Airtal suspension powder for oral use 3g sachets, 20pcs

Composition

of 1 pack:

– aceclofenac 100 mg

Auxiliary substances:

sorbitol-2.639 g,

sodium saccharinate-0.01 g,

aspartame-0.01 g,

colloidal silicon dioxide-0.006 g,

hypromellose-0.018 g,

titanium dioxide-0.012 g,

milk flavor-0.1 g,

caramel flavor-0.05 g,

cream flavor-0.05 g

Pharmacological action

:

NSAIDs.

Pharmaceutical action:  

Airtal is an NSAID. It has anti-inflammatory, analgesic and antipyretic effects. Inhibits the synthesis of prostaglandins and, thus, affects the pathogenesis of inflammation, pain and fever.

In rheumatic diseases, the anti-inflammatory and analgesic effect of aceclofenac significantly reduces the severity of pain, morning stiffness, and joint swelling, which improves the patient’s functional state.

Pharmacokinetics:  

Absorption: Rapidly and completely absorbed after oral use. Cmax in plasma after oral use is reached in 1.25-3 hours.

Distribution Binding to plasma albumins by 99%.

Penetrates the synovial fluid, where its concentration reaches 57% of the plasma concentration level and Cmax is reached 2-4 hours later than in the blood plasma. Vd – 25 liters.

Metabolism is metabolized to a small extent. Its main metabolite found in plasma is 4′ – hydroxyaceclofenac.

Excretion1 / 2-4 hours Is excreted by the kidneys mainly in the form of hydroxy derivatives (about 2/3 of the administered dose).

Indications

Relief of inflammation and pain in: – lumbago;- toothache;- scapular periarthritis;- rheumatic lesions of soft tissues. Symptomatic treatment: — rheumatoid arthritis— – osteoarthritis;- ankylosing spondylitis.

Use during pregnancy and lactation

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 are used: – having cardiopulmonary toxicity, they can cause premature closure of the Botall duct with the development of pulmonary hypertension;- may cause impaired fetal kidney function, which may progress to renal failure in combination with lack of water.

Mothers in late pregnancy and newborns: – the drug can affect the duration of bleeding due to the antiplatelet effect, which can develop even after very low doses; – the drug can suppress uterine contractions, leading to delayed labor or prolonged labor.

Lactation: Airtal® should not be taken during breastfeeding. There are no data on the excretion of aceclofenac in human milk; no significant transfer of radioactivity into milk was observed when 14C-aceclofenac was administered to lactating rats.

Fertility: NSAIDs can affect fertility and are not recommended for use in women planning pregnancy.

Contraindications

-erosive and ulcerative lesions of the gastrointestinal tract in the acute phase (including ulcerative colitis, Crohn’s disease);- gastrointestinal bleeding or suspected bleeding;- complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis);- hypersensitivity to aceclofenac or components of Airtal;- severe liver failure or active liver disease; – disorders of hematopoiesis and coagulation;- severe renal insufficiency (creatinine clearance;- severe heart failure; – the period after aorto-coronary bypass surgery;- pregnancy and lactation;- children under 18 years of age: – fructose intolerance;- feinlketonuria.

With caution: Chronic heart failure, ischemic heart disease, arterial hypertension, decreased blood volume (including the condition after extensive surgical interventions), cerebrovascular diseases, peripheral arterial diseases, chronic renal failure (creatinine clearance less than 60 ml/min), liver failure, liver, kidney and gastrointestinal diseases in the anamnesis, ulcerative colitis in the anamnesis, Crohn’s disease in the anamnesis, bronchial asthma, dyspeptic disorders symptoms at the time of prescribing the drug, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, diabetes mellitus, dyslipidemia/hyperlipidemia, elderly age, smoking, long-term use of NSAIDs, taking systemic glucocorticosteroids, anticoagulants, antiplatelet agents, serotonin reuptake inhibitors, diuretics, alcoholism, severe somatic diseases, hematological diseases, hematopoietic disorders, systemic lupus erythematosus (SLE), porphyria, chickenpox.

Side effects

Adverse events reported in clinical trials and post-marketing follow-up are listed below; adverse events are grouped according to organ system classes according to the Medical Dictionary for Regulatory Affairs (MedDRA) and frequency of occurrence. Very common (≥1/10); common (≥1/100

) – Blood and lymphatic system disorders Rarely: anemia. Very rare: bone marrow suppression, granulocytopenia, thrombocytopenia, neutropenia, hemolytic anemia. – Disorders of the immune system Occasionally: anaphylactic reactions (including shock), hypersensitivity.

– Metabolic and nutritional disorders are very rare: hyperkalemia.

– Mental disorders are very rare: depression, unusual dreams, insomnia.

– Nervous system disorders often: dizziness. Very rare: paresthesia, tremor, drowsiness, headache, dysgeusia (perversion of taste).

– Disorders of the visual organarea: visual disorder.

– Hearing disorders and labyrinth disorders are very rare: dizziness, ringing in the ears.

– Disorders of the heart: heart failure. Very rare: palpitation of the heart.

– Vascular disorders occasionally: increased blood pressure, worsening of arterial hypertension. Very rare: hyperemia, hot flashes, vasculitis.

– Respiratory system, thoracic and mediastinal disorders Occasionally: shortness of breath. Very rare: bronchospasm.

– Gastrointestinal disorders Often: dyspepsia, abdominal pain, nausea, diarrhea. Infrequently: flatulence, gastritis, constipation, vomiting, ulcerative stomatitis. Rare: melena, ulceration of the stomach and intestines, hemorrhagic diarrhea, gastrointestinal bleeding. Very rare: stomatitis, vomiting of blood, intestinal perforation, exacerbation of Crohn’s disease and ulcerative colitis, pancreatitis.

– Disorders of the liver and biliary tract often: increased activity of liver enzymes. Very rare: liver disease (including hepatitis), increased alkaline phosphatase activity.

– Skin and subcutaneous tissue disorders often: pruritus, rash, dermatitis, urticaria. Rare: Angioedema. Very rare: purpura, eczema, severe mucocutaneous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

– Disorders of the kidneys and urinary tract often: increased serum urea concentration, increased serum creatinine concentration. Very rare: nephrotic syndrome, renal failure.

– General disorders and disorders at the injection site are very rare: edema, weakness, muscle spasms.

– Changes in laboratory and instrumental studies are very rare: weight gain.

Interaction

No drug interaction studies have been conducted, with the exception of interaction studies with warfarin. Aceclofenac is metabolized in the cytochrome P4502C9 system and, according to in vitro studies, can inhibit this isoenzyme. Therefore, there may be a risk of pharmacokinetic interactions with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfafenazole. As with other NSAID drugs, there is also a risk of pharmacokinetic interactions with other drugs that are actively excreted by the kidneys, such as methotrexate and lithium. Aceclofenac is almost completely bound to plasma proteins, therefore, there is a possibility of interaction with other drugs that have a high affinity for plasma proteins, by the type of substitution that should be considered.

Since there are not enough studies of pharmacokinetic interactions, the following information is based on data obtained for other NSAIDs:

The following drug combinations should be avoided: Lithium and digoxin: Some NSAIDs inhibit the renal clearance of lithium and digoxin, which leads to an increase in serum concentrations of these drugs. This combination of medications should be avoided unless frequent monitoring of lithium and digoxin levels is possible.

Anticoagulants: NSAIDs inhibit platelet aggregation and damage the gastrointestinal mucosa, which can lead to increased anticoagulant activity and increase the risk of gastrointestinal bleeding in patients taking anticoagulants. The use of a combination of aceclofenac and coumarin anticoagulants for oral use, ticlopidine, thrombolytic drugs and heparin should be avoided, except in cases where careful monitoring is carried out.

Antiplatelet medications and selective serotonin reuptake inhibitors in combination with NSAIDs may increase the risk of gastrointestinal bleeding. The following drug combinations may require dose adjustment and caution:

Methotrexate: NSAIDs inhibit the tubular secretion of methotrexate, so possible interactions between NSAIDs and methotrexate should also be considered when treating low-dose methotrexate, especially in patients with renal insufficiency. In cases where combined treatment is necessary, renal function should be monitored. Caution should be exercised when both NSAIDs and methotrexate are administered together within 24 hours, as the concentration of methotrexate may increase, which will lead to an increase in its toxicity.

Cyclosporine, tacrolimus: concomitant use of NSAIDs and cyclosporine or tacrolimus increases the risk of renal toxicity due to decreased renal prostacyclin synthesis. Therefore, it is very important to carefully monitor kidney function during combination treatment.

Other NSAIDs: concomitant use of acetylsalicylic acid and other NSAIDs may increase the frequency of adverse events, so caution should be exercised.

Glucocorticosteroids: the risk of developing gastrointestinal ulcers or gastrointestinal bleeding may increase.

Diuretics: aceclofenac, like other NSAIDs, can inhibit the activity of diuretics, reduce the diuretic effect of furosemide, bumetanide and the antihypertensive effect of thiazides. Simultaneous treatment with potassium-sparing diuretics may be associated with an increase in potassium content, therefore, it is necessary to monitor the content of potassium in the blood serum.

It has been shown that aceclofenac does not affect blood pressure control when co-administered with bendrofluazide, despite the fact that drug interactions with other diuretics cannot be excluded.

Antihypertensive medications: NSAIDs may also reduce the effectiveness of certain antihypertensive medications. ACE inhibitors or angiotensin II receptor antagonists in combination with NSAIDs can lead to impaired renal function. Some patients with reduced renal function, such as elderly patients or patients with dehydration, may be at risk of developing acute renal failure, which is usually reversible. Therefore, caution should be exercised when using these drugs in combination with NSAIDs, especially in the treatment of elderly patients or patients with dehydration. Patients should be sufficiently hydrated, and it is recommended to take into account the need to monitor renal function after starting combination treatment, as well as periodically during treatment.

Aceclofenac has been shown to have no effect on blood pressure control when co-administered with bendrofluazide, although interactions with other diuretics cannot be excluded.

Hypoglycemic drugs: in clinical studies, it has been shown that diclofenac can be used simultaneously with hypoglycemic drugs for oral use, without affecting their clinical effectiveness. However, there are separate reports of hypoglycemic and hyperglycemic effects of this drug. Therefore, the possibility of dose adjustment of drugs that may cause hypoglycemia should be considered for aceclofenac.

Zidovudine: concomitant use of NSAIDs and zidovudine increases the risk of hematological toxicity. There is evidence of an increased risk of hemarthrosis and hematoma formation in HIV-positive patients suffering from hemophilia and receiving concomitant treatment with zidovudine and ibuprofen.

How to take, course of use and dosage

The contents of the sachets should be dissolved in 40-60 ml of water and taken immediately. Simultaneous use of pisha slows down the rate of absorption of the Active ingredient, but does not reduce the degree of absorption from the gastrointestinal tract.

Adults:The recommended dose of Airtal is 1 sachet 2 times a day (one in the morning and one in the evening).

Children:The safety and efficacy of the drug for the treatment of children and adolescents has not been established.

Elderly patients:Usually, no dose reduction is required, but the precautions described in the “Special instructions”section should be taken into account.

Liver failure:Lower doses of aceclofenac should be used in patients with mild to moderate hepatic impairment. The recommended starting dose is 100 mg per day.

Kidney failure:There is no evidence that the dose of aceclofenac should be modified in patients with mild to moderate renal impairment, but caution is recommended.

Adverse events can be minimized by reducing the duration of treatment to the minimum necessary to achieve control of the symptoms of the disease.

Overdose

There are no data on aceclofenac overdose in humans.

Possible symptoms: nausea, vomiting, stomach pain, dizziness, headache, hyperventilation with increased convulsive readiness.

Treatment: gastric lavage, use of activated charcoal, symptomatic therapy. Forced diuresis and hemodialysis are not effective enough.

Special instructions

Avoid concomitant use of Airtal with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Adverse events can be reduced by reducing 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 administered with caution and under close medical supervision to patients with the diseases listed below, as their course may worsen:

– symptoms that indicate gastrointestinal diseases, including upper and lower gastrointestinal tract;- a history of ulceration, bleeding or perforation of a stomach or intestinal ulcer in the presence of Helicobacter pylori infection; – a history of ulcerative colitis;- a history of Crohn’s disease; – hematological diseases, systemic lupus erythematosus( SLE), porphyria and hematopoietic disorders.

Gastrointestinal bleeding, ulceration of the stomach or intestines, or perforation of the ulcer have been reported, which can lead to death if any NSAIDs are taken at any time during treatment, with or without alarming symptoms, regardless of the history of serious gastrointestinal complications.

The risk of gastrointestinal bleeding, ulceration, or ulcer perforation is higher when treated with high-dose NSAIDs in patients with a history of gastric or intestinal ulcers, especially if they are 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 diseases, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), paying maximum attention to the symptoms in the early stages of 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 medications such as acetylsalicylic acid.

If gastrointestinal bleeding or ulceration occurs in patients taking Airtal®, treatment should be discontinued.

Influence on the cardiovascular system and blood circulation of the brain.

When treating patients with arterial hypertension and/or chronic heart failure, appropriate monitoring and recommendations should be made, as there are reports of the development of fluid retention and edema against the background of NSAID treatment.

There is evidence to suggest that some NSAIDs (especially in high doses and with long-term treatment) may cause an increased risk of arterial thrombotic complications (for example, myocardial infarction or stroke). There are insufficient data to exclude this risk when using aceclofenac.

Patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral artery disease, and / or cerebral vascular disease should only start treatment with aceclofenac after an informed decision by the attending physician. Similarly, it is necessary to carefully evaluate the indications for long-term treatment of patients with risk factors for developing cardiovascular disease (for example, hypertension, hyperlipidemia, diabetes mellitus, and smoking) before starting it.

Caution and close medical supervision should also be exercised when using aceclofenac in patients with a history of cerebral hemorrhage.

Effects on the liver and kidneys. Treatment with NSAIDs can cause a dose-dependent decrease in prostaglandin synthesis and provoke renal failure. The importance of prostaglandins for maintaining renal blood flow should be taken into account in patients with impaired heart or kidney function, liver dysfunction, patients receiving diuretic treatment or recovering from oral surgery, and elderly patients.

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 can lead to impaired renal function and fluid retention in the body. Caution should also be exercised when using the drug in patients treated with diuretics, or, conversely, in patients at risk of hypovolemia. The minimum effective dose should be prescribed and regular monitoring of renal function should be performed. The effect of the drug on renal function is usually reversible after discontinuation of aceclofenac.

Treatment with aceclofenac should be discontinued if deviations in liver function tests from normal values persist or increase with the appearance of clinical symptoms corresponding to the development of liver failure, or in the event of other manifestations (for example, eosinophilia, rash).

Hepatitis can develop without previous symptoms. In patients with hepatic porphyria, the use of NSAIDs may cause an exacerbation of the disease.

Hypersensitivity and skin reactions. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur even in the early stages of using the drug. In very rare cases, serious skin reactions have been reported with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, some of which can lead to death. Patients are at the highest risk of developing these reactions at the beginning of the course of treatment, in most cases the reactions manifest themselves in the first month of treatment. At the first sign of skin rash, mucosal damage, or any other symptoms of hypersensitivity, discontinue treatment with Airtal®.

In extremely rare cases, chickenpox can cause serious infectious complications from the skin and soft tissues. Currently, 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.

Influence on hematological parameters. Aceclofenac may reversibly inhibit platelet aggregation.

Respiratory system disorders. Caution should be exercised when using the drug in patients with bronchial asthma or with a history of bronchial asthma, as there are reports that NSAIDs can cause bronchospasm in such patients.

Elderly patients. Caution should be exercised when treating elderly patients, as this age group has an increased incidence of adverse events associated with NSAID treatment, especially gastrointestinal bleeding and ulceration, which can lead to death. In addition, elderly patients are more susceptible to renal, hepatic or cardiovascular insufficiency.

Long-term treatment. All patients receiving long-term NSAID treatment should be carefully monitored, including regular general blood tests, liver and kidney function tests.

Each sachet of Airtal®, a 100 mg oral suspension powder, contains 2.64 g of sorbitol, which can cause gastrointestinal disorders and diarrhea. Patients with rare hereditary problems of fructose intolerance should not be prescribed this medication.

Airtal®, Oral suspension powder,100 mg, contains aspartame, a source of phenylalanine. Patients with phenylketonuria should consider that each sachet contains 5.61 mg of phenylalanine.

Influence on the ability to drive vehicles and work with mechanisms.

You should refrain from driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as the drug can cause dizziness and other side effects that may affect these abilities.

Form of production

Airtal powder for the preparation of a suspension for oral use.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Aceclofenac

Conditions of release from pharmacies

By prescription

Dosage form

oral solution