Fioricet Common Medical Uses:
Fioricet is a pain reliever and sedative. Acetaminophen is a pain reliever and fever reducer. Butalbital is in a class of drugs called barbiturates that slow down central nervous system causing relaxation. Caffeine is believed to constrict dilated blood vessels that may contribute to tension headaches. Together, acetaminophen, butalbital, and caffeine are used to relieve complex tension headaches although exactly how it works is unknown. Fioricet may be used for purposes other than those listed in this instruction.

Fioricet Dosage:
Usual dosage: 1 or 2 tablets every 4 hours as needed.

Maximum dosage: total daily dosage should not exceed 6 tablets.

Limit Fioricet use to twice weekly to avoid rebound headache.

Extended and repeated use of Fioricet is not recommended because of the potential for physical dependence.

Fioricet Possible Side Effects:
Frequent side effects:

drowsiness
lightheadedness
dizziness
sedation
shortness of breath
nausea
vomiting
abdominal pain,
intoxicated feeling

Infrequent side effects:

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.
Autonomic Nervous System: dry mouth, hyperhidrosis.
Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.
Cardiovascular: tachycardia.
Musculoskeletal: leg pain, muscle fatigue.
Genitourinary: diuresis.
Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.
Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

If you notice other effects not listed above, contact your doctor or pharmacist.

Pregnancy & Lactation:

Pregnancy Risk: C. Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen, and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers: Caffeine, barbiturates, and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen, and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Fioricet Warnings & Precautions:

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Fioricet may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided.

Drug Interactions:

Effects of the following drugs may be decreased:
b Beta-blockers (eg, propranolol)
corticosteroids
doxycycline
estrogens (including oral contraceptives)
felodipine
griseofulvin
nifedipine
phenylbutazone
quinidine
theophylline
warfarin
Carbamazepine, sulfinpyrazone - may increase risk of hepatotoxicity
MAOIs - may increase CNS effects
CNS depressants (eg, ethanol, narcotics, general anesthetics, tranquilizers, sedative-hypnotics) - increased drowsiness, dizziness, and other CNS depressive effects may occur.
Tricyclic antidepressants - antidepressant effect may decrease.
Laboratory Test Interactions: with Chemstrip bG and Dextrostix home blood glucose systems, may cause false decrease in mean glucose values; may give false-positive urinary 5-hydroxyindoleacetic acid test result.

Overdosage:
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.

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.

Toxic Doses (for adults)

Butalbital	1 g	20 tablets
Acetaminophen	10 g	30 tablets
Caffeine	1 g	25 tablets

Missed Dose:
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose of this medication.

Storage:
Store it at room temperature, away from excess heat and moisture. Keep this medication in the container it came in, tightly closed. Keep this and all medications out of the reach of children.

Notes:
Do not share this product with others.

Where to Buy:
If you would like to purchase brand name or generic Fioricet (butalbital) with no prior doctor's prescription, choose the offer from the above table.

References:

1. U.S. Food and Drug Administration. Fioricet (Butalbital/APAP/Caffeine) U.S. Prescribing Information.