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 event reports 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.
Because of the risks of intravenous
injection, the preferred route of administration of
PHENERGAN Injection is deep intramuscular injection (see DOSAGE AND ADMINISTRATION). Subcutaneous injection is
contraindicated. Due to the close proximity of arteries and
veins in the areas most commonly used for intravenous
injection, extreme care should be exercised to avoid
perivascular extravasation or unintentional intra-arterial
injection as pain, severe chemical irritation, severe spasm
of distal vessels, and resultant gangrene requiring
amputation are likely under such circumstances. Aspiration
of dark blood does not preclude intra-arterial needle
placement because blood is discolored upon contact with
PHENERGAN Injection. Use of syringes with rigid plungers or
of small-bore needles might obscure typical arterial
backflow if this is relied upon alone.
In the event that a patient complains
of pain during intravenous injection of Phenergan Injection,
the injection should be stopped immediately to evaluate for
possible arterial injection or perivascular
extravasation.
There is no proven successful
management of unintentional intra-arterial injection or
perivascular extravasation after it occurs. Sympathetic
block and heparinization have been employed during the acute
management of unintentional intra-arterial injection,
because of the results of animal experiments with other
known arteriolar irritants.
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, 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).