Butalbital APAP Prescription

Common Medical Uses:

Butalbital APAP with Caffeine (widely known as 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 these agents are used to relieve complex tension headaches although exactly how it works is unknown.

Butalbital/APAP/Caffeine - No prescription required

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Dosage:

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

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

Limit use to twice weekly to avoid rebound headache.

Extended and repeated use of analgesics with barbiturate is not recommended because of the potential for physical dependence.

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.
• 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.

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 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.

Warnings & Precautions:

• Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Take the drug only for as long as it is prescribed, and no more frequently than prescribed.
• Barbiturates 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.
• Do not take any other prescription or non-prescription medications without talking to your health care provider. Many OTC (over-the-counter) medicines contain acetaminophen. Read the label of any medicine you are taking to see if it contains APAP (acetaminophen).

Drug Interactions:

• Effects of the following drugs may be decreased:
  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, prescription pain meds) - 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)

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.

Where to Buy:

If you need to buy medicine for licensed (FDA approved) uses but have no prescription, choose the offer from the price list.

References:

• 1. U.S. Food and Drug Administration. Butalbital/APAP/Caffeine Prescribing Information.