Release form, composition and packing Airtal
Tablets, film-coated white, round, biconvex, engraved on one side of the letter "A". 1 tab. aceclofenac 100 mg.
Excipients: microcrystalline cellulose (Avicel pH 101, Avicel pH 102), povidone (polyvinylpyrrolidone), glyceryl palmitostearat, croscarmellose sodium. The composition of the shell: sepifilm 752 white (hypromellose, microcrystalline cellulose, macrogol-40-stearate (polyoxyl-40-stearate), titanium dioxide). Pharmacological action of NSAIDs.
Has anti-inflammatory, analgesic and antipyretic effect. Inhibits the synthesis of prostaglandins and thereby affect the pathogenesis of inflammation, pain and fever. In rheumatic diseases aceclofenac significantly less severity of pain, morning stiffness, swollen joints, which helps improve the functional status of the patient.
Pharmacokinetics
Suction
Rapidly and completely absorbed after oral administration. Cmax in plasma after oral administration is achieved through 1.25-3 pm
Distribution
Binding to plasma albumin by 99%. Penetrates into synovial fluid, where its concentration reaches 57% of the plasma concentration and Cmax is achieved in 2-4 hours later than in plasma. Vd - 25 liters.
Metabolism
Undergoes metabolism to a minor extent. Its main metabolite detected in plasma is 4'-gidroksiatseklofenak.
Breeding
T1 / 2 - 4 h. Write the kidneys mainly as hydroxy derivatives (about 2 / 3 of the administered dose).
Statement
symptomatic treatment of rheumatoid arthritis;
symptomatic treatment of osteoarthritis;
symptomatic treatment of ankylosing spondylitis;
Rheumatism of soft tissues accompanied by pain.
Dosing regimen
Adults appointed interior, 100 mg (1 tab.) 2 times a day, morning and evening. The tablets should be swallowed whole, drinking plenty of fluids.
Side effect
From the digestive system: nausea, vomiting, diarrhea, epigastric pain, intestinal colic, dyspepsia, flatulence, anorexia, constipation, transient elevation of liver transaminases, rarely - erosive and ulcerative lesions, gastrointestinal bleeding and perforation (gematemezis, melena) stomatitis (including aphthous), pancreatitis, hepatitis, and in some cases - fulminant hepatitis.
CNS and peripheral nervous system: possible headache, dizziness, sleep disturbances (insomnia or drowsiness), excitation, and in some cases - violations of sensitivity, disorientation, impaired memory, vision, hearing, taste, tinnitus, muscle cramps, irritability , tremor, depression, anxiety, aseptic meningitis, paresthesia.
Allergic reactions: possible skin rash, rarely - urticaria, bronchospasm, systemic anaphylactic reactions, in some cases - eczema, erythema multiforme, erythroderma, vasculitis, pneumonitis, Stevens-Johnson syndrome, Lyell's syndrome.
With the urinary system: rarely - peripheral edema in some cases - acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria.
From the hemopoietic system: leucopenia, in some cases - thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia.
Cardio-vascular system: in rare cases - tachycardia, hypertension, congestive heart failure, coronary artery disease.
Contraindications
erosive and ulcerative lesions of the gastrointestinal tract in acute phase;
gastrointestinal bleeding or suspicion of it;
indicate a history of bronchospasm, urticaria, rhinitis after taking aspirin or other NSAIDs (full or partial syndrome of intolerance to acetylsalicylic acid - rhinosinusitis, urticaria, polyps, nasal mucosa, bronchial asthma);
period after coronary artery bypass grafting;
hematopoietic disorders, and coagulation;
severe hepatic impairment or active liver disease;
renal failure, progressive renal disease;
confirmed hyperkalemia;
pregnancy;
Lactation (breastfeeding);
childhood and adolescence to 18 years;
hypersensitivity to the drug.
Precautions should be used in the preparation for liver, kidney and gastrointestinal tract in the history of, bronchial asthma, hypertension, lowering the bcc (including immediately after major surgery), ischemic heart disease, chronic kidney, liver and heart failure with CC <60 ml / min, the instructions in the history of the development of gastrointestinal ulceration, the presence of infection Helicobacter pylory, in cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial disease, in elderly patients, chronic administration of NSAIDs, with severe somatic diseases in smokers in chronic alcoholism.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation. Clinical data on the use Aertala during pregnancy are not available. Regular use of NSAIDs in the III trimester of pregnancy may reduce the tone and weaker contractions of the uterus.
The use of NSAIDs can lead to premature closure botallova flow in the fetus and possibly to prolonged pulmonary hypertension of the newborn, delayed onset of labor and increase the duration of labor. In epidemiological studies in humans have been received data indicating embryotoxicity NSAIDs. However, experimental studies on rabbits when administered aceclofenac (10 mg / kg / day) in some cases, morphological changes were observed in the fetus. Data on the presence of teratogenic effects in rats are absent.
Data on the allocation of aceclofenac with breast milk in humans. In experimental studies, the introduction of radioactive 14C-aceclofenac lactating rats a significant transfer of radioactivity in milk were observed.
Use in hepatic dysfunction
With great care should be given to patients with liver disease. Keep in mind that in patients with liver failure may change the kinetics and metabolism of the drug. The drug is contraindicated in severe hepatic impairment or active liver disease.
Use in renal impairment
With great care should be given to patients with kidney disease with chronic renal failure. The drug is contraindicated in severe renal failure, progressive kidney disease, confirmed by hyperkalemia.
Cautions
Because of the important role of prostaglandins in maintaining renal blood flow should be particularly careful when assigning patients with cardiac or renal failure, advanced age, taking diuretics, and patients with lower BCC (for example, after extensive surgery). If in such cases, appoint aceclofenac, it is recommended to monitor kidney function.
In patients with liver failure kinetics and metabolism differ from similar processes in patients with normal liver function. To reduce the risk of adverse effects on the gastrointestinal tract should use the minimum effective dose is minimal, short-course.
Monitoring of laboratory parameters
During the period of drug treatment should be systematic monitoring of peripheral blood picture, liver function, kidney disease, a study of feces for the presence of blood.
Effects on ability to drive vehicles and management mechanisms
Patients taking the drug, you must refrain from activities requiring a high concentration of attention and quickness of psychomotor reactions.
Overdose
Symptoms: The clinical picture is determined disorders of the central nervous system (including headache, dizziness, hyperventilation phenomenon with increased convulsive readiness) and the digestive system (including abdominal pain, nausea, vomiting).
Treatment: gastric lavage, ingestion of activated charcoal, symptomatic therapy. A specific antidote does not exist. Forced diuresis, hemodialysis ineffective.
Drug Interactions
In an application with Aertalom may increase the plasma concentrations of digoxin, phenytoin and lithium.
In an application with Aertalom may decrease the effectiveness of diuretics and antihypertensive drugs.
With the simultaneous reception Aertala and SCS or other NSAIDs increases the risk of side effects the digestive system. With the simultaneous reception Aertala and selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) increases the risk of bleeding from the gastrointestinal tract.
In an application with acetylsalicylic acid may reduce the concentration of aceclofenac in plasma.
Simultaneous reception Aertala may increase nephrotoxicity of cyclosporine.
Tablets, film-coated white, round, biconvex, engraved on one side of the letter "A". 1 tab. aceclofenac 100 mg.
Excipients: microcrystalline cellulose (Avicel pH 101, Avicel pH 102), povidone (polyvinylpyrrolidone), glyceryl palmitostearat, croscarmellose sodium. The composition of the shell: sepifilm 752 white (hypromellose, microcrystalline cellulose, macrogol-40-stearate (polyoxyl-40-stearate), titanium dioxide). Pharmacological action of NSAIDs.
Has anti-inflammatory, analgesic and antipyretic effect. Inhibits the synthesis of prostaglandins and thereby affect the pathogenesis of inflammation, pain and fever. In rheumatic diseases aceclofenac significantly less severity of pain, morning stiffness, swollen joints, which helps improve the functional status of the patient.
Pharmacokinetics
Suction
Rapidly and completely absorbed after oral administration. Cmax in plasma after oral administration is achieved through 1.25-3 pm
Distribution
Binding to plasma albumin by 99%. Penetrates into synovial fluid, where its concentration reaches 57% of the plasma concentration and Cmax is achieved in 2-4 hours later than in plasma. Vd - 25 liters.
Metabolism
Undergoes metabolism to a minor extent. Its main metabolite detected in plasma is 4'-gidroksiatseklofenak.
Breeding
T1 / 2 - 4 h. Write the kidneys mainly as hydroxy derivatives (about 2 / 3 of the administered dose).
Statement
symptomatic treatment of rheumatoid arthritis;
symptomatic treatment of osteoarthritis;
symptomatic treatment of ankylosing spondylitis;
Rheumatism of soft tissues accompanied by pain.
Dosing regimen
Adults appointed interior, 100 mg (1 tab.) 2 times a day, morning and evening. The tablets should be swallowed whole, drinking plenty of fluids.
Side effect
From the digestive system: nausea, vomiting, diarrhea, epigastric pain, intestinal colic, dyspepsia, flatulence, anorexia, constipation, transient elevation of liver transaminases, rarely - erosive and ulcerative lesions, gastrointestinal bleeding and perforation (gematemezis, melena) stomatitis (including aphthous), pancreatitis, hepatitis, and in some cases - fulminant hepatitis.
CNS and peripheral nervous system: possible headache, dizziness, sleep disturbances (insomnia or drowsiness), excitation, and in some cases - violations of sensitivity, disorientation, impaired memory, vision, hearing, taste, tinnitus, muscle cramps, irritability , tremor, depression, anxiety, aseptic meningitis, paresthesia.
Allergic reactions: possible skin rash, rarely - urticaria, bronchospasm, systemic anaphylactic reactions, in some cases - eczema, erythema multiforme, erythroderma, vasculitis, pneumonitis, Stevens-Johnson syndrome, Lyell's syndrome.
With the urinary system: rarely - peripheral edema in some cases - acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria.
From the hemopoietic system: leucopenia, in some cases - thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia.
Cardio-vascular system: in rare cases - tachycardia, hypertension, congestive heart failure, coronary artery disease.
Contraindications
erosive and ulcerative lesions of the gastrointestinal tract in acute phase;
gastrointestinal bleeding or suspicion of it;
indicate a history of bronchospasm, urticaria, rhinitis after taking aspirin or other NSAIDs (full or partial syndrome of intolerance to acetylsalicylic acid - rhinosinusitis, urticaria, polyps, nasal mucosa, bronchial asthma);
period after coronary artery bypass grafting;
hematopoietic disorders, and coagulation;
severe hepatic impairment or active liver disease;
renal failure, progressive renal disease;
confirmed hyperkalemia;
pregnancy;
Lactation (breastfeeding);
childhood and adolescence to 18 years;
hypersensitivity to the drug.
Precautions should be used in the preparation for liver, kidney and gastrointestinal tract in the history of, bronchial asthma, hypertension, lowering the bcc (including immediately after major surgery), ischemic heart disease, chronic kidney, liver and heart failure with CC <60 ml / min, the instructions in the history of the development of gastrointestinal ulceration, the presence of infection Helicobacter pylory, in cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial disease, in elderly patients, chronic administration of NSAIDs, with severe somatic diseases in smokers in chronic alcoholism.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation. Clinical data on the use Aertala during pregnancy are not available. Regular use of NSAIDs in the III trimester of pregnancy may reduce the tone and weaker contractions of the uterus.
The use of NSAIDs can lead to premature closure botallova flow in the fetus and possibly to prolonged pulmonary hypertension of the newborn, delayed onset of labor and increase the duration of labor. In epidemiological studies in humans have been received data indicating embryotoxicity NSAIDs. However, experimental studies on rabbits when administered aceclofenac (10 mg / kg / day) in some cases, morphological changes were observed in the fetus. Data on the presence of teratogenic effects in rats are absent.
Data on the allocation of aceclofenac with breast milk in humans. In experimental studies, the introduction of radioactive 14C-aceclofenac lactating rats a significant transfer of radioactivity in milk were observed.
Use in hepatic dysfunction
With great care should be given to patients with liver disease. Keep in mind that in patients with liver failure may change the kinetics and metabolism of the drug. The drug is contraindicated in severe hepatic impairment or active liver disease.
Use in renal impairment
With great care should be given to patients with kidney disease with chronic renal failure. The drug is contraindicated in severe renal failure, progressive kidney disease, confirmed by hyperkalemia.
Cautions
Because of the important role of prostaglandins in maintaining renal blood flow should be particularly careful when assigning patients with cardiac or renal failure, advanced age, taking diuretics, and patients with lower BCC (for example, after extensive surgery). If in such cases, appoint aceclofenac, it is recommended to monitor kidney function.
In patients with liver failure kinetics and metabolism differ from similar processes in patients with normal liver function. To reduce the risk of adverse effects on the gastrointestinal tract should use the minimum effective dose is minimal, short-course.
Monitoring of laboratory parameters
During the period of drug treatment should be systematic monitoring of peripheral blood picture, liver function, kidney disease, a study of feces for the presence of blood.
Effects on ability to drive vehicles and management mechanisms
Patients taking the drug, you must refrain from activities requiring a high concentration of attention and quickness of psychomotor reactions.
Overdose
Symptoms: The clinical picture is determined disorders of the central nervous system (including headache, dizziness, hyperventilation phenomenon with increased convulsive readiness) and the digestive system (including abdominal pain, nausea, vomiting).
Treatment: gastric lavage, ingestion of activated charcoal, symptomatic therapy. A specific antidote does not exist. Forced diuresis, hemodialysis ineffective.
Drug Interactions
In an application with Aertalom may increase the plasma concentrations of digoxin, phenytoin and lithium.
In an application with Aertalom may decrease the effectiveness of diuretics and antihypertensive drugs.
With the simultaneous reception Aertala and SCS or other NSAIDs increases the risk of side effects the digestive system. With the simultaneous reception Aertala and selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) increases the risk of bleeding from the gastrointestinal tract.
In an application with acetylsalicylic acid may reduce the concentration of aceclofenac in plasma.
Simultaneous reception Aertala may increase nephrotoxicity of cyclosporine.
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