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Indian Pediatr 2014;51:
839 |
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Paracetamol – High Strength Formulations and
Toxicity
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S Balasubramanian and Venkateswari Ramesh
Kanchi Kamakoti CHILDS Trust Hospital and The CHILDS
Trust Medical Research Foundation,
Nungambakkam, Chennai , India.
Email: [email protected]
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In India, paracetamol is available in many formulations such as liquid
suspension, drops, tablets, injection, rectal suppositories with varying
concentrations (120/125/150/250/500 mg/5 mL). The usual cause of
paracetamol overdose is frequent administration of the drug round the
clock by an anxious parent who regards fever as a potential dangerous
event and as a trigger for febrile seizures. Unfortunately, therapeutic
misadventure (wrong prescription by a doctor) is also an important cause
of paracetamol toxicity in our set-up. In an earlier study, paracetamol
syrup (250mg/5 mL) was common reason of accidental single over dose
(46%) and ‘drops’ was the common formulation causing toxicity due to
multiple dose ingestion (63%) [1]. Even if the medical practitioner
prescribes paracetamol in the right dosage, caregivers inadvertently
administer a high strength formulation, resulting in over-dosage. The
American Academy of Paediatrics has recently recommended the use of a
single strength liquid preparation and the pharma industry in USA has
been adhering to this recommendation. As an initiative, our hospital,
administration has implemented a policy of use of only a single strength
preparation of 125mg/5 mL to prevent over-dosage. This initiative needs
to be propagated all over India through the Indian Academy of
Paediatrics. There is a need to counsel parents that antipyretic agents
do not prevent febrile convulsions and should not be used specifically
for this purpose [2]. Antipyretic agents with the sole aim of reducing
body temperature in children with fever is not recommended and should
only be considered for children with fever-related discomfort [3].
Pediatricians should also promote patient safety by advocating for
simplified formulations, dosing instructions, and dosing devices [4].
References
1. Lakshmi M, Radhika R. Analysis of acetaminophen
toxicity in children in a tertiary care setting, Indian J Trauma Emerg
Pediatr. 2013;5:5-8.
2. Steering Committee on Quality Improvement and
Management, Subcommittee on Febrile Seizures American Academy of
Pediatrics. Febrile seizures: Clinical practice guideline for the
long-term management of the child with simple febrile seizures.
Pediatrics. 2008;121:1281-6.
3. Fields E, Chard J, Murphy MS, Richardson M;
Guideline Development Group and Technical Team. Assessment and initial
management of feverish illness in children younger than 5 years: Summary
of updated NICE guidance. BMJ. 2013;346:f2866.
4. Section on Clinical Pharmacology and Therapeutics;
Committee on Drugs, Sullivan JE, Farrar HC. Fever and antipyretic use in
children. Pediatrics. 2011; 127:580-7.
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