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Butalbital, Aspirin, Caffeine, and Codeine Phosphate
Overview
What is Fiorinal with Codeine?
FIORINAL with CODEINE (butalbital, aspirin, caffeine, and codeine phosphate, USP) is supplied in capsule form for oral administration.
Each capsule contains the following active ingredients:Butalbital, USP……………..50mgAspirin, USP………………..325mgCaffeine, USP………………40mgCodeine phosphate, USP…...30mg
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:
Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug.. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:
Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is an opioid agonist. It has the following structural formula:
c
Ingredients:
What does Fiorinal with Codeine look like?
What are the available doses of Fiorinal with Codeine?
What should I talk to my health care provider before I take Fiorinal with Codeine?
How should I use Fiorinal with Codeine?
FIORINAL with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate.
•
Have not been tolerated, or are not expected to be tolerated,
•
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse
What interacts with Fiorinal with Codeine?
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What are the warnings of Fiorinal with Codeine?
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What are the precautions of Fiorinal with Codeine?
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What are the side effects of Fiorinal with Codeine?
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What should I look out for while using Fiorinal with Codeine?
FIORINAL with CODEINE is contraindicated for :
• All children younger than 12 years of age [see Warnings and Precautions ()]
• Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions ()] .
FIORINAL with CODEINE is also contraindicated in patients with:
• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity or intolerance to aspirin, caffeine, butalbital, or codeine.
• Hemophilia
• Reye’s Syndrome
• Known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)
• Syndrome of asthma, rhinitis, and nasal polyps
Addiction, Abuse, and Misuse
FIORINAL with CODEINE exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing FIORINAL with CODEINE, and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions (
)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of FIORINAL with CODEINE. Monitor for respiratory depression, especially during initiation of FIORINAL with CODEINE or following a dose increase
[see Warnings and Precautions (
)].
Accidental Ingestion
Accidental ingestion of even one dose of FIORINAL with CODEINE, especially by children, can result in a fatal overdose of FIORINAL with CODEINE
[see Warnings and Precautions (
)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
[see Warnings and Precautions (
), Drug Interactions (
)].
•
Reserve concomitant prescribing of FIORINAL with CODEINE and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
•
Limit dosages and durations to the minimum required.
•
Follow patients for signs and symptoms of respiratory depression and sedation.
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received codeine.
Most of the reported cases occu
r
red following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism.
[see Warnings and Precautions (
)].
FIORINAL with CODEINE is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
[see Contraindications (
)].
Avoid the use of FIORINAL with CODEINE in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of FIORINAL with CODEINE during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
[see Warnings and Precautions (
)].
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with FIORINAL with CODEINE requires careful consideration of the effects on codeine, and the active metabolite, morphine
[see Warnings and Precautions (
) Drug Interactions (
)].
What might happen if I take too much Fiorinal with Codeine?
Clinical Presentation
[
see
Clinic
a
l Pharmacology (
)
]
Signs and Symptoms
Acute Barbiturate Poisoning:Symptoms include drowsiness, confusion, and coma; respiratory depression; hypotension; hypovolemic shock.
Acute Aspirin Poisoning:Symptoms include hyperpnea; acid-base disturbances with development of metabolic acidosis; vomiting and abdominal pain; tinnitus, hyperthermia; hypoprothrombinemia; restlessness; delirium; convulsions.
Acute Caffeine Poisoning:Symptomsinclude insomnia, restlessness, tremor, and delirium; tachycardia and extrasystoles.
Codeine:Acute overdose with codeine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations
.
Treat
m
ent of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to codeine phosphate overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to codeine overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of codeine in FIORINAL with CODEINE, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
Treatment consists primarily of management of barbiturate intoxication, reversal of the effects of codeine, and the correction of the acid-base imbalance due to salicylism. Vomiting should be induced mechanically or with emetics in the conscious patient. Gastric lavage may be used if the pharyngeal and laryngeal reflexes are present and if less than 4 hours have elapsed since ingestion. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary to provide assisted respiration. Diuresis, alkalinization of the urine, and correction of electrolyte disturbances should be accomplished through administration of intravenous fluids such as1% sodium bicarbonate and 5% dextrose in water.
Meticulous attention should be given to maintaining adequate pulmonary ventilation. The value of vasopressor agents such as Norepinephrine or Phenylephrine Hydrochloride in treating hypotension is questionable since they increase vasoconstriction and decrease blood flow. However, if prolonged support of blood pressure is required, Norepinephrine Bitartrate (Levophed) may be given I.V. with the usual precautions and serial blood pressure monitoring. In severe cases of intoxication, peritoneal dialysis, hemodialysis, or exchange transfusion may be lifesaving. Hypoprothrombinemia should be treated with vitamin K, intravenously.
Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.
Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Typically, a dose of 0.4 to 2 mg is given parenterally and may be repeated if an adequate response is not achieved. Since the duration of action of codeine may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
How should I store and handle Fiorinal with Codeine?
Store original packages at room temperature; avoid excessive heat.FIORINAL with CODEINE (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP)Blue cap with a yellow body. Cap is imprinted twice with “FIORINAL” and “CODEINE” in red. Body is imprinted twice with “WATSON 956” in red. High density polyethylene bottles of 100 capsules are supplied with child-resistant closures. (NDC 52544-956-01)Store and DispenseFIORINAL with CODEINE (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP)Blue cap with a yellow body. Cap is imprinted twice with “FIORINAL” and “CODEINE” in red. Body is imprinted twice with “WATSON 956” in red. High density polyethylene bottles of 100 capsules are supplied with child-resistant closures. (NDC 52544-956-01)Store and DispenseFIORINAL with CODEINE (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP)Blue cap with a yellow body. Cap is imprinted twice with “FIORINAL” and “CODEINE” in red. Body is imprinted twice with “WATSON 956” in red. High density polyethylene bottles of 100 capsules are supplied with child-resistant closures. (NDC 52544-956-01)Store and DispenseFIORINAL with CODEINE (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP)Blue cap with a yellow body. Cap is imprinted twice with “FIORINAL” and “CODEINE” in red. Body is imprinted twice with “WATSON 956” in red. High density polyethylene bottles of 100 capsules are supplied with child-resistant closures. (NDC 52544-956-01)Store and Dispense
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Butalbital, a barbiturate, is a GABA receptor agonist and may inhibit excitatory AMPA receptors.
Aspirin is a nonsteroidal anti-inflammatory drug and a non-selective irreversible inhibitor of cyclooxygenases.
Caffeine is a methylxanthine and CNS stimulant. The exact mechanism with respect to the indication is not clear; however, the effects of caffeine may be due to antagonism of adenosine receptors.
Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.
Non-Clinical Toxicology
FIORINAL with CODEINE is contraindicated for :• All children younger than 12 years of age [see Warnings and Precautions ()]
• Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions ()] .
FIORINAL with CODEINE is also contraindicated in patients with:
• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity or intolerance to aspirin, caffeine, butalbital, or codeine.
• Hemophilia
• Reye’s Syndrome
• Known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)
• Syndrome of asthma, rhinitis, and nasal polyps
Addiction, Abuse, and Misuse
FIORINAL with CODEINE exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing FIORINAL with CODEINE, and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions (
)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of FIORINAL with CODEINE. Monitor for respiratory depression, especially during initiation of FIORINAL with CODEINE or following a dose increase
[see Warnings and Precautions (
)].
Accidental Ingestion
Accidental ingestion of even one dose of FIORINAL with CODEINE, especially by children, can result in a fatal overdose of FIORINAL with CODEINE
[see Warnings and Precautions (
)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
[see Warnings and Precautions (
), Drug Interactions (
)].
•
Reserve concomitant prescribing of FIORINAL with CODEINE and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
•
Limit dosages and durations to the minimum required.
•
Follow patients for signs and symptoms of respiratory depression and sedation.
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received codeine.
Most of the reported cases occu
r
red following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism.
[see Warnings and Precautions (
)].
FIORINAL with CODEINE is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
[see Contraindications (
)].
Avoid the use of FIORINAL with CODEINE in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of FIORINAL with CODEINE during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
[see Warnings and Precautions (
)].
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with FIORINAL with CODEINE requires careful consideration of the effects on codeine, and the active metabolite, morphine
[see Warnings and Precautions (
) Drug Interactions (
)].
FIORINAL with CODEINE contains codeine. Codeine in combination with butalbital, aspirin, and caffeine is a Schedule III controlled substance . As FIORINAL with CODEINE contains butalbital and codeine, it exposes users to the risks of addiction, abuse, and misuse
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed FIORINAL with CODEINE. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for addiction, abuse, or misuse prior to prescribing FIORINAL with CODEINE, and monitor all patients receiving FIORINAL with CODEINE for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as FIORINAL with CODEINE, but use in such patients necessitates intensive counseling about the risks and proper use of FIORINAL with CODEINE along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids and barbiturates are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing FIORINAL with CODEINE. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [ Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are described, or described in greater detail, in other sections:
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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