Aertal powder for suspension for oral administration 100mg in 3g bags №20

Name:
Aertal por. d / adj. susp. d / ingestion 100 mg in pack. 3g in a pack. №20
Description:
Powder of white or almost white color. The main active ingredient Aceclofenac Release form Powder Dosage 100 mg Pharmacological properties Pharmacodynamics Aceclofenac is a non-steroidal agent with anti-inflammatory and analgesic effects. It is believed that the mechanism of action of this drug is based on the inhibition of prostaglandin synthesis. Pharmacokinetics Absorption: After oral administration, aceclofenac is rapidly absorbed, its bioavailability is almost 100%. The maximum plasma concentration is reached approximately 1.25 to 3 hours after ingestion. Eating slows down absorption, but does not affect its extent. Distribution: Aceclofenac is highly bound to plasma proteins (>99.7%). Aceclofenac penetrates the synovial fluid, where its concentration reaches approximately 60% of its plasma concentration. The volume of distribution is approximately 30 liters. Withdrawal: The average elimination half-life is 4-4.3 hours. The clearance is 5 l/h. Approximately two-thirds of the dose taken is excreted in the urine, mostly in the form of conjugated hydroxy metabolites. Only 1% of a single oral dose is excreted unchanged. Aceclofenac is probably metabolized by CYP2C9 to the main metabolite 4-OH-aceclofenac, whose contribution to the clinical effect of the drug is likely to be minimal. Diclofenac and 4-OH-diclofenac have been found among many metabolites. Special populations: There are no differences in the pharmacokinetics of aceclofenac in elderly patients. A slower elimination of aceclofenac after a single dose of the drug was observed in patients with reduced liver function. In a multiple dose study at 100 mg once daily, no differences in pharmacokinetic parameters were observed between participants with mild to moderate liver cirrhosis and healthy volunteers. In patients with mild or moderate renal impairment, after a single dose of aceclofenac, there were no clinically significant differences in pharmacokinetic parameters. Indications for use In osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and other diseases of the musculoskeletal system, accompanied by pain (for example, humeroscapular periarthritis and other extra-articular manifestations of rheumatism). Symptomatic therapy of pain syndrome of various localization (back pain, toothache, primary dysmenorrhea). Route of administration and doses Undesirable effects can be minimized by reducing the duration of treatment necessary to control symptoms (see section “Precautions for use”). The contents of the sachets should be dissolved in 40-60 ml of water and taken orally immediately after preparation. Simultaneous ingestion of food slows down the rate of absorption of the active substance, but does not reduce the degree of absorption from the gastrointestinal tract. Adults: The recommended dose is 1 sachet 2 times a day (one in the morning and one in the evening). Children: There are no data on the efficacy and safety of taking the drug in children. Elderly: Usually there is no need to reduce the dose; however, the precautions indicated in the Precautions for Use section must be followed. Hepatic insufficiency: The dose of aceclofenac should be reduced in patients with mild or moderate liver disease. The recommended starting dose is 100 mg daily (see Precautions for Use). Renal insufficiency: There is no evidence of the need to reduce the dose of aceclofenac in patients with mild renal impairment, but caution should be exercised when using the drug Aertal® powder for oral suspension, 100 mg (see section “Precautions for use”) . Use during pregnancy and lactation Pregnancy There are no data on the use of aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and/or development of the embryo/fetus. Data from epidemiological studies indicate an increased risk of miscarriage, heart disease and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of heart disease increases from less than 1% to about 1.5%. The risk increases with increasing dose and duration of treatment. In animals, the use of prostaglandin synthesis inhibitors leads to pre- and post-implantation fetal death and embryonic and fetal mortality. In addition, there is an increased incidence of various malformations, including heart disease, in animals receiving prostaglandin synthesis inhibitors during organogenesis. During the first and second trimester of pregnancy, drugs containing aceclofenac are not prescribed unless absolutely necessary. If aceclofenac is being taken by a woman who is planning a pregnancy or is in the first or second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis: may affect the fetus, with cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); can affect the fetus, causing kidney dysfunction, which can lead to kidney failure and oligohydramnios. Mothers and newborns at the end of pregnancy: the drug may affect the duration of bleeding, due to the antiplatelet effect, which can develop even after the use of very low doses; the drug can inhibit uterine contractions, leading to delayed labor or prolonged labor. Thus, the use of aceclofenac is contraindicated in the third trimester of pregnancy (see sections “Contraindications” and “Precautions for use”). Lactation: There is no information on the penetration of aceclofenac into breast milk. In studies on rats, the penetration of a significant amount of radiolabeled 14C into milk was not detected. The decision to continue/stop breastfeeding or the use of aceclofenac should be made after evaluating the benefits of breastfeeding for the baby and the benefits of taking aceclofenac for the mother. The use of aceclofenac should be avoided during pregnancy and lactation, unless the potential benefit to the mother outweighs the possible risks to the fetus. Fertility: The use of Aertal®, as well as other cyclooxygenase/prostaglandin synthesis inhibitors, may reduce fertility and is not recommended for women planning children. Women who have difficulty conceiving or who are undergoing a fertility study should stop taking Aertal®. Precautions Avoid concomitant use of Aertal and other NSAIDs, including selective cyclooxygenase-2 inhibitors. Undesirable effects can be minimized by using the minimum effective dose and reducing the duration of treatment necessary to control symptoms (see section “Method of application and dose” and a description of the risks for the gastrointestinal tract and cardiovascular system below). Influence on the gastrointestinal tract Bleeding, ulceration or perforation of the gastrointestinal tract with a fatal outcome was observed with any NSAID during any period of treatment, both with dangerous symptoms and without them, both with a history of serious pathological conditions of the gastrointestinal tract, and without them . The risk of bleeding, ulceration and perforation of the gastrointestinal tract increases with an increase in the dose of NSAIDs in patients who have had an ulcer, especially if it was accompanied by hemorrhage or perforation (see section “Contraindications”), as well as in elderly patients. These patients should take the lowest effective dose of the drug. They need combination therapy with the use of protective drugs (for example, misoprostol, or proton pump inhibitors), and such therapy is also necessary for patients who take small doses of aspirin or other drugs that adversely affect the state of the gastrointestinal tract (see section “Interaction with other drugs). Patients with gastrointestinal disease, including the elderly, should report any unusual gastrointestinal symptoms (especially bleeding), including when first taking the drug. Particular caution should be observed in patients taking concomitant drugs that may increase the risk of bleeding or ulcers, such as systemic corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (such as acetylsalicylic acid) (see section “Interaction with other drugs). If bleeding or gastrointestinal ulcers occur in patients taking Aertal, treatment should be discontinued. Influence on the cardiovascular and central nervous system For patients with arterial hypertension and / or congestive heart failure of mild or moderate degree, appropriate monitoring and special instructions are necessary, since fluid retention and edema associated with NSAIDs have been reported. Clinical studies and epidemiological data show that the use of some NSAIDs (particularly at high doses and with long-term use) may slightly increase the risk of arterial thrombotic events (eg, myocardial infarction or stroke). There is no reliable data on the absence of this risk when taking aceclofenac. Patients with uncontrolled hypertension, heart failure (NYHA functional class I), congestive heart failure, cardiovascular risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, and smoking), and a history of cerebral hemorrhage , special care should be taken when taking aceclofenac. Aceclofenac should be taken with caution and under the supervision of a physician in patients with the following conditions, as there is a risk of exacerbation of the disease (see section “Side effect”): symptoms indicating the presence of a disease of the gastrointestinal tract, including its upper and lower sections; a history of ulcers, bleeding, or perforation of the gastrointestinal tract; ulcerative colitis; Crohn’s disease; bleeding tendency, SLE (systemic lupus erythematosus), porphyria, and disorders of hematopoiesis and hemostasis. Aceclofenac should be used with caution and under medical supervision in patients with a history of hemorrhagic stroke. Effects on the liver and kidneys Taking NSAIDs can cause a dose-dependent reduction in prostaglandin formation and sudden renal failure. The importance of prostaglandin to ensure renal blood flow should be considered when taking the drug in patients with impaired cardiac, renal or hepatic function, in patients receiving diuretics or in patients after surgery, as well as in elderly patients. Caution should be exercised when taking the drug in patients with mild or moderate hepatic and renal impairment, as well as in patients with other conditions predisposing to fluid retention in the body. In these patients, the use of NSAIDs can lead to impaired renal function and fluid retention. Caution should also be exercised when taking Aertal in patients taking diuretics or in individuals at increased risk of hypovolemia. The minimum effective dose and regular medical monitoring of kidney function are required. Renal side effects usually resolve after discontinuation of aceclofenac. Aceclofenac should be discontinued if changes in liver function tests persist or worsen, clinical signs or symptoms of liver disease develop, or other manifestations occur (eosinophilia, rash). Hepatitis can develop without prodromal symptoms. The use of NSAIDs in patients with hepatic porphyria may provoke an attack. Hypersensitivity and skin reactions As with other NSAIDs, the drug may cause allergic reactions, including anaphylactic/anaphylactoid reactions, even if the drug is taken for the first time. Severe skin reactions (some of which can be fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed very rarely after taking NSAIDs (see section “Side Effects”). The highest risk of these reactions in patients is observed at the beginning of taking the drug, and the development of these adverse reactions is observed during the first month of taking the drug. If a skin rash, lesions on the oral mucosa, or other signs of hypersensitivity occur, aceclofenac should be discontinued. In special cases, with chickenpox, complications can occur: serious infections of the skin and soft tissues. At present, the role of NSAIDs in worsening the course of these infections cannot be ruled out. Therefore, you should avoid taking Aertal, film-coated tablets, 100 mg for chicken pox. Hematological disorders Aceclofenac can cause reversible inhibition of platelet aggregation (see section “Interaction with other drugs”). Respiratory system disorders Caution should be exercised when taking the drug in patients with bronchial asthma at present or in history, since taking NSAIDs can provoke the development of sudden bronchospasm in such patients. Elderly Caution should be exercised when taking the drug in elderly patients, tk. they are more likely to experience side effects (especially bleeding and perforation of the gastrointestinal tract) when taking NSAIDs. Complications can lead to death. In addition, older patients are more likely to suffer from diseases of the kidneys, liver or cardiovascular system. Long-term use All patients receiving long-term treatment with non-steroidal anti-inflammatory drugs should be closely monitored (eg complete blood count, liver and kidney function tests). Interactions with other drugs No drug interaction studies have been conducted, with the exception of warfarin. Aceclofenac is metabolized by cytochrome P450 2C9, and in vitro data indicate that aceclofenac may be an inhibitor of this enzyme. Thus, the risk of pharmacokinetic interaction is possible when taken simultaneously with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfafenazole. As with other drugs in the NSAID group, the risk of pharmacokinetic interactions with other drugs that are excreted from the body by active renal excretion, such as methotrexate and lithium preparations, also increases. Aceclofenac is almost completely bound to plasma albumin and, therefore, there is the possibility of displacement-type interactions with other drugs that bind to proteins. Due to the lack of studies on the pharmacokinetic interaction of aceclofenac, the following information is based on data on other NSAIDs: Simultaneous use should be avoided: Methotrexate: NSAIDs inhibit tubular secretion of methotrexate; moreover, there may be a small metabolic interaction, which leads to a decrease in the clearance of methotrexate. Therefore, when using high doses of methotrexate, NSAIDs should be avoided. Lithium and digoxin: Some NSAIDs inhibit the renal clearance of lithium and digoxin, resulting in increased serum concentrations of both. Co-administration should be avoided unless lithium and digoxin concentrations are being administered. Anticoagulants: NSAIDs inhibit platelet aggregation and damage the mucosal lining of the gastrointestinal tract, which can lead to an increase in the effect of anticoagulants and an increased risk of gastrointestinal bleeding in patients taking anticoagulants. The co-administration of aceclofenac and oral anticoagulants of the coumarin group, ticlopidine and thrombolytics should be avoided unless the patient’s condition is closely monitored. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) when used together with NSAIDs may increase the risk of bleeding from the gastrointestinal tract (see section “Precautions for use”). The following combinations require dose selection and use with caution: Methotrexate: Be aware of the possible interaction of NSAIDs and methotrexate, even at low doses of methotrexate, especially in patients with impaired renal function. When taken simultaneously, kidney function indicators should be monitored. Caution should be exercised if both drugs, NSAIDs and methotrexate, were taken within 24 hours, as the concentration of methotrexate may increase, which will increase the toxicity of this drug. Cyclosporine, tacrolimus: When NSAIDs are taken concomitantly with cyclosporine or tacrolimus, the risk of increased nephrotoxicity due to a decrease in renal prostacyclin formation should be considered. Therefore, while taking it, you should carefully monitor the indicators of kidney function. Other NSAIDs: While taking acetylsalicylic acid or other NSAIDs, the incidence of side effects may increase, so caution should be exercised. Corticosteroids: Increased risk of ulcers or bleeding from the gastrointestinal tract (see section “Precautions for use”). Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics, may reduce the diuretic effect of furosemide and bumetanide, and the antihypertensive effect of thiazides. Co-administration with potassium-sparing diuretics may lead to an increase in potassium; therefore, it is necessary to regularly monitor the content of potassium in the blood serum. Antihypertensive drugs: NSAIDs can also reduce the effectiveness of certain antihypertensive drugs. ACE inhibitors or angiotensin II receptor antagonists in combination with NSAIDs can lead to impaired renal function. Some patients with reduced renal function, such as elderly or dehydrated patients, may be at risk for acute renal failure, which is usually reversible. Therefore, care must be taken when using these drugs in combination with NSAIDs, especially in the treatment of elderly or dehydrated patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of combination therapy and periodically thereafter. Aceclofenac has been shown to have no effect on blood pressure control when co-administered with bendrofluazid, although interactions with other diuretics cannot be ruled out. Hypoglycemic agents: Clinical studies show that diclofenac can be used in conjunction with oral hypoglycemic agents without affecting their clinical effect. However, there are separate reports of hypoglycemic and hyperglycemic effects of the drug. Thus, when taking aceclofenac, the doses of drugs that can cause hypoglycemia should be adjusted. Zidovudine: Concomitant use of NSAIDs and zidovudine increases the risk of haematological toxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV (+) patients with hemophilia receiving zidovudine and ibuprofen. Contraindications Aceclofenac is contraindicated in the following cases: hypersensitivity to the active substance or other excipients listed in the “Composition” section; patients in whom acetylsalicylic acid or other NSAIDs provoked attacks of asthma, bronchospasm, acute rhinitis or urticaria; or if there is hypersensitivity to these substances; patients who have had cases of bleeding or perforation of the gastrointestinal tract due to the use of NSAIDs. Patients with acute, recurrent or possible gastric or duodenal ulcer or bleeding history (two or more clear and proven episodes of ulcer or bleeding); patients with acute bleeding or diseases accompanied by bleeding (hemophilia or bleeding disorders); heart failure (NYHA functional class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease; severe violations of the liver and kidneys; during pregnancy, especially in the last trimester, except for serious indications for use. In this case, the minimum effective dose should be used (see section “Use during pregnancy and lactation”). Composition Each sachet of Aertal® powder for oral suspension contains: Active ingredient: aceclofenac – 100 mg milk flavoring, caramel flavoring, creamy flavoring. Overdose There are no data on the effects of an overdose of aceclofenac in humans. Symptoms may include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhea, confusion, agitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, syncope, rarely convulsions. In case of severe poisoning, acute renal failure and liver damage are possible. Treatment of acute NSAID poisoning typically includes antacids as needed and other supportive and symptomatic treatment of complications such as hypotension, renal failure, convulsions, gastrointestinal irritation, and respiratory depression. Treatment of acute poisoning with oral aceclofenac consists of preventing absorption as quickly as possible after an overdose of the drug by gastric lavage and repeated administration of activated charcoal. Forced diuresis, dialysis, and hemoperfusion may not be effective in eliminating NSAIDs due to their high affinity for plasma proteins and active metabolism. Good diuresis should be ensured, and kidney and liver function should be carefully monitored. The patient should be observed for at least 4 hours after taking a potentially toxic dose. With the development of frequent or prolonged seizures, intravenous diazepam should be used. Other measures may be necessary depending on the clinical condition of the patient. Treatment of acute NSAID poisoning is mainly supportive and symptomatic therapy. Adverse Effects Gastrointestinal Disorders: Most commonly observed adverse reactions are gastrointestinal disorders. Gastric ulcers, perforation or bleeding from the gastrointestinal tract, sometimes fatal, may occur, especially in elderly patients (see section “Precautions for use”). When taking NSAIDs, nausea, vomiting, diarrhea, bloating, constipation, dyspepsia, stomach pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease were observed (see section “Precautions for use”). Gastritis was observed less frequently. During treatment with NSAIDs, edema, arterial hypertension and heart failure were observed. Clinical studies and epidemiological data show that some NSAIDs (especially when taken at high doses and long-term use) may slightly increase the risk of arterial thrombotic events (for example, myocardial infarction or stroke) (see section “Precautions for use”). The table below lists undesirable adverse reactions, information about which was obtained from clinical studies and during post-marketing surveillance; adverse reactions are grouped by classes of organ systems and with an indication of the frequency of occurrence: very often (?1/10); often (from? 1/100 to <1/10); infrequently (from ?1/1000 to <1/100), rarely (from ?1/10000 to <1/1000), very rarely (<1/10000). MedDRA (MedDRA) Organ System Class Common (?1/100 to <1/10) Uncommon (?1/1000 to <1/100) Rare (?1/100) 10,000 to <1/1,000) Very rare (<1/10,000) Blood and lymphatic disorders Anemia Bone marrow suppression Granulocytopenia Thrombocytopenia Neutropenia Hemolytic anemia Immune system disorders Anaphylactic reactions (including shock) Hypersensitivity Malnutrition and metabolism Hyperkalemia Psychiatric disorders Depression Unusual dreams Insomnia Nervous system disorders Dizziness Paresthesia Tremor Drowsiness Headache Dysgeusia (taste perversion) Visual disorders Visual impairment Hearing and labyrinth disorders Vertigo Tinnitus Heart disorders Heart failure Sensation palpitations Disorders of the vascular system Arterial Hypertension Worsening of hypertension Skin flushing Hot flushes Vasculitis Respiratory, chest and mediastinal disorders Dyspnea Bronchospasm Gastrointestinal disorders Dyspepsia Abdominal pain Nausea Diarrhea Bloating Gastritis Constipation Vomiting Oral mucosal ulceration Melena Ulceration of the gastrointestinal mucosa Hemorrhagic diarrhea Hemorrhages in the gastrointestinal tract Stomatitis Hematemesis Bowel perforation Worsening of Crohn's disease and ulcerative colitis Pancreatitis Liver and biliary tract disorders Increased activity of "liver" enzymes Liver damage (including hepatitis) Increased activity of alkaline phosphatase in the blood sides of the skin and subcutaneous tissue Itching Rash Dermatitis Urticaria Angioedema Purpura Eczema Severe skin and mucosal reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) Naru effects on the kidneys and urinary tract Increased blood urea and creatinine levels Nephrotic syndrome Renal failure General disorders and disorders at the injection site Edema Increased fatigue Muscle spasms (in the legs) Effects on laboratory and instrumental test results Weight gain Other class effects observed when taking NSAIDs: Very rare (<1/10,000): Renal and urinary disorders: interstitial nephritis. Skin and subcutaneous tissue disorders: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). In special cases, serious skin infections and soft tissue infections have been observed when taking NSAIDs during chickenpox. See also sections "Precautions for use" and "Interaction with other medicinal products". Storage conditions The medicinal product does not require special storage conditions. Keep out of the reach of children. Buy Aertal powder for oral suspension 100mg in 3g bags #20 Price for Aertal powder for oral suspension 100mg in 3g bags #20 in packages 3g №20