NEW DELHI: Paracetamol, a drug with analgesic and anti-pyretic (fever reducing) properties, is marketed either separately or in combination with other drugs like Nimesulide, Nabumetone, Lornoxicam and Ibuprofen. Speaking on the combination effects, drug regulatory expert CM Gulhati points out that liver toxicity gets compounded when acetaminophen (paracetamol) is combined with other drugs, for instance, NSAIDS. Apart from paracetamol’s effects on the liver, excess over the daily recommended dose can cause allergic reactions such as swelling of the face, mouth and throat, difficulty in breathing, itching or rashes, according to the regulatory body, according to the Drugs Controller of India (DCGI).

A recent regulation of the DCGI stipulates that prescription formulations of paracetamol, when marketed in combination with other drugs, cannot have more than 325 grams of the drug. In order to preempt a shortage of paracetamol in the market, however, the DGCI will allow a three year transition period before the dose norms come into effect. Apart from the dosage criterion, manufacturers of paracetamol-combination drugs are required to indicate on the package in which the medicine is sold that liver damage can ensue if the daily safe dose is exceeded.

Source: The Financial Express