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How is Esgic Tablets Supplied

Esgic ® Tablets (butalbital 50 mg [ Warning: May be habit-forming], acetaminophen 325 mg and caffeine 40 mg) are white, capsule-shaped, single-scored debossed ” ” on one side and “535/11” on the other side, in bottles of 100 tablets, NDC 68308-220-01.

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 closure.

Rx only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Distributed by:

Mayne Pharma

Greenville, NC 27834

Code 687J00

Rev. 04/2017

ESGIC
butalbital, acetaminophen and caffeine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:68308-220
Route of Administration	ORAL	DEA Schedule	CIII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTALBITAL (BUTALBITAL)	BUTALBITAL	50 mg
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg
CAFFEINE (CAFFEINE)	CAFFEINE	40 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
POVIDONE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL (CAPSULE SHAPED)	Size	14mm
Flavor		Imprint Code	535;11
Contains

Packaging
#	Item Code	Package Description
1	NDC:68308-220-01	100 TABLET in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA089175	05/01/2014

Labeler – Mayne Pharma Inc. (867220261)

Mayne Pharma Inc.

Esgic Over-dosage and Treatment

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

Treatment

A single or multiple drug 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.

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.

Esgic Abuse and Dependence

Butalbital: Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg.

As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller.

The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days.

Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Fioricet Warnings

Fioricet carries a black-box warning cautioning users about the link of acetaminophen to acute liver failure. In some cases, users of Fioricet have needed a liver transplant; in other cases, use of Fioricet has proven fatal.

Most problems have occurred with an acetaminophen dose of more than 4,000 mg a day. Those affected are often taking more than one product containing acetaminophen at the same time or have underlying liver disease.

Another caution concerns butalbital, which may be habit-forming and therefore has the potential to be abused.

Those with a condition known as porphyria, a rare hereditary blood disorder, should not use Fioricet.

Pregnancy and Fioricet

Fioricet is in Pregnancy Category C, according to the FDA, which means that injury to the developing fetus cannot be ruled out. Even so, the benefits of the drug to the mother must be weighed against the potential risk to the unborn baby.

All three drugs found in Fioricet are found in small amounts in human milk, but the significance of that is not known.

You should discuss with your doctor whether to stop breastfeeding or stop taking the drug, weighing the benefits against the costs.

Fioricet Addictive

Fioricet (butalbital-acetaminophen-caffeine) is a combination drug indicated to treat tension or muscle contraction headaches. Butalbital has a generalized depressant effect on the central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects; its analgesic effects may be mediated through inhibition of prostaglandin synthetase enzyme complex.

Caffeine is thought to produce constriction of cerebral blood vessels. The most common side effects reported with Fioricet include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Butalbital, a barbiturate, may be habit-forming and potentially abusable. Therefore, extended and repeated use of Fioricet is not recommended.

Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold.

As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days.

Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patientâ€™s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Esgic Adverse Reactions

Adverse Reactions

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: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

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 OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

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: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. 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 dos age are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Drug Abuse And Dependence

Abuse and Dependee

Butalbital

Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

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-hydroxy-indoleacetic acid.

What is narcotic analgesic apap caffeine butalbital oral ?

What is the dosage for narcotic analgesic-apap-caffeine-butalbital-oral?

Adults and children of 12 years of age and older

50/325/40 mg tablets or capsules: Take 1 to 2 tablets by mouth every 4 hours. Maximum of 6 doses per day. Not to exceed 4000 mg of acetaminophen per day to avoid liver injury.
Dolgic Plus (50/750/40 mg): Take 1 tablet by mouth every 4 hours. Maximum of 5 tablets per day.
Alagesic LQ: Take 1 to 2 tablespoons (15-30 ml) by mouth every 4 hours. Maximum daily dose of 6 tablespoons (180 ml) per day.
Safe and effective use of butalbital/acetaminophen/caffeine is not established in children under 12 years of age.

Which drugs or supplements interact with narcotic analgesic-apap-caffeine-butalbital-oral?

Butalbital/acetaminophen/caffeine should not be used with MAOI (monoamine oxidase inhibitors) like phenelzine (Nardil) and selegiline (Emsam) because they can significantly increase central nervous system effects of butalbital and increased blood levels of caffeine.

Butalbital can increase the effects of narcotic pain killers, alcohol, sedative or hypnotic medications, and other medications that depress the central nervous system. Loss of consciousness, troubled breathing, lowered heart rate, coma, and in severe cases death can occur.