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TopCeclo-P
Composition
Each film coated bilayered tablet contains:
Aceclofenac BP…………100mg
Paracetamol IP…………...500mg
Pharmacodynamics
Aceclofenac relieves pain and inflammation through a variety of mechanisms and in addition exerts stimulatory effects on cartilage matrix synthesis.

Anti-inflammatory activity: The anti-inflammatory effects of Aceclofenac have been shown in both acute and chronic inflammation. It inhibits various mediators of pain and inflammation including:

PGE2 via cyclooxygenase inhibition (COX-1 & COX-2) after intracellular metabolism to 4’ hydroxy-aceclofenac and diclofenac in human rheumatoid synovial cells and other inflammatory cells.

IL-1β, IL-6 and tumor necrosis factor in human osteoarthritic synovial cells and human articular chondrocytes.

Reactive oxygen species (which plays a role in joint damage) has also been observed in patients with osteoarthritis of knee.

Expression of cell adhesion molecules (which is implicated in cell migration and inflammation) has also been shown in human neutrophils.

Stimulatory effects on cartilage matrix synthesis: Aceclofenac stimulates glycosaminoglycan synthesis in human osteoarthritic cartilage by inhibition of IL- 1β and suppresses cartilage degeneration by inhibiting IL-1β mediated promatrix metalloproteinase production and proteoglycan release. Paracetamol is a clinically proven analgesic and antipyretic agent with weak anti-inflammatory effect.

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 (believed to be splice variant product of the COX-1 gene) could represent a primary central mechanism by which Paracetamol decreases pain and possibly fever.
Special Population
As with other NSAIDs and combinations, caution is advised in elderly patients who are more likely to have concomitant renal, hepatic or cardiovascular impairment or receiving concurrent medication. In patients with hepatic impairment, dosage reductions are recommended. Ace/para should be avoided in patients with moderate and severe renal impairment. Regular use of ace/para during pregnancy and lactation should be avoided, unless the potential benefits outweigh the risks.
Indication
Acle/para is indicated for relief from severe pain and inflammation in Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, Low back pain, Dental pain, Gynaecological pain and painful & Inflammatory conditions of ear, nose & throat.
Contraindications
Ace/para is contraindicated in the following situations:
  • Patients sensitive to Aceclofenac, Paracetamol or to any of the excipients of the product
  • Patients in whom aspirin or other NSAIDs, precipitate attacks of bronchospasm, acute rhinitis or urticaria or patients hypersensitive to these drugs
  • Patients with active or suspected peptic ulcer or gastrointestinal bleeding or bleeding disorders
  • Patients with severe heart failure, hypertension, hepatic or renal insufficiency
  • Third trimester of pregnancy
Drug interactions
Drug interactions associated with Aceclofenac are similar to those observed with other NSAIDs. Aceclofenac may increase the plasma concentrations of lithium, digoxin and methotrexate. It may increase the activity of anticoagulants, inhibit the activity of diuretics, enhance cyclosporine nehrotoxicity and precipitate convulsions when coadministered with quinolone antibiotics. Coadministration of Aceclofenac with other NSAIDs and corticosteroids are to be avoided due to increased incidence of side-effects.
The risk of Paracetamol toxicity may be increased in patients receiving other potentially heatotoxic drugs or drugs that induce hepatic microsomal enzymes. Coadministration of Paracetamol with rifampicin, isoniazid, chloramphenicol, antiepileptic drugs and antiviral drugs is to be avoided. Metoclopromide may increase the absorption of Paracetamol whereas excretion and plasma concentration may be altered when coadministered with probenecid. Cholestyramine also reduces the absorption of Paracetamol
Pregnancy
The drug in not recommended in pregnant women and in lactation.
 

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