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ACETAMINOPHEN, BUTALBITAL AND CAFFEINE
Overview
What is ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
Each tablet, for oral administration, contains:
Butalbital, USP..................50 mg
Acetaminophen.................325 mg
Caffeine, USP...................40 mg
In addition, each tablet contains the following inactive ingredients:
FD and C Lake Blue #1, Magnesium Stearate, Microcrystalline Cellulose, Colloidal
Silicon Dioxide, and Sodium Starch Glycolate.
Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless,
crystalline powder having a slightly bitter taste, is a short to
intermediate-acting barbiturate. It has the following structural formula:
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless,
crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula:
What does ACETAMINOPHEN, BUTALBITAL AND CAFFEINE look like?




What are the available doses of ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
Sorry No records found.
What should I talk to my health care provider before I take ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
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How should I use ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
Butalbital, acetaminophen and caffeine tablets are indicated for
the relief of the symptom complex of tension (or muscle contraction)
headache.
Evidence supporting the efficacy and safety of this combination product in
the treatment of multiple recurrent headaches is unavailable. Caution in this
regard is required because butalbital is habit-forming and potentially abusable.
Oral: One or two tablets every four hours. 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.
What interacts with ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
- This product is contraindicated under the following conditions:
- Hypersensitivity or intolerance to any component of this product.
- Patients with porphyria.
What are the warnings of ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What are the precautions of ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
General:
Information for Patients:
Alcohol and other CNS depressants may produce an additive CNS depression,
when taken with this combination product, and should be avoided.
Butalbital may be habit-forming. Patients should take the drug only for as
long as it is prescribed, in the amounts prescribed, and no more frequently than
prescribed.
Laboratory Tests:
Drug Interactions:
Butalbital, acetaminophen and caffeine may enhance the effects of: other
narcotic analgesics, alcohol, general anesthetics, tranquilizers such as
chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing
increased CNS depression.
Drug/Laboratory Test Interactions:
Carcinogenesis, Mutagenesis, Impairment of
Fertility:
Pregnancy:
Teratogenic
Effects:
Nonteratogenic Effects:
Nursing Mothers:
Pediatric Use:
Geriatric Use:
Butalbital is known to be substantially excreted by the kidney, and the risk
of toxic reactions to this drug may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to
monitor renal function.
What are the side effects of ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
Frequently Observed:
Infrequently Observed:
Central Nervous:
Autonomic Nervous:
Gastrointestinal:
Cardiovascular:
Musculoskeletal:
Genitourinary:
Miscellaneous:
Several cases of dermatological reactions, including toxic epidermal
necrolysis and erythema multiforme, have been reported.
The following adverse drug events may be borne in mind as
potential effects of the components of this product. Potential effects of high
dosage are listed in the section.
Acetaminophen:
Caffeine:
What should I look out for while using ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
This product is contraindicated under the following
conditions:
Butalbital is habit-forming and potentially abusable. Consequently, the extended
use of this product is not recommended.
What might happen if I take too much ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
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.
Signs and Symptoms:
barbiturate
In overdosage: dose-dependent,
potentially fatal hepatic necrosis is the most serious adverse effect. Renal
tubular necroses, hypoglycemic coma and thrombocytopenia may also occur. Early
symptoms following a potentially hepatotoxic overdose may include: nausea,
vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of
hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In
adults hepatic toxicity has rarely been reported with acute overdoses of less
than 10 grams, or fatalities with less than 15 grams.
Acute poisoning may cause insomnia,
restlessness, tremor, and delirium, tachycardia and extrasystoles.
Treatment:
Immediate treatment includes support of cardiorespiratory function and
measures to reduce drug absorption. Vomiting should be induced mechanically, or
with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal
reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The
first dose should be accompanied by an appropriate cathartic. If repeated doses
are used, the cathartic might be included with alternate doses as required.
Hypotension is usually hypovolemic and should respond to fluids. Pressors should
be avoided. A cuffed endotracheal tube should be inserted before gastric lavage
of the unconscious patient and, when necessary, to provide assisted respiration.
If renal function is normal, forced diuresis may aid in the elimination of the
barbiturate. Alkalinization of the urine increases renal excretion of some
barbiturates, especially phenobarbital.
Meticulous attention should be given to maintaining adequate pulmonary
ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably
hemodialysis may be considered. If hypoprothrombinemia occurs due to
acetaminophen overdose, vitamin K should be administered intravenously.
If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine
should be administered as early as possible. Serum acetaminophen levels should
be obtained, since levels four or more hours following ingestion help predict
acetaminophen toxicity. Do not await acetaminophen assay results before
initiating treatment. Hepatic enzymes should be obtained initially, and repeated
at 24-hour intervals.
Methemoglobinemia over 30% should be treated with methylene blue by slow
intravenous administration.
How should I store and handle ACETAMINOPHEN, BUTALBITAL AND CAFFEINE?
Butalbital, Acetaminophen and Caffeine Tablets 50 mg/325 mg/40 mg are blue, round, unscored tablets; imprinted “West-ward 787”. They are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724Revised April 2003Butalbital, Acetaminophen and Caffeine Tablets 50 mg/325 mg/40 mg are blue, round, unscored tablets; imprinted “West-ward 787”. They are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724Revised April 2003Butalbital, Acetaminophen and Caffeine Tablets 50 mg/325 mg/40 mg are blue, round, unscored tablets; imprinted “West-ward 787”. They are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724Revised April 2003Butalbital, Acetaminophen and Caffeine Tablets 50 mg/325 mg/40 mg are blue, round, unscored tablets; imprinted “West-ward 787”. They are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724Revised April 2003