Aertal coated pills 100 mg 20 pcs
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Aceclofenac
Release form
Pills
Composition
Active ingredient: Aceclofenac. Concentration of active ingredient (mg): 100 mg
Pharmacological effect
Aertal is a drug of the group of nonsteroidal anti-inflammatory drugs. Aertal contains the active ingredient, aceclofenac, which inhibits the activity of the enzyme cyclooxygenase and thus reduces the synthesis of pro-inflammatory cytokines, in particular prostaglandins and prostacyclins. The drug has anti-inflammatory, analgesic and antipyretic effects. Due to the high activity of the drug in the tissues of the peripheral nervous system and soft tissues, aceclofenac eliminates pain, reduces morning stiffness and swelling of the joints in patients with rheumatic diseases. After oral administration, the drug is well absorbed in the gastrointestinal tract, the peak of the plasma concentration of aceclofenac is observed 1.5-3 hours after taking the drug. Aceclofenac is characterized by a high degree of association with plasma proteins (mainly albumin). The active ingredient of the drug creates high concentrations in synovial fluid. A small part of the drug is metabolized. It is excreted mainly by the kidneys, both unchanged and in the form of metabolites. The half-life reaches 4 hours.
Pharmacokinetics
Absorption: After oral administration, aceclofenac is rapidly absorbed, its bioavailability is close to 100%. The maximum concentration (Cmax) in the blood plasma is reached after 1.25-3 hours after ingestion. Meal slows down absorption, but does not influence its degree. Distribution: Aceclofenac is highly bound to plasma proteins (> 99.7%). Aceclofenac penetrates the synovial fluid, where its concentration reaches 60% of its concentration in plasma. The volume of distribution is 30 liters. Metabolism. Aceclofenac is believed to be metabolized by the CYP2C9 isoenzyme to produce the 4-OH-aceclofenac metabolite, whose contribution to the clinical action of the drug is likely to be minimal. Diclofenac and 4-OH-diclofenac are among the numerous metabolites of aceclofenac. Excretion: The average half-life (t1 / 2) is 4-4.3 hours. Clearance is 5 l / h.Approximately 2/3 of the dose taken is excreted by the kidneys, mainly in the form of conjugated hydroxymetabolites. Only 1% of the dose after ingestion is excreted unchanged.
Indications
Symptomatic treatment of rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis. Rheumatic soft tissue damage with pain.
Contraindications
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 acetylsalicylic acid - rhinosinusitis, urticaria, nasal mucous polyps, bronchial asthma). Hypersensitivity to aceclofenac or drug components. Period after coronary artery bypass surgery. Severe liver failure or active liver disease. Violations of blood formation and coagulation. Severe renal failure, progressive kidney disease, confirmed hyperkalemia. Pregnancy and lactation. Children's age up to 18 years.
Precautionary measures
It should be used with caution when working with drivers of vehicles and people whose profession is associated with increased concentration of attention.
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and during breastfeeding. Clinical data on the use of the drug Aertal during pregnancy are not available. Regular use of NSAIDs in the third 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 botanal duct in the fetus and, possibly, to prolonged pulmonary hypertension in the newborn, delayed onset of labor and increase the length of labor. In epidemiological studies, no evidence was obtained in humans indicating the NSAID embryotoxicity. However, in experimental studies on rabbits with the administration of aceclofenac (10 mg / kg / day), morphological changes in the fetus were observed in some cases. Data on the presence of teratogenic effect in rats are absent.Data on the secretion of aceclofenac with breast milk in humans are not available. In experimental studies with the introduction of radioactive 14C-aceclofenac to lactating rats, there was no noticeable transfer of radioactivity into milk.
Dosage and administration
Inside Tablets should be swallowed whole, washed down with a sufficient amount of liquid. Usually, adults are prescribed 1 tablet of 100 mg 2 times a day. one tablet in the morning and one tablet in the evening.
Side effects
On the part of the gastrointestinal tract: nausea, vomiting, diarrhea, pain in the epigastric region, intestinal colic, dyspepsia, flatulence, anorexia, constipation. in rare cases, the occurrence of erosive-ulcerative lesions, bleeding and perforation of the gastrointestinal tract (hematemesis, melena), stomatitis including 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 - urticaria, isolated cases of eczema, polymorphic erythema, erythroderma, rarely noted attacks of asthma. 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. Since the cardiovascular system: isolated cases of tachycardia, hypertension, congestive heart failure, coronary artery disease.
Overdose
Symptoms: the clinical picture is determined by disorders of the central nervous system (includingheadache, dizziness, hyperventilation with increased convulsive readiness) and the digestive system (incl. abdominal pain, nausea, vomiting). Treatment: gastric lavage, ingestion of activated carbon, symptomatic therapy. There is no specific antidote. Forced diuresis, hemodialysis, blood transfusion are ineffective.
Interaction with other drugs
With simultaneous use with the drug Aertal may increase concentrations in the blood plasma of digoxin, phenytoin, lithium. With simultaneous use with the drug Aertal may decrease the effectiveness of diuretics and antihypertensive agents. The simultaneous use of potassium-sparing diuretics and the drug Aertal can lead to the development of hyperglycemia and hyperkalemia. At the same time taking the drug Aertal and GCS or other NSAIDs increases the risk of side effects from the digestive system. At the same time taking the drug Aertal and selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) increases the risk of bleeding from the gastrointestinal tract. Simultaneous administration of the drug Aertal can increase the nephrotoxic effect of cyclosporine. Against the background of simultaneous administration of Aertal and hypoglycemic drugs, both hypo- and hyperglycemia may develop (control of blood glucose level is necessary). The drug Aertal within 24 hours before or after the use of methotrexate can lead to an increase in plasma methotrexate concentration and to an increase in its toxic action. With simultaneous use with acetylsalicylic acid may decrease the concentration of aceclofenac in the blood plasma. With the simultaneous use of antiplatelet agents and anticoagulants increases the risk of bleeding (requires regular monitoring of blood coagulation).
special instructions
During the period of drug treatment should be systematically monitored patterns of peripheral blood, liver, kidney, feces for the presence of blood. Due to the important role of prostaglandins in maintaining renal blood flow, special care should be taken when prescribing to patients with cardiac or renal failure, the elderly 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 differ 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 taking the drug should refrain from drinking alcohol. Impact on the ability to drive vehicles and control mechanismsPatients suffering from dizziness and other disorders of the central nervous system during the period of taking the drug Aertal need to refrain from activities requiring increased concentration and psychomotor reactions (driving vehicles and working with dangerous machinery).