Airtal pills 100 mg, 60 pcs.

Composition

1 tablet contains:

Active ingredient:

aceclofenac 100 mg.

Auxiliary substances:

MCC-89.2 mg;

povidone-6.6 mg;

glyceryl distearate type I-2.6 mg;

croscarmellose sodium-6.6 mg

film shell:

Sepifilm 752 white (hypromellose, MCC, macrogol stearate type I, titanium dioxide) — 9 mg

. Pharmacological action

Pharmaceutical group:

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 administration. Cmax in plasma after oral administration 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

The drug is contraindicated during pregnancy. Regular use of NSAIDs in the last trimester of pregnancy can lead to a decrease in tone and weaker uterine contractions.

The use of NSAIDs can lead to premature closure of the Botall duct in the fetus and possibly-to prolonged pulmonary hypertension in the newborn, delay the onset of labor and increase the duration of labor.

Airtal should not be taken during lactation. There are no data on the excretion of Airtal in human milk.

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

The undesirable effects listed below are presented by organ-system classes according to the MedDRA classification with the following frequency::

• Often – ≥1/100 to < 1/10.
• Infrequently – ≥1/1000 to < 1/100.
• Rarely – ≥1/10000 to
• Very rare —

Blood and lymphatic system disorders: rarely-anemia; very rarely-bone marrow depression, granulocytopenia, neutropenia, hemolytic anemia.

From the immune system: rarely — anaphylactic reaction (including shock), hypersensitivity.

From the side of metabolism and nutrition: very rarely — hyperkalemia.

Mental disorders: very rarely — depression, unusual dreams, insomnia.

Nervous system disorders: often — dizziness; very rarely-paresthesia, tremor, drowsiness, headache, dysgeusia.

From the side of the visual organ: rarely-visual disorders.

From the side of the organ of hearing and labyrinth: very rarely — vertigo, ringing in the ears.

From the CCC side: rarely-heart failure, arterial hypertension, aggravated arterial hypertension; very rarely-tachycardia, hot flashes, vasculitis.

Respiratory, thoracic and mediastinal disorders: rarely-shortness of breath; very rarely-bronchospasm.

From the gastrointestinal tract: often — dyspepsia (7.5%), abdominal pain (6.2%), nausea (1.5%), diarrhea (1.5%); infrequently — flatulence, gastritis, constipation, vomiting, oral ulcer; rarely — melena, gastrointestinal ulcer, diarrhea with blood, gastrointestinal bleeding; very rarely-stomatitis, vomiting of blood, stomach ulcer, perforation of the small intestine, worsening of Crohn’s disease and ulcerative colitis. colitis, pancreatitis.

Liver and biliary tract disorders: often-an increase in the activity of liver enzymes; very rarely-liver damage (including hepatitis), an increase in the activity of blood alkaline phosphatase.

Skin and subcutaneous tissue disorders: infrequently-pruritus, rash, dermatitis, urticular rash; rarely-angioedema; very rarely-purpura, eczema, skin and mucosal reactions, bullous skin reactions, including Stevens-Johnson syndrome and acute epidermal necrolysis.

From the side of the kidneys and urinary tract: infrequently-increased blood urea concentration, increased blood creatinine concentration; very rarely-interstitial nephritis, nephrotic syndrome, renal failure.

General disorders and disorders at the injection site: very rarely — swelling, weakness, muscle spasms, weight gain.

Interaction

No drug interaction studies have been conducted, with the exception of warfarin.

Aceclofenac is metabolized by the cytochrome P450-CYP2C9 system, and in vitro data indicate that aceclofenac may be an inhibitor of this enzyme. Therefore, there may be a risk of pharmacokinetic interactions with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfafenazole.

As with other NSAIDs, there is a risk of pharmacokinetic interaction with drugs that are metabolized in the liver, 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 strongly bind to plasma proteins.

Due to the lack of pharmacokinetic interaction studies, the following information is based on information obtained from other NSAIDs.

The following combinations should be avoided

: NSAIDs inhibit the tubular secretion of methotrexate, and there may also be a metabolic interaction leading to a decrease in the clearance of methotrexate. Therefore, NSAIDs should always be avoided during treatment with high doses of methotrexate.

Some NSAIDs inhibit the excretion of lithium by the kidneys, which leads to increased concentrations of lithium in the blood serum. This combination should be avoided if frequent monitoring of serum lithium concentrations is not possible.

NSAIDs inhibit platelet aggregation and damage the gastrointestinal mucosa, which can increase the activity of anticoagulants and increase the risk of bleeding from the gastrointestinal mucosa in patients taking anticoagulants.

The combination of aceclofenac with oral coumarin anticoagulants, ticlopidine, thrombolytics, and heparin should be avoided unless carefully monitored.

The following combinations may require dose adjustment and precautionary measures:

Possible interactions between NSAIDs and methotrexate should be considered, especially in patients with renal insufficiency. When taking both drugs, monitoring of renal function is necessary. Precautions should be taken when taking NSAIDs and methotrexate simultaneously for 24 hours, as the concentration of methotrexate may increase, leading to increased toxicity of methotrexate.

It is suggested that taking NSAIDs together with cyclosporine or tacrolimus increases the risk of nephrotoxicity due to a decrease in prostacyclin synthesis in the kidneys. Therefore, when taking medications at the same time, it is important to monitor kidney function.

Concomitant administration of acetylsalicylic acid and other NSAIDs may increase the frequency 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 certain 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 increase in some patients with impaired renal function, such as elderly patients or patients with fluid deficiency. 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.

No effect of aceclofenac on blood pressure was found when it was taken simultaneously with bendrofluazide, although interaction with other antihypertensive drugs, such as beta-blockers, 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 used concomitantly with Airtal®:

• Digoxin, phenytoin or lithium preparations — the plasma level of these drugs may increase.
• Diuretics and antihypertensive agents — the effect of these drugs may be weakened.
• Potassium-sparing diuretics — may lead to the development of hyperglycemia and hyperkalemia.
• Other NSAIDs or CORTICOSTEROIDS — increases the risk of gastrointestinal side effects.
• SSRIs (citalopram, fluoxetine, paroxetine, sertraline) — increases the risk of gastrointestinal bleeding.
• Cyclosporine — may increase the toxic effect of the latter on the kidneys.
• Antidiabetic agents — may cause both hypo-and hyperglycemia. With this combination of drugs, blood sugar control is necessary.
• Acetylsalicylic acid-reduces the concentration of aceclofenac in the blood.
• Antiplatelet agents and anticoagulants — the risk of bleeding increases (regular monitoring of blood clotting parameters is necessary).

How to take, course of administration and dosage

Inside. Film-coated tablets should be swallowed whole, washed down with a sufficient amount of liquid.

For adults: usually 1 tablet (100 mg) 2 times a day: 1 tablet in the morning and 1 in the evening.

Elderly people: usually, no dose adjustment is required.

Liver failure: patients with moderate hepatic insufficiency should reduce the dose of aceclofenac. The recommended initial dose is 100 mg daily.

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

Overdose

Symptoms:dizziness, headache, hyperventilation with increased convulsive readiness, vomiting, abdominal pain, nausea.

Treatment: symptomatic therapy, gastric lavage, administration of activated charcoal is indicated. There is no specific antidote to the drug. Forced diuresis and hemodialysis are ineffective.

Special instructions

The severity of adverse reactions can be corrected by reducing the effective single dose required to control symptoms.

Patients with a history of hypertension and/or mild to moderate congestive heart failure require appropriate monitoring and medical advice, as fluid retention and edema have been reported with NSAIDs.

Data from clinical and epidemiological studies suggest that the use of certain NSAIDs (especially in high doses and with prolonged use) may increase the risk of arterial thrombosis (for example, myocardial infarction or stroke). There are insufficient data to rule out such a risk for aceclofenac.

Patients with uncontrolled hypertension, congestive heart failure, coronary heart disease, peripheral artery disease, and / or cerebrovascular diseases should only take aceclofenac after a thorough analysis of the clinical situation. Patients at risk of cardiovascular disease (such as hypertension, hyperlipidemia, diabetes mellitus, and smokers) should also be considered with the same caution before starting long-term treatment.

Aceclofenac should be taken with caution and under close medical supervision in patients suffering from gastrointestinal diseases, a history of peptic ulcer, after acute cerebrovascular accident, with systemic lupus erythematosus, porphyria, disorders of the hematopoietic system and blood clotting.

Patients with Crohn’s disease, ulcerative colitis, the drug is not recommended.

Caution should be exercised in patients with hepatic, renal, and heart failure, as well as in patients with other diseases predisposed to the development of edema. The use of NSAIDs in this category of patients may lead to deterioration of renal excretion and the appearance of edema. Patients taking diuretic medications or at an increased risk of hypovolemia should also exercise caution when taking Airtal®.

Caution should be exercised in elderly patients, as they are more likely to experience side effects. Bleeding from the gastrointestinal tract and / or perforation may occur during treatment, especially if there is a history of gastrointestinal diseases. In addition, older patients are more likely to have liver, kidney, and cardiovascular disorders.

All patients receiving long-term NSAID treatment should be monitored to reduce the risk of adverse reactions (for example, general urinalysis, general and biochemical blood tests).

Concomitant administration of Airtal® with any medication that suppresses COX activity and PG synthesis may reduce fertility and is not recommended for women planning pregnancy. Women with a history of infertility should stop taking Airtal®.

Each bag of Airtal powder contains 2.64 g of sorbitol, which can cause stomach upset and diarrhea. Patients with fructose intolerance should not take this medicine.

Airtal ® powder 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

Patients who experience a feeling of weakness, dizziness, or other central nervous system disorders while taking NSAIDs should not drive a car or work with mechanisms.

Form of production

Film-coated tablets

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

3 years

Active ingredient

Aceclofenac

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For athletes, For adults as prescribed by a doctor

Indications

Osteoarthritis and Arthritis, Lumbago, Osteoarthritis, Sciatica, Periarthritis, Rheumatoid Arthritis, Sciatica

Weight

Weight: 31 g.