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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

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Overview

What is BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration.

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, 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:

     ACETAMINOPHEN STRUCTURE IMAGE

Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:

Each Butalbital, Acetaminophen and Caffeine Tablet contains:

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and stearic acid.



What does BUTALBITAL, ACETAMINOPHEN AND CAFFEINE look like?



What are the available doses of BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

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What should I talk to my health care provider before I take BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

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How should I use BUTALBITAL, ACETAMINOPHEN 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.

One tablet every 4 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 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

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What are the warnings of BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

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What are the precautions of BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

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What are the side effects of BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

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What should I look out for while using BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

This product is contraindicated under the following conditions:


What might happen if I take too much BUTALBITAL, ACETAMINOPHEN 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.

Toxicity from   poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

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.

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.

In all cases of suspected overdosage, call your Regional Poison Control Center to obtain the most up-to-date information about the treatment of overdosage. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians' Desk Reference


How should I store and handle BUTALBITAL, ACETAMINOPHEN AND CAFFEINE?

GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).Butalbital, Acetaminophen and Caffeine Tablets, USPContaining butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg, are white, caplet-shaped tablets, bisected, debossed "23/57" on one side, and debossed "V" on the reverse side. Bottles of 10, 100, 500 and 1000.Butalbital, Acetaminophen and Caffeine Tablets, USPContaining butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg, are white, caplet-shaped tablets, bisected, debossed "23/57" on one side, and debossed "V" on the reverse side. Bottles of 10, 100, 500 and 1000.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

This combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Non-Clinical Toxicology
This product is contraindicated under the following conditions:

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital, Acetaminophen and Caffeine Tablets 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

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Butalbital, Acetaminophen and Caffeine Tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous System:

Autonomic Nervous System:

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:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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