WARNINGS
Respiratory Depression – Pediatrics
PHENERGAN Injection 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 in pediatric patients less than 2 years of age. Caution should be exercised when administering PHENERGAN Injection to pediatric patients 2 years of age and older (see
WARNINGS - RESPIRATORY DEPRESSION).
Severe Tissue Injury, Including Gangrene
PHENERGAN Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required (see
WARNINGS - SEVERE TISSUE INJURY, INCLUDING GANGRENE).
Due to the risks of intravenous injection,
the preferred route of administration of PHENERGAN Injection is deep intramuscular injection. Subcutaneous injection is contraindicated. See
DOSAGE AND ADMINISTRATION for important notes on administration.