SOCOMOL Tablet Ref.[115638] Active ingredients: Diclofenac Paracetamol

Source: Registered Drug Product Database (NG)  Publisher: Importer: MOREHOPE PHARMA NIGERIA LIMITED, NO. 1 OMOLABAKEADEOTI STREET, AJAO ESTATE, ISOLO, LAGOS STATE, NIGERIA Manufacturing Site: MCW HEALTHCARE PVT LTD., 286, 287-A, 287-B, SECTOR-E, INDUSTRIAL AREA SANWAR ROAD, INDORE, INDIA

5.1. Pharmacodynamic properties

In postoperative pain treatment, the doses of morphinic analgesics can be significantly reduced when SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablet is associated to the treatment.

Diclofenac is a potent anti-inflammatory with analgesic and antipyretic action. Its analgesic and antipyretic effects are further reinforced by paracetamol. The mode of action can best be understood by looking at each active constituent of SOCOMOL Paracetamol 325 mg & DiclofenacSodium 50 mg Tablets separately.

Diclofenac sodium

It is an NSAID which has been demonstrated to inhibit prostaglandin biosynthesis, thus exerting a pronounced anti-inflammatory, analgesic and antipyretic action.

Paracetamol

The analgesic and antipyretic actions of paracetamol are similar to those of the salicylates. Analgesia is mediated peripherally and also centrally whereas antipyresis is produced by a central action on the hypothalamic regulatory centre.

5.2. Pharmacokinetic properties

Absorption

Diclofenac sodium is well absorbed after oral administration, and peak concentrations are usually attained after 1-4 hours. Absorption occurs more rapidly when ingested on an empty stomach than when administered after a meal.

Paracetamol is rapidly and almost completely absorbed from the Gastrointestinal tract. Both diclofenac sodium and paracetamol in SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets are well absorbed from the Gastrointestinal tract.

Distribution

Plasma concentrations show a linear relationship with the size of the dose. Doses are maintained at higher levels in the synovial fluid rather than in plasma.

However, paracetamol achieves peak plasma concentration much faster than diclofenac sodium, as the latter is enteric coated. This ensures rapid action and at the same time minimises the chances of gastric irritation.

Metabolism

A large proportion of diclofenac sodium is metabolised in the liver and about 30% of the ingested dose undergoes first pass metabolism.

The complete ingested dose is extensively metabolised in the liver and excreted in the urine as inactive metabolites.

SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablet is metabolised in the liverand excreted mainly in the urine.

Excretion

Approximately 60% of the dose is excreted through the kidney and the remainder in the faeces, in the form of metabolites. Less than 1% is excreted via the kidneys in an unchanged form. The plasma half-life to the terminal elimination phase is about 1-2 hours. More than 99% is protein bound.

5.3. Preclinical safety data

Not data available.

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