Aertal powder for suspension 100mg sachets 3g №20

• Aceclofenac

Class of diseases

• Rheumatoid arthritis, unspecified
• Osteoarthritis, unspecified
• Rheumatic polymyalgia
• Ankylosing Spondylitis

Mechanism of action

• Anti inflammatory
• Antipyretic
• Pain reliever

Powder for the preparation of suspensions for oral administration Aertal (Airtal)

Indications and usage

Rheumatoid arthritis, osteoarthritis,  ankylosing spondyloarthritis (symptomatic treatment) is a rheumatic lesion of soft tissues, accompanied by pain.

Inhibits the synthesis of PG and thus affects the pathogenesis of inflammation, the occurrence of pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic effect of aceclofenac significantly reduces the severity of pain, morning stiffness, and swelling of the joints, which improves the functional state of the patient.

Aceclofenac is rapidly and completely absorbed after ingestion. The time to reach Cmax is 1.25–3 hours. It penetrates into the synovial fluid, where its concentration reaches 57% of the concentration level in plasma and the time to reach maximum concentration 2-4 hours later than in plasma. The volume of distribution - 25 liters.

Plasma protein binding (albumin) - 99%.Aceclofenac circulates mainly in an unchanged form, its main metabolite is 4-hydroxyaceclofenac.

T1 / 2 - 4 h. Excreted by the kidneys, mainly in the form of hydroxy derivatives (about 2/3 of the administered dose).

Pregnancy and Breastfeeding

The drug is contraindicated during pregnancy (see "Contraindications"). Information on the use of Aertal during pregnancy is not available. Regular use of NSAIDs in the last trimester of pregnancy can lead to a decrease in tone and weaker contractions of the uterus. The use of NSAIDs can lead to premature closure of the Botallova duct in the fetus and, possibly, to prolonged pulmonary hypertension in the newborn, delayed onset of labor and increase the length of labor.  Aertal should also not be taken during lactation.

Contraindications

Hypersensitivity to aceclofenac or drug components -
erosive and ulcerative lesions of the gastrointestinal tract in the acute phase — Gastrointestinal bleeding or suspicion of it — anamnestic data on bronchial obstruction, urticaria, rhinitis, after taking Acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance syndrome of acetylsalicylic acid — rhinosinusitis, arshivarypathyr syndrome, rhinitis, and ivaluvitis, in a cerebrospinal syndrome;, bronchial asthma) - the period after coronary artery bypass surgery — severe liver failure or active liver disease — impaired blood formation and coagulation — is pronounced Naya renal failure, progressive kidney disease,confirmed hyperkalemia, pregnancy, breastfeeding period, children under 18 years of age.

With caution: diseases of the liver, kidney and gastrointestinal tract in the history of bronchial asthma-arterial hypertension-reduced BCC (including immediately after extensive surgical interventions) - CHD-chronic renal, hepatic and heart failure-Cl creatinine and lt-60 ml / min-anamnestic data on ulcerative lesions of the gastrointestinal tract-presence of Helicobacter pylori infection-cerebrovascular diseases-dyslipidemia / hyperlipidemia- diabetes mellitus peripheral arterial disease-smoking-old age-long-term use of NSAIDs-frequent use of alcohol-cha elye somatic diseases.

Adverse reactions

On the part of the gastrointestinal tract: nausea, vomiting, diarrhea, pain in the area of ​​epigastria, intestinal colic, dyspepsia, flatulence, anorexia, zapor-in rare cases, the occurrence of erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract (hematemesis, melena), stomatitis, t. h. aphthous, pancreatitis.

On the part of the nervous system: sometimes there is headache, dizziness, sleep disturbances (insomnia or drowsiness), agitation, in some cases, sensitivity disorders, disorientation, memory, vision, hearing, taste sensations, tinnitus, convulsions, irritability, tremor, depression, anxiety, vertigo, aseptic meningitis, paresthesia.

Allergic manifestations: skin rash sometimes occurs, rarely - hives,isolated cases of eczema, polymorphic erythema, erythroderma, rarely noted asthma attacks - systemic Anaphylactic reactions, in some cases - vasculitis, pneumonitis, Stevens-Johnson syndrome and Lyell's syndrome, anaphylactic shock.

On the part of the kidneys: rarely - peripheral edema, in some cases - acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria.

On the part of the liver: a transient increase in the activity of transaminases in the blood, rarely - hepatitis, in some cases - fulminant hepatitis.

On the part of the hematopoietic system: leukopenia, isolated cases of thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia are described.

Cardiovascular: isolated cases of tachycardia, hypertension, congestive heart failure, coronary artery disease.

Dosage and administration

Adults - usually 100 mg 2 times a day.

Overdosage

Symptoms: the clinical picture is determined by disorders of the central nervous system (headache, dizziness, hyperventilation with increased convulsive readiness) and gastrointestinal disorders (abdominal pain, nausea, vomiting).

Treatment: in case of overdose, gastric lavage, administration of Activated carbon, symptomatic therapy are indicated. There is no specific antidote.Forced diuresis, hemodialysis, blood transfusion are ineffective.

Drug interactions

With simultaneous use with Aertal:

digoxin, phenytoin or lithium preparations - the plasma levels of these drugs may increase

diuretics and antihypertensives - the effect of these agents may be weakened

potassium-saving diuretics - can lead to the development of hyperglycemia and hyperkalemia-

other NSAIDs or GCS - increases the risk of side effects from the gastrointestinal tract -

selective serotonin reuptake inhibitors (citalopram, Fluoxetine, paroxetine, sertraline) - increase the risk of gastrointestinal bleeding -

cyclosporine - can increase the toxic effects of the latter on the kidneys-

antidiabetic agents - can cause both hypo-and hyperglycemia. With this combination of means, it is necessary to control the level of blood sugar

within 24 h before or after taking it - can lead to an increase in the concentration of Methotrexate and to an increase in its toxic action -

acetylsalicylic acid - the concentration of aceclofenac in the blood decreases

antiplatelet agents and anticoagulants - the risk of bleeding increases (regular monitoring of blood clotting is necessary).

During the period of drug treatment should be systematically monitored patterns of peripheral blood, liver, kidney, feces for the presence of blood.Patients taking the drug should refrain from activities that require increased attention and quick mental and motor reactions, alcohol consumption.

Due to the important role of PGs in maintaining renal blood flow, special care should be taken when prescribing to patients with cardiac or renal failure, elderly people taking diuretics, and patients with reduced BCC (for example, after extensive surgery). If aceclofenac is prescribed in such cases, it is recommended to monitor renal function. In patients with liver failure, the kinetics and metabolism are different from similar processes in patients with normal liver function.

To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the shortest possible course.

Patients suffering from dizziness and other disorders of the central nervous system, in the period of receiving Aertal should refrain from driving a car and working with dangerous machinery.

In a dry place, at a temperature not higher than 25 ° C.