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butalbital, acetaminophen and caffeine
Overview
What is Esgic?
Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration.
Each capsule contains:
Butalbital ................... 50 mg
Warning:
Acetaminophen ........ 325 mg
Caffeine ...................... 40 mg
In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose with capsule shell composed of gelatin and titanium dioxide. Imprinting ink composed of alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, titanium dioxide, D&C Yellow #10, and FD&C Blue #1.
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:
C
H
N
O
MW = 224.26
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:
C
H
NO
MW = 151.16
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:
C
H
N
O
MW = 194.19
What does Esgic look like?
What are the available doses of Esgic?
Sorry No records found.
What should I talk to my health care provider before I take Esgic?
Sorry No records found
How should I use Esgic?
Esgic
Capsules (butalbital, acetaminophen and caffeine capsules USP 50 mg/325 mg/40 mg) 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 two capsules 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.
What interacts with Esgic?
- 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 Esgic?
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 Esgic
Capsules immediately and seek medical care if they experience these symptoms. Do not prescribe Esgic
Capsules for patients with acetaminophen allergy.
What are the precautions of Esgic?
General
Esgic
Capsules 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 Esgic Capsules if you are allergic to any of its ingredients.
- If you develop signs of allergy such as a rash or difficulty breathing, stop taking Esgic Capsules 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.
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 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.
What are the side effects of Esgic?
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:
What should I look out for while using Esgic?
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 Esgic?
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 Esgic?
Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].Keep out of the reach of children.Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].Keep out of the reach of children.Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].Keep out of the reach of children.Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017Esgic Capsules, containing butalbital 50 mg , acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted " " on one side and “535-12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 68308-219-01. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closureRx onlyManufactured by:MIKART, INC.Atlanta, GA 30318Distributed by:Mayne PharmaGreenville, NC 27834Code 785N00Rev. 01/2017
Clinical Information
Chemical Structure
No Image foundClinical 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:Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
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.
Esgic Capsules 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.
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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