| Drug Name: | Promethazine Hydrochloride |
| Manufacturer: | Perrigo New York, Inc. |
| Other Info: | Mfg By: Clay Park Labs, Inc.Bronx, NY 104571759-2X R0305 |
| Clinical Trials: | |
Promethazine HCl suppositories are contraindicated for use in pediatric patients less than two years of age.Promethazine HCl suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenolhiazines.
Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.PROMETHAZINE HCl SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCl SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE.
A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.
IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl SUPPOSITORIES BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.