Generic Fioricet

Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity     may result from the barbiturate or the acetaminophen. Toxicity due to caffeine     is less likely, due to the relatively small amounts in this formulation.

Signs and Symptoms

Toxicity from barbiturate poisoning include drowsiness, confusion, and coma;     respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis     is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma,     and thrombocytopenia may also occur. Early symptoms following a potentially     hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general     malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent     until 48 to 72 hours post-ingestion. In adults hepatic toxicity has rarely been     reported with acute overdoses of less than 10 grams, or fatalities with less     than 15 grams.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium,     tachycardia and extrasystoles.

Treatment

A single or multiple overdose with this combination product is a potentially     lethal polydrug overdose, and consultation with a regional poison control center     is recommended.

Immediate treatment includes support of cardiorespiratory function and measures     to reduce drug absorption. Vomiting should be induced mechanically, or with     syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal     reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying.     The first dose should be accompanied by an appropriate cathartic. If repeated     doses are used, the cathartic might be included with alternate doses as required.     Hypotension is usually hypovolemic and should respond to fluids. Pressors should     be avoided. A cuffed endotracheal tube should be inserted before gastric lavage     of the unconscious patient and when necessary, to provide assisted respiration.     If renal function is normal, forced diuresis may aid in the elimination of the     barbiturate. Alkalinization of the urine increases renal excretion of some barbiturates,     especially phenobarbital.

Meticulous attention should be given to maintaining adequate pulmonary ventilation.     In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis     may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose,     vitamin K should be administered intravenously.

If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should     be administered as early as possible. Serum acetaminophen levels should be obtained,     since levels four or more hours following ingestion help predict acetaminophen     toxicity. Do not await acetaminophen assay results before initiating treatment.     Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.

Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous     administration.

Toxic Doses (for adults)

In all cases of suspected overdosage, call your Regional Poison Control Center     to obtain the most up-to-date information about the treatment of overdosage.     Telephone numbers of certified Regional Poison Control Centers are listed in     the Physicians’ Desk Reference®*.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, dizziness, drowsiness, diarrhea, increased sweating, shallow breathing, confusion, uneven heartbeats, seizure (convulsions), or coma.