Aceclofenac

BRANDS OF ACECLOFENAC IN KENYA:

Aceclo®, Aristo

Aclofre®, Crown Healthcare

Acenac®, Medley Pharmaceuticals Limited

Achaid®, Inventia Healthcare Pvt. Ltd.

Airtal®, Almirall S.A.

Aceclodeal®, Sava Healthcare Ltd

Acefan®, Aspen

Acefen®, Shelys Pharmaceuticals Ltd.

Acexx®, Metro Pharmaceuticals Limited

Aclotas®, Intas Pharmaceuticals Ltd

Apitac®, The ACME Laboratories Ltd

Aroff®, Unichem Laboratories Ltd.

Clanza®, Veteran

Ceclonec®,Questa Care Inc. c/o Surgilinks Ltd

Dolowin®, Microlabs Ltd India

Flexi®, Square Pharmaceuticals Ltd.

Flamofenac®, Flamingo

G-Alfenac® 100 Suppository, Bliss GVS Pharma Ltd.

Lofen®, Lords Healthcare Ltd

Lysodol®, Meyer

Movex®, Opsonin Pharma Limited

Orthofen®, Prism

Rilif®, Unicorn

Siclofen®, Synermed

Stalace®, Stallion Laboratories Pvt Ltd C/o Medox Pharmaceuticals Ltd

Stednac®, Stedman Pharmaceuticals Private Limited

Vovnec®, Mednext

Zacy SR®, Comed Chemicals Limited

Zalac Tablets®, Laboratory & Allied Ltd

Zerodol®, Ipca Laboratories Limited

Zofen®, Zawadi Healthcare Ltd

Zolfin®, Beximco Pharmaceuticals Ltd.

Zyrtal® , Saga


Aceclofenac in Kenya: Prices,Brands,Alternatives,uses
Aceclofenac Chemical Structure

Aceclofenac Mode of Action:

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.

ACECLOFENAC INDICATIONS

Aceclofenac film-coated tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

DOSAGE AND ADMINISTRATION:

Adults

The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Paediatric population

There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of age.

Elderly

The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Renal insufficiency

There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see Section 4.4).

Hepatic insufficiency

There is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.

CONTRAINDICATIONS:

  • Hypersensitivity to Aceclofenac or to any of the excipients .
  • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
  • NSAIDS are contraindicated in patients who have previously shown hypersensitivity reactions (eg. Asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
  • Hepatic failure and renal failure.
  • Patients with established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
  • History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy.
  • Active bleedings or bleeding disorders.
  • Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used

DRUG INTERACTIONS:

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 activity 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, 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 .

Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). Close monitoring of patients on combined anti-coagulants and Aceclofenac Tablets therapy 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 ciclosporin 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 haematological toxicity when NSAIDs are given with zidovudine. There are indications of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs 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.

UNDESIRABLE EFFECTS:

Undesirable effects associated with NSAIDs in general:
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. diarrhea. 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.
Vascular and cardiac disorders: 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 rare or very rare class effects reported with NSAIDs In general are:
Blood and the lymphatic system disorders– Aplastic anaemia.
Psychiatric disorders– Hallucination, Confusionai state.
Nervous system disorders – Optic neuritis, somnolence.
Ear and labyrinth disorders – Tinnitus.
Respiratory, thoracic and mediastinal disorders– Aggravated asthma.
Skin and Subcutaneous tissue disorders – Toxic epidermal necrolysis, Erythema multiforme, Exfoliative dermatitis, photosensitivity reaction.
Renal and urinary disorders-Interstitial nephritis.
General disorders and administration site conditions – Malaise

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 authorization of the medicinal product are 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, pv@pharmacyboardkenya.org or clicking below button:

OVERDOSAGE:

Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.


Aceclofenac in Kenya
Aceclofenac in Kenya
Aceclofenac in Kenya
Aceclofenac in Kenya
Aceclofenac in Kenya
Aceclofenac in Kenya
Aceclofenac in Kenya

Clinical | Pharmacokinetic data


Pregnancy Category: There is no information on the use of Aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development.
Routes of Administration: Oral | Topical
Bioavailability: Not Available
Protein Binding: >99%
Metabolosim: Liver
Onset of Action: Not Available
Elimination Half life: 4 hrs
Excretion: 80% Urine , 20% feces

Legal Status | Dosage forms & Strengths


Prescription Category:
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:
Tablets | Gel

Drug Indentifiers:

CAS Number
PubChem CID
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard


Drug Images

References/ Citation:




What was the patient being treated for
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