Dexalgin® 25 (Dexalgin® 25)
The following interactions are common to all NSAIDs.
Undesirable combinations
With other NSAIDs, including salicylates in high doses (more than 3 g/day):
simultaneous use of several NSAIDs due to the synergistic effect increases the risk of gastrointestinal bleeding and ulcers.
With anticoagulants
: Dexketoprofen, like other NSAIDs, may enhance the effect of anticoagulants such as warfarin due to high plasma protein binding, inhibition of platelet aggregation and damage to the gastrointestinal mucosa. If simultaneous use is necessary, careful monitoring of the patient's condition and regular monitoring of laboratory parameters is necessary.
With heparin:
with simultaneous use, the risk of bleeding increases (due to inhibition of platelet aggregation and damaging effects on the mucous membrane of the gastrointestinal tract). If simultaneous use is necessary, careful monitoring of the patient's condition and regular monitoring of laboratory parameters is necessary.
With glucocorticosteroids:
with simultaneous use, the risk of ulcerative lesions of the gastrointestinal tract and bleeding increases.
With lithium preparations:
NSAIDs increase the concentration of lithium in the blood plasma up to toxic levels, and therefore this indicator must be monitored when used simultaneously with dexketoprofen, changing the dosage, and also after discontinuation of NSAIDs.
With methotrexate in high doses (15 mg/week or more):
it is possible to increase the hematological toxicity of methotrexate due to a decrease in its renal clearance when used simultaneously with NSAIDs.
With hydantoins and sulfonamides:
their toxic effect may be enhanced.
Combinations
requiring caution
With diuretics, angiotensin-converting enzyme (ACE) inhibitors, aminoglycoside antibiotics, angiotensin II :
simultaneous use with NSAIDs is associated with a risk of developing acute renal failure in dehydrated patients (decreased glomerular filtration rate due to decreased synthesis of prostaglandins). When used concomitantly, NSAIDs may reduce the antihypertensive effect of some drugs. When using dexketoprofen and diuretics simultaneously, it is necessary to ensure that the patient has no signs of dehydration, and also monitor renal function at the beginning of simultaneous use.
With methotrexate in low doses (less than 15 mg/week):
it is possible to increase the hematological toxicity of methotrexate due to a decrease in its renal clearance during simultaneous use with NSAIDs. A blood cell count is necessary when coadministration is initiated. In the presence of even mild renal dysfunction, as well as in elderly people, careful medical supervision is necessary.
With pentoxifylline:
there may be an increased risk of bleeding. Close clinical monitoring and regular checking of bleeding time (blood clotting time) is necessary.
With zidovudine:
There is a risk of increased toxicity to red blood cells due to effects on reticulocytes, with the development of severe anemia one week after starting NSAID use. It is necessary to conduct a general blood test with counting the number of reticulocytes 1-2 weeks after starting NSAID therapy.
With oral hypoglycemic agents:
NSAIDs may enhance the hypoglycemic effect of sulfonylureas due to the displacement of sulfonylurea from sites of binding to plasma proteins.
Combinations
that
need to be taken into account
With
beta -blockers:
When used simultaneously with NSAIDs, the antihypertensive effect of beta-blockers may be reduced 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 use, it is necessary to monitor renal function.
With thrombolytics:
the risk of bleeding increases.
The risk of bleeding from the gastrointestinal tract increases when used simultaneously with serotonin reuptake inhibitors
(citalopram, fluoxetine, sertraline) and anticoagulants.
With probenecid:
it is possible to increase the concentration of NSAIDs in the blood plasma, which may be due to the inhibitory effect of probenecid on renal tubular secretion and/or conjugation with glucuronic acid; NSAID dose adjustment may be required.
With cardiac glycosides:
simultaneous use with NSAIDs may lead to an increase in the concentration of cardiac glycosides in the blood plasma.
With mifepristone:
Due to the theoretical risk of changes in the effectiveness of mifepristone under the influence of prostaglandin synthesis inhibitors, NSAIDs should not be used 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 NSAIDs are used concomitantly with quinolones in high doses.
If necessary, simultaneous use of the drug Dexalgin
®
25 with the above medications, you should consult your doctor.
Enantyum 25 mg 20 Compresse Rivestite
Product Card Therapeutic Indications Enantyum Tablets are used to treat symptoms of disease pain of mild to moderate intensity, such as musculoskeletal pain, dysmenorrhea, toothache.
Dosage and method of administration Depending on the nature and intensity of the pain, the recommended dose of Enantyum Tablets is usually 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg.
Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment to control symptoms. Long-term treatment is not indicated and administration is limited to symptomatic periods only. Concomitant meals slow down the rate of absorption of the drug, so in case of acute pain it is recommended that the administration occurs at least 30 minutes before meals.
In elderly patients, it is recommended to initiate therapy at the lower end of the therapeutic range (50 mg total daily dose). The dosage may be increased to reach these workers in the general population only after general well-tolerance has been established. Patients with mild to moderate hepatic impairment should begin therapy with low doses (50 mg total daily dose) and should undergo strict monitoring. Do not use in patients with severe hepatic impairment. The initial dosage should be reduced to 50 mg total daily dose in patients with moderate renal impairment. Do not use in patients with moderate to severe renal impairment. Has not been studied in children and adolescents; therefore, safety and effectiveness have not been established, this product cannot be used.
Contraindications
Hypersensitivity to dexketoprofene, or other NSAIDs, or any of the excipients of the drug. Patients in whom active actions similar (eg, aspirin or other NSAIDs) cause asthma attacks, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioedema. In patients with active or suspected peptic ulcer/bleeding or a positive medical history of peptic ulcer/bleeding (two or more separate episodes, verify ulceration or bleeding) or chronic dyspepsia. Patients with a history of gastrointestinal bleeding or perforation due to previous NSAID therapy. Patients who have gastrointestinal bleeding or other active bleeding or clotting disorders. Patients with: diseases such as Crohn's disease or ulcerative colitis; history of bronchial asthma; severe heart failure; moderate to severe renal failure; severe liver failure; hemorrhagic diathesis and other blood clotting disorders. Pregnancy and lactation period.
Special instructions The safety of use in children and adolescents has not been established. Use with caution in patients with a history of allergic conditions. Concomitant use with other NSAIDs, including selective cyclooxygenase 2 inhibitors, should be avoided. Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment to control symptoms.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at various stages of treatment, with or without symptoms or a history of serious GI events. If gastrointestinal bleeding or ulceration occurs, you should stop treatment. The risk increases with increasing dose of NSAIDs, in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation, and in elderly patients. These have an increased incidence of adverse reactions to NSAIDs, particularly bleeding and gastrointestinal perforation, which can be fatal; start treatment with the lowest dose possible.
Before starting treatment with dexketoprofene trometamol, one should look for a past history of esophagitis, gastritis and/or gastric ulcer and ensure their complete healing. Patients with gastrointestinal symptoms or a history of gastrointestinal disorders should be carefully monitored for the occurrence of digestive upset, in particular gastrointestinal bleeding. Administer with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as their conditions may be exacerbated.
Combination therapy with protective agents (eg, misoprostolo or proton pump inhibitors) should be taken into account for these patients, as well as for patients who are concomitantly taking low-dose aspirin or other drugs that may increase the risk of gastrointestinal symptoms. Patients with a history of gastrointestinal poisoning, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.
Caution is advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin. All selective NSAIDs fail to inhibit platelet aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. Therefore, the use of dexketoprofene trometamol in patients who are receiving other medications that interfere with blood clotting, such as warfarin or other coumarin or heparin derivatives, is not recommended. The drug may cause an increase in blood urea nitrogen and creatinine. This may be due to side effects on the load on the kidneys, which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. May cause slight transient increases in some liver parameters and even significant increases in AST and ALT. If a significant increase in these parameters occurs, treatment should be discontinued. Administer with caution in patients with hematopoietic disorders, systemic lupus erythematosus, or connective tissue diseases. And dexketoprofene may mask the symptoms of an infectious disease.
Use with caution in patients with impaired liver and/or kidney function and in patients with arterial hypertension and/or heart failure. In these patients, the use of NSAIDs may lead to deterioration of renal function, fluid retention and edema. Caution is also required in patients under diuretic therapy or in those patients who may develop hypovolemia, due to the increased risk of nephrotoxicity'. Use with extreme caution in patients with a history of cardiovascular disease, in particular those with past episodes of heart failure, for a greater risk of precipitating heart failure. Elderly patients tend to be more likely to have kidney failure, cardiovascular failure, or liver failure. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in combination with NSAIDs. Patients appear to be at increased risk of developing such reactions early in therapy, as the onset of reactions occurs in most cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rashes, mucosal lesions or any other signs of hypersensitivity. May cause infertility in women and is not recommended in women wishing to become pregnant.
You should consider stopping treatment with dexketoprofene trometamol in women who are having difficulty conceiving or are undergoing investigations for infertility. Adequate monitoring and appropriate instructions are required in patients with a positive medical history of hypertension and/or mild to moderate congestive heart failure, since fluid retention and edema have been observed in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increase in the risk of arterial thrombotic events (eg, myocardial infarction or stroke). There is insufficient data to exclude a similar risk for dexketoprofene trometamol. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking).
Pregnancy and lactation It is contraindicated during pregnancy and lactation.
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the development of the embryo/fetus. The results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformations and gastroschisis after the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. The absolute risk of heart defects appears to have increased from less than 1% to about 1.5%. And it was believed that the risk increases with increasing dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to lead to increased loss of pre- and post-implantation and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, has been reported in animals that were administered prostaglandin synthesis inhibitors during the period of organogenesis.
However, studies conducted in animals with dexketoprofene trometamol have not shown reproductive toxicity. During the first and second trimester of pregnancy, it should not be prescribed unless absolutely necessary. If dexketoprofene trometamol is used in women awaiting conception, or during the first and second trimester, the dose and duration of treatment should be kept as low as possible. During the third quarter, all prostaglandin synthesis inhibitors may expose the fetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) and/or renal dysfunction, which may progress to renal failure with oligoidroamnios; mother and newborn, at the end of pregnancy, there may be an increase in bleeding time, an antiaggregation effect that can occur even in low doses and/or inhibition of uterine contractions that lead to delay or prolongation of labor.
During lactation
It has not been established if dexketoprofene is secreted into breast milk.
Expiry date and shelf life Check the expiration date indicated on the packaging. The expiration date indicated on the package refers to the product in the package being in good working order and stored correctly. Do not store at temperatures above 30°C. Store in blisters in outdoor packaging to keep it away from light.
Attention: do not use the drug after the expiration date indicated on the package.
Composition of Efferalgan Suppositories contains: Active ingredient: dexketoprofene 25 mg Excipients: corn starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearato, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.
Enantyum 25 mg Pack of 20 Tablets, Coated
