But/acetaminophen 50-325mg Tabs
WARNING: This drug has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen. @ COMMON USES: It is used to treat tension headaches.
Drug Class
Analgesic, Barbiturate
Pharmacologic Class
Barbiturate; Para-aminophenol derivative
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Schedule III
Overview
What is this medicine?
This medication is a combination of two drugs: butalbital, which is a sedative that helps relax you and reduce tension, and acetaminophen, which is a pain reliever and fever reducer. It is used to treat tension headaches.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. To prevent accidental ingestion, store it in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe from others.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. To prevent accidental ingestion, store it in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe from others.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Do not take more than the prescribed dose, and do not take it more often than prescribed, as this can lead to serious liver damage or addiction.
- Avoid alcohol completely while taking this medication, as it can increase the risk of severe drowsiness, breathing problems, and liver damage.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Be aware of other medications you are taking that may also contain acetaminophen to avoid exceeding the maximum daily dose (4000 mg from all sources).
- Do not stop taking this medication suddenly if you have been using it regularly for a long time, as this can cause withdrawal symptoms. Talk to your doctor about how to safely stop the medication.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 to 2 tablets every 4 hours as needed
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
maximumDailyDose:
Not to exceed 6 tablets per day (300mg Butalbital, 1950mg Acetaminophen) due to risk of butalbital dependence and acetaminophen hepatotoxicity.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended for pediatric use due to butalbital component)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but use with caution.
Moderate:
Use with caution. Consider extending dosing interval or reducing dose, especially for acetaminophen component if GFR < 50 mL/min.
Severe:
Use with extreme caution or avoid. Acetaminophen dose reduction (e.g., 325mg every 6-8 hours) may be necessary if GFR < 10 mL/min. Butalbital clearance is reduced.
Dialysis:
Acetaminophen is dialyzable. Butalbital is not significantly dialyzable. Avoid or use with extreme caution and monitor closely.
Hepatic Impairment:
Mild:
Use with caution. Monitor liver function.
Moderate:
Use with extreme caution; consider dose reduction or avoidance due to acetaminophen hepatotoxicity risk and reduced butalbital metabolism.
Severe:
Contraindicated due to risk of severe hepatotoxicity from acetaminophen and impaired butalbital metabolism.
Pharmacology
Mechanism of Action
Butalbital is a barbiturate that produces generalized central nervous system depression, primarily by enhancing the inhibitory effects of GABA at the GABA-A receptor. Acetaminophen is a non-opioid analgesic and antipyretic, believed to act primarily through central inhibition of prostaglandin synthesis (COX-3 inhibition) and possibly through serotonergic pathways.
Pharmacokinetics
Absorption:
Bioavailability:
Butalbital: Approximately 90%; Acetaminophen: 60-90%
Tmax:
Butalbital: 2-4 hours; Acetaminophen: 0.5-2 hours
FoodEffect:
Food may slightly delay absorption but does not significantly affect extent of absorption.
Distribution:
Vd:
Butalbital: 0.8-1.0 L/kg; Acetaminophen: 0.95 L/kg
ProteinBinding:
Butalbital: 45%; Acetaminophen: 10-25%
CnssPenetration:
Yes (Butalbital); Limited (Acetaminophen)
Elimination:
HalfLife:
Butalbital: Approximately 35-40 hours; Acetaminophen: 1.25-3 hours
Clearance:
Not available (varies)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Butalbital: <5%; Acetaminophen: <5%
Pharmacodynamics
OnsetOfAction:
Butalbital: 30-60 minutes; Acetaminophen: 10-30 minutes
PeakEffect:
Butalbital: 2-4 hours; Acetaminophen: 0.5-2 hours
DurationOfAction:
Butalbital: 4-6 hours (sedation may last longer); Acetaminophen: 4-6 hours
Safety & Warnings
BLACK BOX WARNING
Risk of Liver Failure: Acetaminophen has been associated with cases of acute liver failure, sometimes resulting in liver transplant or death. Most cases of liver injury are associated with the use of acetaminophen at doses exceeding 4000 mg per day, and often involve more than one acetaminophen-containing product. Risk of Addiction, Abuse, and Misuse: Butalbital-containing products carry risks of addiction, abuse, and misuse, which can lead to overdose and death. Risk of Withdrawal: Prolonged use of butalbital can lead to physical dependence. Abrupt discontinuation can result in withdrawal symptoms, including seizures.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you encounter any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Urination problems, such as inability to pass urine or changes in urine output
Shortness of breath
Neurological symptoms, including:
+ Slurred speech
+ Stumbling
+ Confusion
+ Excessive sleepiness or dizziness
+ Feeling drunk
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Dizziness or sleepiness
Stomach pain
* Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you encounter any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Urination problems, such as inability to pass urine or changes in urine output
Shortness of breath
Neurological symptoms, including:
+ Slurred speech
+ Stumbling
+ Confusion
+ Excessive sleepiness or dizziness
+ Feeling drunk
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Dizziness or sleepiness
Stomach pain
* Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of liver damage: yellowing of skin or eyes (jaundice), dark urine, persistent nausea/vomiting, severe stomach pain, unusual tiredness.
- Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
- Signs of severe CNS depression: extreme drowsiness, difficulty waking up, slow or shallow breathing, blue lips/fingernails.
- Signs of medication overuse headache: headaches becoming more frequent or severe after regular use of this medication.
- Signs of withdrawal (if stopped suddenly after prolonged use): anxiety, tremors, seizures, insomnia, nausea, vomiting.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including liver disease or porphyria, as these may affect your ability to take this medication safely.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including liver disease or porphyria, as these may affect your ability to take this medication safely.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
While taking this medication, avoid driving and engaging in other activities that require alertness, as it may impair your ability to perform these tasks safely.
Risk of Dependence and Tolerance
Long-term use of this medication may lead to dependence. Do not take this medication for an extended period beyond what your doctor has prescribed. If you have been taking this medication for a long time or at high doses, you may develop tolerance, which means you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose.
Withdrawal Precautions
If you have been taking this medication regularly and stop suddenly, you may experience withdrawal symptoms. Do not stop taking this medication abruptly without consulting your doctor. If you experience any adverse effects, inform your doctor promptly.
Acetaminophen Precautions
Be cautious not to take other products that contain acetaminophen, as excessive intake may cause liver problems. Carefully check the labels of other medications and products to avoid accidental overdose. If you are unsure about the safe amount of acetaminophen you can take in a day, consult your doctor or pharmacist. The recommended daily limit is 4,000 mg (milligrams) for some individuals, but people with liver problems or children may require lower doses. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Interactions with Other Substances
Avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may slow your reactions, as they may interact with this medication.
Lab Test Interactions
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Special Precautions
If you have a deficiency of the enzyme G6PD, you may be at risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Use caution when taking this medication if you have low levels of G6PD.
Age-Related Precautions
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of taking this medication to you and your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
While taking this medication, avoid driving and engaging in other activities that require alertness, as it may impair your ability to perform these tasks safely.
Risk of Dependence and Tolerance
Long-term use of this medication may lead to dependence. Do not take this medication for an extended period beyond what your doctor has prescribed. If you have been taking this medication for a long time or at high doses, you may develop tolerance, which means you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose.
Withdrawal Precautions
If you have been taking this medication regularly and stop suddenly, you may experience withdrawal symptoms. Do not stop taking this medication abruptly without consulting your doctor. If you experience any adverse effects, inform your doctor promptly.
Acetaminophen Precautions
Be cautious not to take other products that contain acetaminophen, as excessive intake may cause liver problems. Carefully check the labels of other medications and products to avoid accidental overdose. If you are unsure about the safe amount of acetaminophen you can take in a day, consult your doctor or pharmacist. The recommended daily limit is 4,000 mg (milligrams) for some individuals, but people with liver problems or children may require lower doses. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Interactions with Other Substances
Avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may slow your reactions, as they may interact with this medication.
Lab Test Interactions
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Special Precautions
If you have a deficiency of the enzyme G6PD, you may be at risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Use caution when taking this medication if you have low levels of G6PD.
Age-Related Precautions
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of taking this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Acetaminophen overdose: Nausea, vomiting, abdominal pain, loss of appetite, sweating, extreme tiredness, yellowing of skin or eyes (jaundice), dark urine.
- Butalbital overdose: Severe drowsiness, confusion, slurred speech, slow/shallow breathing, weak pulse, cold/clammy skin, loss of consciousness, coma.
What to Do:
Call 911 or your local poison control center immediately (1-800-222-1222 in the US). Seek emergency medical attention. Treatment may include activated charcoal, N-acetylcysteine (for acetaminophen), and supportive care for butalbital overdose.
Drug Interactions
Contraindicated Interactions
- Severe hepatic impairment (due to acetaminophen)
- Porphyria (due to butalbital)
Major Interactions
- Other CNS depressants (e.g., opioids, benzodiazepines, alcohol, sedatives, hypnotics, tricyclic antidepressants, muscle relaxants): Increased risk of profound sedation, respiratory depression, coma, and death.
- Hepatotoxic drugs: Increased risk of liver injury (e.g., isoniazid, methotrexate, high-dose niacin).
- Warfarin: Acetaminophen can increase INR, especially with chronic high doses.
- CYP450 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin): May increase metabolism of butalbital and increase formation of toxic acetaminophen metabolites.
- CYP450 inhibitors (e.g., fluconazole, fluvoxamine, omeprazole): May decrease metabolism of butalbital.
Moderate Interactions
- Anticholinergics: May enhance CNS depression.
- Metoclopramide: May increase acetaminophen absorption.
- Cholestyramine: May decrease acetaminophen absorption.
- Lamotrigine: Acetaminophen may reduce lamotrigine levels.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function due to acetaminophen hepatotoxicity risk.
Timing: Prior to initiation, especially if risk factors for liver disease are present.
Renal Function (BUN, Creatinine)
Rationale: To assess baseline renal function, as both components are renally eliminated.
Timing: Prior to initiation, especially if risk factors for renal impairment are present.
Routine Monitoring
Pain relief and headache frequency
Frequency: Regularly during therapy
Target: Acceptable pain control with minimal side effects; reduction in headache frequency.
Action Threshold: Lack of efficacy, increasing headache frequency (suggesting medication overuse headache), or need for escalating doses.
Signs of CNS depression (drowsiness, dizziness, confusion)
Frequency: Regularly, especially during initiation or dose changes.
Target: Minimal to no impairment of daily activities.
Action Threshold: Excessive sedation, impaired coordination, or respiratory depression.
Liver Function Tests (LFTs)
Frequency: Periodically, especially with chronic use or higher doses.
Target: Within normal limits.
Action Threshold: Significant elevation of AST/ALT (>3x ULN), bilirubin, or signs of liver injury.
Signs of dependence/withdrawal
Frequency: Regularly, especially with prolonged use.
Target: Absence of drug-seeking behavior or withdrawal symptoms upon dose reduction/discontinuation.
Action Threshold: Patient reporting cravings, inability to reduce dose, or experiencing withdrawal symptoms (e.g., anxiety, tremors, seizures) upon cessation.
Symptom Monitoring
- Excessive drowsiness
- Dizziness
- Nausea
- Vomiting
- Abdominal pain (especially upper right quadrant)
- Dark urine
- Yellowing of skin or eyes (jaundice)
- Unusual bleeding or bruising
- Difficulty breathing or shallow breathing
- Confusion
- Slurred speech
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Use only if the potential benefit justifies the potential risk to the fetus. Category C.
Trimester-Specific Risks:
First Trimester:
Butalbital: Potential for increased risk of congenital malformations (though data are limited and conflicting). Acetaminophen: Generally considered safe at recommended doses, but high doses or chronic use may have risks.
Second Trimester:
Butalbital: Risk of neonatal withdrawal syndrome if used chronically. Acetaminophen: Generally considered safe at recommended doses.
Third Trimester:
Butalbital: Risk of neonatal withdrawal syndrome (irritability, tremors, hypertonia, seizures) and respiratory depression in the neonate if used near term. Acetaminophen: Generally considered safe at recommended doses, but chronic high doses may be associated with adverse fetal outcomes.
Lactation
Both butalbital and acetaminophen are excreted in breast milk. Use with caution and monitor the infant for sedation or feeding difficulties.
Infant Risk:
L3 (Moderate risk). Butalbital can cause sedation in the infant. Acetaminophen is generally considered safe in usual doses, but combination products should be used cautiously.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not generally recommended for use in children due to the butalbital component and risk of respiratory depression and dependence.
Geriatric Use
Geriatric patients may be more sensitive to the CNS depressant effects of butalbital (e.g., sedation, dizziness, confusion) and may have reduced clearance of both components. Start with lower doses and monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- High potential for physical and psychological dependence due to butalbital. Avoid prolonged use.
- Risk of medication overuse headache (MOH) with chronic use. Patients should be educated on this risk.
- The acetaminophen component carries a significant risk of hepatotoxicity, especially with doses exceeding 4000 mg/day or in patients with underlying liver disease or alcohol use.
- Patients should be advised to check all other medications for acetaminophen content to avoid accidental overdose.
- Abrupt discontinuation after prolonged use can lead to severe withdrawal symptoms, including seizures. Tapering is necessary.
- Not recommended for chronic daily use due to dependence and MOH risks.
Alternative Therapies
- NSAIDs (e.g., ibuprofen, naproxen) for tension headaches
- Tricyclic antidepressants (e.g., amitriptyline) for headache prophylaxis
- SSRIs/SNRIs for co-morbid depression/anxiety contributing to tension headaches
- Muscle relaxants (e.g., cyclobenzaprine) for muscle tension
- Non-pharmacological therapies (e.g., stress management, biofeedback, physical therapy)
Cost & Coverage
Average Cost:
Price range varies widely per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.