Acefen tablets (acceclofenac)
ACEFEN NAFDAC NO: A4 – 5599
Each film coated tablet contains
Systematic (IUPAC) name 2-[2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxyacetic acid
Pharmacological Properties :Aceclofenac is a non steroidal anti-inflammatory drug(NSAID).
Aceclofenac is an orally active phenyl acetic acid derivative (related to diclofenac) with analgesic and anti-inflammatory properties. It is a potent inhibitor of the enzyme cyclo-oxygenase,which is involved in the production of prostaglandins. It has higher anti-inflammatory actions than the conventional NSAIDs.It is a cytokine Inhibitor.
INDICATIONS: For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
DOSAGE AND ADMINISTRATION: Aceclofenac should be taken preferably with or after food. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
ADULTS: The recommended dose is 200mg daily, taken in divided100mg doses, one tablet in the morning and one in the evening.
CHILDREN: It is not recommended for use in children.
Hypersensitivity to any of the constituents.
Severe hepatic and cardiac failure
Moderate to severe renal failure
During the last trimester of pregnancy/breast feeding.
Active or previous peptic ulcer
History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Use with concomitant NSAIDs including cyclo-oxygenase 2 specific inhibitors.
SIDE EFFECT: The most frequent side effect are gastro-intestinal disorders, in particular dyspepsia, abdominal pain,nausea,vomiting,diarrhea,and occasional occurrence of dizziness. Dermatological complaints includes puritus,rash,abnormal hepatic enzyme and serum creatinine levels have also been reported. In case of serious adverse reactions, Aceclofenac should be withdrawn.
DRUG INTERACTIONS: Aceclofenac may increase plasma concentrations of lithium, digoxin and methotrexate,Increase the activity of anticoagulant, Inhibits the activity of diuretics, enhance cyclosporine nephrotoxicity and precipitate convulsions when co-administered with quinolone antibiotics. Furthermore hypo or hyperglycemia may result from the concomitant administration of aceclofenac with other NSAIDS or corticosteroids may results in increased frequency of adverse effects.
PRECAUTIONS & WARNINGS:
Like other NSAIDs, allergic reactions, including anaphylactic reaction, can occur without earlier exposure to the drug.
Caution should also be exercised in patients with history of coagulation defects and history of liver problem.
Kidney, liver function and blood counts should be monitor during long term treatment. A persistent elevated level of hepatic enzyme is an indication for withdrawal of aceclofenac.
Chronic heavy alcohol abusers may be at risk of liver toxicity from excessive aceclofenac use. Renally impairment patient with mild renal function should be monitored regularly since the use of NSAIDs may result in deterioration of renal function.
Elderly: The pharmacokinetics of Aceclofenac are not altered in elderly patients. Therefore it is not considered necessary to modify the dose or dose frequency.
OVERDOSAGE: There are no human data available on the consequences of Aceclofenac overdose.
SYMPTOMS: Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting occasionally and convulsions. In case of significant poisoning acute renal failure and liver damage are possible.
THERAPEUTIC MEASURE: Patients should be treated symptomatically as required.
STORAGE: Store in a cool place and protect from light. keep out of children.
PRESENTATION: Blister of 10 tablets.