From rxpgnews.com
New FDA Warning Contraindicates Promethazine Use in Children Less Than 2 years of Age
By Akanksha, Pharmacology Correspondent
Feb 23, 2005, 12:24
Based on a review of adverse events for promethazine in pediatric patients, the Food and Drug Administration (FDA) and Wyeth notified healthcare professionals of revisions to the contraindications, warnings in pediatric patients, and dosage and administration sections of the prescribing information for promethazine.
The new warning contraindicates the use of promethazine Tablets and Suppositories in pediatric patients less than two years of age.
Promethazine 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 fatalitiles, have been repoted with use of promethazine in pediatric patiens less than 2 years of age. A wide range of weight-based doses of promethazine have resulted in respiratory depression in these patients.
Caution should be exercised when administering promethazine to pediatric patients 2 years of age and older.
It is recommended that the lowest effective dose of promethazine be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided.
Respiratory depression and apnea, sometimes associated with death, are strongly associated with promethazine products and are not directly related to individualized weight-based dosing, which might otherwise permit safe administration.
Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.
Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. The extrapyramidal symptoms which can occur secondary to
promethazine tablets and suppositories administration may be confused with the CNS signs of undiagnosed primary disease, e.g.,encephalopathy OR Reye�s Syndrome.
Promethazine tablets and supossitories should be avoided in pediatric patients whose signs and symptoms may suggest Reye's Syndrome or other hepatic diseases.
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