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HYDROCHLORIDE TABLETS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSIONRESPIRATORY DEPRESSION AND APNEASOMETIMES ASSOCIATED WITH DEATHARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSINGWHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATIONCONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSIONAND SOMETIMES DEATHIN PEDIATRIC PATIENTS.

Promethazine is used to prevent and treat nausea and vomiting related to certain conditionssuch as before/after surgerymotion sicknessIt is also used to treat allergy symptoms such as rashitchingand runny noseIt may be used to help you feel sleepy/relaxed before and after surgery or to help certain narcotic pain relieverssuch as meperidinework betterIt may also be used for a short time to treat a runny nose due to the common cold.

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant SyndromeNMShas been reported in association with promethazine HClpromethazine hydrochloridealone or in combination with antipsychotic drugsClinical manifestations of NMS are hyperpyrexiamuscle rigidityaltered mental status and evidence of autonomic instabilityirregular pulse or blood pressuretachycardiadiaphoresis and cardiac dysrhythmiasThe diagnostic evaluation of patients with this syndrome is complicatedIn arriving at a diagnosisit is important to identify cases where the clinical presentation includes both serious medical illnesse.gpneumoniasystemic infectionetcand untreated or inadequately treated extrapyramidal signs and symptomsEPSOther important considerations in the differential diagnosis include central anticholinergic toxicityheat strokedrug fever and primary central nervous systemCNSpathology.

Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age.

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