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Generic name: butalbital and acetaminophen
tablet Butalbital and Acetaminophen 25 mg/ 325 mg tablet ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx only · Larken Laboratories, Inc.
Dosage Form
tablet Butalbital and Acetaminophen 25 mg/ 325 mg tablet ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx only
Manufacturer
Larken Laboratories, Inc.
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
WARNING: 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 4,000 milligrams per day, and often involve more than one acetaminophen-containing product.
Butalbital and Acetaminophen 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.
Butalbital and Acetaminophen, 50 mg/ 325 mg tablets: One or two tablets every four hours as needed. Do not exceed not exceed 6 tablets per day.
Butalbital and Acetaminophen, 25 mg/ 325 mg tablets: Two tablets every four hours. Total daily dosage should not exceed 12 tablets.
ALLZITAL (butalbital and acetaminophen, 25 mg / 325 mg): Two tablets every four hours. Total daily dosage should not exceed 12 tablets.
Extended and repeated use of these products is not recommended because of the potential for physical dependence.
This product is contraindicated under the following conditions:
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital and acetaminophen 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.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Larken Laboratories, Inc. at 1-601-855-7678 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Pregnancy Category C:
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 and acetaminophen, 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.
Safety and effectiveness in children below the age of 12 have not been established.
Clinical studies of butalbital and acetaminophen tablets 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.
Following an acute overdosage, toxicity may result from the barbiturate or the acetaminophen.
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 necrosis, 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.
Treatment: A single or multiple drug overdose with butalbital and acetaminophen 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.
Protect from light and moisture. Store Butalbital and Acetaminophen tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).
Dispense in a tight, light-resistant container with a child-resistant closure.
Distributed by:
Larken Laboratories, Inc.
Canton, MS 39046
www.larkenlabs.com
Rev. 06/2022
500411-07
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.
Each Butalbital and Acetaminophen 50 mg/ 325 mg tablet for oral administration contains:
Butalbital, USP ………...….. 50 mg
Acetaminophen, USP ……. 325 mg
Each Butalbital and Acetaminophen 25 mg/ 325 mg tablet for oral administration contains:
Butalbital, USP ………...….. 25 mg
Acetaminophen, USP ……. 325 mg
Each ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet for oral administration contains:
Butalbital, USP ………...….. 25 mg
Acetaminophen, USP ……. 325 mg
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
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:
[image: MM1]C 11H 16N 2O 3 M.W. = 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:
[image: MM2]C 8H 9NO 2 M.W. = 151.16
[image: MM3]
NDC 68047-721-01
Butalbital and Acetaminophen 50 mg/ 325 mg tablets
Each white capsule shaped tablet debossed “LL 721” on one side and plain on the other side contains:
Butalbital, USP 50 mg
Acetaminophen, USP 325 mg
Rx only
100 Tablets
[image: MM4]
NDC 68047-753-01
Butalbital and Acetaminophen, 25 mg/ 325 mg tablets
Each white capsule shaped tablet debossed “LL 722” on one side and plain on the other side contains:
Butalbital, USP 25 mg
Acetaminophen, USP 325 mg
Rx only
100 Tablets
[image: MM5]
NDC 68047-752-01
ALLZITAL (butalbital and acetaminophen, 25 mg/ 325) mg tablets
Each white capsule shaped tablet debossed “LL 722” on one side and plain on the other side contains:
Butalbital, USP 25 mg
Acetaminophen, USP 325 mg
Rx only
100 Tablets
Butalbital and Acetaminophen, 50 mg/ 325 mg: White, capsule shaped tablet debossed “LL 721” on one side and plain on the other, in bottles
of 30 tablets (NDC 68047-721-30), and 100 tablets (NDC 68047-721-01).
Butalbital and Acetaminophen, 25 mg / 325 mg: White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles
of 30 tablets (NDC 68047-753-30) and 100 tablets (NDC 68047-753-01).
ALLZITAL (butalbital and acetaminophen, 25 mg / 325 mg): White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-752-30) and 100 tablets (NDC 68047-752-01).
Photos of the product and/or packaging supplied by the manufacturer.
This combination drug product is intended as a treatment for tension headache.
It consists of a fixed combination of butalbital and acetaminophen. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.
The behavior of the individual components is described below.
Butalbital: Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.
Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxy-propyl) barbituric acid (about 24% of the dose), 5-allyl-5 (3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated. The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity indicating that there is no preferential distribution of butalbital into either plasma or blood cells See OVERDOSAGE for toxicity information.
Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.
See OVERDOSAGE for toxicity information.
No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.
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