Aceclofenac has anti-inflammatory, analgesic and antipyretic activity. It inhibits synthesis of prostaglandins and thus affects the pathogenesis of inflammation, pain and fever occurrence. In rheumatic diseases inflammatory and analgesic effect of aceclofenac contributes to a significant reduction in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the patient.
Aceclofenac is rapidly and completely absorbed after oral administration. Time to maximum concentration -. 1.25-3 h penetrates into the synovial fluid, where its concentration reaches 57% of the level of concentration in plasma and the time to reach maximum concentration at 2-4 hours later than in plasma. The volume of distribution – 25 l. The connection to plasma proteins (albumin) – 99%. Aceclofenac circulates mainly in unchanged form, its main metabolite is 4′-gidroksiatseklofenak. The half-life -. 4 hours excreted by the kidneys, mainly in the form of hydroxy (about 2/3 of the administered dose).
Indications Symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis. Rheumatism of soft tissues, accompanied by pain.
Contraindications – erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, gastrointestinal bleeding or suspicion of it; – a history of bronchial obstruction, urticaria, rhinitis, after taking aspirin or other NSAIDs (complete or partial syndrome of intolerance to acetylsalicylic acid – rhinosinusitis , urticaria, polyps of the nasal mucosa, bronchial asthma); – hypersensitivity to aceclofenac or components of the preparation; – the period after coronary artery bypass surgery; – severe hepatic impairment or active liver disease; – violation of hematopoiesis and coagulation; – severe renal failure, progressive renal disease confirmed hyperkalemia; – pregnancy and lactation – children under 18 years old.
Precautions Liver disease, kidney and gastrointestinal tract in the history of bronchial asthma, hypertension, decreased blood volume (including immediately after major surgery), coronary heart disease, chronic kidney, liver and heart failure, creatinine clearance less than 60 ml / min, medical history data about the development of ulcerative lesions gastrointestinal tract, the presence of Helicobacter pylory infection, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral vascular disease, smoking, advanced age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases.
Pregnancy and lactation The drug is contraindicated during pregnancy (see. Section “Contraindications”). Information Aertala use 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. The use of NSAIDs may cause premature closure of the arterial duct in the fetus and possibly to a prolonged pulmonary hypertension of the newborn, delayed onset of labor and an increase in the duration of labor. In epidemiological studies have not received data in humans, indicating the toxicity of NSAIDs for the embryo. However, in experiments on rabbits assignment aceclofenac (10 mg / kg / day) in some cases resulted testosterone suspension in a number of morphological changes in the fetus. Data on the presence of a teratogenic effect in rats no. Lactation: Aertal should not be taken during lactation (see section “Contraindications”.).Data on the allocation of Aertala with human milk is not available; when assigning radioactive 14 P-lactating rats aceclofenac appreciable transfer of radioactivity was observed in the milk.
Dosage and administration. Inside. The buy testosterone suspensions should be swallowed whole, drinking plenty of fluids. Usually adults appoint 1 buy testosterone suspension of 100 mg 2 times a day; one buy testosterone suspension in the morning and one – in the evening.
Side effect On the part of the digestive tract: nausea, vomiting, diarrhea, epigastric pain, intestinal colic, dyspepsia, flatulence, anorexia, constipation; in rare cases, noted the appearance of erosive and ulcerative lesions, bleeding or perforation of the gastrointestinal tract (hematemesis, melena), stomatitis including aphthous, pancreatitis. From the nervous system: sometimes marked headache, dizziness, sleep disturbances (insomnia or drowsiness) , agitation, in some cases, marked sensory disturbances, disorientation, impaired memory, vision, hearing, taste, tinnitus, convulsions, irritability, tremor, depression, anxiety, vertigo, aseptic meningitis, paresthesia. Allergic manifestations: sometimes a skin rash rarely – urticaria, marked individual cases of eczema, erythema multiforme, erythroderma, rarely observed bouts of bronchial asthma; systemic anaphylactic reactions, in some cases, vasculitis, pneumonitis, Stevens – Johnson and Lyell’s syndrome, anaphylactic shock. On the part of the kidney: rarely peripheral edema, in some cases, acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria. Liver : . transient increase in transaminases in the blood, rarely – hepatitis, in some cases, fulminant hepatitis Hematopoietic system: leukopenia, described isolated cases of thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia. cardio-vascular system: marked by sporadic cases of tachycardia, hypertension, congestive heart failure, coronary artery disease.
Symptoms: The clinical picture is determined disorders of the central nervous system (headache, dizziness, hyperventilation phenomenon with increased convulsive readiness) and gastrointestinal disorders (abdominal pain, nausea, vomiting).
Treatment: In case of overdose shown gastric lavage, administration of activated charcoal, symptomatic therapy. There is no specific antidote. Forced diuresis, dialysis, blood transfusions – are ineffective.
Interaction with other medicinal products In an application and AERTALA:
- digoxin, phenytoin or lithium preparations – may increase plasma levels of these drugs;
- diuretics and antihypertensives – can weaken the effect of these funds;
- potassium-sparing diuretics – may lead to hyperglycemia and hyperkalemia;
- other NSAIDs or glucocorticosteroids – 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 – may increase the toxic effect of the latter on the kidneys;
- antidiabetic agents – can cause both hypo- and hyperglycemia. With this combination of resources necessary to monitor blood sugar levels;
- methotrexate for 24 hours before or after administration – may lead to increased concentrations of methotrexate to enhance its toxic effect;
- acetylsalicylic acid reduces the concentration of aceclofenac in the blood;
- antiplatelet agents and anticoagulants – the risk of bleeding (requires regular monitoring of blood clotting).Effects on ability to drive and control mechanisms for patients suffering from vertigo and other disorders of the central nervous system while taking Aertala should refrain from driving and working with dangerous machinery.Cautions In the period of drug treatment should be systematic monitoring of peripheral blood, liver, kidney, feces study on the presence of blood. Patients receiving the drug should refrain from activities requiring increased attention and rapid mental and motor reactions, the use of alcohol. Because of the important role of prostaglandins in maintaining renal blood flow should be particularly careful when administered to patients with cardiac or renal insufficiency, elderly taking diuretics, and patients with a reduced volume of circulating blood (such as after major surgery). If in such cases appoint aceclofenac, it is recommended to monitor renal function. In patients with hepatic impairment the kinetics and metabolism differ from analogichngh processes in patients with normal liver function. To reduce the risk of adverse effects on the gastrointestinal tract to use the minimum effective dose as low as possible short course.