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.

Each tablet contains the following active ingredients:

Butalbital, USP 50 mg Acetaminophen, USP 325 mg Caffeine, USP 40 mg

Inactive Ingredients:

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:

Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:

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, 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.

One or 2 tablets every 4 hours as needed. 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?

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 Butalbital, Acetaminophen, and Caffeine?

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 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 tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe butalbital, acetaminophen, and caffeine tablets, USP for patients with acetaminophen allergy.

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

What are the precautions of Butalbital, Acetaminophen, and Caffeine?

General

Butalbital, acetaminophen, and caffeine tablets, USP 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.

Information for Patients/Caregivers

Do not take butalbital, acetaminophen, and caffeine tablets, USP if you are allergic to any of its ingredients.
If you develop signs of allergy such as a rash or difficulty breathing stop taking butalbital, acetaminophen, and caffeine tablets, USP and contact your healthcare provider immediately.
Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.

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.

For information on use in geriatric patients, see .

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

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

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

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects

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.

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, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use

Clinical studies of butalbital, acetaminophen, and caffeine tablets, USP 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.

What are the side effects of Butalbital, Acetaminophen, and Caffeine?

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.

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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.

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What should I look out for while using Butalbital, Acetaminophen, and Caffeine?

This product is contraindicated under the following conditions:

- Hypersensitivity or intolerance to any component of this product - Patients with porphyria.

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.

How should I store and handle Butalbital, Acetaminophen, and Caffeine?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED.XELODA is a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs.Storage and HandlingStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED.XELODA is a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs.Storage and HandlingStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED.XELODA is a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs.Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USACIB70307BRev. 04/16

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Clinical Information

Chemical Structure

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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:

- Hypersensitivity or intolerance to any component of this product - Patients with porphyria.

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

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.

Butalbital, acetaminophen, and caffeine tablets, USP 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.

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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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Review

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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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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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