butalbital 50 MG / acetaminophen 500 MG / caffeine 40 MG Oral Capsule
WARNINGS
: Butalbital is habit-forming and potentially abusable.
Consequently, the extended use of this product is not recommended.
Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.
The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen.
Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
Patients should be informed about the signs of serious skin reactions.
And use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hypersensitivity/anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting.
There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention.
Instruct patients to discontinue Butalbital, Acetaminophen and Caffeine Capsules immediately and seek medical care if they experience these symptoms.
Do not prescribe Butalbital, Acetaminophen and Caffeine Capsules for patients with acetaminophen allergy.
DRUG INTERACTIONS
Drug Interactions: The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital, Acetaminophen, and Caffeine Capsules 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.
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.
Signs and Symptoms: Toxicity from barbiturate poisoning includes 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.
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 caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.
Treatment: A single or multiple overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.
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.
Toxic Doses (for adults): Butalbital: toxic dose 1 g (20 capsules) Acetaminophen: toxic dose 10 g (20 capsules) Caffeine: toxic dose 1 g (25 capsules)
DESCRIPTION
: Butalbital, Acetaminophen, and Caffeine is supplied in capsule form for oral administration.
Each capsule contains: Butalbital, USP……………………..50 mg Acetaminophen, USP………………500 mg Caffeine, USP…………………… …40 mg In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate, and sodium starch glycolate.
Capsule shell contains: D&C Red #33, D&C Yellow #10, FD&C Red #40, Gelatin and Titanium Dioxide.
The imprinting ink contains Titanium Dioxide.
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: Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant.
It has the following structural formula: Structural formula for Butalbital.
The structural formula for Acetaminophen.
The stuctural formula for Caffeine.
HOW SUPPLIED
: Butalbital 50 mg, Acetaminophen 500 mg and Caffeine 40 mg Capsules, USP are supplied as salmon/red capsules printed “170” in white ink and are available in: Bottles of 100 capsules Store at 20° to 25°C (68° to 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: West-Ward Pharmaceutical Corp.
Eatontown, NJ 07724 Revised November 2013
GERIATRIC USE
Geriatric Use: Clinical studies of butalbital, acetaminophen and caffeine capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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.
INDICATIONS AND USAGE
: Butalbital, Acetaminophen, and Caffeine Capsules, USP 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.
PEDIATRIC USE
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 have not been established.
PREGNANCY
Pregnancy: Teratogenic Effects: Pregnancy Category 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.
Nonteratogenic Effects: Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug 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.
NUSRING MOTHERS
Nursing Mothers: Barbiturates, acetaminophen and caffeine 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, taking into account the importance of the drug to the mother.
BOXED WARNING
Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.
DOSAGE AND ADMINISTRATION
: Oral: one capsule every four hours.
Total daily dosage should not exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.