Dolomec SP

Description

Aceclofenac is an orally administered phenylacetic acid derivative with effects on a variety of inflammatory mediators. It is an effective analgesic and anti- inflammatory agent with a good tolerability profile. Through it’s analgesic and anti-inflammatory properties, Aceclofenac provides symptomatic relief in a variety of painful conditions. Aceclofenac has been shown to exert effects on a variety of mediators of inflammation. The drug inhibits synthesis of the inflammatory cytokines, prostaglandins and interleukins.

Aceclofenac is rapidly and completely absorbed after oral administration. Peak plasma concentration are reached in 1-3 hours after an oral dose. The drug is highly protein bound (>99%). Aceclofenac is metabolized to a major metabolite, 4-hydroxyaceclofenac and to a number of other metabolites including 5-hydroxyaceclofenac and diclofenac. These other metabolites account for the fate of approximately 20% of each dose of Aceclofenac. The plasma elimination half life of Aceclofenac is approximately 4 hours.

Paracetamol (Acetaminophen)

Paracetamol produces antipyresis by acting centrally on the Hypothalamic heat-regulating center to produce peripheral vasodilation resulting increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

Paracetamol inhibits prostaglandin synthesis in the brain but hardly any in the periphery. Thus paracetamol has central effect. Aceclofenac has more of peripheral effect. Thus Aceclofenac and Paracetamol with different mechanisms of action this combination may be more effective than each drug used alone.

Serratiopeptidase

is a proteolytic enzyme isolated from non pathogenic Enterobacteria serratia E15. Serratiopeptidase is a powerful treatment for pain and inflammation. Serratiopeptidase speeds the tissue repair process. It is also known as Serratia peptidase, Serrapeptidase or Serrapeptase. When this enzyme is isolated and coated in the form of a tablet,it has been shown to act as an anti-inflammatory and a pain blocker.

Serratiopeptidase Inhibits inflammatory mediators like bradykinin, serotonin and histamine and there by reducing of vascular permeability due to injury.

It blocks plasmin inhibitors thus helping fibrinolytic action of plasmin. Degradation of extra fibrin prevents clogging of micro-capillaries, reduces swelling.

Rationale for combination of Aceclofenac + Paracetamol with Serratiopeptidase

The Pathophysiology of inflammation and pain is a complex process and the use of combination will improve analgesia, antipyresis and oedema by acting on inflammatory mediators. Thus Serratiopeptidase improves the spectrum of activity of NSAIDS by reducing the swelling and dissolving the dead and damaged tissue. Also the mechanism of drugs is acting at different inflammatory mediators. i.e. Aceclofenac and Paracetamol on prostaglandins and Serratiopeptidase on histamine and bradykinin. Thus combination of Aceclofenac with Serratiopeptidase enhances the efficacy of Aceclofenac.

Contraindications

• Any hypersensitivity to any of the ingredients
• Hepatic failure since Paracetamol is metabolized in liver and can aggravate

Warnings

Usage in pregnancy and nursing mothers: no well controlled studies are available regarding the use of Serratiopeptidase in pregnancy and lactation. The drug is not recommended in pregnant or breast feeding women.

Usage in children

Experience with Serratiopeptidase in children is not available.

Indications

• Fracture, Trauma and Injury with swelling
• Episiotomy and Hysterectomy
• Dental caries, Periodontitis and Tooth abscess
• Post-Operative pain with swelling
• Low back pain, Fever and
• Pain associated with Tonsillitis, Sinusitis and pharyngitis

Dosage and Administration

One tablet twice daily

Pack

Blister pack of 10 tabs. 10 Blisters in a box