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Contraindicated Use in Pediatric Patients less than 2 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
• Post marketing cases of respiratory depression, including fatalities, have been reported with the use of promethazine in pediatric patients less than 2 yrs 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 this drug to pediatric patients 2 years of age or older. It is recommended that the lowest effective dose of promethazine be used in such patients and concomitant administration of other drugs with respiratory depressant effects be avoided.

Severe Tissue Injury, Including Gangrene

Language for Black Box Warning Has Not Been Finalized: The Following is A Summary of Information and Not Complete. See FDA Link Below

• Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage, including gangrene.
• The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.
• Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering