OVERDOSE
Because of the dose ratio of dipyridamole to aspirin,
overdosage of AGGRENOXTM is likely to be dominated by
signs and symptoms of dipyridamole overdose. In case of
real or suspected overdose, seek medical attention or
contact a Poison Control Center immediately. Careful medical
management is essential.
Dipyridamole
Based upon the known hemodynamic effects of dipyridamole,
symptoms such as warm feeling, flushes, sweating, restlessness,
feeling of weakness and dizziness may occur. A drop in
blood pressure and tachycardia might also be observed.
Symptomatic treatment is recommended, possibly including
a vasopressor drug. Gastric lavage should be considered.
Since dipyridamole is highly protein bound, dialysis is
not likely to be of benefit.
Aspirin
Salicylate toxicity may result from acute ingestion (overdose)
or chronic intoxication. The early signs of salicylic
overdose (salicylism), including tinnitus (ringing in
the ears), occur at plasma concentrations approaching
200 µg/mL. Plasma concentrations of aspirin above
300 µg/mL are clearly toxic. Severe toxic effects
are associated with levels above 400 µg/mL. A single
lethal dose of aspirin in adults is not known with certainty
but death may be expected at 30 g.
Treatment consists primarily of supporting vital functions,
increasing salicylate elimination, and correcting the
acid-base disturbance. Gastric emptying and/or lavage
are recommended as soon as possible after ingestion, even
if the patient has vomited spontaneously. After lavage
and/or emesis, administration of activated charcoal, as
a slurry, is beneficial, if less than 3 hours have passed
since ingestion. Charcoal absorption should not be employed
prior to emesis and lavage.
Severity of aspirin intoxication is determined by measuring
the blood salicylate level. Acid-base status should be
closely followed with serial blood gas and serum pH measurements.
Fluid and electrolyte balance should also be maintained.
In severe cases, hyperthermia and hypovolemia are the
major immediate threats to life. Children should be sponged
with tepid water. Replacement fluid should be administered
intravenously and augmented with correction of acidosis.
Plasma electrolytes and pH should be monitored to promote
alkaline diuresis of salicylate if renal function is normal.
Infusion of glucose may be required to control hypoglycemia.
Hemodialysis and peritoneal dialysis can be performed
to reduce the body drug content. In patients with renal
insufficiency or in cases of life-threatening intoxication,
dialysis is usually required. Exchange transfusion may
be indicated in infants and young children.
AGGRENOXTM
A single oral dose of combination of dipyridamole and
aspirin at doses of up to 6.75 g/kg in a ratio of 8:1
was non-lethal in rats. Decreased locomotor activity,
prone position and piloerection were observed at doses
of combination of dipyridamole and aspirin at 2.25 and
6.75 g/kg.
CONTRAINDICATIONS
AGGRENOXTM is contraindicated in patients with hypersensitivity
to dipyridamole, aspirin or any of the other product components.
Allergy: Aspirin is contraindicated
in patients with known allergy to nonsteroidal anti-inflammatory
drug products and in patients with the syndrome of asthma,
rhinitis, and nasal polyps. Aspirin may cause severe urticaria,
angioedema or bronchospasm (asthma).
Reye’s Syndrome: Aspirin should not
be used in children or teenagers for viral infections, with
or without fever, because of the risk of Reye’s syndrome
with concomitant use of aspirin in certain viral illnesses.
|
|
