The Drugs Controller General (India) had sought an
expert opinion from the Indian Academy of Pediatrics (IAP) regarding
the use of Metoclopramide in children following a newspaper report
linking this drug to death of a two and a half year old child. The
following sources and methods were utilized by the IAP Committee for
Protection of Child Consumer to make specific recommendations
regarding its use in children: (i) Available relevant
literature including the Physicians Desk Reference (2002), Goodman and
Gillman Textbook on Pharmacology, MIMS India (May 2003), Nelson's
Textbook of Pediatrics, and Medline search on internet including FDA
website; (ii) Opinion from the Royal College of Paediatrics and
Child Health, U.K.; (iii) Brochures provided by the
manufacturers; (iv) Opinions from the members of the IAP
Committee for Protection of Child Consumer, members of the Executive
Board and some senior members of the profession; and (v)
Discussions held during the Consensus Meeting of the IAP to formulate
"Guidelines for Management of Diarrhea". This statement is primarily
intended to update the members regarding the current recommendations
for usage of Metoclopramide in children; it does not attempt to guide
preferential use of one anti-emetic over another. To retain scientific
independence, no funding was taken from any source for formulating
this statement.
1. The safety profile of Metoclopramide in adults
cannot be extrapolated to pediatric patients. The recommended
indications for its usage in children include: (i)
Pre-medication for jejunal biopsy and small bowel intubation to
assist passage through pylorus. The suggested dosage is: under 6
years of age 0.1 mg/kg, 6-14 years of age 2.5 to 5 mg and over 14
years of age 10 mg; (ii) Prophylaxis and treatment of
vomiting associated with chemotherapy, radiotherapy and
post-operatively; (iii) Persistent vomiting of a known cause
like gastro-esophageal reflux.
2. Except for isolated product information
supplied by manufacturer, other available literature does not
advocate the use of Metoclopramide in children as a general
anti-emetic, including for vomiting associated with gastroenteritis.
However, this drug is often used as a general anti-emetic in India.
On the basis of the conducted review it is not feasible to comment
on this practice; systematic evidence needs to be generated for this
purpose.
3. Adverse effects of Metoclopramide, especially
extrapyramidal reactions including acute dystonic reactions are more
common in children, adolescents and young adults, more so with
increased dosage. Diphenhydramine hydochloride is advised for
prevention/treatment of extrapyramidal reactions but there is no
parenteral preparation in the Indian market.
4. Commercially available Metoclopramide injection is usually
marketed as 2 mL ampules containing 10 mg of the drug. The drug can be
given intravenously or intramuscularly but without dilution. In a
child weighing 10 kg, only 1 mg (0.2 mL) of the drug can be given. For
different weights of children, not only is the calculation prone to
error but, also difficult to administer precisely and can result in
over-dosage. Manufacturers should provide a ready reckoner for dosage
in milliliters plus a 1ml syringe with each ampule.
Members of IAP Committee for Protection of Child
Consumer: Subhash C. Arya (Chairman), Baldev S.
Prajapati (Convenor), Satish Pandya (Advisor),
B.K. Dutt (Member), Dinesh Khosla (Member),
Anupam Sachdeva (Member), H.P.S. Sachdev
(Ex-officio member), Nitin K. Shah (Ex-officio member).
Correspondence: Dr. S.C. Arya, B-453, New Friends Colony, New
Delhi 110 065, India. E-mail; scaryanfc@yahoo. com
