What are Aertal tablets for?
The active ingredient of Aertal is aceclofenac. This is an anti-inflammatory drug with an analgesic effect. The tablets are taken for severe pain in the joints and tissues; the drug is especially often used for toothache, when it is not possible to quickly get to the dentist. In addition, sudden pain in the lumbar region can also be easily eliminated by taking the Aertal tablet.
Food intake does not affect the absorption and activity of the components. For severe and persistent pain, take the drug twice a day, one tablet. Exceeding the daily dose is not recommended to avoid negative reactions.
Airtal, 100 mg, film-coated tablets, 20 pcs.
No drug interaction studies have been conducted with the exception of warfarin.
Aceclofenac is metabolized by the cytochrome P450 - CYP2C9 system, and in vitro
indicate that aceclofenac may be an inhibitor of this enzyme. Therefore, there is a possible risk of pharmacokinetic interaction with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole.
As with other NSAIDs, there is a risk of pharmacokinetic interaction with drugs that are actively excreted by the kidneys, such as methotrexate and lithium preparations.
Aceclofenac is almost completely bound to plasma proteins, and, therefore, it is necessary to consider the possibility of substitution with other drugs that are highly bound to plasma proteins.
Due to the lack of pharmacokinetic interaction studies, the following information is based on information obtained for other NSAIDs.
The following combinations should be avoided
NSAIDs inhibit tubular secretion of methotrexate, and a metabolic interaction may also occur leading to decreased clearance of methotrexate. Therefore, NSAIDs should always be avoided during treatment with large doses of methotrexate.
Some NSAIDs inhibit the renal excretion of lithium and digoxin, resulting in elevated serum concentrations of both substances. This combination should be avoided unless frequent monitoring of lithium and digoxin serum concentrations is possible.
NSAIDs inhibit platelet aggregation and damage the GI mucosa, which may increase the activity of anticoagulants and increase the risk of GI mucosal bleeding in patients taking anticoagulants.
The combination of aceclofenac with oral anticoagulants of the coumarin group, ticlopidine, thrombolytics and heparin should be avoided unless carefully monitored.
The following combinations may require dose adjustment and precautions:
The possible interaction of NSAIDs and methotrexate must be taken into account, especially in patients with renal failure. When taking both drugs, monitoring of kidney function is necessary. Precautions should be taken when taking NSAIDs and methotrexate simultaneously within 24 hours, because methotrexate concentrations may increase, resulting in increased methotrexate toxicity.
It is believed that taking NSAIDs with cyclosporine or tacrolimus increases the risk of nephrotoxicity due to decreased renal prostacyclin synthesis. Therefore, when taking drugs simultaneously, it is important to monitor renal function.
Concomitant use of acetylsalicylic acid and other NSAIDs may increase the incidence of adverse reactions and, therefore, caution is required when taking them together.
NSAIDs may reduce the diuretic effect of furosemide, bumetanide and the hypotensive effect of thiazide diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with an increase in serum potassium levels, so monitoring of blood potassium levels is necessary.
NSAIDs may also reduce the effect of some antihypertensive medications. ACE inhibitors or angiotensin II receptor antagonists in combination with NSAIDs can lead to renal failure. The risk of developing acute renal failure, which is usually reversible, may be increased in some patients with impaired renal function, such as elderly patients or patients who are fluid-depleted. Therefore, the combination of such drugs with NSAIDs should be used with caution, patients should receive sufficient fluids with food, and renal function should be monitored.
There was no effect of aceclofenac on blood pressure when it was taken concomitantly with bendrofluazide, although interaction with other diuretics cannot be excluded.
Other possible interactions
Isolated cases of hypoglycemia and hyperglycemia have been reported. Therefore, for aceclofenac it is necessary to adjust the dose of drugs that cause hypoglycemia.
When taking NSAIDs and zidovudine concomitantly, the risk of hematological toxicity increases.
When used simultaneously with the drug Airtal®:
— digoxin, phenytoin or lithium drugs
- the plasma level of these drugs may increase;
— diuretics and antihypertensive drugs
- the effect of these drugs may be weakened;
— potassium-sparing diuretics
- can lead to the development of hyperglycemia and hyperkalemia;
— other NSAIDs or corticosteroids
— the risk of side effects from the gastrointestinal tract increases;
— SSRIs
(citalopram, fluoxetine, paroxetine, sertraline) - increases the risk of gastrointestinal bleeding;
— cyclosporine
- the toxic effect of the latter on the kidneys may increase;
— antidiabetic drugs
- can cause both hypo- and hyperglycemia. With this combination of drugs, control of blood sugar levels is necessary;
— antiplatelet agents and anticoagulants
- the risk of bleeding increases (regular monitoring of blood clotting indicators is necessary).
What is Aertal powder from?
Powder is a type of dosage form. It is intended for preparing a suspension. A single dose of the drug is packaged in a sachet. The advantage of using the powder is its rapid absorption. The tablet requires time to be broken down and processed in the gastrointestinal tract, and the powder, once in the stomach, begins to be absorbed into the blood without waiting for delivery to the intestines. The active substance contained in the tablets is contained in the same volume in one sachet.
Another advantage of using powder is the ability to accurately adjust the dose. For example, people with kidney or liver failure need to reduce the single dose by half. By dividing the contents of the package into two parts, it is easy to prepare a suspension of the desired concentration.
Aertal® ()
The simultaneous use of Airtal® and other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
Adverse events can be minimized by using the lowest effective dose and reducing the duration of treatment needed to control symptoms.
Effect on the gastrointestinal tract (GIT)
Bleeding, ulcers or perforation of the gastrointestinal tract with a fatal outcome were observed when taking any NSAIDs during any period of treatment, both in the presence of corresponding symptoms and a history of serious gastrointestinal diseases (peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis, etc.), and and without them.
The risk of bleeding, ulceration, and gastrointestinal perforation increases with increasing doses of NSAIDs in patients with a history of peptic ulcers, especially those accompanied by bleeding or perforation, and in elderly patients. These patients should take the minimum effective dose of the drug. They require combination therapy with protective drugs (for example, misoprostol or proton pump inhibitors). Such treatment is necessary for patients who take small doses of aspirin or other drugs that negatively affect the gastrointestinal tract.
Patients with gastrointestinal diseases, including the elderly, should report any unusual gastrointestinal symptoms (especially bleeding), including when initially taking the drug. Particular caution should be exercised in patients concomitantly taking drugs that may increase the risk of bleeding or ulceration, such as systemic corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (such as acetylsalicylic acid).
If gastrointestinal bleeding or ulcers occur in patients taking Airtal®, treatment should be discontinued.
Effects on the cardiovascular and central nervous system
Patients with arterial hypertension and/or mild or moderate congestive heart failure require appropriate monitoring, since fluid retention and edema are associated with the use of NSAIDs.
Aceclofenac is structurally close to diclofenac and has similar metabolism. With regard to diclofenac, there is evidence indicating an increased risk of thromboembolic complications (for example, myocardial infarction or stroke, particularly with long-term treatment with high doses). There is also an increased risk of developing acute coronary syndrome associated with aceclofenac. Patients with chronic heart failure (New York Heart Association class I) and patients with risk factors for developing complications from the cardiovascular system (for example, hypertension, diabetes mellitus, smoking) should begin treatment with aceclofenac only after an informed decision by the attending physician. . Cardiovascular risks may depend on the dose and duration of treatment, so the drug should be prescribed at the lowest effective dose and for the shortest possible period of time.
Effect on the liver and kidneys
Taking NSAIDs can cause a dose-dependent decrease in prostaglandin formation and acute renal failure. The importance of prostaglandins in maintaining renal blood flow should be considered when taking the drug in patients with impaired cardiac, renal or hepatic function, in patients receiving diuretics or in patients after surgery, as well as in the elderly.
Caution should be exercised when prescribing the drug to patients with mild or moderate impairment of liver and kidney function, as well as patients with other conditions predisposing to fluid retention in the body. In these patients, NSAIDs may cause renal dysfunction and fluid retention. Patients taking diuretics and those with an increased risk of hypovolemia should also be careful when taking the drug Airtal®, film-coated tablets, 100 mg. It is necessary to prescribe the minimum effective dose and regular medical monitoring of renal function. Adverse renal events usually resolve after discontinuation of aceclofenac.
Aceclofenac should be discontinued if changes in liver function tests persist or worsen, clinical signs or symptoms of liver disease develop, or other manifestations (eosinophilia, rash) occur. Hepatitis can develop without prodromal symptoms.
The use of NSAIDs in patients with hepatic porphyria may precipitate an attack. Hypersensitivity and skin reactions
Like other NSAIDs. the drug may cause allergic reactions, including anaphylactic/anaphylactic reactions, even if the drug is taken for the first time. Severe skin reactions (some of which can be fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been very rare after taking NSAIDs. The highest risk of these reactions occurring in patients is observed at the beginning of taking the drug, and the development of these adverse reactions is observed during the first month of taking the drug. If skin rash, damage to the oral mucosa, or other signs of hypersensitivity occur, stop taking aceclofenac.
In some cases, chickenpox can cause skin and soft tissue infections.
At present, the role of NSAIDs in worsening the course of these infections cannot be ruled out. Therefore, you should avoid taking Airtal® for chickenpox.
Hematological disorders
Aceclofenac may cause reversible inhibition of platelet aggregation.
Respiratory system disorders
Caution should be exercised when taking the drug in patients with a history or current bronchial asthma, since taking NSAIDs may trigger the development of sudden bronchospasm in such patients.
Elderly patients
Caution should be exercised when taking the drug in elderly patients, as they are more likely to experience side effects (especially bleeding and perforation of the gastrointestinal tract) when taking NSAIDs. Complications can be fatal. Older patients are also more likely to suffer from kidney, liver or cardiovascular diseases.
Long-term use
All patients receiving long-term treatment with nonsteroidal anti-inflammatory drugs should be closely monitored (eg, complete blood count, liver function tests, and renal function tests).
What is Aertal ointment for?
Ointment is a form for topical use. It is applied to damaged joints or areas of the body. Indications for use are bruises, sprains, dislocations, torticollis, or shooting sharp pain in the lower back.
The ointment is applied in a small amount to the sore spot and thoroughly rubbed into the tissue with massaging movements. Once in the body, the drug is absorbed into the blood, from where it is distributed throughout the body. As additional components, the ointment contains liquid paraffin and wax, which make its consistency soft and elastic.
Buy Airtal powder for the preparation of an oral suspension 100 mg pack. 3g No. 20 in pharmacies
Aertal Buy Aertal in pharmacies
DOSAGE FORMS powder d/prig suspension 100 mg
MANUFACTURERS Almirall Prodespharma S.A. (Spain) Gedeon Richter JSC (Hungary)
GROUP Anti-inflammatory drugs - phenylacetic acid derivatives
COMPOSITION Active substance - aceclofenac.
INTERNATIONAL NON-PROPENTED NAME Aceclofenac DESCRIPTION Pharmacological action: NSAID, a derivative of phenylacetic acid. It has anti-inflammatory, analgesic and antipyretic effects associated with the suppression of COX 1 and 2, which regulate the synthesis of prostaglandins.
Pharmacokinetics : After oral administration, aceclofenac has a high degree of absorption. Cmax is reached within 1.25-3 hours. Penetrates into the synovial fluid, where its concentration reaches 57% of the concentration level in plasma and the time to reach Cmax is 2-4 hours later than in plasma. Vd - 25 l. Binding to plasma proteins (albumin) - 99%. Aceclofenac circulates mainly unchanged, its main metabolite being 4′-hydroxyaceclofenac. T1/2 is 4 hours. It is excreted by the kidneys, mainly in the form of hydroxy derivatives (about 2/3 of the administered dose).
Indications for use of the drug AERTAL®: Inflammatory diseases of the musculoskeletal system, incl. rheumatoid arthritis, psoriatic and juvenile arthritis, ankylosing spondylitis; gouty arthritis, osteoarthritis.
Dosage regimen: Adults are prescribed 100 mg orally 2 times a day. in the morning and in the evening.
Side effects: From the digestive system: gastralgia, nausea, vomiting, dyspepsia, flatulence, anorexia, increased activity of liver transaminases, gastrointestinal bleeding, erosive and ulcerative lesions and perforation of the gastrointestinal tract, hematemesis, melena, fulminant hepatitis, constipation. From the central nervous system and peripheral nervous system: headache, dizziness, agitation, perceptual disturbances, paresthesia, memory loss, disorientation, visual, hearing and taste disturbances, tinnitus, sleep disturbances (drowsiness or insomnia), irritability, convulsions, depression , anxiety, tremor, aseptic meningitis. Allergic reactions: skin rash; rarely - urticaria, eczema, erythema multiforme, erythroderma, systemic anaphylactoid reactions, bronchial asthma, in some cases - vasculitis, pneumonitis, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). From the urinary system: rarely - peripheral edema; in some cases - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome. From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, aplastic anemia. From the cardiovascular system: tachycardia, increased blood pressure, chronic heart failure.
Contraindications to the use of the drug AERTAL®: Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), gastrointestinal bleeding or suspicion of it, “aspirin triad” (a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid and pyrazolone-type drugs ), impaired hematopoiesis of unknown etiology, blood coagulation disorders, severe liver failure or active liver disease, severe renal failure, progressive kidney disease, hyperkalemia, the period after coronary artery bypass surgery, pregnancy, childhood and adolescence under 18 years of age, increased sensitivity to aceclofenac.
Use of the drug AERTAL® during pregnancy and breastfeeding: Aceclofenac is contraindicated for use in the third trimester of pregnancy. In the first and second trimesters of pregnancy and during lactation, aceclofenac is prescribed with caution, only in cases where the expected therapeutic effect for the mother exceeds the potential risk for the fetus or infant.
Use for liver dysfunction: Contraindicated in active liver disease. Use with caution if you have a history of liver disease. In patients with liver failure (chronic hepatitis, compensated cirrhosis of the liver), the kinetics and metabolism do not differ from similar processes in patients with normal liver function. When carrying out long-term therapy, it is necessary to monitor liver function, peripheral blood patterns, and stool analysis for occult blood.
Use for impaired renal function: Contraindicated in cases of severe renal failure or progressive kidney disease. Use with caution if you have a history of kidney disease. Due to the important role of prostaglandins in maintaining renal blood flow, particular caution should be exercised when administered to patients with moderate renal impairment.
Use in elderly patients: Particular caution should be exercised when prescribing to elderly patients.
Use in children: Contraindicated: children and adolescents under 18 years of age.
Special instructions: Use with caution if there is a history of liver, kidney or gastrointestinal diseases, bronchial asthma, arterial hypertension, coronary artery disease, indications in the anamnesis of the development of ulcerative lesions of the gastrointestinal tract, in the presence of Helicobacter pylori infection, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, diseases of peripheral arteries, in smokers, in elderly patients, with long-term use of NSAIDs, with frequent alcohol consumption, with severe somatic diseases. Prostaglandins play an important role in maintaining renal blood flow, so special caution should be exercised when prescribing to patients with heart or renal failure, the elderly, those taking diuretics, and patients who, for any reason, have a decrease in blood volume (for example, after major surgery). . If aceclofenac is prescribed in such cases, it is recommended to monitor renal function as a precaution. In patients with liver failure (chronic hepatitis, compensated cirrhosis of the liver), the kinetics and metabolism do not differ from similar processes in patients with normal liver function. When carrying out long-term therapy, it is necessary to monitor liver function, peripheral blood patterns, and stool analysis for occult blood. Impact on the ability to drive vehicles and operate machinery During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Drug interactions: With simultaneous use, aceclofenac increases the plasma concentrations of digoxin, lithium and phenytoin. With the simultaneous use of potassium-sparing diuretics, the risk of hyperkalemia increases, and with anticoagulants - the risk of bleeding (regular monitoring of blood clotting is required). Aceclofenac reduces the effects of diuretics and antihypertensive drugs. With simultaneous use, aceclofenac increases the risk of side effects of NSAIDs and corticosteroids on the gastrointestinal tract, the toxicity of methotrexate (the interval between doses is 24 hours) and the nephrotoxicity of cyclosporine. Acetylsalicylic acid reduces the concentration of aceclofenac in the blood. When used simultaneously with oral hypoglycemic drugs, both hypo- and hyperglycemia are possible (monitoring of blood glucose levels is necessary).
Storage conditions and periods:
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life : 4 years.
Aertal or Xefokam: which is better?
Ksefokam, like Airtal, is an anesthetic drug. Its activity is primarily observed in rheumatoid arthritis, osteoarthritis and other types of joint and bone pain. However, unlike Airtal, Xefocam is based on another active substance - lornoxicam, which does not in any way affect the level of inflammation and the patient’s body temperature. The drug is suitable for symptomatic use and relief of sudden pain.
Adverse reactions for both drugs are identical. Long-term use can cause anemia, thrombocytopenia, insomnia, and depression. When choosing between medications, you need to pay special attention to individual intolerance to the components, and the need to relieve inflammation and normalize the temperature.
Both drugs are contraindicated during pregnancy and breastfeeding, since their active ingredients are instantly and almost completely absorbed into the blood. These drugs are also not prescribed to patients under 18 years of age. Bronchial asthma is a direct contraindication to the use of both drugs, since both of them can cause bronchospasm.
Use of Aertal (aceclofenac) in clinical practice
The NSAID group includes a large number of drugs that differ in analgesic and anti-inflammatory activity, routes of drug administration into the body, the range of adverse events, etc. In this regard, approaches to their prescription differ depending on the clinical manifestations of the disease, the age of the patients, the predicted duration of treatment and etc. It is necessary to take into account that when taking NSAIDs, especially long-term, the development of undesirable effects is possible - nausea, discomfort and pain in the epigastric region, flatulence, diarrhea, as well as erosive and ulcerative lesions, bleeding and perforation of the stomach wall, duodenum and intestines. The administration of NSAIDs in some patients can provoke the development of bronchospasm, dizziness, insomnia, and a disorder of bone marrow hematopoiesis, manifested by a decrease in the number of red blood cells, leukocytes and platelets in the peripheral blood, which, however, are rare. Some NSAIDs contribute to an increase in blood pressure, and their use reduces the effectiveness of ACE inhibitors, diuretics and beta-blockers [2].
One of the side effects of NSAIDs is their possible adverse effect on articular cartilage, which is especially important when treating patients with articular syndrome (rheumatoid arthritis, osteoarthritis, etc.). Thus, some non-selective NSAIDs (indomethacin, ibuprofen, etc.) with long-term use inhibit the proliferation of chondrocytes, thereby causing increased degradation of cartilage tissue [6]. The different effects of NSAIDs on the synthesis of proteoglycans by chondrocytes are also considered proven. In particular, Dingle JT and M. Parker (1997) divided all NSAIDs into 3 groups depending on their effect on the synthesis of cartilage matrix components in vitro
: inhibitory (indomethacin, naproxen, ibuprofen, nimesulide), neutral (piroxicam, nabumetone) and stimulating (tenidap, aceclofenac) [9]. There is also evidence of an increase in the frequency of destructive changes in articular cartilage when taking indomethacin and naproxen, detected radiographically [4].
The therapeutic effect of NSAIDs is realized through the suppression of the production of cyclooxygenase (COX) with a subsequent decrease in the synthesis of pro-inflammatory prostaglandins, in particular PGE2. All NSAIDs, according to the degree of COX inhibition, are divided into 2 groups - non-selective (“classical”, standard), equally inhibiting the production of COX-1 and COX-2 (diclofenac, indomethacin, ibuprofen, etc.) and selective (specific) COX-2 inhibitors – nimesulide, meloxicam, coxibs.
Varying degrees of effectiveness and inhibition of COX, as well as variability in the pharmacodynamic and pharmacokinetic properties of NSAIDs, apparently underlie the explanation (if not completely explain) of their very wide range of pharmacological activities. This functional heterogeneity also applies to the analgesic efficacy of these drugs, although the definition of NSAIDs as “weak analgesics” is not entirely correct, given the fact that for postoperative pain, some NSAIDs have a significantly better analgesic effect than opioid analgesics [7]. In recent years, evidence has accumulated indicating that the analgesic effect of NSAIDs cannot always be explained solely by their ability to inhibit prostaglandin synthesis in peripheral tissues. In particular, it has been found that some NSAID drugs that cross the blood-brain barrier interfere with the processing of nociceptive signals in the spinal cord. Proposed targets of NSAIDs in the central nervous system are excitatory neurotransmitters, in particular glutamate, G proteins, serotonergic and opiate pathways, and polyamines. In addition, it has been shown that some NSAIDs can inhibit prostaglandin synthesis directly in the CNS [1].
One of the drugs that is widely used in rheumatological practice is aceclofenac (Aertal), a derivative of phenylacetic acid, which has a short half-life (4 hours) and good efficacy, comparable to other “standard” NSAIDs [3,14]. It has been proven that aceclofenac inhibits both isoenzymes of cyclooxygenase with a predominant inhibition of COX-2, and also suppresses the synthesis of a number of pro-inflammatory cytokines, in particular IL-1 [13]. Aceclofenac is quickly absorbed in the body - the peak concentration of the drug in the blood is reached within 1-3 hours after administration, while in the synovial fluid it is about 50% of the plasma concentration. Elimination of the drug occurs predominantly (up to 66%) in the urine [8]. The therapeutic dose of Aertal is 200 mg per day, maintenance – 100 mg per day [5].
The pharmacokinetics of Aertal (aceclofenac) does not change with age, which is very important when prescribing it to elderly patients, and bioavailability does not decrease when taken with food [24]. In addition, no interaction of the drug with other pharmacological agents was detected, in particular, with diuretics, ACE inhibitors, anticoagulants, etc. In particular, with the combined administration of aceclofenac and diuretics, no changes in blood pressure and urine osmolarity were observed. There were also no negative clinical effects identified when taking aceclofenac together with antidiabetic drugs, however, with long-term use of NSAIDs, dose adjustment of glucose-lowering drugs is sometimes necessary. The combined use of aceclofenac and warfarin led to a slight increase in the plasma concentration of the latter, but this did not have a significant effect on coagulogram parameters. No changes were detected when taking aceclofenac and methotrexate together, which is widely used in the complex therapy of rheumatic diseases [3].
Taking into account the fact that Airtal has been widely used in clinical practice since 1992 (the drug was registered in Russia in 2002), a lot of practical experience has now been accumulated in its use for various rheumatic diseases. Many clinical studies have demonstrated similar effectiveness of aceclofenac and other non-selective NSAIDs (diclofenac, piroxicam, naproxen) for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, etc. In animal experiments, it was shown that aceclofenac, with equal effectiveness with standard NSAIDs, has much less damaging effects effect on the gastrointestinal mucosa. Thus, its ulcerogenic dose in the experiment turned out to be approximately 4 times higher than that of diclofenac, indomethacin and naproxen. A comparative study of aceclofenac and selective NSAIDs (celecoxib and rofecoxib) in relation to the suppression of the activity of COX-1 and COX-2 in human whole blood showed that aceclofenac inhibits both isoenzymes, but predominantly the expression of COX-2 and, thus, the mechanism of action is close to to selective [17].
The ability of Aertal (aceclofenac) to inhibit the synthesis of a number of pro-inflammatory cytokines (TNF-α and IL-1β) has been proven, which is important when used both for inflammatory diseases of the joints (rheumatoid arthritis, gouty arthritis, ankylosing spondylitis, etc.) and for osteoarthritis. The results of the study by Y. Henrotin et al. (2001) indicate the potential ability of aceclofenac to influence the processes of degradation of the cartilage matrix by inhibiting the activity of IL-1β and stimulating the synthesis of glycosaminoglycans (GAGs) in cartilage during osteoarthritis [13]. As is known, IL-1β suppresses the synthesis of chondrocytes and initiates cartilage degradation processes as a result of increased release of proteolytic enzymes. The stimulating effect of aceclofenac on the synthesis of IL-1β receptor antagonist in human chondrocytes and suppression of the production of metalloproteinases has also been established [4]. Thus, the prescription of aceclofenac in these cases has both a symptom-modifying and, to some extent, a pathogenetic effect. In particular, clinical studies demonstrated the inhibitory effect of aceclofenac on PGE2 production in the synovial fluid of patients with gonarthrosis.
Taking these data into account, the use of aceclofenac for osteoarthritis (OA) is pathogenetically justified. Thus, in a study by HEL Hajjal et al. (2003), performed in vitro
on cartilage obtained during surgical treatment of patients with OA, it was shown that the use of celecoxib, in contrast to diclofenac, increased the number of [3H]-PG molecules involved in the synthesis of cartilage prostaglandins, and also increased the concentration of newly synthesized hyaluronic acid molecules [11].
Similar effects were also detected with the use of aceclofenac, which in in vitro
led to stimulation of GAG synthesis in cartilage tissue in patients with osteoarthritis.
Also important is the established fact that the analgesic effect of aceclofenac in patients with OA is comparable to other NSAIDs, including diclofenac, piroxicam and naproxen. Thus, in a study by DE Ward et al. (1995) demonstrated that in two groups of patients with OA of the knee joints (n=397) after 12 weeks of therapy with aceclofenac (200 mg/day) and diclofenac (150 mg/day) there was a significant reduction in pain assessed by 100 –mm visual analogue scale (VAS), while in the aceclofenac group the pain intensity decreased by 75%, in the diclofenac group – by 70% [23]. Other parameters of the disease - general health, pain on movement and functional activity - also significantly improved in both groups, however, according to the survey, patients gave greater preference to aceclofenac (71% versus 59%, p = 0.005).
In another 8-week, double-blind study, aceclofenac and piroxicam were used in patients with knee OA (n=240). During therapy, both groups showed a significant decrease in pain intensity and improvement in joint function according to the LOSI (Lequense Osteoarthritis Severity Index) osteoarthritis severity index, but the best result was observed in patients receiving aceclofenac [21]. Similar results were obtained in another comparative study of aceclofenac and piroxicam in patients with gonarthrosis [22].
In a 12-week study, which involved 374 patients with knee OA, comparable therapeutic efficacy of aceclofenac (200 mg/day, group 1) and naproxen (1000 mg/day, group 2) was established. By the end of the course of therapy, the majority of the examined patients noted a decrease in pain at rest and during movement, while the range of motion in the affected joints increased in 81% of patients in group 1 and 84% in group 2, and an improvement in general condition was noted by 73 and 69% of patients respectively [15].
In patients with rheumatoid arthritis, when prescribed aceclofenac, a good anti-inflammatory and analgesic effect was observed, comparable to taking “standard” NSAIDs - diclofenac, indomethacin and tenoxicam. Thus, in a multicenter, double-blind, 6-month study, a comparison was made of aceclofenac (200 mg/day, 170 patients) and diclofenac (150 mg/day, 173 patients) in parallel groups [19]. Both drugs significantly reduced the severity of pain, Ritchie index and morning stiffness after 15 days from the start of therapy, while the achieved positive effect was maintained throughout the entire treatment period. According to the patients' assessment, good or very good treatment results were observed in 70.3% of patients treated with aceclofenac and in 65.6% with diclofenac, and according to the researcher's assessment - in 76.3 and 69.6% of patients, respectively.
Taking into account the fact that for seronegative spondyloarthropathies, NSAIDs are the basis of drug therapy, special requirements are placed on their effectiveness and tolerability. Studies of the effectiveness of aceclofenac and standard NSAIDs in patients with ankylosing spondylitis (AS) have shown their equivalence, however, aceclofenac demonstrated a better tolerability and safety profile. Thus, in a randomized controlled trial, aceclofenac was prescribed at a dose of 200 mg/day. and naproxen at a dose of 1000 mg/day. equally effectively reduced the intensity of pain and contributed to the improvement of functional activity in 126 patients with AS [20]. Another study demonstrated equal therapeutic efficacy of aceclofenac and other NSAIDs (indomethacin, tenoxicam and naproxen) in relieving pain, reducing the duration of morning stiffness and improving motor activity in ankylosing spondylitis [10].
As is known, the feasibility of using a particular drug in clinical practice is impossible without a comprehensive study of its tolerability. One of the serious side effects of NSAIDs that limits their use is the development of NSAID-induced gastropathy, manifested by erosions (often multiple) and ulcers of the antrum of the stomach. The main risk factors for their development are the elderly age of patients, a history of peptic ulcer disease, gastrointestinal bleeding or melena, long-term use of high doses of NSAIDs, and concurrent use of NSAIDs and drugs of other pharmacological groups (glucocorticoids, anticoagulants, etc.) [2].
Data from numerous clinical studies indicate that the incidence of adverse events from the gastrointestinal tract when taking the vast majority of non-selective NSAIDs reaches 30%, and hospitalization of elderly patients due to the development of peptic ulcers is 4 times higher compared with people of the same age group who are not taking NSAIDs.
Today, it is generally accepted that there are no absolutely safe NSAIDs, and therefore they can be divided into 2 groups: with a high and low risk of developing side effects from the gastrointestinal tract. The spectrum of adverse events during treatment with aceclofenac was similar to that during treatment with other NSAIDs, but differed significantly in the frequency of their development. This was demonstrated in the SAMM (Safety Assessment of Marketed Medicines) study, which involved 10,142 patients (7,890 patients were prescribed aceclofenac, 2,252 patients were prescribed diclofenac) suffering from rheumatoid arthritis, osteoarthritis and ankylosing spondylitis [12]. The results of the study indicated a better tolerability profile of aceclofenac compared to diclofenac (Fig. 1). The authors concluded that the use of aceclofenac was accompanied by a lower risk of developing NSAID gastropathy and better tolerability, even taking into account the fact that among the patients receiving aceclofenac, there were significantly more patients with a history of gastrointestinal pathology.
In a study by A. Yanagawa et al. (1998) studied the possible side effects of aceclofenac and diclofenac on the mucous membrane of the duodenum (according to the results of fibrogastroduodenoscopy) in a double-blind, placebo-controlled study [25]. Endoscopic changes after 2 weeks of taking aceclofenac, diclofenac and placebo were significantly more often observed in the diclofenac group. It was found that in patients receiving diclofenac, the content of hexosamine (a factor that has a cytoprotective effect) and local blood flow in the mucous membrane of the stomach and duodenum were significantly reduced, while when treated with aceclofenac, these indicators did not differ significantly from placebo groups.
The results of these studies correspond with the work of MJ Llorente Melero et al. (2002), which presented a comparative population analysis of the incidence of gastrointestinal bleeding when taking various NSAIDs according to data from medical institutions in Spain (data were studied on 180,995 patients over a 4-year period) [18]. As can be seen from Figure 2, taking aceclofenac and meloxicam was accompanied by the lowest risk of bleeding from the upper gastrointestinal tract, while when prescribing ketorolac and indomethacin, the risk of gastrointestinal bleeding was more than 10 times higher.
Based on the presented data, it can be stated that the key point in choosing an NSAID by a rheumatologist is its high clinical effectiveness, safety, and good tolerability. In this regard, the results of the European observational cohort study, which analyzed the effectiveness of aceclofenac in 23,407 patients with inflammatory and degenerative rheumatic diseases, are interesting [16]. This study assessed the severity of pain during therapy, overall satisfaction with treatment, and the level of compliance. The results obtained demonstrated the rapid and long-lasting analgesic effect of aceclofenac, with an improvement in general condition observed in 84% of the patients examined, and 93.5% of patients noted satisfaction with treatment at the end of the study.
Thus, summing up the data on the effectiveness and tolerability of aceclofenac obtained in numerous controlled clinical studies, we can conclude that aceclofenac (Aertal) is a highly effective NSAID and has a number of advantages over other “standard” NSAIDs: fast half-life (4 hours), which reduces the possibility of drug accumulation and, accordingly, the risk of side effects; high bioavailability, which does not depend on food intake; comparable pharmacokinetics in individuals of different age groups; comparable effectiveness with diclofenac, indomethacin, naproxen and ketoprofen in the treatment of degenerative and inflammatory joint diseases; better gastrointestinal tolerability in comparison with other “standard” NSAIDs according to clinical and endoscopic studies; the possibility of combined use with drugs from other pharmacological groups (indirect anticoagulants, hypoglycemic drugs, diuretics); no evidence of negative effects on cartilage.
Literature 1. Dexketoprofen trometamol / Description of the medicinal product. – B.I., 2003. – 58 p. 2. Nasonov E.L. Non-steroidal anti-inflammatory drugs: new aspects of use in rheumatology and cardiology // Russian Medical Journal. – 2003. – T.11, No. 23. – P.1280–1284. 3. Nasonova V.A. Aceclofenac – safety and effectiveness // Russian Medical Journal. – 2003. – T.11, No. 5. – P. 3–6. 4. Chichasova N.V. Treatment of osteoarthritis: the effect of various anti-inflammatory drugs on cartilage tissue // Russian Medical Journal. – 2005. – T.13, No. 8. – P.539–543. 5. Aceclofenac. Almirall Prodespharma SA – Barcelona, 2003. – 120 p. 6. Brandt KD The mechanism of action of nonsteroidal anti-inflammatory drugs //J.Rheum. – 1991. – Vol.18. – P. 120–121. 8. Brandt KD The role of analgesics in the management of osteoarthritis pain // Am.J.Therap. – 2000. – Vol. 7. – P. 75–90. 9. Creamer J. A comparison of the pharmacokinetics of single and repeated doses of aceclofenac in young and elderly volunteers // Brit.J.Clin.Res. – 1992. – Vol. 3. – P. 99–107. 10. Dingle JT, Parker M. NSAID stimulation of human cartilage matrix synthesis: a study of the mechanism of action of aceclofenac // Clin.Drug Invest. – 1997. – Vol. 14. – P. 353–362. 11. Dooley M, Spencer CM, Dunn CJ et al. Aceclofenac. A reappraisal of its use in the management of pain and rheumatic disease // Drugs. – 2001. – Vol. 61, N 9. – P. 1351–1378. 12. Hajjal HEL, Marcelis A., Devogelaer J–P., Manicourt D–H. Celecoxib has a positive effect on the overall metabolism of hyaluronan and proteoglycans in human osteoarthritic cartilage // J. Rheum. – 2003. – Vol. 30. – P. 2444–2451. 13. Haskinsson EC, Irani M., Murray F. A large prospective open-label, multi-centre SAMM study, comparing the safety of aceclofenac with diclofenac in patients with rheumatic disease // Eur.J.Rheumatol.Inflam. – 2000. – Vol. 17. – P. 1–7. 14. Henrotin Y., De Leval H, Mathy-Hartet M et al. In vitro effects of aceclofenac and its metabolites on the production by chondrocytes of inflammatory mediators // Inflamm.Res. – 2001. – Vol. 50. – P. 391–399. 15. Huskisson EC Editorial. Aceclofenac: Ace or just another Jack? // Europ.J.Rheum.Inform. – 1996. – Vol. 16, N1. – P. 1–2. 16. Kornasoff D., Frerick H., Bowdler J., Montull E. Aceclofenac is a well-tolerated alternative to naproxen in the treatment of osteosrthrosis. Clin.Rheumatol. – 1997. – Vol. 16. – P. 32–38. 17. Lemmel E.M., Leeb B., De Bast J., Aslanidis S. Patient and physician satisfaction with aceclofenac results of the European Observational Cohort Dtudy // Curr. Med. Res. Opt. – 2002. – Vol. 18, N3. – P. 146–153. 18. Lidburg Ps, Vojnovic J., Warner TD “COX2/COX1 selectivity of aceclofenac in comparison with celecoxib and rofecoxob in the human whole blood assay / Fith world Congress og the OARS, Barselona, Spain, 4–6 October, 2000. – Suppl B, Th053. 19. Llorente Melero MJ, Tenias Burillo JM, Zaragoza M. Comparative incidence of upper gastrointestinal bleeding associated with individual non-steroidal anti-inflammatory drugs. Rev. Esp. Enferm. Dig. – 2002. – Vol. 94. – P. 7–18. 20. Pasero G, Marcolongo R, Serni U et al. A multi-centre, double-blind comparative study of the efficacy and safety of aceclofenac and diclofenac in the treatment of rheumatoid arthritis // Rev.Esp.Reumatol. – 1992. – Vol. 19. – P. 263–268. 21. Pasero G, Ruju G, Macolongo R et al. Aceclofenac versus naproхen in the treatment of ankylosing spondylitis: a double–blend, controlled study // Curr.Nher.Res. – 1994. – Vol. 55. – P. 833–842. 22. Perez Busquiner M., Calero E., Rodriguez M. et al. Comparison of aceclofenac with piroxicam in the treatment of osteosrthrosis // Clin.Rheumatol. – 1997. – Vol. 16. – P. 154–159. 23. Torri G., Vignati C., Agrifoglio E. et al. Aceclofenac versus piroxicam in the management of osteosrthrosis of the knee: a double–blind controlled study // Curr.Ther.Res. – 1994. – Vol. 55. – P. 576–583. 24. Ward DE, Veys EM, Bowdker JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthrosis // Clin.Rheumatol. – 1995. – Vol. 14. – P. 656–662. 25. Wood SG, Fitzpatrik K. et al. Pharmacokinetics and metabolism of a new NSAID/analgesic aceclofenac in man // Pharm.Res. – 1990. – Vol. 7, N9. – S–212. 26. Yanagawa A., Endo T., Kusakari K. et al. Endoscopie evaluation of aceclofenac–induced gastroduodenal mucosal damage: a double–blind comparison with sodium diclofenac and placebo // JJRheumaco L. – 1998 – Vol. 18. – P. 249–259.
Is it possible to take Aertal with alcohol?
Removing Airtal from the body puts a serious burden on the liver and kidneys. Alcohol, entering the blood at the same time as Aertal, can aggravate the condition of the filtering organs, because its presence puts additional stress on the liver. Alcoholism is a direct contraindication to the use of Aertal, as this can lead to organ dysfunction.
In addition, many alcoholic drinks are diuretics, which increases the load on the kidneys. If there is stagnation of fluid in the body and the simultaneous use of Aertal, intoxication is possible, since the initially taken dose of the drug will not be removed from the body before the patient takes the second tablet.
Instructions for use AIRTAL®
Adverse reactions can be minimized by using the lowest effective dose and reducing the duration of treatment to achieve symptom control.
The simultaneous use of Airtal and other NSAIDs, including selective COX-2 inhibitors, should be avoided.
Effect on the gastrointestinal tract
Bleeding, ulceration or perforation of the gastrointestinal tract with a fatal outcome was observed when taking any NSAIDs during any period of treatment, both with and without dangerous symptoms, both with and without a history of serious pathological conditions of the gastrointestinal tract.
The risk of bleeding, ulceration and gastrointestinal perforation increases with increasing dose of NSAIDs in patients who have had an ulcer, especially if it was accompanied by hemorrhage or perforation, and in elderly patients. In such cases, the drug should be taken in the minimum effective dose. In addition, these patients require combination therapy with drugs that have a protective effect on the gastrointestinal tract (for example, misoprostol, or proton pump inhibitors). Such therapy is necessary for patients who take small doses of acetylsalicylic acid (aspirin) or other drugs that negatively affect the gastrointestinal tract.
Patients with gastrointestinal diseases, as well as elderly patients, should report any unusual symptoms associated with the gastrointestinal tract (especially bleeding), incl. when taking the drug for the first time. Particular caution should be exercised when using Airtal in patients concomitantly receiving drugs that may increase the risk of bleeding or ulceration, such as systemic corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (such as acetylsalicylic acid).
If bleeding or gastrointestinal ulcers occur while taking Airtal, the drug should be discontinued.
Effect on the cardiovascular system and central nervous system
For patients with hypertension and/or mild to moderate congestive heart failure, appropriate monitoring and special precautions are required because Fluid retention and edema associated with NSAIDs have been reported.
Clinical studies and epidemiological data indicate that the use of some NSAIDs (particularly at high doses and for long periods of time) may not significantly increase the risk of arterial thrombotic events (eg, myocardial infarction or stroke). There is no reliable data on the absence of this risk when taking aceclofenac.
Particular caution should be exercised when using Airtal in patients with uncontrolled arterial hypertension, heart failure (NYHA functional class I), congestive heart failure, with risk factors for the cardiovascular system (for example, arterial hypertension, hyperlipidemia, diabetes mellitus and smoking ).
Aceclofenac should be prescribed with caution and under medical supervision to patients with the following conditions, because: there is a threat of exacerbation of the disease:
- symptoms indicating the presence of gastrointestinal disease, including its upper and lower sections;
- a history of ulcers, bleeding or perforation of the gastrointestinal tract;
- Crohn's disease;
- bleeding tendency, SLE, porphyria, and disorders of hematopoiesis and hemostasis.
—
ulcerative colitis;
The drug should be used with caution and under medical supervision in patients with a history of hemorrhagic stroke.
Effect on the liver and kidneys
Taking NSAIDs may cause a dose-dependent decrease in prostaglandin formation and sudden renal failure. The importance of prostaglandin in maintaining renal blood flow should be considered when using the drug in patients with impaired cardiac, renal or hepatic function, in patients receiving diuretics or in patients after surgery, as well as in elderly patients.
Caution should be exercised when using the drug in patients with mild or moderate impairment of liver and kidney function, as well as in patients with other conditions predisposing to fluid retention in the body. In these patients, the use of NSAIDs can lead to impaired renal function and fluid retention. Caution should also be exercised when using Airtal in patients taking diuretics or in individuals at increased risk of hypovolemia. A minimum effective dose and regular medical monitoring of renal function are required. Renal reactions usually resolve after discontinuation of aceclofenac.
Aceclofenac should be discontinued if changes in liver function tests persist or worsen, clinical signs or symptoms of liver disease develop, or other manifestations (eosinophilia, rash) occur. Hepatitis can develop without prodromal symptoms.
The use of NSAIDs in patients with hepatic porphyria may precipitate an attack.
Allergic and skin reactions
Like other NSAIDs, the drug can cause allergic reactions, including anaphylactic/anaphylactoid reactions, even when taken for the first time. Severe skin reactions (which can sometimes be fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been very rare after taking NSAIDs. The highest risk of these reactions occurring in patients is observed at the beginning of using the drug, and the development of these adverse reactions is observed during the first month of using the drug. If skin rash, lesions on the oral mucosa, or other signs of hypersensitivity occur, discontinue use of aceclofenac.
In special cases, complications may occur with chickenpox:
- serious skin and soft tissue infections. At present, the role of NSAIDs in worsening the course of these infections cannot be ruled out. Therefore, the use of Airtal for chickenpox should be avoided.
Hematological disorders
Aceclofenac may cause reversible inhibition of platelet aggregation.
Respiratory system disorders
The drug should be used with caution in patients with bronchial asthma currently or in history, because taking NSAIDs may trigger the development of sudden bronchospasm in such patients.
Elderly patients
Caution should be exercised when using the drug in elderly patients, because they are more likely to experience adverse reactions (especially bleeding and gastrointestinal perforation) when taking NSAIDs. Complications can be fatal. In addition, older patients are more likely to suffer from kidney, liver or cardiovascular diseases.
Long-term use
All patients receiving long-term treatment with NSAIDs should be closely monitored (eg, complete blood count, monitoring of liver and kidney function).
Impact on the ability to drive vehicles and operate machinery
Patients who have experienced symptoms such as weakness, dizziness, vertigo, nausea or other central nervous system symptoms while using NSAIDs should refrain from driving vehicles or operating dangerous machinery.
How to replace the drug Airtal
The group of non-steroidal anti-inflammatory analgesics includes a whole list of drugs, including cheaper ones and those that have fewer contraindications in their description.
Paracetamol and ibuprofen are considered the safest. These substances, being part of many multicomponent drugs, relieve pain, normalize body temperature and reduce the intensity of the inflammatory process. Both paracetamol and ibuprofen are approved for use in children. The dosage form in the form of syrup allows use by children over 3 months. Ibuprofen is better for toothache and joint pain.
Paracetamol is aimed at combating headaches and muscle aches. For severe joint pain, Aertan can be replaced with Diclofenac. This active substance is sold in pharmacies. Under the same name it is found not only in the form of tablets, but also in the form of ointments, patches and ampoules for intramuscular administration. The extended-release formula of the tablets allows you to take one dose, which will relieve severe pain for 24 hours.
Aertal
Use during pregnancy and breastfeeding
Pregnancy
Airtal® is contraindicated during pregnancy. There is no information on the use of aceclofenac during pregnancy.
Inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and/or the development of the embryo/fetus.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors:
- having cardiopulmonary toxicity, they can cause premature closure of the ductus bollus with the development of pulmonary hypertension;
- may cause impaired fetal renal function, which can progress to renal failure in combination with oligohydramnios.
Late pregnant mothers and newborns:
- the drug may affect the duration of bleeding due to the antiplatelet effect, which can develop even after using very low doses;
- the drug may suppress uterine contractions, leading to delayed labor or prolonged labor.
Lactation
Airtal® should not be taken during breastfeeding. There is no data on the excretion of aceclofenac in human milk; When radioactive 14C-aceclofenac was administered to lactating rats, no noticeable transfer of radioactivity into milk was observed.
Fertility
NSAIDs may affect fertility and are not recommended for use by women planning pregnancy.
Use for liver dysfunction
The drug is contraindicated in patients with severe liver failure or active liver disease.
When treating patients with mild to moderate liver dysfunction, lower doses of aceclofenac should be used. The recommended starting dose is 100 mg/day.
Use for renal impairment
The drug is contraindicated in patients with severe renal failure (creatinine clearance <30 ml/min), progressive kidney disease, confirmed hyperkalemia.
There is no evidence for the need to change the dose of aceclofenac when treating patients with mild to moderate renal impairment, but caution is recommended.
Use in children
The drug is contraindicated in children under 18 years of age. The safety and effectiveness of the drug for the treatment of children and adolescents has not been established.
Use in elderly patients
Caution should be exercised when taking the drug to elderly patients.
special instructions
Avoid using Airtal® simultaneously with other NSAIDs, including selective COX-2 inhibitors.
Adverse events can be reduced by shortening the duration of treatment as much as possible and reducing the dose of the drug to the minimum necessary to achieve control of the symptoms of the disease.
Effect on the gastrointestinal tract
Aceclofenac should be prescribed with caution and under close medical supervision to patients with the diseases listed below, because their course may worsen:
- symptoms indicating gastrointestinal diseases, including the upper and lower gastrointestinal tract;
- a history of ulcer, bleeding or perforation of a stomach or intestinal ulcer in the presence of Helicobacter pylori infection;
- history of ulcerative colitis;
- history of Crohn's disease;
- hematological diseases, systemic lupus erythematosus (SLE), porphyria and hematopoietic disorders.
There have been reports of gastrointestinal bleeding, gastric or intestinal ulceration or perforation of the ulcer, which can lead to death with any NSAID at any time during treatment, with or without alarm symptoms, regardless of a history of serious gastrointestinal complications .
The risk of gastrointestinal bleeding, ulceration, or ulcer perforation is greater when treated with high doses of NSAIDs in patients with a history of gastric or intestinal ulcers, especially if complicated by bleeding or perforation, and in elderly patients. Treatment of these patients should begin with the lowest effective dose. Also, when treating these groups of patients and patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal complications, the need for combination therapy with protective drugs (for example, misoprostol or proton pump inhibitors) should be considered. .
Patients with a history of gastrointestinal disease, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), paying maximum attention to symptoms early in treatment. Caution should be exercised when treating patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet drugs such as acetylsalicylic acid.
If gastrointestinal bleeding or ulceration occurs in patients taking Airtal®, treatment should be discontinued.
Effect on the cardiovascular system and cerebral circulation
When treating patients with arterial hypertension and/or chronic heart failure, it is necessary to carry out appropriate monitoring and give recommendations, because There are reports of the development of fluid retention and edema during treatment with NSAIDs.
There is evidence to suggest that some NSAIDs (especially in high doses and in long-term treatment) may increase the risk of arterial thrombotic complications (eg, myocardial infarction or stroke). There is insufficient data to exclude this risk when using aceclofenac.
Patients with uncontrolled arterial hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease and/or cerebrovascular disease should begin treatment with aceclofenac only after an informed decision by the attending physician. Likewise, the indications for long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, and smoking) should be carefully assessed before initiation.
Caution and close medical supervision should also be exercised when using aceclofenac in patients with a history of cerebral hemorrhage.
Effect on the liver and kidneys
Treatment with NSAIDs may cause a dose-dependent decrease in prostaglandin synthesis and precipitate renal failure. The importance of prostaglandins in maintaining renal blood flow in patients with impaired cardiac or renal function, liver dysfunction, patients receiving diuretic treatment or recovering from abdominal surgery, and elderly patients should be taken into account.
Caution should be exercised when treating patients with impaired liver or kidney function, as well as patients with other diseases predisposing to fluid retention. In these patients, treatment with NSAIDs may lead to impaired renal function and fluid retention. Caution must also be exercised when using the drug in patients receiving diuretic treatment or, conversely, in patients at risk of hypovolemia. The minimum effective dose should be prescribed and renal function should be regularly monitored. The effect of the drug on renal function is usually reversible after discontinuation of aceclofenac.
Treatment with aceclofenac should be discontinued if deviations from normal liver function tests persist or increase, clinical symptoms consistent with the development of liver failure appear, or other manifestations (eg, eosinophilia, rash) appear.
Hepatitis can develop without previous symptoms.
In patients with hepatic porphyria, the use of NSAIDs may provoke an exacerbation of the disease.
Hypersensitivity and skin reactions
As with the use of other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur early in the use of the drug. In very rare cases, serious skin reactions have been observed with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, some of which can be fatal. Patients are at highest risk of developing these reactions early in treatment, with most reactions occurring within the first month of treatment. At the first sign of skin rash, damage to the mucous membranes or any other symptoms of hypersensitivity, treatment with Airtal® should be discontinued.
In extremely rare cases, chickenpox can cause serious infectious complications of the skin and soft tissues. At the moment, the role of NSAIDs in worsening the course of these infectious complications cannot be excluded. Therefore, it is recommended to avoid the use of Airtal® for chickenpox.
Effect on hematological parameters
Aceclofenac can reversibly inhibit platelet aggregation.
Respiratory system disorders
Caution must be exercised when using the drug in patients with bronchial asthma or with a history of bronchial asthma, because There are reports that NSAIDs may cause bronchospasm in such patients.
Elderly patients
Caution should be exercised when treating elderly patients, because... In this age group, the incidence of adverse events associated with NSAID treatment is increased, especially gastrointestinal bleeding and ulcer perforation, which can lead to death. In addition, older patients are more susceptible to renal, hepatic or cardiovascular failure.
Long-term treatment
It is necessary to carefully monitor all patients receiving long-term treatment with NSAIDs, regularly performing complete blood count, liver and kidney function tests.
Each sachet of Airtal®, powder for oral suspension, 100 mg, contains 2.64 g of sorbitol, which can cause gastrointestinal disorders and diarrhea. Patients with rare hereditary fructose intolerance should not be prescribed this drug.
Airtal®, powder for oral suspension, 100 mg, contains aspartame, a source of phenylalanine. Patients with phenylketonuria should note that each sachet contains 5.61 mg of phenylalanine.
Impact on the ability to drive vehicles and operate machinery
You should refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, because the drug may cause dizziness and other side effects that may affect these abilities.