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butalbital, acetaminophen and caffeine

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Overview

What is Vanatol?

VANATOL S (butalbital, acetaminophen and caffeine) is supplied in liquid form for oral administration.

Each 15 mL contains:

Butalbital USP.................................................... 50 mg

Warning:

Acetaminophen USP.......................................... 325 mg

Caffeine USP...................................................... 40 mg

Alcohol ............................................................... 7.368%

In addition, this drug product contains the following inactive ingredients: citric acid, ethyl maltol, liquid glucose, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with FD&C yellow #6 as coloring, and natural and artificial flavoring.

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 Vanatol look like?



What are the available doses of Vanatol?

Sorry No records found.

What should I talk to my health care provider before I take Vanatol?

Sorry No records found

How should I use Vanatol?

VANATOL S is 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 two tablespoonfuls (15 mL or 30 mL) every four hours. Total daily dosage should not exceed 6 tablespoonfuls.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.


What interacts with Vanatol?


  • This product is contraindicated under the following conditions:




What are the warnings of Vanatol?



Hepatotoxcity:

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:

Hypersensitivity/anaphylaxis:


What are the precautions of Vanatol?

General

VANATOL S 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

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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



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 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 Vanatol?

Frequently Observed:

Infrequently Observed:

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:


What should I look out for while using Vanatol?

This product is contraindicated under the following conditions:

Hepatotoxcity:

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:

Hypersensitivity/anaphylaxis:


What might happen if I take too much Vanatol?

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:

In overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects 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.

Acute poisoning may cause insomnia, restlessness, tremor, delirium, tachycardia and extrasystoles.

Treatment:

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.


How should I store and handle Vanatol?

VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318VANATOL S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows:1 fl oz NDC 58809-359-30Storage: Dispense in a tight, light-resistant container with a child-resistant closure.Rx onlyManufactured for:GM Pharmaceuticals, Inc.Arlington, TX 76015Manufactured by:Mikart, Inc.Atlanta, GA 30318


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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:

Hepatotoxcity:

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:

Hypersensitivity/anaphylaxis:

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.

VANATOL S 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:

Infrequently Observed:

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

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Tips

Tips

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Interactions

Interactions

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