$Unique_ID{BRK01836}
$Pretitle{}
$Title{ASPIRIN, CAFFEINE, BUTALBITAL, AND CODEINE COMBINATION}
$Subject{B-A-C #3 (Mayrand)
Fiorinal with Codeine (Sandoz)}
$Volume{}
$Log{
Fiorinal with Codeine*0183601.scf}

Copyright (C) 1991 Publications International, Ltd.


ASPIRIN, CAFFEINE, BUTALBITAL, AND CODEINE COMBINATION
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BRAND NAMES (Manufacturers):
     B-A-C #3 (Mayrand)
     Fiorinal with Codeine (Sandoz)
TYPE OF DRUG:
     Analgesic combination and sedative
INGREDIENTS:
     aspirin, caffeine, butalbital, and codeine
DOSAGE FORMS:
     Tablets (325 mg aspirin, 40 mg caffeine, 50 mg butalbital, and 30 mg
       codeine)
     Capsules (325 mg aspirin, 40 mg caffeine, 50 mg butalbital, and 7.5 mg,
       15 mg, or 30 mg codeine)
     Note that on the label of the vial of tablets or capsules the name of
       this drug is followed by a number.  This number refers to the amount of
       codeine present (#1 contains 7.5 mg codeine, #2 has 15 mg codeine, and
       #3 contains 30 mg codeine).
STORAGE:
     Aspirin, caffeine, butalbital, and codeine combination tablets and
       capsules should be stored at room temperature in tightly closed
       containers.  Moisture causes the aspirin in this product to decompose.

USES

     This combination medication is used to relieve tension headaches and mild
to moderate pain.  Codeine is a narcotic analgesic that acts on the central
nervous system (brain and spinal cord) to relieve pain.  Butalbital belongs to
a group of drugs known as barbiturates.  The barbiturates act on the central
nervous system to produce relaxation.  Caffeine is a central nervous system
stimulant.  It constricts blood vessels in the head, which may help to relieve
headaches.

TREATMENT

     In order to avoid stomach upset, you can take this medication with food
or milk.
     This medication works most effectively if you take it at the onset of
pain, rather than waiting until the pain becomes intense.
     If you are taking this medication on a regular schedule and you miss a
dose, take the missed dose as soon as possible, unless it is almost time for
your next dose.  In that case, don't take the missed dose at all; just return
to your regular dosing schedule.  Do not double the next dose.

SIDE EFFECTS

     Minor.

     Constipation, dizziness, drowsiness, flushing, headache, indigestion,
loss of appetite, nausea, nervousness, sleep disorders, sweating, tiredness,
or vomiting.  These side effects should disappear as your body adjusts to the
medication.
     If you feel dizzy or light-headed, sit or lie down for a while; get up
from a sitting or lying position slowly, and be careful on stairs.
     If you are constipated, increase the amount of fiber in your diet (fresh
fruits and vegetables, salads, bran, and whole-grain breads), drink more
water, and exercise (unless your doctor directs you to do otherwise).

     Major.

     Tell your doctor about any side effects that are persistent or
particularly bothersome.  IT IS ESPECIALLY IMPORTANT TO TELL YOUR DOCTOR about
bloody or black, tarry stools; blurred vision; chest tightness; confusion;
difficult or painful urination; loss of coordination; palpitations; rash;
ringing in the ears; shortness of breath; severe abdominal pain; sore throat
and fever; or yellowing of the eyes or skin.

INTERACTIONS

     This combination medication interacts with several other types of drugs:
     1. Concurrent use of this medication with other central nervous system
depressants (such as alcohol, antihistamines, barbiturates, benzodiazepine
tranquilizers, muscle relaxants, or phenothiazine tranquilizers) or with
tricyclic antidepressants can cause extreme drowsiness.
     2. Alcohol and anti-inflammatory medications can increase the
gastrointestinal side effects of this medication.
     3. The side effects of anticoagulants (blood thinners, such as warfarin),
oral antidiabetic agents, phenytoin, and methotrexate may be increased by the
aspirin in this product.
     4. Large doses of antacids increase the elimination of the aspirin
portion of this medication from the body and decrease its effectiveness.
     5. Aspirin may decrease the antigout effects of probenecid and
sulfinpyrazone.
     6. Butalbital can increase the elimination from the body of oral
contraceptives (birth control pills), carbamazepine, adrenocorticosteroids
(cortisone-like drugs), digoxin, doxycycline, tricyclic antidepressants,
griseofulvin, metronidazole, theophylline, aminophylline, and quinidine,
thereby decreasing the effectiveness of these medications.
     7. The side effects of cyclophosphamide may be increased by butalbital.
     8. This medication may interact with monoamine oxidase (MAO) inhibitors.
     BE SURE TO TELL YOUR DOCTOR about any medications you are currently
taking, especially any of those listed above.

WARNINGS

     * Tell your doctor about unusual or allergic reactions you have had to
medications, especially to aspirin, methyl salicylate (oil of wintergreen),
diclofenac, diflunisal, flurbiprofen, fenoprofen, ibuprofen, indomethacin,
ketoprofen, meclofenamate, mefenamic acid, naproxen, piroxicam, sulindac, or
tolmetin; to codeine or other narcotic analgesics (such as hydrocodone,
hydromorphone, meperidine, methadone, morphine, oxycodone, and propoxyphene);
to caffeine; or to butalbital or other barbiturates (such as phenobarbital,
pentobarbital, and secobarbital).
     * Tell your doctor if you now have or if you have ever had abdominal
disease, Addison's disease, bleeding or blood disorders, brain disease,
colitis, epilepsy, gallstones or gallbladder disease, head injuries, heart
disease, hemophilia, kidney disease, liver disease, lung disease, peptic
ulcers, porphyria, prostate disease, or thyroid disease.
     * If this drug makes you dizzy or drowsy, do not take part in any
activity that requires alertness, such as driving a car or operating
potentially dangerous equipment.
     * Before having surgery or any other medical or dental treatment, be sure
to tell your doctor or dentist that you are taking this medication.
Aspirin-containing medication is usually discontinued five to seven days
before surgery, to prevent bleeding complications.
     * The use of aspirin in children (about 16 years of age or less) with the
flu or chicken pox has been associated with a rare, life-threatening condition
called Reye's syndrome.  Aspirin-containing products should, therefore, not be
given to children with signs of infection.
     * Because this drug contains codeine and butalbital, it has the potential
for abuse and must be used with caution.  Usually, it should not be taken on a
regular schedule for longer than ten days at a time.  Tolerance develops
quickly; do not increase the dosage or stop taking the drug abruptly, unless
you first consult your doctor.  If you have been taking large amounts of this
medication for long periods, you may experience a withdrawal reaction (muscle
aches, diarrhea, gooseflesh, runny nose, nausea, vomiting, shivering,
trembling, stomach cramps, sleep disorders, irritability, weakness, excessive
yawning, or sweating).  Your doctor may, therefore, want to reduce the dosage
gradually.
     * Because this product contains aspirin, additional medications that
contain aspirin should not be taken without your doctor's approval.  Check the
labels on over-the-counter (nonprescription) pain, sinus, allergy, asthma,
cough, and cold products to see if they contain aspirin.
     * You should not take more than six tablets or capsules of this drug in
one day, unless your doctor specifically directs you to do so.
     * Diabetic patients should be aware that large doses of aspirin (more
than eight 325-mg tablets or capsules per day) may interfere with urine sugar
testing.  Diabetics should, therefore, check with their doctor before changing
their insulin dose.
     * Be sure to tell your doctor if you are pregnant.  The effects of this
medication during pregnancy have not been thoroughly studied in humans.
Codeine and butalbital, used regularly in large doses during pregnancy, may
result in addiction of the fetus, leading to withdrawal symptoms
(irritability, excessive crying, tremors, fever, vomiting, diarrhea, sneezing,
or excessive yawning) at birth.  Large amounts of aspirin taken close to the
end of pregnancy may prolong labor and cause bleeding problems in the mother
and heart problems in the newborn infant.  Also, tell your doctor if you are
breast-feeding an infant.  Small amounts of this medication may pass into
breast milk and cause excessive drowsiness in the nursing infant.

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The material contained here is "FOR INFORMATION ONLY" and should not replace 
the counsel and advice of your personal physician.  Promptly consulting your 
doctor is the best path to a quick and successful resolution of any medical 
problem.
