Aceclagin
Aceklagin: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Aceclagin
ATX code: M01AB16
Active ingredient: aceclofenac (Aceclofenac)
Manufacturer: Korea United Pharm. Inc. (Korea United Pharm. Inc.) (Republic of Korea)
Description and photo update: 2020-28-05
Prices in pharmacies: from 200 rubles.
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Aceclagin is a drug of anti-inflammatory, analgesic and antipyretic action.
Release form and composition
The drug is produced in the form of tablets with a modified release, film-coated: white or almost white, biconvex, oblong, UT engraved on one side, CL CR on the other (10 pcs. In a blister, in a cardboard box 1, 3 or 10 blisters and instructions for use of Aceklagin).
1 tablet contains:
- active substance: aceclofenac - 200 mg;
- additional substances: croscarmellose sodium, microcrystalline cellulose, sodium stearyl fumarate, hypromellose, povidone-K30, carbomer 941, poloxamer 407;
- film casing: Opadry white OY-C-7000A [ethylcellulose 10cP, titanium dioxide (E171), hypromellose 5cP (E464), diethyl phthalate].
Pharmacological properties
Pharmacodynamics
Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic and antipyretic effects. The active substance inhibits the production of prostaglandins (Pg) and, as a result, affects the pathogenesis of inflammation, the occurrence of pain and fever. Against the background of rheumatic lesions, due to analgesic and anti-inflammatory efficacy, taking the drug significantly reduces the severity of pain syndrome, weakens morning stiffness and reduces swelling of the joints, which helps to improve the functional state of the patient.
Pharmacokinetics
After oral administration, Aceclagin is intensively absorbed. The maximum concentration of the active substance (C max) in the blood plasma is observed after 1.25–3 hours. Food intake inhibits the absorption of the drug, but does not affect its degree.
Aceclofenac is characterized by a high degree of binding to plasma proteins (more than 99.7%), the volume of distribution is 30 liters. The active substance is detected in the synovial fluid at a concentration reaching 60% of that in blood plasma.
Presumably, the metabolic transformation of the drug occurs with the participation of the isoenzyme CYP2C9, as a result of which the metabolite 4-OH-aceclofenac is formed. Numerous aceclofenac derivatives include diclofenac and 4-OH-diclofenac.
When using modified-release tablets, the average half-life (T 1/2) is approximately 5 hours, and the clearance is 5 l / h. About of the dose taken is excreted by the kidneys, mainly in the form of conjugated hydroxymetabolites. After oral administration, only 1% of the dose is excreted unchanged.
Indications for use
Taking Aceklagin is indicated for the following diseases / conditions:
- rheumatic lesions of soft tissues, periarthritis of the shoulder scapula, lumbago, toothache (in order to relieve inflammation and pain syndrome);
- rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (for symptomatic treatment);
- dysmenorrhea.
Aceclagin is used for symptomatic therapy, relieving inflammation and pain at the time of use, it does not affect the progression of the disease.
Contraindications
Absolute:
- disorders of coagulation and hematopoiesis;
- diagnosed / suspected gastrointestinal bleeding;
- phase of exacerbation of erosive and ulcerative lesions of the gastrointestinal tract (GIT), including Crohn's disease, ulcerative colitis;
- active stage of liver disease or severe liver failure;
- progressive kidney damage, severe renal failure, with creatinine clearance (CC) less than 30 ml / min; confirmed hyperkalemia;
- the period after the operation of coronary artery bypass grafting;
- severe heart failure II – IV class according to the classification of the New York Heart Association (NYHA) and coronary heart disease (IHD), lesions of the arteries of the brain and / or peripheral arteries;
- a history of urticaria, rhinitis or bronchospasm after using acetylsalicylic acid (ASA) or other NSAIDs (complete / partial ASA intolerance syndrome - urticaria, polyps of the nasal mucosa, rhinosinusitis, bronchial asthma);
- age up to 18 years;
- pregnancy and lactation;
- hypersensitivity to any component of the drug.
Relative (take Aceklagin should be under medical supervision):
- chronic hepatic, renal and heart failure;
- Ischemic heart disease, arterial hypertension;
- a decrease in the volume of circulating blood (BCC), including after extensive surgical interventions;
- presence of Helicobacter pylori infection;
- a history of indications of diseases of the kidneys, liver and gastrointestinal tract (including ulcerative gastrointestinal defects);
- CC below 60 ml / min;
- bronchial asthma (due to the risk of sudden bronchospasm);
- diabetes;
- dyslipidemia / hyperlipidemia;
- severe somatic diseases;
- long-term use of NSAIDs;
- elderly age;
- alcoholism and smoking.
Aceklagin, instructions for use: method and dosage
Aceclagin is taken orally. The tablet is swallowed whole and washed down with water in sufficient quantity.
The recommended dose for adult patients is 200 mg (1 tablet) once a day.
Side effects
Undesirable effects of Aceclagin recorded during clinical trials and post-marketing surveillance:
- cardiovascular system (CVS): rarely - worsening of the course of arterial hypertension, increased blood pressure (BP), heart failure; extremely rare - palpitations, flushing of the skin, a short sensation of heat with increased sweating, vasculitis;
- immune system: rarely - hypersensitivity, anaphylactic reactions, including shock;
- blood and lymphatic system: rarely - anemia; extremely rare - thrombocytopenia, hemolytic anemia, neutropenia, bone marrow suppression, granulocytopenia;
- metabolism and nutrition: extremely rare - weight gain, hyperkalemia;
- organ of hearing and labyrinthine disorders: very rarely - tinnitus, vertigo;
- organ of vision: rarely - visual impairment;
- nervous system: often - dizziness; extremely rare - dysgeusia (taste perversion), drowsiness, headache, tremor, paresthesia;
- psyche: extremely rarely - insomnia, atypical dreams, depression;
- liver and biliary tract: often - increased activity of liver enzymes; extremely rarely - an increase in the activity of alkaline phosphatase, liver damage (including hepatitis);
- kidneys and urinary tract: infrequently - an increase in serum levels of urea and creatinine in the blood; extremely rare - renal failure, nephrotic syndrome;
- digestive system: often - abdominal pain, dyspepsia, nausea, diarrhea; infrequently - vomiting, constipation, flatulence, ulceration of the oral mucosa, gastritis; rarely - ulceration of the gastrointestinal tract mucosa, melena, hemorrhages of the gastrointestinal tract, hemorrhagic diarrhea; extremely rare - stomatitis, intestinal perforation, vomiting of blood, pancreatitis, worsening Crohn's disease and ulcerative colitis;
- respiratory system, mediastinal and chest organs: rarely - shortness of breath; extremely rare - bronchospasm;
- skin and subcutaneous tissue: infrequently - urticaria, rash, itching, dermatitis; rarely - angioedema; extremely rare - eczema, purpura, severe skin reactions and reactions of mucous membranes (including toxic epidermal necrolysis), Stevens-Johnson syndrome; in some cases, when using NSAIDs during the period of chickenpox lesions - serious infections of the skin and soft tissues (with chickenpox, you should avoid taking Aceklagin);
- systemic disorders and complications at the injection site: extremely rarely - increased fatigue, edema, muscle spasms of the lower extremities.
Overdose
There are no reports of an overdose of aceklagin in humans.
Possible symptoms of overdose may include headache, dizziness, hyperventilation with increased convulsive readiness, pain in the stomach, nausea, vomiting.
In this condition, gastric lavage, intake of activated charcoal and symptomatic treatment are prescribed. Hemodialysis and forced diuresis are not effective enough to remove aceclofenac from the body.
special instructions
In order to minimize adverse reactions, Aceclagin should be taken at the lowest effective dose for the minimum short course necessary to control symptoms.
Ulcers, bleeding, perforation of the gastrointestinal tract with a fatal outcome were recorded with the use of any NSAID, both with the appearance of the corresponding symptoms and a history of severe lesions of the gastrointestinal tract, and without them. With an increase in the dose, the threat of adverse events from the gastrointestinal tract is aggravated in patients with a history of peptic ulcer disease, especially if it was complicated by bleeding / perforation, as well as in the elderly. Patients from this risk group should use aceclofenac in the minimum effective dose. If such patients need to take ASA in low doses or other drugs that negatively affect the state of the gastrointestinal tract, it is necessary to decide whether to carry out combined treatment with protective drugs, including proton pump inhibitors or misoprostol.
Since the use of NSAIDs can provoke fluid retention and the development of edema, patients with arterial hypertension and / or mild to moderate congestive heart failure should be monitored accordingly. In structure, aceclofenac is close to diclofenac and has a similar metabolism. The available data indicate that the threat of thromboembolic complications, such as myocardial infarction or stroke, is aggravated against the background of long-term use of high doses of diclofenac. There is also an increased risk of acute coronary syndrome associated with aceclofenac therapy.
Patients with NYHA class I chronic heart failure or with arterial hypertension, diabetes mellitus, hyperlipidemia or other risk factors for CVS complications (including smoking) should start taking aceclofenac only on the recommendation of a physician after a thorough assessment of the benefit / risk ratio.
The use of NSAIDs can lead to a decrease in Pg production and the appearance of acute renal failure. The important role of Pg in ensuring renal blood flow should be taken into account when prescribing Aceclagin to patients with functional disorders of the heart, liver, kidneys, or after surgery, as well as in elderly patients and / or receiving diuretics. Such patients need to use the drug under regular monitoring of renal performance indicators. It is required to take Aceclagin with extreme caution in persons with impaired liver and / or kidney function of mild / moderate severity, or with other conditions that may contribute to the accumulation of excess fluid in the body, due to the possible aggravation of renal failure and the appearance of fluid retention. Patients receiving diuretics also need to be monitored.or with an increased risk of hypovolemia. Adverse renal reactions usually resolve after drug withdrawal.
In the event that the changes in liver function tests persist or worsen, symptoms or clinical signs of liver damage occur, or such responses to the drug as skin rash, eosinophilia, therapy with aceclagin should be discontinued. The development of hepatitis is possible without prodromal symptoms. In the presence of hepatic porphyria, taking the drug can cause an attack.
If long-term use of NSAIDs is necessary, patients should be closely monitored, including blood tests and functional renal and hepatic tests.
Influence on the ability to drive vehicles and complex mechanisms
During the period of therapy, it is recommended to refrain from driving vehicles and controlling other complex mechanisms, since Aceclagin can lead to dizziness or other undesirable effects on the part of the nervous system.
Application during pregnancy and lactation
Aceklagin is contraindicated in pregnant women. There is no information on taking the drug during pregnancy.
Suppression of Pg production can adversely affect pregnancy and / or embryo / fetal development. Since all blockers of Pg synthesis have cardiopulmonary toxicity, during the third trimester of pregnancy, taking the drug can provoke premature closure of the Botallov duct with the development of pulmonary hypertension, as well as functional impairment of the fetal kidneys, which can worsen to renal failure in combination with polyhydramnios. Aceclagin, by inhibiting uterine contractions, can lead to prolonged labor or delayed labor. In late pregnancy, even when the drug is used in very small doses, it can affect the duration of bleeding as a result of the antiplatelet effect.
Aceklagin is contraindicated to be taken during breastfeeding, since there is no data on its excretion in human milk.
NSAIDs can affect fertility and are therefore not recommended for use in women planning a pregnancy.
Pediatric use
Aceclagin 200 mg tablets are not prescribed for patients under 18 years of age.
With impaired renal function
With progressive kidney disease or severe renal failure (CC below 30 ml / min), treatment with aceclofenac is contraindicated.
Caution is required to take Aceclagin in patients with chronic renal failure (CC 30-60 ml / min) or with a history of kidney disease.
For violations of liver function
In patients with liver disease in the active phase or in severely impaired liver function, drug therapy is contraindicated.
It is recommended to use Aceclagin with caution in persons with chronic hepatic insufficiency or with a history of liver disease.
Use in the elderly
In elderly patients, while taking NSAIDs, compared with young patients, undesirable effects are more often observed, especially gastrointestinal perforation and bleeding, which can be fatal. Elderly people are also more likely to be affected by liver, kidney or cardiovascular damage. Aceclagin should be taken with extreme caution in patients of this age group.
Drug interactions
Interaction studies of aceclofenac with other medicinal substances / drugs, with the exception of warfarin, have not been performed.
Since the isoenzyme CYP2C9 is responsible for the metabolism of aceclofenac, according to in vitro data, the drug can be an inhibitor of this enzyme. There is a possibility of pharmacokinetic interaction with the combined use of the drug with the following drugs: amiodarone tolbutamide, sulfafenazole, miconazole, phenytoin, cimetidine, phenylbutazone. It is possible to interact with drugs that are excreted from the body through active renal secretion - methotrexate, lithium preparations. There is also a risk of displacement interactions with other protein-binding agents, since the association of aceclofenac with plasma albumin is almost 100%.
Possible interaction reactions, according to available information on other NSAIDs:
- ticlopidine, oral anticoagulants of the coumarin group, thrombolytics: the effect of these drugs increases and the risk of gastrointestinal bleeding increases, since NSAIDs suppress platelet aggregation and lead to damage to the gastrointestinal mucosa; if necessary, these combinations require careful monitoring of the patient's condition;
- digoxin, lithium preparations: there is an inhibition of the renal clearance of these drugs and, as a result, an increase in their serum level in the blood; these combinations should be avoided, and if necessary, ensure frequent monitoring of serum lithium and digoxin levels;
- ASA or other NSAIDs: there is an increase in the incidence of undesirable effects, because of this, one should beware of the simultaneous use of Aceclagine and other NSAIDs, including selective inhibitors of cyclooxygenase-2 (COX-2);
- selective serotonin reuptake inhibitors (SSRIs), antiplatelet agents: the threat of gastrointestinal bleeding is aggravated;
- methotrexate: suppression of tubular secretion of this substance is recorded, it is also possible to develop a small metabolic interaction, which causes a decrease in the clearance of methotrexate, when using the latter in high doses, NSAIDs should be avoided;
- tacrolimus, cyclosporine: the threat of increased nephrotoxicity is aggravated due to a decrease in the formation of renal prostacyclin; requires careful monitoring of indicators of renal function;
- glucocorticosteroids (GCS): the risk of ulcers or gastrointestinal bleeding increases;
- diuretics: the activity of these drugs is suppressed;
- thiazides, bumetanide, furosemide: the diuretic effect of bumetanide and furosemide decreases, as well as the hypotensive effect of thiazide diuretics;
- potassium-sparing diuretics: an increase in serum potassium concentration may be recorded, so it is necessary to monitor its level in the blood;
- bendrofluazide: the effect of aceclofenac on blood pressure control is not observed, and possible interaction with other diuretics cannot be ruled out;
- antihypertensive drugs: there may be a weakening of their action;
- inhibitors of angiotensin II receptor antagonists or angiotensin-converting enzyme (ACE): the threat of renal dysfunction is aggravated; against the background of dehydration or in the elderly, the risk of acute renal failure (reversible) increases; when these funds are used together with aceclofenac, it is required to control the activity of the kidneys, as well as ensure the intake of a sufficient amount of fluid;
- zidovudine: the likelihood of hematological toxicity increases; in patients with human immunodeficiency virus (HIV-positive) and hemophilia, using zidovudine and ibuprofen, there may be an increased risk of developing hemarthrosis and hematomas;
- hypoglycemic agents: the clinical effect of these funds, according to research results, does not undergo changes when combined with diclofenac, however, the latter sometimes has hypo- and hyperglycemic effects; during therapy with aceclofenac, the dosage of drugs that can cause hypoglycemia should be adjusted.
Analogs
The analogs of Aceklofenac are Aceclofenac, Alental, Aceclofenac Velpharm, Asinak, Aertal, etc.
Terms and conditions of storage
Store out of the reach of children, at a temperature not exceeding 30 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Aceklagin
According to the few reviews about Aceclagin, left by patients on specialized sites, it effectively relieves pain and reduces inflammation during symptomatic therapy of rheumatic diseases and degenerative-dystrophic lesions of the joints. At the same time, the drug, like other NSAIDs, has a large number of side effects, especially from the digestive system.
Price for Aceklagin in pharmacies
The price for Aceklagin 200 mg can be 250-290 rubles. for 10 pcs. in the package and 600-750 rubles. - for 30 film-coated tablets with modified release.
Aceklagin: prices in online pharmacies
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Drug name Price Pharmacy |
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Aceklagin 200 mg film-coated tablets 10 pcs. RUB 200 Buy |
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Aceclagin 200 mg film-coated tablets 30 pcs. RUB 400 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
