Interacting drugs -summary

Aceclofenac +

 Lithium/Digoxin

 Aceclofenac increase the plasma concentration of lithium and digoxin.

Diuretics

Concomitant use of aceclofenac and diuretics inhibit the activity of diuretics.

 Potassium sparing diuretic

 Serum potassium should be monitored when used with potassium sparing diuretics.

 Anticoagulants

Activity of anticoagulants enhanced when used concomittantly with aceclofenac

NSAIDs

 NSAIDs when administered within 24 hours of methotrexate administration, increase the plasma methotrexate levels leading to toxicity.

Quinolones

Convulsions occur due to interaction between quinolones and NSAIDs

Gastrointestinal events like indigestion,

heartburn, dyspepsia,

diarrhoea, nausea,

abdominal pain and flatulence.

Hypersenitivity to the drug (may precipitate attacks of asthma, bronchospasm, acute rhinitis, or urticaria ). GI bleeding, moderate to severe renal impairment, last three months of pregnancy.

Special precautions

 Csautiouslyt administer tompatients with renal disease,

History of peptic ulceration, cardiovascular bleeding,

Ulcerative colitis, Chrons disease,sytemic lupus erythmatosus,

Porphria, hemopoietic or coagulation disorders.

The dose should be reduced in patients with mild to moderate hepatic, renal or cardiac impairment.

Date of Aprroval      2003

Inflammation in osteoarthiritis, rheumatoid arthiritis and ankylosing spondylitis.

Dosage

Take with or immediately after meals

100mg orally b.i.d. Dosage recductions are recommendede in patients withnhepatic impairment, with a suggested initial dosage of 100mg/day

1. Dosage reduction is not generally needed in elderly patients or in those with mild renal impairment. Monitoring is recommened in such cases.

2. A dosage reduction of 100mg daily is recommended in patients with hepatic impairment.

3. Aceclofenac should be given with caution to elderly patients with renal, hepatic or cardiovascular impairment. and to those receiving other medications

4. Aceclofenac should not be administered to patients with peptic ulcers or GI bleeding, moderate or severe renal impairment , sensitivity to aceclofenac or other NSAIDs or a history of aspirin or NSAID related allergic or anaplylactic reactions.

5. The drug is not recommended in pregnant or breast feeding women.

6. Renal and hepatic function and blood counts should be monitored during long term treatment.

7. Persistently elevated hepatic enzyme levels necessiates withdrawal of aceclofenac.

Pharmacology

Aceclofenac has beenshown to exert effects on many mediators of inflammation. It inhibits synthesis of the inflammatory cytokines interluhin- 1beta and tumor necrosis factor ,and inhibits protstaglandin E2 production.

Pharmacokinetics

 On oral administration aceclofenac israpidly absorbed and peak plasma levels are reached within 1.25 to 3 hours. Food delays tmax of aceclofenac but other pharmacokinetic parameters are unaltered. studies show that approximately 70% of aceclofenac dose is excreted in urine as conjugated hydroxy metabolites and it has the elimination half life of 4 to 4.3 hours.

Take with or immediately after meals

Food delays absorption but other pharmocokinetic parameters are unaltered.

Pregnancy

Not recommended during last three months of pregnancy

Lactation

Not recommended in breast feeding women.