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Fioricet®
(Butalbital, Acetaminophen, and Caffeine
Tablets USP)
Also see:
Butalbital APAP
Esgic Plus
Fioricet
Drug Uses
Fioricet is a barbiturate sedative mixed with a
non-aspirin pain medication and caffeine. This non-narcotic pain medication and
relaxant is often prescribed for tension headaches caused by contractions of the
muscles in the neck and shoulder area, and migraine.
How Taken
Fioricet comes as a capsule and tablet to take by
mouth. One or 2 tablets every 4 hours as needed. Total daily dosage should not
exceed 6 tablets. Extended and repeated use of this product is not recommended
because of the potential for physical dependence.
Warnings/Precautions
Fioricet may cause you to become drowsy or less
alert; therefore, driving or operating dangerous machinery or participating in
any hazardous activity that requires full mental alertness is not recommended
until you know your response to this drug. If you are being treated for severe
depression or have a history of severe depression or drug abuse, consult with
your doctor before taking Fioricet. Use this drug with caution if you are
elderly or in a weakened condition, if you have liver or kidney problems, or if
you have severe abdominal trouble. If you are pregnant or plan to become
pregnant, inform your doctor immediately. Fioricet can affect a developing baby.
It also appears in breast milk. If this medication is essential to your health,
your doctor may advise you to discontinue breastfeeding your baby until your
treatment is finished.
Missed Dose
Take the missed dose as soon as you remember it.
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 to make up for
a missed one.
Possible Side Effects
Side effects cannot be anticipated. If any
develop or change in intensity, inform your doctor as soon as possible. Only
your doctor can determine if it is safe for you to continue taking Fioricet.
More common side effects may include: Abdominal pain, dizziness, drowsiness,
intoxicated feeling, light-headedness, nausea, sedation, shortness of breath,
vomiting. Less common or rare side effects may include: Agitation, allergic
reactions, constipation, depression, difficulty swallowing, dry mouth, earache,
exaggerated feeling of well-being, excessive sweating, excessive urination,
excitement, fainting, fatigue, fever, flatulence, headache, heartburn, heavy
eyelids, high energy, hot spells, itching, leg pain, mental confusion, muscle
fatigue, numbness, rapid heartbeat, ringing in the ears, seizure, shaky feeling,
skin redness and/or peeling, sluggishness, stuffy nose, tingling.
Storage
Store below 86° F (30° C); dispense in a tight
container and out of reach of children.
Overdose
An overdose of Fioricet, or combining this
medication with alcohol or other central nervous system depressant, may lead to
unconsciousness or perhaps death. Fioricet overdose is indicated by severe
drowsiness, confusion, extreme weakness, hallucination, shortness of breath, too
slow or troubled breathing, slurred speech, lack of coordination, vomiting with
blood, unusually slow heartbeat.
More Information
Do not take Fioricet if you have taken a
monoamine oxidase inhibitor (MAOI) in the last 14 days. Dangerous side effects
could result. Fioricet may increase the effects of other drugs that cause
drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used
to treat insomnia), other pain relievers, anxiety medicines, and muscle
relaxants. Tell your doctor about all medicines that you are taking, and do not
take any medicine unless your doctor approves.
Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets, USP) is supplied in
tablet form for oral administration.
Each tablet contains:
butalbital*, USP ........................................................ 50 mg
*warning: May be habit-forming.
acetaminophen, USP
.................................................325 mg
caffeine, USP ............................................................ 40 mg
Active Ingredients: butalbital, USP, acetaminophen, USP, and caffeine, USP
Inactive Ingredients: crospovidone, FD&C Blue #1, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
Butalbital: (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate. It has the following molecular formula:
C11H16N2O3 with molecular weight 224.26.
Acetaminophen: (4'-hydroxyacetanilide), is a non- opiate, non-salicylate
analgesic and antipyretic. It has the following molecular formula: C8H9NO2 with
molecular weight 151.16.
Caffeine: (1 ,3,7- trimethylxanthine), is a central nervous system stimulant. It
has the following molecular formula: C8H10N4O2 with molecular weight 194.19.
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