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Author: Admin | 2025-04-28
Be administered with caution in children 2 years of age and older, because of possible respiratory depression and/or apnea that may be fatal. The lowest effective dose of the drug should be used. Concomitant use of promethazine with other respiratory depressants should be avoided. Children receiving promethazine should be closely supervised while performing hazardous activities such as bike riding. Adults responsible for the supervision of a child receiving promethazine should be warned that children may be at increased risk for experiencing CNS-stimulant effects with antihistamines. The drug should not be used in acutely ill or dehydrated children or in those with acute infections, since these patients have an increased susceptibility to dystonias. Use of promethazine also should be avoided in children with signs and symptoms that suggest Reye’s syndrome, since the potential extrapyramidal effects produced by the drug may obscure the diagnosis of or be confused with the CNS signs and symptoms of this condition, and in children with signs and symptoms of other hepatic disease. Because promethazine may cause marked drowsiness that may be potentiated by other CNS depressants (e.g., sedatives, tranquilizers), the antihistamine should be used in children receiving one of these drugs only under the direction of a clinician. Promethazine should not be used in children with asthma, liver disease, a seizure disorder, or glaucoma unless otherwise directed by a clinician. Excessively high dosages of promethazine hydrochloride have caused sudden death in pediatric patients, although sleep apnea, and sudden infant death syndrome (SIDS) have been reported in a number of infants and young children who were receiving usual dosages of promethazine hydrochloride or trimeprazine (no longer commercially available in the US). The relationship to the drugs and possible mechanism(s) of such effects have not been elucidated. In one study, the number but not the duration of central apneas during sleep was increased and obstructive apnea during sleep (accompanied by decreased heart rate and arterial oxygen pressure) developed in 4 healthy infants who were receiving 1 mg/kg of promethazine hydrochloride daily for 3 days. Promethazine should be used with caution in children with a history of sleep apnea,
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