ACEFEN (Aceclofenac Tablets 100 mg)
Composition, Indications, Contraindications, Side effects, Drug interactions, Precautions and warnings, Dosage and administration, Overdosage, Storage, Presentation, Manufacturer and Marketer of Acefen Tablet Medicine for Arthritis and Pains.
Each film coated tablet contains:
Aceclofenac BP 100mg
For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Hypersensitivity to any of the constituents.
NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticarla) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
Severe hepatic and cardiac failure.
Moderate to severe renal failure.
During the last trimester of pregnancy.
Active or previous peptic ulcer.
History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Use with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors.
The most frequent side effects are gastro-intestinal disorders, in particular dyspepsia, abdominal pain, nausea, vomiting, diarrhea, and occasional occurrence of dizziness. Dermatological complaints includes pruritus, rash, abnormal hepatic enzyme and serum creatinine levels have also been reported. In case of serious adverse reactions, Aceclofenac should be withdrawn.
Aceclofenac may increase plasma concentrations of lithium, digoxin and methotrexate, increase the activity of anticoagulant, inhibits the activity of diuretics, enhance cyclosporin nephrotoxicity and precipitate convulsions when co-administered with quinolone antibiotics. Furthermore, hypo or hyperglycaemia may result from the concomitant administration of aceclofenac and antidiabetic drugs, although this is rare. The co administration of aceclofenac with other NSAIDS of corticosteroids may results in increased frequency of adverse event.
PRECAUTIONS & WARNINGS
* Like other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur without earlier exposure to the drug.
*Caution should also be exercised in patients with history of coagulation defects and history of liver problems.
* Kidney, liver function and blood counts should be monitored during long term treatment. Persistent elevated levels 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. Renal impairment Patients with mild renal function should be monitored regularly since the use of NSAIDS may result in deterioration of renal function. Renal function usually reversible on withdrawal of acedofenac.
Other Precautions: Contraindicated in pregnancy, breast feeding and elderly patients with a history of coagulation, liver dysfunction should use this drug with care.
* Aceclofenac should be used with caution in elderly patients with renal, hepatic or cardiovascular impairment.
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 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
Children: It is not recommended for use in children.
Elderly : 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.
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 100mg be used.
There are no human data available on the consequences of Aceclofenac overdose.
Symptoms: Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally and convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.
Therapeutic measure: Patients should be treated symptomatically as required.
Store in a cool place and protect from light. Keep out of reach of children.
Blister of 3 x 10 tablets.
AUROCHEM LABORATORIES (I) PVT. LTD.
At 58, P.T.I.C.E. Ltd. Palghar – 401 404.
Dist: Thane, India.
BARATA PHARMACEUTICALS & CO. LTD.
416, lkwerre Road, Port Harcourt,
Rumuokuta Junction, Rivers State Nigeria