Chemical formula: C₁₆H₁₃Cl₂NO₄ Molecular mass: 354.18 g/mol PubChem compound: 71771
Aceclofenac interacts in the following cases:
Increased risk of gastrointestinal ulceration or bleeding by concomitant use of NSAIDS and corticosteroids.
The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of aceclofenac.
If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), aceclofenac should be discontinued. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Hepatitis may occur without prodromal symptoms.
Clinical studies have shown that aceclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with aceclofenac, consideration should be given to adjustment of the dosage of hypoglycaemic agents.
NSAIDs may enhance the effects of anti-coagulants, such as warfarin. Close monitoring of patients on combined anti-coagulants and aceclofenac therapy should be undertaken.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels.
NSAIDs may reduce anti-hypertensive effect of anti-hypertensives.
The nephrotoxicity of NSAIDs increases when co-administered with diuretics, while NSAIDs inhibit the activity of diuretics. Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs. Although it was not shown to affect blood pressure control when co-administered with bendrofluazide, interactions with other diuretics cannot be ruled out.
Possible increased risk of hyperkalaemia when NSAIDs given with potassium-sparing diuretics and aldosterone antagonists.
Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
The use of Aceclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of aceclofenac should be considered.
The nephrotoxicity of ciclosporin may be increased by the effect of NSAIDs on prostaglandins of kidneys.
Aceclofenac reduces excretion of lithium, leading to increased concentrations of lithium and increased risk of toxicity.
Decreased elimination of methotrexate. Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours of each other, since NSAIDs may increase plasma levels, resulting in increased toxicity.
Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Use of aceclofenac in patients with hepatic porphyria may trigger an attack.
There is no information on the use of aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and postimplantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, aceclofenac should not be given unless clearly necessary. If aceclofenac is used by a women attempting to conceive, or during the first the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus) and on the possible risk of persistent pulmonary hypertension of the new born, use in the last trimester of pregnancy is contraindicated. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
Τhe mother and the neonate, at the end of pregnancy, to:
Consequently, aceclofenac is contraindicated during the third trimester of pregnancy.
There is no information on the secretion of aceclofenac to breast milk, there was however no notable transfer of radio labelled (14C) aceclofenac to the milk of lactating rats.
The use of aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus.
NSAIDs may impair fertility and are not recommended in women trying to conceive. The temporary discontinuation of aceclofenac should be considered in women having difficulties to conceive or undergoing investigations for infertility.
Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment.
Aceclofenac is both structurally related and metabolised to diclofenac for which a greater amount of clinical and epidemiological data consistently point towards an increased risk of general arterial thrombotic events (myocardial infarction or stroke, particularly at high doses and in long treatment). Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac.
Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or © assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Other adverse reactions reported less commonly include:
Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure
Hepatic: Abnormal liver function, hepatitis and jaundice.
Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Rare: Anaemia
Very rare/isolated reports: Bone Marrow depression, Granulocytopenia, Thrombocytopenia, Neutropenia, Haemolytic anaemia
Rare: Anaphylactic reaction (including shock), Hypersensitivity
Very rare/isolated reports: Hyperkalemia
Very rare/isolated reports: Depression, Abnormal dreams, Insomnia
Common: Dizziness
Very rare/isolated reports: Paraesthesia, Tremor, Somnolence, Headache, Dysgeusia (abnormal taste)
Rare: Visual disturbance
Very rare/isolated reports: Vertigo, Tinnitus
Rare: Cardiac failure
Very rare/isolated reports: Palpitations
Rare: Hypertension
Very rare/isolated reports: Flushing, Hot flush, vasculitis
Rare: Dyspnoea
Very rare/isolated reports: Bronchospasm, Stridor
Common: Dyspepsia, Abdominal pain, Nausea, Diarrhoea
Uncommon: Flatulence, Gastritis, Constipation, Vomiting, Mouth ulceration
Rare: Melaena, Gastrointestinal haemorrhage, Gastrointestinal ulceration
Very rare/isolated reports: Stomatitis, Intestinal perforation, Exacerbation of Crohn’s disease and colitis Ulcerative, Haematemesis, Gastrointestinal haemorrhage, Gastric ulcer, Pancreatitis
Uncommon: Pruritus, Rash, Dermatitis, Urticaria
Rare: Face oedema, Angioedema
Very rare/isolated reports: Purpura, Severe mucocutaneous skin reaction (including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis), Dermatitis bullous
Very rare/isolated reports: Cramps in the leg
Uncommon: Blood urea increased, Blood creatinine increased
Very rare/isolated reports: Renal insufficiency, Nephrotic syndrome, Renal failure
Common: Hepatic enzyme increased
Very rare/isolated reports: Hepatitis, Jaundice, Hepatic injury (including hepatitis), Blood alkaline phosphatase increased
Very rare/isolated reports: Oedema, Fatigue, Cramps in legs
Very rare/isolated reports: Weight increase
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