Brands of Aceclofenac / Paracetamol in Kenya
Acecor P®,coral Laboratories Ltd
Aceclopyn® , Salama Pharmaceuticals Limited
Acenac P® ,Medley Pharmaceuticals Limited
Acepar®, Dawa Limited
Aclofre P®,Crown Healthcare
Aclosara-P®, Krishna Chemists Ltd
Aclotas-P® ,Intas Pharmaceuticals Ltd
ACP®, National Pharmacy Ltd
Actinac plus® ,Ajanta Pharma Limited
Acufen XP®,Pulse Pharmaceuticals Private Limited
Algic-P®, MSN Laboratories Private Limited.
Apigesic Plus®,Cosmos Limited
Ceclonec-P®, Questa Care Inc
Celfast®, Indchemie Health specialities Pvt. Ltd.
Dolowin-Plus®,Micro Labs Limited India
G – Alfenac P®, Bliss GVS Pharma Ltd.
Lysodol P®,Galaxy Pharmaceutical Limited
Mobyle-A®, Lincoln Pharmaceuticals Ltd
Rilif Plus® , Umedica Laboratories Pvt Ltd
Rucadol-P®, Ravenbhel Healthcare Pvt. Ltd
Stalace-P®, Stallion Laboratories Pvt Ltd
Zacy-P®, Comed Chemicals Limited
Zalac P®,Laboratory & Allied Ltd
Zerodol-P®, Ipca Laboratories Limited
Zofen CZ®,Zawadi Healthcare Ltd
Zulu®, Innocia Lifesciences Pvt. Ltd.
Zyrtal Plus®, Pharmaken Ltd
MODE OF ACTION
Paracetamol has a central analgesic effect that is mediated through activation of descending serotonergic pathways. Debate exists about its primary site of action, which may be inhibition of prostaglandin (PG) synthesis or through an active metabolite influencing cannabinoid receptors.
Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.
Indicated for relief from severe pains and inflammation in osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, Low back pain, Dental pain, Gynaecological pain, and painful & inflammatory conditions of the ear, nose & throat.
DOSAGE & ADMINISTRATION
The maximum recommended dose is two tablets daily, taken as one tablet in the morning and one in the evening.
Use in special populations
The drug is not recommended in pregnant women
The drug is not recommended in breastfeeding women.
There are no clinical data on the use of aceclofenac in children.
Generally, no dose reduction is necessary, however, consider the precautions
Hypersensitivity to aceclofenac or Paracetamol or any component of the tablet
In patients in whom substances with a similar action (eg. aspirin, or other NSAIDs ), precipitate attacks of asthma, bronchospasm, acute rhinitis or urticaria or patients are hypersensitive to these drugs
Severe heart failure or severely impaired hepatic or renal organ function and during the last three months of pregnancy (last trimester)
This drug should be administered with caution and under close medical surveillance to patients suffering from gastrointestinal disease and to those with a history of peptic ulceration, cerebrovascular bleeding, ulcerative colitis. Crohn’s disease. SLE, porphyria, hematopoietic, or coagulation disorders.
Caution should be exercised in patients with mild to moderate impairment of hepatic, renal or cardiac function as well as in patients with other conditions predisposing to fluid retention
Caution is also required in patients, who are generally more prone to adverse reactions. The consequences. e.g. gastrointestinal bleeding and or perforation, are often more serious and may occur without warning symptoms or previous history, at any time during treatment.
Elderly patients are more likely to be suffering from impaired renal, cardiovascular, or hepatic function.
All patients who are receiving long-term treatment with NSAIDs should be monitored as a precautionary measure (e.g. renal, hepatic function, and blood counts).
Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use, although reports of this event are rare.
Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, including GI bleeding.
Anti-hypertensives: NSAIDs may reduce the effect of antihypertensives. The risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE- inhibitors or angiotensin II receptor antagonists are combined with NSAIDs. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. 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. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored.
Cardiac glycosides, like digoxin: NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and inhibit the renal clearance of glycosides, resulting in increased plasma glycoside levels. The combination should be avoided unless frequent monitoring of glycoside levels can be performed.
Lithium: Several NSAID drugs inhibit the renal clearance of lithium, resulting in increased serum concentrations of lithium. The combination should be avoided unless frequent monitoring of lithium can be performed.
Methotrexate: The possible interaction between NSAIDs and methotrexate should be born in mind also when low doses of methotrexate are used, especially in patients with decreased renal function. When combination therapy has to be used, the renal function should be monitored. Caution should be exercised if both an NSAID and methotrexate are administered within 24 hours of each other, since NSAIDs may increase plasma levels of methotrexate, resulting in increased toxicity.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin . Close monitoring of patients on combined anti-coagulants and this should be undertaken.
Quinolone antibiotics: 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.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Ciclosporin, tacrolimus: Administration of NSAID drugs together with cyclosporin or tacrolimus is thought to increase the risk of nephrotoxicity due to decreased synthesis of prostacyclin in the kidney. During combination therapy, it is therefore important to carefully monitor renal function.
Zidovudine: Increased risk of hematological toxicity when NSAIDs are given with zidovudine. There are indications of an increased risk of haemarthroses and hematoma in HIV(+) hemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents with 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.
Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.
Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.
Warfarin: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Chloramphenicol: Increased plasma concentration of chloramphenicol.
Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causality related to paracetamol.
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 (c) 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 and cerebrovascular: Oedema, hypertension and cardiac failure have 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 (for example myocardial infarction or stroke, particularly at high doses or in long treatment). Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac.
Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment
Other adverse reactions reported less commonly include:
Renal: interstitial nephritis.
Neurological and special senses: optic neuritis, 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, confusion, hallucinations, malaise and drowsiness.
Haematological: agranulocytosis, aplastic anaemia .
Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
Reporting of suspected adverse reactions
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, firstname.lastname@example.org or clicking below button:
Clinical | Pharmacokinetic data
Pregnancy Category: Not Recommended
Routes of Administration: Oral
Bioavailability: Not Available
Protein Binding: Not Available
Metabolosim: Not Available
Onset of Action: Not Available
Elimination Half life: Not Available
Excretion: Not Available
Legal Status | Dosage forms & Strengths
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
- 2003: an evidence based approach to the managementof knee osteoarthritis: Report of a Task Force of theStanding Committee for International Clinical Studies In-cluding Therapeutic Trials (ESCISIT). Ann Rheum Dis2003;62:1145e55