as needed or 25 mg (1 tablet) 1 to 3 times/day every 8 hours.
The maximum daily dose is 75 mg (6 tablets).
In patients with impaired liver or kidney function, or in the elderly, the drug should be started in lower doses - no more than 50 mg / day.
The drug is not intended for long-term use: the duration of use should not exceed 3-5 days.
pharmachologic effect
Non-steroidal anti-inflammatory drug (NSAID).
Dexketoprofen trometamol is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory and antipyretic effects.
Dexketoprofen is the S-(+) enantiomer of the racemate of ketoprofen.
The mechanism of action of dexketoprofen is based on inhibition of prostaglandin synthesis at the level of cyclooxygenases (COX-1 and COX-2).
After oral administration of dexketoprofen in tablet form, the analgesic effect begins within 30 minutes, the duration of the therapeutic effect is 4-6 hours.
The faster absorption of dexketoprofen when taken orally in the form of granules for the preparation of a solution compared to the tablet form may result in a faster onset of analgesic effect.
Contraindications
- peptic ulcer of the stomach and duodenum;
- gastrointestinal bleeding;
- active bleeding of various origins;
- increased bleeding;
- anticoagulant therapy;
- Crohn's disease;
- nonspecific ulcerative colitis;
- bronchial asthma (including history);
- severe heart failure;
- severe renal failure;
- severe liver failure;
- pregnancy;
- lactation period;
- hypersensitivity to dexketoprofen or other NSAIDs.
special instructions
Caution should be exercised when prescribing the drug to elderly patients, patients with allergic reactions, systemic connective tissue diseases and patients with hematopoietic disorders.
Patients should be informed that in case of side effects, as well as in the absence of clinical effect within 3-5 days of treatment, it is necessary to inform the attending physician.
Particular caution is required when using Dexalgin 25 simultaneously with phenytoin, sulfonamides and drugs that reduce blood clotting.
Since Dexalgin 25 can cause dizziness and drowsiness, the drug should be prescribed with caution to patients engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.
Dexalgin 25 tab.pp.p.o.25mg No. 10 26934
Description
Round, biconvex, white film-coated tablets with a score line on both sides of the tablet. Absorption. Cmax after oral administration of dexketoprofen trometamol is achieved on average after 30 minutes (15–60 minutes). Concomitant food intake slows down the absorption of the drug. AUC after single and repeated doses are similar, indicating the absence of drug accumulation. Distribution. Dexketoprofen trometamol is characterized by a high level of binding to plasma proteins (99%). The average Vd value is less than 0.25 l/kg, the half-life is about 0.35 hours. Elimination. The main route of excretion of dexketoprofen is its conjugation with glucuronic acid, followed by excretion by the kidneys. T1/2 of dexketoprofen trometamol is 1.65 hours. In elderly people, there is an increase in T1/2, on average up to 48%, and a decrease in the total clearance of the drug. Dexketoprofen trometamol is the active ingredient of the drug Dexalgin® 25 - an NSAID that has analgesic, anti-inflammatory and antipyretic effect. The mechanism of action is associated with inhibition of PG synthesis at the level of COX-1 and COX-2. The analgesic effect occurs 30 minutes after oral administration, the duration of the therapeutic effect reaches 4–6 hours. When combined with the opioid analgesics dexketoprofen, trometamol significantly (up to 30–45%) reduces the need for opioids. For patients with gastrointestinal or gastrointestinal disorders - history of intestinal diseases requires careful monitoring. If gastrointestinal bleeding or ulcers occur, therapy with Dexalgin® 25 should be discontinued. It has been clinically proven that the simultaneous use of dexketoprofen and low molecular weight heparin drugs in prophylactic doses in the postoperative period does not change coagulation rates. However, when using Dexalgin® 25 simultaneously with other drugs that affect blood clotting, careful medical monitoring of the blood clotting system is necessary. Like other NSAIDs, Dexalgin® 25 can lead to increased concentrations of creatinine and nitrogen in the blood plasma. Like other PG synthesis inhibitors, Dexalgin® 25 may 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 the use of other NSAIDs, during therapy with Dexalgin® 25, a slight transient increase in some liver parameters, as well as a significant increase in the activity of AST and ALT in the blood serum, may be observed. At the same time, monitoring liver and kidney function is necessary in elderly people. In case of a significant increase in the corresponding indicators, Dexalgin® 25 should be discontinued. Like other NSAIDs, dexketoprofen may mask the symptoms of infectious diseases. If signs of infection or deterioration in health are detected during therapy with Dexalgin® 25, the patient should immediately consult a doctor. Influence on the ability to drive vehicles and operate machinery. Due to possible dizziness and drowsiness while taking Dexalgin® 25, the ability to concentrate and the speed of psychomotor reactions in patients may decrease in the first hour after taking the drug. Therefore, during treatment with Dexalgin® 25, caution should be exercised when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Compound
Film-coated tablets 1 tablet. dexketoprofen trometamol 36.9 mg (corresponding to 25 mg of dexketoprofen) excipients: MCC; corn starch; sodium carboxymethyl starch; glyceryl palmitostearate shell: hypromellose; macrogol 6000; titanium dioxide; propylene glycol in blister 10 pcs.; in a cardboard pack there are 1, 3 or 5 blisters.
Application
relief of pain syndrome of various origins (including postoperative, post-traumatic pain, pain due to bone metastases, renal colic, algomenorrhea, sciatica, sciatica, neuralgia, toothache); symptomatic treatment of acute and chronic inflammatory, inflammatory-degenerative and metabolic diseases of the musculoskeletal system (including rheumatoid arthritis, spondyloarthritis, osteoarthritis, osteochondrosis). The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use. The use of Dexalgin® 25 during pregnancy and lactation is contraindicated. Possible side effects when using Dexalgin® 25, as well as when using other dexketoprofen drugs, are listed below in descending order of frequency occurrence: often (1–10% of patients); uncommon (0.1–1% of patients); rare (0.01–0.1% of patients); very rare (less than 0.01% of patients), including isolated reports. From the blood and lymphatic system: very rarely - neutropenia, thrombocytopenia. From the nervous system: infrequently - headache, dizziness, insomnia, drowsiness; rarely - paresthesia. From the senses: rarely - tinnitus; very rarely - blurred vision. From the cardiovascular system: infrequently - feeling of heat, hyperemia of the skin; rarely - extrasystole, increased blood pressure; very rarely - tachycardia, decreased blood pressure. From the respiratory system: rarely - bradypnea; very rarely - bronchospasm, shortness of breath. From the gastrointestinal tract: often - nausea, vomiting, abdominal pain, dyspepsia, diarrhea; infrequently - constipation, dry mouth, flatulence; rarely - erosive and ulcerative lesions of the gastrointestinal tract, bleeding from an ulcer or its perforation, anorexia; very rarely - damage to the pancreas. From the liver and biliary tract: rarely - increased activity of liver enzymes (including AST and ALT), jaundice; very rarely - liver damage. From the kidneys and urinary tract: rarely - polyuria; very rarely - nephritis or nephrotic syndrome. From the reproductive system: rarely - menstrual irregularities (in women), transient dysfunction of the prostate gland with long-term use (in men). From the musculoskeletal system: rarely - back pain, muscle spasm, difficulty moving the joints. From the skin and subcutaneous tissues: infrequently - dermatitis, rash; rarely - urticaria, acne, sweating; very rarely - severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome), angioedema, allergic dermatitis, photosensitivity. Metabolic disorders: rarely - hyperglycemia, hypoglycemia, hypertriglyceridemia. From laboratory data: rarely - ketonuria, proteinuria. From the general status: infrequently - fever, fatigue; very rarely - anaphylactic shock, facial swelling. Other disorders: infrequently - 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. The following interactions are typical for all NSAIDs. Undesirable combinations With other NSAIDs, including salicylates in high doses (more than 3 g/day): simultaneous use of several NSAIDs due to a synergistic effect increases the risk of gastrointestinal bleeding and ulcers. With oral anticoagulants, heparin, in doses exceeding prophylactic ones, and ticlopidine: increased risk of bleeding due to inhibition of platelet aggregation and damage to the gastrointestinal mucosa. With lithium preparations: NSAIDs increase the concentration of lithium in the blood, up to toxic levels, and therefore this indicator must be monitored when using, changing the dose and after discontinuation of NSAIDs. With methotrexate in high doses (15 mg/week or more): increased hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. With hydantoins and sulfonamides: the risk of increased toxic effects of these drugs. Combinations requiring caution With diuretics, ACE inhibitors: NSAID therapy is associated with a risk of developing acute renal failure in dehydrated patients (decreased glomerular filtration rate due to reduced PG synthesis). NSAIDs may reduce the antihypertensive effect of some drugs. With methotrexate in low doses (less than 15 mg/week): increased hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. It is necessary to conduct weekly blood cell counts during the first weeks of concomitant therapy. In the presence of even mild renal dysfunction, as well as in elderly people, careful medical supervision is necessary. With serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline), oral glucocorticoids: increased risk of gastrointestinal bleeding. With pentoxifylline: increased risk of bleeding. Intensive clinical monitoring and frequent checking of bleeding time (blood clotting time) is necessary. With zidovudine: risk of increased toxicity to red blood cells due to effects on reticulocytes, with the development of severe anemia one week after administration of NSAIDs. It is necessary to conduct a complete blood count with a reticulocyte count 1–2 weeks after starting NSAID therapy. With sulfonylurea derivatives: NSAIDs can enhance the hypoglycemic effect of sulfonylurea due to its displacement from sites of binding to plasma proteins. With low molecular weight heparin preparations: increased risk of bleeding. Combinations that need to be taken into account With beta-blockers: NSAIDs may reduce the hypotensive effect of beta-blockers due to inhibition of PG synthesis. With cyclosporine and tacrolimus: NSAIDs may increase nephrotoxicity, which is mediated by the action of renal PGs. During concomitant therapy, renal function should be monitored. With thrombolytics: increased risk of bleeding. With probenecid: NSAID plasma concentrations may increase, which may be due to the inhibitory effect of probenecid on renal tubular secretion and/or conjugation with glucuronic acid, requiring NSAID dose adjustment. With cardiac glycosides: NSAIDs may lead to increased plasma concentrations of glycosides. With mifepristone: due to the theoretical risk of changes in the effectiveness of mifepristone under the influence of PG synthesis inhibitors, NSAIDs should not be prescribed earlier than 8-12 days after discontinuation of mifepristone. With quinolones: data obtained from experimental studies in animals indicate a high risk of developing seizures when using NSAIDs during therapy with quinolones in high doses. Orally, with food. Depending on the intensity of the pain syndrome, the recommended dose for adults is 12.5 mg (1/2 tablet) every 4-6 hours or 25 mg (1 tablet) every 8 hours. The maximum daily dose is 75 mg. In elderly patients and patients with impaired liver and/or kidney function, therapy with Dexalgin® 25 should be started with lower doses. The maximum daily dose is 50 mg. Dexalgin® 25 is not intended for long-term therapy; the course of treatment with the drug should not exceed 3–5 days. Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia. Treatment: symptomatic therapy, if necessary - gastric lavage, hemodialysis. increased sensitivity to dexketoprofen or other NSAIDs, or any of the excipients included in the drug; peptic ulcer of the stomach and duodenum in the acute phase; history of gastrointestinal bleeding, other active bleeding (including suspected intracranial bleeding), anticoagulant therapy; inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase; severe liver dysfunction (10–15 points on the Child-Pugh scale); moderate or severe renal impairment (Cl creatinine <50 ml/min); complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history); severe heart failure; period after coronary artery bypass surgery; bleeding diathesis or other coagulation disorders; age under 18 years (there are no data on the effectiveness and safety of the drug). With caution: history of allergic reactions; violation of the blood coagulation system; systemic lupus erythematosus or mixed connective tissue diseases; simultaneous therapy with other drugs (see “Interaction”); state of severe hypovolemia; cardiac ischemia; cerebrovascular diseases; diabetes mellitus, hyperlipidemia; peripheral arterial disease; anamnestic data on the development of ulcerative lesions of the gastrointestinal tract; long-term use of NSAIDs; alcoholism, heavy smoking; old age (over 65 years).
Possible product names
- Dexalgin 25 tablets By. 25 mg. No. 10
- DEXALGIN 25 MG TAB. P/OB. No. 10
- DEXALGIN 25 0.025 N10 TABLE P/PLEN/COACH
- DEXALGIN 25 TABLES. P/O PLEN 25 MG X10
- DEXALGIN 25 TAB. P/O PLEEN. 25MG No. 10
- DEXALGIN 25 25MG TAB. P/PL/OB. X10
- (Dexalgin 25) Dexalgin 25 tablets. By. 25 mg. No. 10
