Fioricet is a combination medication commonly used to treat tension headaches but doctors also recommend it for recurring migraines. Fioricet is a prescription medication that combines acetaminophen, butalbital, and caffeine. It is primarily used for treating tension headaches and, in some cases, migraines.
Acetaminophen is used to decrease the pain associated with muscular tension and caffeine increases the efficiency of the pain-killing effect. The last constituent of Fioricet is butalbital, a powerful sedative having the property to reduce anxiety and induce relaxation. This barbiturate is also responsible for the sleepiness appearing after Fioricet intake. Fioricet is available as tablets for oral administration, to be taken whole, by mouth, with or without food.
Approved Uses of Fioricet
- Tension Headaches
- Fioricet is FDA-approved for the treatment of tension or muscle-contraction headaches.
- It works by relaxing muscle tension, dulling pain, and stimulating blood flow.
- Headache Relief
- It provides quick relief for headaches that involve mild to moderate pain, often accompanied by stress or anxiety.
Off-Label Uses of Fioricet
While not officially FDA-approved for these conditions, Fioricet may be prescribed off-label in certain situations:
- Migraine Relief
- Some healthcare providers prescribe Fioricet for migraines when other medications are ineffective. However, frequent use can lead to rebound headaches.
- Other Chronic Pain Conditions
- In some cases, Fioricet is used for other types of chronic pain, although this is less common due to the risk of dependence.
- Cluster Headaches
- Occasionally, it may be prescribed to manage cluster headaches, though this is rare and not a first-line treatment.
The Dosages of Fioricet
The recommended dosage is of 1-2 tablets every 4 hours or as the doctor prescribes. Fioricet treatments can cause nausea and this is why most patients prefer to take this medication without food. Talking to the doctor about the nausea problem could lead to finding out essential information on how to reduce this unwanted effect. In fact, he/she can prescribe antihistamines for the nausea but there is also the possibility of lying down one hour after taking the medication.
The standard dosage of Fioricet depends on the specific formulation and the patient’s medical condition.
Standard Fioricet Dosage
Each tablet of Fioricet Butalbital APAP Caffeine contains:
- Acetaminophen: 325 mg
- Butalbital: 50 mg
- Caffeine: 40 mg
Adults
- Usual Dosage: 1-2 tablets every 4 hours as needed.
- Maximum Dosage: Do not exceed 6 tablets per day to avoid the risk of acetaminophen toxicity and other adverse effects.
Pediatric Use
- Fioricet is not typically recommended for children. If prescribed, the dosage should be determined and closely monitored by a healthcare provider.
For the treatment of the symptom complex of tension headache. Oral dosage (capsules or tablets containing 50 mg of butalbital, 300 or 325 mg of acetaminophen, 40 mg of caffeine) Adults
1 or 2 capsules or tablets PO every 4 hours as needed. Max: 6 capsules or tablets/day.
Children and Adolescents 12 to 17 years
1 or 2 capsules or tablets PO every 4 hours as needed. Max: 6 capsules or tablets/day.
Oral dosage (solution containing 50 mg of butalbital, 325 mg of acetaminophen, 40 mg of caffeine per 15 mL) Adults
15 to 30 mL PO every 4 hours as needed. Max: 90 mL/day.
Children and Adolescents 12 to 17 years
15 to 30 mL PO every 4 hours as needed. Max: 90 mL/day.
For the acute treatment of migraine†. Oral dosage (capsules or tablets containing 50 mg of butalbital, 325 mg of acetaminophen, 40 mg of caffeine) Adults
50 mg butalbital/325 mg acetaminophen/40 mg caffeine PO as a single dose. Guidelines classify butalbital; acetaminophen; caffeine as having possible efficacy for the treatment of acute migraine.
Mechanism of Action of Fioricet
Butalbital is a barbiturate with CNS depressive (sedative) properties; acetaminophen is an analgesic; caffeine is a methylxanthine CNS psychostimulant. The role each component plays in the relief of tension headache symptoms is incompletely understood.
Butalbital: Barbiturates inhibit ascending conduction in the reticular formation, which interferes with conduction of impulses to the cortex causing sensory cortex depression, decreased motor activity, drowsiness, sedation and changes in cerebral function. Barbiturates bind to gamma-aminobutyric acid (GABA) A and alpha-amino-3-hydroxy-5-methyl-isoxazole-4-propionic acid (AMPA) receptors.
GABA A receptor binding by barbiturates causes inhibition of the postsynaptic neuron, as the physiologic substrate for the receptor is GABA, which is an inhibitory amino acid. Barbiturates enhance GABA binding to GABA A receptors, which prolongs the duration of GABA-induced chloride channel opening and promotes binding of a benzodiazepine to the GABA A receptor. Benzodiazepines increase the frequency of GABA-induced chloride channel opening. Thus, additive CNS depressant effects occur with concomitant barbiturate and benzodiazepine usage.
Binding of a barbiturate to the AMPA receptor prevents the binding of the physiologic substrate, AMPA, an excitatory amino acid. The activation of GABA A receptors and the inhibition of AMPA receptors causes a nonselective depressant effect throughout the CNS that can range from mild sedation to general anesthesia. Butalbital does not have a direct analgesic action; pain perception is relatively unimpaired until the moment of unconsciousness. Thus, butalbital has a low therapeutic index.
Acetaminophen: Acetaminophen acts primarily in the CNS and increases the pain threshold by inhibiting cyclooxygenase, an enzyme involved in prostaglandin (PG) synthesis. Acetaminophen inhibits both isoforms of central cyclooxygenase, COX-1 and COX-2. It does not inhibit PG synthesis in peripheral tissues, which is the reason for its lack of peripheral anti-inflammatory effects.
Caffeine: Caffeine causes cerebral vasoconstriction, which decreases blood flow and oxygen tension. In combination with acetaminophen, caffeine may provide a quicker onset of action and enhance pain relief allowing for lower doses of analgesics. In some patients, caffeine relieves headaches by treating the effects of caffeine withdrawal.
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Fioricet Side Effects
Severe Side Effects
hepatic necrosis / Delayed / Incidence not known
interstitial nephritis / Delayed / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
renal tubular necrosis / Delayed / Incidence not known
renal papillary necrosis / Delayed / Incidence not known
methemoglobinemia / Early / Incidence not known
pancytopenia / Delayed / Incidence not known
hemolytic anemia / Delayed / Incidence not known
agranulocytosis / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
exfoliative dermatitis / Delayed / Incidence not known
erythema multiforme / Delayed / Incidence not known
acute generalized exanthematous pustulosis (AGEP) / Delayed / Incidence not known
toxic epidermal necrolysis / Delayed / Incidence not known
seizures / Delayed / Incidence not known
Moderate Side Effects
constipation / Delayed / Incidence not known
jaundice / Delayed / Incidence not known
dysphagia / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
hypoprothrombinemia / Delayed / Incidence not known
encephalopathy / Delayed / Incidence not known
elevated hepatic enzymes / Delayed / Incidence not known
thrombocytosis / Delayed / Incidence not known
neutropenia / Delayed / Incidence not known
hemolysis / Early / Incidence not known
thrombocytopenia / Delayed / Incidence not known
edema / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known
erythema / Early / Incidence not known
tolerance / Delayed / Incidence not known
euphoria / Early / Incidence not known
depression / Delayed / Incidence not known
hot flashes / Early / Incidence not known
confusion / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known
palpitations / Early / Incidence not known
withdrawal / Early / Incidence not known
psychological dependence / Delayed / Incidence not known
physiological dependence / Delayed / Incidence not known
medication overuse headache / Delayed / Incidence not known
dyspnea / Early / Incidence not known
Mild Side Effects
anorexia / Delayed / Incidence not known
xerostomia / Early / Incidence not known
abdominal pain / Early / Incidence not known
vomiting / Early / Incidence not known
flatulence / Early / Incidence not known
nausea / Early / Incidence not known
dyspepsia / Early / Incidence not known
increased urinary frequency / Early / Incidence not known
polyuria / Early / Incidence not known
purpura / Delayed / Incidence not known
photosensitivity / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
rash / Early / Incidence not known
pruritus / Rapid / Incidence not known
maculopapular rash / Early / Incidence not known
urticaria / Rapid / Incidence not known
fever / Early / Incidence not known
agitation / Early / Incidence not known
vertigo / Early / Incidence not known
drowsiness / Early / Incidence not known
irritability / Delayed / Incidence not known
lethargy / Early / Incidence not known
anxiety / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known
dizziness / Early / Incidence not known
syncope / Early / Incidence not known
tremor / Early / Incidence not known
insomnia / Early / Incidence not known
ptosis / Delayed / Incidence not known
headache / Early / Incidence not known
nasal congestion / Early / Incidence not known
hyperhidrosis / Delayed / Incidence not known
musculoskeletal pain / Early / Incidence not known
fatigue / Early / Incidence not known
tinnitus / Delayed / Incidence not known
otalgia / Early / Incidence not known
Fioricet Common Brand Names
Alagesic, Americet, Anolor-300, Arcet, BAC, CAPACET, Esgic, Ezol, Fioricet, Geone, Margesic, Medigesic, Orbivan, Pacaps, Phrenilin Forte, Repan, Tenake, Triad, Vanatol LQ, Vanatol S, Vtol LQ, Zebutal
Fioricet Drug Interactions
Drug-Drug
- Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, opioid analgesics, and sedative/hypnotics.
- May increase the liver metabolism and ↓ the effectiveness of other drugs including amiodarone, benzodiazepines, bupropion, calcium channel blockers, carbamazepine, citalopram, clarithromycin, cyclosporine, erythromycin, fluoxetine, fluvoxamine, glipizide, hormonal contraceptives, losartan, methadone, mirtazapine, nateglinide, nefazodone, nevirapine, phenytoin, pioglitazone, promethazine, propranolol, protease inhibitors, proton pump inhibitors, rifampin, ropinirole, selegiline, sertraline, tacrolimus, theophylline, venlafaxine, voriconazole, warfarin, and zafirlukast.
- MAO inhibitors, felbamate, primidone, and valproic acid may prevent metabolism and ↑ the effectiveness of butalbital.
Drug-Natural Products:
- St. John’s wort may ↓ barbiturate effect.
- Concurrent use of kava kava, valerian, skullcap, chamomile, or hops can increase CNS depression.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.