AERTAL
Active material: aceclofenac
When ATH: M01AB16
CCF: NSAIDs
ICD-10 codes (testimony): M05, M15, M45, M79
When CSF: 05.01.01.03.01
Manufacturer: PRODESPHARMA ROYAL S.A. (Spain)
DOSAGE FORM, COMPOSITION AND PACKAGING
Pills, Film-coated white, round, lenticular, on one side is engraved with the letter “A”.
| 1 tab. | |
| aceclofenac | 100 mg |
Excipients: microcrystalline cellulose (Avizel pH 101 and Avizel pH 102), povidone (polyvinylpyrrolidone), glyceryl palmitostearate, Croscarmellose sodium.
The composition of the shell: sepifilm 752 white (gipromelloza, microcrystalline cellulose, makrogola-40-stearate (polyoxyl-40-stearate), Titanium dioxide).
10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
10 PC. – blisters (4) – packs cardboard.
10 PC. – blisters (6) – packs cardboard.
10 PC. – blisters (9) – packs cardboard.
Pharmacological action
NSAIDs. Anti-inflammatory, analgesic and antipyretic effect. Inhibits the synthesis of prostaglandins and thereby affect the pathogenesis of inflammation, pain and fever.
Rheumatic diseases of aceclofenac contributes significantly to reduce the severity of pain, morning stiffness, swelling of joints, that improves the functional condition of the patient.
Pharmacokinetics
Absorption
Quickly and completely absorbed after administration inwards. Cmax in the plasma after oral administration is achieved through 1.25-3 no.
Distribution
Linking albuminami plasma on 99%.
It penetrates into synovial fluid, where its concentration reaches 57% the level of concentration in the plasma and Cmax achieved at 2-4 hours later, than in blood plasma. Vd – 25 l.
Metabolism
Metabolizmu marginally. Its main metabolite, detected in plasma, is 4′-gidroksiaceklofenak.
Deduction
T1/2 – 4 no. Report kidneys were in the form of the hydroxy derivatives (about 2/3 of the administered dose).
Testimony
-symptomatic treatment of rheumatoid arthritis;
-symptomatic treatment of osteoarthritis;
-symptomatic treatment of ankylosing spondylitis;
-rheumatic defeated soft tissues, accompanied by pain.
Dosage regimen
Adults appointed interior 100 mg (1 tab.) 2 times / day, morning and evening.
The tablets should be swallowed whole, drinking plenty of fluids.
Side effect
From the digestive system: nausea, vomiting, diarrhea, pain in the epigastria, kišečnaâ how, dyspepsia, flatulence, anorexia, constipation, transient increase in liver transaminases; rarely – erosive and ulcerative lesions, bleeding or perforation of the gastrointestinal tract (gematjemezis, ground), stomatitis (incl. aphthous), pancreatitis, hepatitis; in some cases – ful'minantnyj hepatitis.
From the central and peripheral nervous system: possible headache, dizziness, sleep disorders (insomnia or drowsiness), excitation; in some cases – sensory disturbances, disorientation, memory impairment, of view, hearing, sense of taste, noise in ears, convulsions, irritability, tremor, depression, anxiety, aseptic meningitis, paraesthesia.
Allergic reactions: possible skin rash; rarely – hives, bronchospasm, systemic anaphylactic reactions; in some cases – eczema, erythema multiforme, erythroderma, vasculitis, pneumonitis, Stevens-Johnson syndrome, Lyell's syndrome.
From the urinary system: rarely – peripheral edema; in some cases – acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria.
From the hematopoietic system: leukopenia; in some cases – thrombocytopenia, agranulocytosis, gemoliticheskaya anemia, aplasticheskaya anemia.
Cardio-vascular system: in a few cases – tachycardia, arterial hypertension, congestive heart failure, CHD.
Contraindications
- Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
-gastrointestinal bleeding or suspicion on him;
- Indicate a history of bronchospasm, krapivnicu, rhinitis after taking acetylsalicylic acid or other NSAIDS (complete or partial syndrome of intolerance to acetylsalicylic acid – rinosinusit, hives, polyps of the nasal mucosa, bronchial asthma);
— Since the aorto-coronary bypass surgery;
— violation of blood and coagulation;
- Severe hepatic impairment or active liver disease;
- Severe renal insufficiency, progressive kidney disease;
- Confirmed hyperkalemia;
- Pregnancy;
- Lactation (breast-feeding);
- Childhood and adolescence up 18 years;
- Hypersensitivity to the drug.
FROM caution the drug should be used in liver diseases, Kidney and BLOOD disorder, asthma, hypertension, reduction of BCC (incl. immediately after extensive surgeries), CHD, chronic renal, liver and heart failure, at CC<60 ml / min, guidance on the development history of ulcerative shock syndrome, presence of Helicobacter pylori infection, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes, Peripheral arterial disease, in elderly patients, in the long admission NPVS, with severe somatic diseases, Smokers, chronic alcoholism.
Pregnancy and lactation
The drug is contraindicated in pregnancy and during breastfeeding.
Clinical data on the use of Ajertala during pregnancy are not available. Regular use of NSAIDS in the third trimester of pregnancy may reduce tone and weaker contractions of the uterus. The use of NSAIDS may cause premature closure of the fetal ductus botallo's and, perhaps, to long-term pulmonary hypertension in the newborn, delay the onset of labour and increase the duration of labour.
In epidemiological studies in humans have not received data, embryo toxicity indicate NSAIDS. However, in the experimental studies in rabbits with the introduction of aceclofenac (10 mg / kg / day) in some cases, the observed morphological changes in fetuses. Evidence of teratogenic effects in rats are missing.
Data about the allocation of aceclofenac in breast milk in humans are missing. IN experimental studies with the introduction of radioactive 14P-aceclofenac in lactating rats notable transfer of radioactivity in milk were observed.
Cautions
Due to the important role of prostaglandins in maintaining renal blood flow should be particularly careful in the appointment of patients with cardiac or renal insufficiency, Seniors, taking diuretics, and patients, with reduced BCC (eg, After extensive surgery). If in such cases appoint aceclofenac, It is recommended to monitor kidney function.
In patients with hepatic insufficiency kinetics and metabolism is different from similar processes in patients with normal liver function.
To reduce the risk of adverse events from the stomach, you should use the minimum effective dose as possible short course.
Monitoring of laboratory parameters
During drug treatment should conduct systematic monitoring picture peripheral blood, liver function, kidney, study of fecal blood.
Effects on ability to drive vehicles and management mechanisms
Patients, receiving the drug, You must refrain from activities, require high concentration and speed of psychomotor reactions.
Overdose
Symptoms: the clinical picture is determined by the violations of the central nervous system (incl. headache, dizziness, phenomena of hyperventilation with high sudorojna readily) and digestive system (incl. stomach ache, nausea, vomiting).
Treatment: gastric lavage, ingestion of activated carbon, simptomaticheskaya therapy. There is no specific antidote. Forced diuresis, hemodialysis maloeffyektivny.
Drug Interactions
Together with the application Ajertalom may increase plasma concentrations of Digoxin, phenytoin, lithium.
Together with the application Ajertalom may reduce the effectiveness of dioretikov and antigipertenziveh funds.
Together admission Ajertala and GKS or other NSAIDS increases the risk of side effects from the digestive system.
Together admission Ajertala and selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline) increases the risk of bleeding from the stomach.
If you are applying with acetylsalicylic acid may reduce concentration in the blood plasma of aceclofenac.
Simultaneous reception Ajertala can improve nefrotoksicescoe effects of Cyclosporine.
Amid simultaneous reception Ajertala and hypoglycemic drugs may develop as Hypo-, and hyperglycemia (requires monitoring of blood glucose).
Simultaneous application of kalisberegath dioretikov and Ajertala could lead to an increase in the level of potassium in the blood and to the development of hyperkalemia.
Reception Ajertala during 24 hours before or after methotrexate may increase methotrexate concentration in plasma and to enhance its toxicity.
Together with the use of antiplatelet agents and anticoagulants increases the risk of bleeding (requires regular monitoring of blood clotting).
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 4 year.
