Although the safety profile of paracetamol compared to other
analgesics is excellent, acute overdosage and therapeutic
excesses are commonly recognized problems [1]. The
recommended dose of paracetamol is 10-15 mg/kg/dose and not
exceeding 60 mg/kg/day [2]. In the United Kingdom
legislations have been introduced to restrict the pack size
of acetaminophen tablets that is available for sale. Its
impact on reducing acetaminophen toxicity is yet to be
determined convincingly as few studies indicate a reduction
in number of fatal cases of toxicity and reduction in
hospitalizations to liver units, whereas some studies
indicate that there has actually been an increase in the
number of cases [3].
In India, it is surprising to find that
the drug controller of India has approved a formulation for
oral paracetamol suspension having strength of 500mg/5ml by
a reputed Indian company specializing in different
paracetamol dose preparations. Is there a percieved need to
have such a preparation? In our opinion It is likely to
cause more confusion and more chances of drug overdosage by
the unassuming lay public if purchased over the counter for
self medication. Having such a preparation at home,
especially without child resistant caps could also lead to
unintentional poisonings among infants and young children.
For an infant weighing ten kilograms, an acute intake of as
low as ten milliliters of the preparation may prove fatal.
There is no justification for its use whatsoever as syrups
or suspensions are costlier than tablets and most children
as well as majority of caregivers prefer tablets over syrups
or suspensions [4]. Hence there is an urgent need to rethink
on the need for introducing such formulations and to
withhold licensing of such formulations in future
considering its potential for causing overdosage and
toxicity.
1. Kelly DA, Mayer D. Liver
transplantation. In: Kelly DA, editor. Diseases of
the Liver and Biliary System in Children. Second ed.
USA: Blackwell Publishing Ltd; 2004. p. 378-401.
2. Russell FM, Shann F, Curtis N,
Mulholland K. Evidence on the use of paracetamol in febrile
children.Bull World Health Organ. 2003;81:367–72.
3. Hawkins LC, Edwards JN, Dargan PJ.
Impact of restricting paracetamol pack sizes on paracetamol
poisoning in the United Kingdom: a review of the literature.
Drug Saf. 2007;30:465-79.
4. Ansah EK, Gyapong JO, Agyepong IA, Evans DB. Improving
adherence to malaria treatment for children: the use of
prepacked chloroquine tablets vs chloroquine syrup.
Trop Med Int Health. 2001;6:496-504.