Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
Adverse Reactions Respiratory Depression Promethazine hydrochloride injection is contraindicated in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression.
Promethazine hydrochloride injection should be used with caution in pediatric patients 2 years of age and older (see Warnings - Respiratory Depression).
Severe Tissue Injury, Including Gangrene Promethazine hydrochloride 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, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, 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;
and Dosage and Administration ).
Central Nervous System Drowsiness is the most prominent CNS effect of this drug.
Sedation, somnolence, blurred vision, dizziness, confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion;
lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria.
Warnings Respiratory Depression Pediatrics Promethazine hydrochloride 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.
A wide range of weight-based doses of promethazine hydrochloride injection have resulted in respiratory depression in these patients.
Caution should be exercised when administering promethazine hydrochloride injection to pediatric patients 2 years of age and older.
It is recommended that the lowest effective dose of promethazine hydrochloride injection be used in pediatric patients 2 years of age and older.
Like all medications, Promethazine Hci can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: