ACEFEN Tablet

For the treatment of Dentalgia, traumatic inflammation, lumbago, ischiadynia, pain due to perineotomy, parturition, and non-articulate rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and scapulohumeral periarthritis.

Dosage and Administration

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

Children: Safety & Efficacy not established.

Dosage may be adjusted according to direction of doctor.

This drug should not be chewed.

Those patients who are sensitive to Aceclofenac, to any of the excipients of the product, the patients with active or suspected peptic or duodenal ulcer, history of recurrent peptic or duodenal ulcer who have gastrointestinal bleeding, other active bleedings or bleeding disorders.

The majority of side effects are of gastrointestinal system (dyspepsia, abdominal pain, nausea and diarrhoea). Other side effects are pruritus, rash, dermatitis.

Metabolic and nutritional, increased serum creatinine, headache, fatigue, face oedema, allergic reaction and weight increase.

No pharmacokinetic interaction studies have been performed, except with warfarin. Aceclofenac is metabolized through CYP2C9 and a risk of pharmacokinetic interaction is therefore possible with phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulphaphenazole. As with other products within the NSAID-group, there also exists a risk of pharmacokinetic interactions with other drugs eliminated by active renal secretion, such as methotrexate and lithium. Aceclofenac is practically bound completely to plasma albumin. Consequently, the possibility of displacement interactions with other highly protein bound drugs must be borne in mind.

Pregnancy

With regular doses of Aceclofenac, there are increased risk of closure of fetal ductus, arteriosus in uterus & possible persistent pulmonary hypertension of the newborn.

Delayed onset & increased duration of labour with increased blood loss Avoid Aceclofenac in the 1st trimester of pregnancy.

Lactation

Avoid in breast feeding.

Aceclofenac should be administered with caution and under close medical surveillance to patients suffering from gastro-intestinal disease and to those with a history of peptic ulceration, cerebro-vascular 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. In these patients, the use of NSAIDs may result in deterioration of renal function and fluid retention.

Aceclofenac is a NSAID which acts specifically on inflammatory sites and thereby decreases the inflammation. It is highly effective as an anti-inflammatory drug for various inflammatory conditions.

Aceclofenac is a phenyl acetic acid derivative (2-{(2,6-dichlorophenyl) amino} phenylacetoxyacetic acid), is a novel NSAID indicated for the symptomatic treatment of pain and inflammation.