CALFENAC P

(Aceclofenac 100 mg +Paracetamol 325 mg)

Aceclofenac is an orally administered phenyla cetic acid derivative with effects on a variety of inflammatory mediators. It is from the class of non-steroidal anti-inflammatory drug (NSAID), related to diclofenac. Through its analgesic and anti-inflammatory properties, aceclofenac provides symptomatic relief in a variety of painful conditions.

PHARMACOLOGY

The mode of action of aceclofenac is largely based on the inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins. Aceclofenac has been shown to exert effects on a variety of mediators of inflammation. In patients with osteoarthritis of the knee, aceclofenc decreases pain, reduces disease severity and improves the functional capacity of the knee. It reduces joint inflammation, pain intensity and the duration of morning stiffness in patients with rheumatoid arthritis. The duration of morning stiffness and pain intensity are reduced and spinal mobility improved, by aceclofenac in patients with ankylosing spondylitis.

PHARMACOKINETICS

Aceclofenac is rapidly and completely absorbed after oral administration. Peak plasma concentrations are reached 1 to 3 hours after an oral dose. The drug is highly protein bound (>99%). The presence of food does not alter the extent of absorption of aceclofenac but the absorption rate is reduced. The plasma concentration of aceclofenac was approximately twice that in synovial fluid after multiple doses of the drug in patients with knee pain and synovial fluid effusion.

Aceclofenac is indicated for the relief of pain and inflammation associated with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.

CONTRAINDICATIONS

Aceclofenac should not be administered to patients hypersensitive to aceclofenac or other NSAIDs, or patients with a history of aspirin or NSAID-related allergic or anaphylactic reactions or with peptic ulcers or Gl bleeding, moderate or severe renal impairment.

Usage in pregnancy and lactation

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

Usage in paediatrics

There are no clinical data on the use of Aceclofenac in children. Usage in geriatrics The pharmacokinetics of Aceclofenac is not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Drug interactions

Drug interactions associated with Aceclofenac are similar to those observed with other NSAIDs.Aceclofenac may increase plasma concentrations of lithium, digoxin and methotrexate, increase the activity of anticoagulants, inhibit the activity of diuretics, enhance cyclosporin nephrotoxicity and precipitate convulsions when co administered with quinolone antibiotics. When concomitant administration with potassium sparing diuretics is employed, serum potassium should be monitored.

PARACETAMOL

Analgesic action :

The central analgesic action of Paracetamol resembles that of aspirin. It produces analgesia by raising pain threshold.

Antipyretic effect :

The antipyretic effect of Paracetamol is attributed to its ability to inhibit COX in the brain where peroxide tone is low. Recent evidence suggests inhibition of COX-3 could represent a primary central mechanism by which Paracetamol decreases pain and possibly fever. Paracetamol is rapidly and almost completely absorbed from gastrointestinal tract with peak plasma concentrations (Cmax) occurring about 10 to 60 minutes after oral administration. Plasma protein binding is negligible at usual therapeutic concentration but increases with increasing concentrations. Acetaminophen is relatively uniformly distributed throughout most body fluids. The plasma half life (t1/2) 2-3 hours and the effect after oral dose lasts for 3-5 hours. Paracetamol is metabolized predominantly in liver and excreted in the urine mainly as glucuronide and sulfate conjugate. Less than 5% is excreted unchanged.

Aceclofenac is effective in painful conditions and has excellent anti inflammatory action. Combination of ACECLOFENAC & PARACETAMOL has synergestic action and provides excellent relief in pain or pain associated with pyrexia.

INDICATIONS:

• SEVERE PAIN
• DENTAL PAIN
• POST SURGICAL PAIN
• FEVER WITH BODY PAIN

DOSAGE: 1 TABLET TWICE A DAY.