Dexalgin 25
Dexalgin 25: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Dexalgin 25
ATX code: M01AE17
Active ingredient: dexketoprofen (dexketoprofen)
Producer: Laboratorios MENARINI (Spain), A. MENARINI Manufacturing Logistics and Servicer (Italy)
Description and photo updated: 20.11.2018
Prices in pharmacies: from 233 rubles.
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Dexalgin 25 is a non-steroidal anti-inflammatory drug (NSAID) with antipyretic and analgesic effects.
Release form and composition
Dosage form Dexalgin 25 - film-coated tablets: round, biconvex, with a dividing line on both sides, with a white shell (in a blister 10 pcs., In a cardboard box 1, 3 or 5 blisters).
Composition of one tablet:
- active substance: dexketoprofen - 25 mg (in the form of dexketoprofen trometamol - 36.9 mg);
- auxiliary components (core): corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), glyceryl palmitostearate;
- shell: hypromellose, titanium dioxide, macrogol, propylene glycol.
Pharmacological properties
Pharmacodynamics
The active substance of the drug, dexketoprofen trometamol, being a non-steroidal agent, has an anti-inflammatory, antipyretic and analgesic effect. The mechanism of action consists in non-selective inhibition of cyclooxygenases (COX), a group of enzymes involved in the synthesis of prostaglandins, which, in addition to other functions, are regulators and mediators in the development of inflammatory processes. Dexketoprofen inhibits the action of COX-I and COX-II.
Relief of pain symptoms occurs half an hour after oral administration of the drug. The therapeutic effect lasts for 4-6 hours.
In the case of combined treatment with opioid analgesics, Dexalgin 25 reduces the need for opioids by up to 30–45%.
Pharmacokinetics
- absorption: the maximum concentration of dexketoprofen trometamol in blood plasma (C max) after oral administration of the drug is achieved in 15-60 minutes. With the simultaneous intake of food, the absorption of the substance slows down. The area under the pharmacokinetic curve (AUC) after single and repeated oral administration of the drug has approximately the same value, which indicates the absence of accumulation of the active substance;
- distribution: about 99% of dexketoprofen trometamol binds to blood plasma proteins. The volume of distribution (V d) averages up to 0.25 l / kg. The half-life is approximately 0.35 hours;
- metabolism and excretion: the metabolism of dexketoprofen occurs mainly by its conjugation with glucuronic acid and subsequent excretion by the kidneys in the form of metabolites. The half-life (T 1/2) is about 1.65 hours. In elderly patients, there is a decrease in the total clearance of dexketoprofen trometamol and an increase in T 1/2 by 48% on average.
Indications for use
- pain syndrome of various origins (including post-traumatic, postoperative pain, pain in renal colic, bone metastases, sciatica, algomenorrhea, neuralgia, radiculitis, toothache);
- acute and chronic inflammatory, inflammatory-degenerative and metabolic diseases of the musculoskeletal system (including spondyloarthritis, rheumatoid arthritis, osteochondrosis, osteoarthritis) - for symptomatic treatment, reducing inflammation and pain at the time of application.
Contraindications
Absolute:
- peptic ulcer of the stomach and duodenum in the acute stage;
- intestinal diseases of an inflammatory nature (ulcerative colitis, Crohn's disease) in the acute stage;
- a history of bleeding in the gastrointestinal tract, other active bleeding (including suspected intracranial bleeding), anticoagulant therapy;
- moderate or severe renal dysfunction (creatinine clearance less than 50 ml / min);
- severe liver dysfunction (according to the Child-Pugh classification 10-15 points);
- severe heart failure;
- hemorrhagic diathesis or other coagulation disorders;
- a combination (complete or incomplete) of bronchial asthma, recurrent nasal polyposis / paranasal sinuses and intolerance to aspirin or other NSAIDs (including a history);
- the period after the procedure of coronary artery bypass grafting;
- pregnancy and lactation;
- age up to 18 years;
- increased individual sensitivity to dexketoprofen, any NSAIDs or any auxiliary component of the drug.
Relative (diseases / conditions in which the use of Dexalgin 25 requires caution):
- violation of the blood coagulation system;
- a history of allergic reactions;
- Liebman-Sachs disease or mixed connective tissue disease;
- severe hypovolemia;
- history of ulcerative lesions of the gastrointestinal tract;
- cardiac ischemia;
- cerebrovascular diseases;
- diabetes;
- hyperlipidemia;
- peripheral arterial disease;
- simultaneous use of other drugs;
- long course of treatment with NSAIDs;
- alcoholism, heavy smoking;
- advanced age (over 65 years).
Instructions for use of Dexalgin 25: method and dosage
Dexalgin 25 tablets are taken orally, during meals.
The recommended dosage regimen: depending on the intensity of the pain symptom - 1/2 tablet (12.5 mg) every 4-6 hours or 1 tablet (25 mg) every 8 hours. The maximum daily dose is 75 mg.
Patients with impaired renal and / or liver function, as well as elderly patients are advised to start taking Dexalgin 25 with lower doses. The daily maximum dose for these categories of patients is 50 mg.
The course of therapy with Dexalgin 25 should not exceed 3-5 days. The drug is not intended for long-term treatment.
Side effects
Possible side effects from systems, organs and their frequency in accordance with a special classification (often - from ≥ 1/100 to <1/10, infrequently - from ≥ 1/1000 to <1/100, rarely - from ≥ 1/10 000 to <1/1000, very rarely - <1/10 000, including individual messages):
- gastrointestinal tract: often - nausea, vomiting, dyspepsia, abdominal pain, diarrhea; infrequently - flatulence, dry mouth, constipation; rarely - anorexia, erosive / ulcerative lesions of the gastrointestinal tract, ulcerative bleeding or perforation; very rarely - lesions of the pancreas;
- nervous system: infrequently - dizziness, headache, drowsiness, insomnia; rarely - paresthesia;
- blood and lymphatic system: very rarely - thrombocytopenia, neutropenia;
- sense organs: rarely - tinnitus; very rarely - decreased visual acuity;
- cardiovascular system: infrequently - hyperemia of the skin, a feeling of heat; rarely - increased blood pressure, extrasystole; very rarely - lowering blood pressure, tachycardia;
- respiratory system: rarely - bradypnea; very rarely - shortness of breath, bronchospasm;
- liver and biliary tract: rarely - increased activity of hepatic transaminases (including aspartate aminotransferase and alanine aminotransferase), jaundice; very rarely - liver damage;
- kidneys and urinary tract: rarely - polyuria; very rarely - nephrotic syndrome or nephritis;
- reproductive system: rarely - menstrual irregularities (in women), transient disorders of the prostate gland with prolonged use (in men);
- musculoskeletal system: rarely - difficulty in movement in the joints, muscle spasm, back pain;
- skin and subcutaneous tissues: infrequently - rash, dermatitis; rarely - sweating, acne, urticaria; very rarely - severe skin reactions (Lyell's syndrome, Stevens-Johnson syndrome), allergic dermatitis, photosensitivity, angioedema;
- metabolism: rarely - hypoglycemia, hyperglycemia, hypertriglyceridemia;
- laboratory data: rarely - proteinuria, ketonuria;
- the body as a whole: infrequently - fatigue, fever; very rarely - facial edema, anaphylactic shock;
- other: infrequently - aseptic meningitis (mainly in patients with systemic lupus erythematosus or mixed connective tissue disease), hematological disorders (hemolytic and aplastic anemia, purpura); rarely - bone marrow hypoplasia and agranulocytosis.
Overdose
In case of an overdose of Dexalgin 25, the following symptoms may occur: dizziness, headache, nausea, abdominal pain, anorexia, insomnia, disorientation.
Treatment consists of symptomatic therapy. If necessary, you should rinse the stomach, carry out hemodialysis.
special instructions
Patients with a history of gastrointestinal tract diseases or gastrointestinal disorders require careful monitoring during treatment with Dexalgin 25. If an ulcer or gastrointestinal bleeding occurs, the drug should be discontinued.
In the course of clinical studies, it has been proven that the use of dexketoprofen simultaneously with low molecular weight heparin preparations in the postoperative period in preventive doses does not affect blood coagulation indicators. Nevertheless, in the case of joint use of the drug with anticoagulants, it is necessary to carefully monitor the blood coagulation system.
Dexalgin 25, like other NSAIDs, can lead to an increase in the concentration of nitrogen and creatinine in the blood plasma. Due to side effects on the urinary system due to the suppression of prostaglandin synthesis, the drug can cause the development of interstitial nephritis, glomerulonephritis, nephrotic syndrome, papillary necrosis and acute renal failure.
If during therapy with Dexalgin 25 there is a significant increase in the activity of hepatic transaminases in the blood serum (especially in elderly patients), the drug should be canceled.
With dexketoprofen therapy, symptoms of infectious diseases may be masked. Therefore, in case of deterioration of health or the occurrence of any signs of infection during treatment with Dexalgin 25, you should immediately consult a doctor.
Influence on the ability to drive vehicles and complex mechanisms
After taking Dexalgin 25 (especially in the first hour), side reactions such as drowsiness and dizziness may occur. Therefore, during drug therapy, it is necessary to drive vehicles and perform actions that require a high concentration of attention and a quick psychomotor reaction with caution.
Application during pregnancy and lactation
According to the instructions, Dexalgin 25 is contraindicated for use in pregnant and breastfeeding women, since there are no reliable clinical data confirming the safety of its use in this category of patients.
Pediatric use
Since there is no information on the efficacy and safety of the drug in pediatrics, Dexalgin 25 is not recommended for use in children and adolescents under 18 years of age.
With impaired renal function
Renal failure of moderate or severe degree (with creatinine clearance less than 50 ml / min) is a contraindication to the use of Dexalgin 25.
For violations of liver function
It is not recommended to prescribe the drug to patients with severely impaired liver function (10-15 points according to the Child - Pugh classification).
Use in the elderly
Dexalgin 25 tablets should be used with caution in elderly patients (over 65 years old). For this category of patients, it is necessary to adjust the initial doses of the drug downward; the maximum daily dose should not exceed 50 mg.
Drug interactions
The use of Dexalgin 25 simultaneously with certain drugs can lead to the development of the following effects:
- other NSAIDs, including salicylates in doses over 3 g / day: increased risk of ulcers and gastrointestinal bleeding (due to a synergistic effect);
- heparin, oral anticoagulants in doses exceeding prophylactic, and ticlopidine: an increase in the likelihood of bleeding due to inhibition of platelet aggregation and damage to the mucous membrane of the gastrointestinal tract;
- lithium preparations: an increase in the concentration of lithium in the blood, up to toxic. When using dexketoprofen, changing its dose or discontinuing the drug, it is necessary to monitor the corresponding indicator;
- hydantoins and sulfonamides: increasing the risk of their toxic effects;
- diuretics, angiotensin-converting enzyme inhibitors: an increase in the likelihood of developing acute renal failure in patients with dehydration (due to a decrease in glomerular filtration due to suppression of prostaglandin synthesis). Dexketoprofen can reduce the antihypertensive effect of some drugs;
- methotrexate: an increase in its hematological toxicity due to a decrease in renal clearance during the use of NSAIDs. A weekly blood cell count is required in the first few weeks of co-therapy. In the event of even mild renal dysfunction, as well as during therapy in elderly patients, careful medical supervision is required;
- sertraline, fluoxetine, citalopram and other serotonin reuptake inhibitors, oral glucocorticoids: increased risk of gastrointestinal bleeding;
- pentoxifylline: increased likelihood of bleeding. Careful clinical monitoring and checking of the duration of bleeding (clotting time) is necessary;
- zidovudine: an increased risk of its toxic effect on erythrocytes, which is due to exposure to reticulocytes, with the possible development of severe anemia a week after starting NSAIDs. It is necessary to conduct a general blood test and count the number of reticulocytes after 1–2 weeks of dexketoprofen therapy;
- sulfonylurea derivatives: increased hypoglycemic effect of sulfonylurea due to its displacement from the sites of binding to blood plasma proteins;
- low molecular weight heparin preparations: increasing the likelihood of bleeding;
- β-blockers: a decrease in their hypotensive effect due to inhibition of prostaglandin synthesis;
- cyclosporine and tacrolimus: increased nephrotoxicity due to the action of renal prostaglandins. During the period of joint therapy, kidney function should be monitored;
- thrombolytics: increased risk of bleeding;
- probenecid: an increase in the concentration of dexketoprofen in the blood plasma due to the inhibitory effect of probenecid on renal tubular secretion / conjugation with glucuronic acid. Dose adjustment of NSAIDs is required;
- cardiac glycosides: an increase in their concentration in blood plasma;
- mifepristone: theoretical risk of altered efficacy of mifepristone due to the effect of inhibitors of prostaglandin synthesis. Dexketoprofen is not recommended to be prescribed earlier than 8–12 days after discontinuation of mifepristone;
- quinolones: a significant risk of seizures when NSAIDs are taken simultaneously with high doses of quinolones (based on the results of experimental studies in animals).
Analogs
Dexalgin 25 analogs are Dexalgin and Flamadex.
Terms and conditions of storage
Store in a dark, dry place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Dexalgin 25
Reviews of Dexalgin 25 indicate that the drug has an effective effect on pain symptoms of various origins: headache, toothache, postoperative pain, primary and secondary neuralgia, pain of the musculoskeletal system, renal pain. The drug begins to act quickly, the analgesic effect is present for a fairly long time.
However, Dexalgin 25 has many contraindications, which must be taken into account when taking pills.
Price for Dexalgin 25 in pharmacies
The price of Dexalgin 25 per pack is on average: 10 tablets - 300 rubles, 50 tablets - 440 rubles.
Dexalgin 25: prices in online pharmacies
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Drug name Price Pharmacy |
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Dexalgin 25 mg / ml solution for intravenous and intramuscular injection 2 ml 5 pcs. 233 r Buy |
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Dexalgin 25 25 mg granules 10 pcs. 275 RUB Buy |
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Dexalgin 25 25 mg film-coated tablets 10 pcs. 301 RUB Buy |
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Dexalgin 25 mg / ml solution for intravenous and intramuscular administration 2 ml 10 pcs. 449 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
