Aceclofenac
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Prices in online pharmacies:
from 119 rubles.
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Aceclofenac is a drug with analgesic, anti-inflammatory and antipyretic effects.
Release form and composition
Aceclofenac dosage form - film-coated tablets: biconvex, white or almost white; on a cross-section - an almost white or white core (10 or 20 pcs. in blisters, 1-4, 6, 9, 10 packs in a cardboard box; 10, 20 30, 40, 60, 90, 100 or 200 pcs. in polymer jars, 1 jar in a cardboard box).
Composition of 1 tablet:
- active substance: aceclofenac - 100 mg;
- additional components: microcrystalline cellulose - 85 mg; lactose monohydrate (milk sugar) - 91 mg; calcium stearate - 3 mg; talc - 9 mg; colloidal silicon dioxide (aerosil) - 1.5 mg; croscarmellose sodium (primellose) - 10.5 mg;
- shell: hypromellose (hydroxypropyl methylcellulose) - 6.4 mg; titanium dioxide (titanium dioxide) - 1.1 mg; macrogol-4000 (polyethylene oxide-4000) - 2.5 mg.
Indications for use
- rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (symptomatic therapy);
- lumbago, toothache, periarthritis of the shoulder scapula, rheumatic lesions of soft tissues (to relieve inflammation and pain).
Aceclofenac has no effect on the progression of the disease.
Contraindications
Absolute:
- lactose intolerance, lactose deficiency, glucose-galactose malabsorption;
- period of exacerbations of erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, or if they are suspected;
- disorders of hematopoiesis and coagulation;
- exacerbation of inflammatory bowel diseases (Crohn's disease, ulcerative colitis);
- a combination (complete or partial) of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses with intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a burdened history);
- period after coronary artery bypass grafting;
- severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, hyperkalemia;
- active liver disease or severe liver failure;
- decompensated heart failure;
- pregnancy and the period of breastfeeding;
- age up to 18 years;
- hypersensitivity to the components of the drug.
Relative (Aceclofenac is prescribed with caution in the presence of the following diseases / conditions):
- history of liver disease, gastrointestinal tract and kidney disease;
- bronchial asthma;
- arterial hypertension;
- cardiac ischemia;
- a decrease in the volume of circulating blood (including after surgery);
- mild and moderate chronic renal failure (creatinine clearance 30-60 ml / min);
- mild to moderate liver failure;
- chronic heart failure;
- cerebrovascular diseases;
- hyperlipidemia / dyslipidemia;
- diabetes;
- peripheral arterial disease;
- frequent alcohol consumption;
- smoking;
- long-term use of non-steroidal anti-inflammatory drugs in history;
- combined use with anticoagulants, antiplatelet agents, oral glucocorticosteroids, selective serotonin reuptake inhibitors;
- presence of Helicobacter pylori infection;
- elderly age.
Method of administration and dosage
Aceclofenac is taken orally with a sufficient amount of liquid.
It is advisable to take the lowest effective dose in a minimally short course.
As a rule, 2 tablets are prescribed per day - in the morning and evening. The duration of the use of Aceclofenac is determined by the doctor individually.
For moderate hepatic insufficiency, the dose is reduced to 100 mg per day.
Side effects
Most often, while taking Aceclofenac, the development of the following disorders is noted: abdominal pain, dyspepsia, diarrhea, nausea, dizziness, rash, itching, changes in the concentration of blood creatinine and the activity of liver enzymes.
Possible side reactions (> 1/100 to 1/1000 to 1/10 000 to <1/1000 - rare; <1/10 000 - very rare):
- digestive system: often - diarrhea, dyspepsia, nausea, abdominal pain; infrequently - ulceration of the oral mucosa, flatulence, constipation, gastritis, vomiting; rarely - bloody diarrhea, melena, ulceration of the gastrointestinal tract, gastrointestinal bleeding; very rarely - stomach ulcer, vomiting of blood, stomatitis, perforation of the small intestine, pancreatitis, worsening of Crohn's disease and ulcerative colitis;
- nervous system: often - dizziness; very rarely - drowsiness, paresthesia, increased fatigue, tremor, headache, dysgeusia;
- cardiovascular system: rarely - heart failure, increased blood pressure; very rarely - hot flashes, tachycardia, vasculitis;
- hematopoietic system: aplastic anemia, thrombocytopenia, agranulocytosis, leukopenia;
- lymphatic system and blood: rarely - anemia; very rarely - neutropenia, bone marrow suppression, granulocytopenia, hemolytic anemia;
- immune system: rarely - hypersensitivity, anaphylactic reaction (including shock);
- respiratory system, mediastinal and chest organs: rarely - shortness of breath; very rarely - bronchospasm;
- allergic reactions: erythroderma, skin rash, eczema, urticaria, bronchial asthma, systemic anaphylactoid reactions; in some cases - pneumonitis, vasculitis, toxic epidermal necrolysis (Lyell's syndrome), polymorphic exudative erythema (including Stevens-Johnson syndrome);
- urinary tract and kidneys: infrequently - an increase in the concentration of urea and blood creatinine; very rarely - nephrotic syndrome, interstitial nephritis, renal failure;
- liver and biliary tract: often - an increase in the activity of liver enzymes; very rarely - an increase in blood alkaline phosphatase activity, liver damage (including hepatitis);
- organ of sight and hearing: rarely - visual impairment; very rarely - ringing in the ears, vertigo;
- skin and subcutaneous tissue: infrequently - rash, itching, dermatitis, urticaria rash; rarely - angioedema; very rarely - bullous skin reactions, reactions of the mucous membranes and skin, purpura;
- metabolism and nutrition: very rarely - weight gain, hyperkalemia;
- psyche: very rarely - atypical dreams, depression, insomnia;
- systemic side effects: very rarely - muscle spasms of the lower extremities.
special instructions
To reduce the severity of adverse reactions, you can reduce the effective dose required to control symptoms.
Since there are reports of fluid retention and edema, with a history of arterial hypertension and / or chronic heart failure of NYHA functional class I-II, prior to using Aceclofenac, it is necessary to consult a specialist and exercise appropriate control during therapy. There is an assumption that long-term therapy with certain non-steroidal anti-inflammatory drugs in high doses increases the likelihood of arterial thrombosis.
With uncontrolled arterial hypertension, congestive heart failure, coronary heart disease, peripheral arterial pathologies and / or cerebrovascular diseases, Aceclofenac can be taken only after a thorough assessment of the clinical situation. Also, care must be taken when prescribing therapy to patients at risk of cardiovascular diseases (for example, with arterial hypertension, hyperlipidemia, diabetes mellitus, as well as smoking patients).
It should be borne in mind that the use of the drug can lead to the development of reversible inhibition of platelet aggregation.
Patients with blood clotting disorders, diseases of the gastrointestinal tract, a history of peptic ulcers, porphyria, systemic lupus erythematosus, disorders of the hematopoietic system and after acute cerebrovascular accident should be treated with Aceclofenac under close medical supervision.
Due to the likelihood of deterioration of renal excretion and the occurrence of edema, the drug should be taken with caution in renal, hepatic, heart failure, as well as in the presence of other diseases that predispose to the development of edema. Also, patients with an increased risk of hypovolemia and taking diuretics need the careful prescription of Aceclofenac.
In elderly patients, adverse reactions develop more often, especially from the kidneys, liver, cardiovascular system.
To reduce the likelihood of side effects during long-term therapy, it is recommended to conduct monitoring, including biochemical and general blood tests, general urine analysis.
The combined use of Aceclofenac with any drugs that suppress the synthesis of prostaglandin / cyclooxygenase is not recommended for women planning a pregnancy (due to the likelihood of reduced fertility). Women with a history of infertility should not take the drug.
During the period of therapy, when driving vehicles and performing other potentially dangerous types of work that require the patient to have an increased concentration of attention and quick psychomotor reactions, care must be taken.
Drug interactions
Studies of drug interactions of Aceclofenac with drugs / substances other than warfarin have not been conducted.
There is a possibility of pharmacokinetic interaction with drugs such as phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole, as well as drugs whose metabolism occurs in the liver (lithium drugs, methotrexate).
It is necessary to take into account the likelihood of replacing Aceclofenac with other drugs that strongly bind to plasma proteins.
Contraindicated combinations (based on information obtained from other non-steroidal anti-inflammatory drugs):
- methotrexate (in doses of 20 mg / week): decrease in its clearance;
- lithium preparations: an increase in the concentration of lithium in the blood (combined use is allowed in cases where it is possible to regularly monitor the serum concentration of lithium);
- anticoagulants: increasing their activity and increasing the likelihood of bleeding from the mucous membrane of the gastrointestinal tract;
- oral anticoagulants of the coumarin group, ticlopidine, thrombolytics, heparin: the likelihood of developing an interaction (combined use is allowed in cases where it is possible to carry out regular monitoring of the condition).
Combined use requires caution and, probably, dose adjustment:
- methotrexate (especially with renal failure): an increase in its concentration and toxicity (it is necessary to monitor renal function);
- cyclosporine or tacrolimus: increased risk of nephrotoxicity (renal function must be monitored);
- acetylsalicylic acid: an increase in the incidence of adverse reactions;
- furosemide, bumetanide: decreased diuretic action;
- thiazide diuretics: reducing the hypotensive effect;
- potassium-sparing diuretics: increasing the concentration of potassium in the blood serum (it is necessary to control the potassium content in the blood);
- some drugs with antihypertensive effects: a decrease in their effectiveness;
- angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists: the development of renal failure is usually reversible, especially with impaired renal function (it is necessary to monitor kidney function and ensure that a sufficient amount of fluid is obtained with food);
- antihypertensive drugs (such as beta-blockers): the likelihood of affecting blood pressure.
Other likely interactions:
- drugs whose use can lead to the development of hypoglycemia: the development of hypoglycemia and hyperglycemia;
- digoxin, phenytoin, or lithium preparations: increasing their plasma concentration;
- potassium-sparing diuretics: development of hyperkalemia and hyperglycemia;
- diuretics and antihypertensive drugs: weakening their action;
- other nonsteroidal anti-inflammatory drugs or glucocorticosteroids: an increase in the likelihood of developing disorders of the digestive system;
- cyclosporine: increasing its toxic effect on the kidneys;
- selective serotonin reuptake inhibitors (fluoxetine, citalopram, sertraline, paroxetine): an increase in the likelihood of gastrointestinal bleeding;
- acetylsalicylic acid: a decrease in the concentration of aceclofenac in the blood;
- hypoglycemic agents: the development of hyper- and hypoglycemia (it is necessary to control the blood sugar content);
- zidovudine: increased likelihood of hematologic toxicity;
- antiplatelet agents and anticoagulants: an increase in the likelihood of bleeding (it is necessary to regularly monitor blood clotting indicators).
Terms and conditions of storage
Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.
Shelf life is 2 years.
Aceclofenac: prices in online pharmacies
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Drug name Price Pharmacy |
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Aceclofenac 100 mg film-coated tablets 20 pcs. 119 RUB Buy |
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Aceclofenac tablets pp 100mg 20pcs 134 r Buy |
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Aceclofenac 100 mg film-coated tablets 20 pcs. 135 RUB Buy |
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Aceclofenac tablets p.o. 100mg 20 pcs. RUB 186 Buy |
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Aceclofenac 100 mg film-coated tablets 20 pcs. 229 r Buy |
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Aceclofenac 100 mg film-coated tablets 60 pcs. 270 RUB Buy |
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Aceclofenac tablets p.p. 100mg 60pcs 271 r Buy |
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Aceclofenac 100 mg film-coated tablets 60 pcs. 329 r Buy |
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Aceclofenac tablets p.o. 100mg 30 pcs. 351 r Buy |
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Aceclofenac 100 mg film-coated tablets 30 pcs. 351 r Buy |
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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
