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Since recurrences of nms have been reported with phenothiazines, the reintroduction of promethazine hcl promethazine hydrochloride should be carefully considered.

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Promethazine hydrochloride tablets may lower seizure thresholdThey should be used with caution in persons with seizure disorders or in persons who are using concomitant medicationssuch as narcotics or local anestheticswhich may also affect seizure threshold.

POSTMARKETING CASES OF RESPIRATORY DEPRESSIONINCLUDING FATALITIESHAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGEA WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTSCAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDERIT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

Promethazine hydrochloride tablets are contraindicated in comatose statesand in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazinesAntihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

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