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Indian Pediatr 2014;51: 1019 |
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Dextromethorphan: Problems with Formulations
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Yash Paul
A-D-7, Devi Marg, Bani Park, Jaipur, Rajasthan, India.
Email:
[email protected]
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Dextromethorphan is a commonly used antitussive drug in children.
Recommended dose of dextromethorphan is 1-2 mg per kg per day [1]. As
such there should be no problem in recommending appropriate doses of
cough formula containing dextromethorphan, whenever necessary. Problems
may occur due to of the following reasons:
1. IAP Pediatric Drug Formularly, 2012 states
1.25 - 2 mg/kg/dose 4 times a day [2], and not per kg/day in 4
divided doses. It appears to be a printing mistake. Some doctors may
inadvertently recommend higher dose.
2. Cough syrups containing dextromethorphan by
different manufacturers have different quantity of dextromethorphan
per 5 mL of liquid (e.g. 5 mg, 10 mg and 15 mg). Some doctors may
not be aware of this fact, which can result in inappropriate dosage
of dextromethorphan. Similarly, a pharmacist may substitute the
brand which may result in lower or higher dose of dextromethorphan
to the child. Lower dose would be in-effective and higher dose can
result in adverse reaction.
3. Some manufacturers print recommended dosage
according to age group on the bottle. For example, two different
brands having different composition of dextromethorphan (Piriton CS
10 mg/5 mL and Piritexyl 5 mg/5 mL) but recommend same dose (2.5 mL
3-4 times a day) for a child between 2 and 6 years. The
manufacturers of cough syrups should not mention dosage at all, so
that pediatricians calculate it as per weight of the child.
Any drug can cause adverse reaction in any
individual, and doctors have to inform the patients or their caregivers
about it. In case of dextromethorphan, in addition to the potential side
effects of the drug, the doctors and patients are exposed to problems
created by three sources viz., by experts in form of wrong dosage
recommendation,; by pharmaceutical industry in making formulations with
different quantity of dextromethorphan and wrong dosage recommendations;
and by pharmacists in substituting one brand with other brand without
checking the quantity of dexomethorphan in substituted brand. Regulatory
agencies should ensure that all brands have similar composition with the
correct instructions on product insert.
References
1. Gupte S, Gupte N. Pediatric Drug Directory.
Antitussives. 8th edition 2014. Jaypee Brothers Medical Publishers: New
Delhi. p. 41.
2. Unni JC, Nair MKC, Menon PSN, Bansal CP. IAP Pediatric Drug
Formulary 2012, 3rd edition. Mumbai: Indian Academy of Pediatrics. p.
311.
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