Promethazine HCl Suppositories, USP should not be used in
pediatric patients less than 2 years of age because of the
potential for fatal respiratory depression. It is recommended
that the lowest effective dose of promethazine HCl be used in
pediatric patients 2 years of age and older and concomitant
administration of other drugs with respiratory depressant
effects be avoided. A potentially fatal symptom complex
sometimes referred to as Neuroleptic Malignant Syndrome (NMS)
has been reported in association with promethazine HCl alone
or in combination with antipsychotic drugs. Promethazine HCl
Suppositories USP are contraindicated in comatose states and
in patients with lower respiratory tract symptoms, including
asthma. Please refer to enclosed full prescribing information
for BOXED WARNING.
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