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Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

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Overview

What is Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate is supplied in capsule form for oral administration.

Each capsule contains the following active ingredients:

Codeine phosphate [7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, CHN0P, anhydrous mw 397.37], is a narcotic analgesic and antitussive. The structural formula of codeine phosphate is:

Butalbital (5-allyl-5-isobutylbarbituric acid, CHN0, mw 224.26), is a short-to intermediate- acting barbiturate. The structural formula of butalbital is:

Caffeine (1,3,7-trimethylxanthine, CHNO, mw 194.19), is a central nervous system stimulant. The structural formula of caffeine is:

Acetaminophen (4'-hydroxyacetanilide, CHNO, mw 151.16), is a non-opiate, non-salicylate analgesic and antipyretic. The structural formula of acetaminophen is:

Active Ingredients:

Inactive Ingredients:



What does Butalbital, Acetaminophen, Caffeine and Codeine Phosphate look like?



What are the available doses of Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

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What should I talk to my health care provider before I take Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

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How should I use Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.

One or two capsules every four hours. Total daily dosage should not exceed six capsules.

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


What interacts with Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

This combination product is contraindicated under the following conditions:


- Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine.


- Patients with porphyria.



What are the warnings of Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

Results from epidemiologic studies indicate an association between aspirin and Reye's Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Butalbital and codeine are both habit-forming and potentially abusable.

Consequently, the extended use of this combination product is not recommended.


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

General

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 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, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.

Ultra-rapid Metabolizers of Codeine

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. (See )

FD&C Yellow No. 5 (Tartrazine)

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Information for Patients

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 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 combination product. Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product and should be avoided. Codeine and 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 .

Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

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, Caffeine, and Codeine Phosphate Capsules 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

Codeine may increase serum amylase levels.

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

Pregnancy

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last 2 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.

Labor and Delivery

Use of codeine during labor may lead to respiratory depression in the neonate.

Nursing Mothers

Caffeine, barbiturates, acetaminophen and codeine 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, Caffeine and Codeine Phosphate Capsules, 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.

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. (See )

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 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 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

Frequently Observed:

Infrequently Observed:

Central Nervous:

Autonomic Nervous:

Gastrointestinal:

Cardiovascular:

Musculoskeletal:

Genitourinary:

Miscellaneous:

The following adverse reactions have been voluntarily reported as temporally associated with Fiorinal with Codeine, a related product containing aspirin, butalbital, caffeine, and codeine phosphate.

Central Nervous:

Autonomic Nervous:

Gastrointestinal:

Cardiovascular:

Skin:

Urinary:

Miscellaneous:

The following adverse drug events may be borne in mind as potential effects of the components of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Potential effects of high dosage are listed in the section.

Acetaminophen:

Caffeine:

Codeine:


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

This combination product is contraindicated under the following conditions:

- Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine.

- Patients with porphyria.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Butalbital and codeine are both habit-forming and potentially abusable.

Consequently, the extended use of this combination product is not recommended.


What might happen if I take too much Butalbital, Acetaminophen, Caffeine and Codeine Phosphate?

Following an acute overdosage of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, toxicity may result from the barbiturate, the codeine, or the acetaminophen. Toxicity due to the caffeine is less likely, due to the relatively small amounts in this formulation.


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

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules:Bottles of 100's (NDC 51991-073-01)Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules:Bottles of 100's (NDC 51991-073-01)


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is a combination drug product intended as a treatment for tension headache. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules consists of a fixed combination of butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Non-Clinical Toxicology
This combination product is contraindicated under the following conditions:

- Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine.

- Patients with porphyria.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Butalbital and codeine are both habit-forming and potentially abusable.

Consequently, the extended use of this combination product is not recommended.

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 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, Caffeine, and Codeine Phosphate 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, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.

Frequently Observed:

Infrequently Observed:

Central Nervous:

Autonomic Nervous:

Gastrointestinal:

Cardiovascular:

Musculoskeletal:

Genitourinary:

Miscellaneous:

The following adverse reactions have been voluntarily reported as temporally associated with Fiorinal with Codeine, a related product containing aspirin, butalbital, caffeine, and codeine phosphate.

Central Nervous:

Autonomic Nervous:

Gastrointestinal:

Cardiovascular:

Skin:

Urinary:

Miscellaneous:

The following adverse drug events may be borne in mind as potential effects of the components of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Potential effects of high dosage are listed in the section.

Acetaminophen:

Caffeine:

Codeine:

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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

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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Tips

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Interactions

Interactions

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