But/acetaminophen 50-300mg 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 (Butalbital), Para-aminophenol derivative (Acetaminophen)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled Federally; Schedule III in some states (e.g., NY, TX, FL) for butalbital-containing products.
Overview
What is this medicine?
This medication is a combination of two drugs: butalbital, which is a barbiturate that helps relax you and reduce tension, and acetaminophen, which is a common pain reliever. It's primarily 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 proper disposal. You may also want to check if there are drug take-back programs available in your area.
Managing Missed Doses
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 proper disposal. You may also want to check if there are drug take-back programs available in your area.
Managing Missed Doses
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
- Avoid alcohol completely while taking this medication, as it can increase drowsiness and the risk of liver damage.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Do not take more than the prescribed dose, and do not take other medications containing acetaminophen (like Tylenol or many cold/flu remedies) without checking with your doctor or pharmacist, to avoid accidental overdose and liver damage.
- If you take this medication regularly, do not stop suddenly without talking to your doctor, as it can cause withdrawal symptoms.
- Limit caffeine intake, as excessive caffeine can worsen headaches or contribute to medication overuse headaches.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 to 2 tablets orally every 4 hours as needed
Dose Range:
1 - 6 mg
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 6 tablets per day (equivalent to 300mg Butalbital and 1800mg Acetaminophen) or 4000mg Acetaminophen from all sources in 24 hours, whichever is less.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended for children under 12 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, monitor for accumulation
Moderate:
Use with caution, consider reduced dose and extended intervals
Severe:
Contraindicated or use with extreme caution; Acetaminophen metabolites can accumulate.
Dialysis:
Acetaminophen is dialyzable; Butalbital is less so. Use with caution, monitor for CNS depression and acetaminophen toxicity.
Hepatic Impairment:
Mild:
Use with caution, consider reduced dose and extended intervals
Moderate:
Contraindicated or use with extreme caution due to acetaminophen hepatotoxicity risk.
Severe:
Contraindicated due to risk of hepatic encephalopathy (butalbital) and severe hepatotoxicity (acetaminophen).
Pharmacology
Mechanism of Action
Butalbital is a barbiturate that produces generalized CNS depression, likely through its action on GABA-A receptors, enhancing the inhibitory effects of GABA. Acetaminophen is a non-opioid analgesic and antipyretic, believed to act primarily through central inhibition of prostaglandin synthesis (COX-3) and possibly through modulation of descending serotonergic pathways.
Pharmacokinetics
Absorption:
Bioavailability:
High (oral)
Tmax:
Butalbital: 2-4 hours; Acetaminophen: 0.5-2 hours
FoodEffect:
Minimal effect on absorption, but may delay Tmax slightly.
Distribution:
Vd:
Butalbital: ~1 L/kg; Acetaminophen: ~0.9 L/kg
ProteinBinding:
Butalbital: 45-50%; Acetaminophen: 10-25%
CnssPenetration:
Yes (both)
Elimination:
HalfLife:
Butalbital: ~35 hours; Acetaminophen: 1.25-3 hours
Clearance:
Not readily available for combination, but primarily renal.
ExcretionRoute:
Renal (urine)
Unchanged:
Butalbital: ~59% (as parent drug and metabolites); Acetaminophen: <5% (as parent drug)
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
Butalbital: 2-4 hours; Acetaminophen: 1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant or death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. Severe skin reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), have been reported with acetaminophen. These reactions can be fatal.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Changes in urine output
Shortness of breath
Neurological symptoms, such as:
+ Slurred speech
+ Stumbling
+ Confusion
+ Excessive sleepiness or dizziness
+ Feeling drunk
Severe skin reactions (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
Most people experience either no side effects or only mild ones. However, if you encounter any of the following side effects or any other unusual symptoms, consult your doctor or seek medical attention:
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 about side effects, 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 people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Changes in urine output
Shortness of breath
Neurological symptoms, such as:
+ Slurred speech
+ Stumbling
+ Confusion
+ Excessive sleepiness or dizziness
+ Feeling drunk
Severe skin reactions (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
Most people experience either no side effects or only mild ones. However, if you encounter any of the following side effects or any other unusual symptoms, consult your doctor or seek medical attention:
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 about side effects, 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:
- Severe drowsiness or dizziness
- Difficulty breathing
- Unusual weakness or fatigue
- Nausea, vomiting, or severe stomach pain
- Dark urine or yellowing of the skin/eyes (jaundice)
- Unexplained bruising or bleeding
- Skin rash, blistering, or peeling
- Swelling of the face, lips, tongue, or throat
- Any signs of an allergic reaction
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, health problems, and concerns with your doctor and pharmacist. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any health problems you have, as they may interact with this medication
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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, health problems, and concerns with your doctor and pharmacist. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any health problems you have, as they may interact with this medication
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
Important Warnings and Cautions
It is crucial that you inform all of 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 tasks or activities that require alertness, as it may impair your ability to perform them safely.
Risk of Dependence and Tolerance
Long-term use of this medication may lead to dependence. Do not take this medication for a longer period than prescribed by your doctor. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well, and you may need higher doses to achieve the same effect. If you notice that the medication is no longer effective, contact your doctor. Do not take more than the prescribed dose.
Withdrawal Symptoms
If you have been taking this medication regularly and suddenly stop, 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 acetaminophen consumption can cause liver problems. Carefully check the labels of other medications and products to avoid accidental overdose.
Lab Test Interactions
This medication may affect certain laboratory tests. Inform all of your healthcare providers and laboratory personnel that you are taking this medication.
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.
Dosage Instructions
Follow the dosage instructions exactly as prescribed. Do not take more than the recommended daily dose of acetaminophen (up to 4,000 mg per day, as directed by your doctor). Some individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dosage for you, consult your doctor or pharmacist. If you suspect that you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Special Precautions
If you have low levels of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at risk of developing anemia. This condition is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Exercise caution when taking this medication.
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 crucial that you inform all of 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 tasks or activities that require alertness, as it may impair your ability to perform them safely.
Risk of Dependence and Tolerance
Long-term use of this medication may lead to dependence. Do not take this medication for a longer period than prescribed by your doctor. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well, and you may need higher doses to achieve the same effect. If you notice that the medication is no longer effective, contact your doctor. Do not take more than the prescribed dose.
Withdrawal Symptoms
If you have been taking this medication regularly and suddenly stop, 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 acetaminophen consumption can cause liver problems. Carefully check the labels of other medications and products to avoid accidental overdose.
Lab Test Interactions
This medication may affect certain laboratory tests. Inform all of your healthcare providers and laboratory personnel that you are taking this medication.
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.
Dosage Instructions
Follow the dosage instructions exactly as prescribed. Do not take more than the recommended daily dose of acetaminophen (up to 4,000 mg per day, as directed by your doctor). Some individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dosage for you, consult your doctor or pharmacist. If you suspect that you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Special Precautions
If you have low levels of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at risk of developing anemia. This condition is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent. Exercise caution when taking this medication.
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:
- Severe drowsiness or coma
- Slow, shallow breathing
- Pinpoint pupils
- Cold, clammy skin
- Low blood pressure
- Liver damage (delayed onset, 24-48 hours post-ingestion, symptoms include nausea, vomiting, abdominal pain, dark urine, jaundice)
- Kidney failure
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Be prepared to provide information about the drug, dose, and time of ingestion.
Drug Interactions
Contraindicated Interactions
- Alcohol (due to increased CNS depression and hepatotoxicity)
- Other barbiturates
- Severe hepatic impairment
Major Interactions
- Other CNS depressants (opioids, benzodiazepines, sedating antihistamines, tricyclic antidepressants, muscle relaxants, general anesthetics) - increased sedation, respiratory depression, hypotension
- Warfarin (Acetaminophen can increase INR, especially with chronic high doses)
- Hepatotoxic drugs (e.g., isoniazid, methotrexate, amiodarone) - increased risk of liver injury
- CYP2B6 inducers (e.g., rifampin, carbamazepine, phenobarbital) - decreased butalbital levels
- CYP2B6 inhibitors (e.g., ticlopidine, clopidogrel) - increased butalbital levels
Moderate Interactions
- Cholestyramine (decreases acetaminophen absorption)
- Lamotrigine (butalbital may decrease lamotrigine levels)
- Oral contraceptives (butalbital may decrease efficacy)
- Zidovudine (acetaminophen may increase zidovudine toxicity)
- Probenecid (may alter acetaminophen metabolism)
Minor Interactions
- Metoclopramide (increases acetaminophen absorption rate)
Monitoring
Baseline Monitoring
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: To assess baseline hepatic function due to acetaminophen's hepatotoxicity risk.
Timing: Prior to initiation, especially in patients with pre-existing liver conditions or risk factors.
Routine Monitoring
Pain/Headache frequency and severity
Frequency: Regularly, at each visit or as needed
Target: Reduction in symptoms
Action Threshold: Lack of efficacy, increasing frequency/severity of headaches (may indicate medication overuse headache), or need for escalating doses.
Signs/Symptoms of CNS depression (drowsiness, dizziness, confusion)
Frequency: Regularly, at each visit or as needed
Target: Absence or minimal
Action Threshold: Significant impairment, falls, or patient complaint; consider dose reduction or discontinuation.
Signs/Symptoms of Liver Toxicity (nausea, vomiting, abdominal pain, dark urine, jaundice)
Frequency: Patient education for self-monitoring; consider LFTs if risk factors or symptoms arise.
Target: Absence
Action Threshold: Presence of symptoms; immediately discontinue drug and perform LFTs.
Signs/Symptoms of Dependence/Withdrawal
Frequency: Regularly, at each visit
Target: Absence
Action Threshold: Patient reporting cravings, inability to stop, or withdrawal symptoms upon cessation; consider tapering plan and referral.
Symptom Monitoring
- Drowsiness
- Dizziness
- Lightheadedness
- Nausea
- Vomiting
- Abdominal pain (especially upper right quadrant)
- Dark urine
- Jaundice (yellowing of skin/eyes)
- Unusual fatigue
- Skin rash or itching
- Difficulty breathing or swallowing (signs of allergic reaction)
Special Patient Groups
Pregnancy
Use generally not recommended during pregnancy due to potential risks. Butalbital is Category C, meaning animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, or no animal studies have been conducted and there are no adequate and well-controlled studies in humans. Chronic use of barbiturates during pregnancy can lead to neonatal withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations with barbiturates, though data are mixed.
Second Trimester:
Risk of fetal CNS depression and growth restriction.
Third Trimester:
Risk of neonatal withdrawal syndrome (irritability, hypertonia, tremors, feeding difficulties) and respiratory depression in the neonate if used close to delivery.
Lactation
Butalbital and acetaminophen are excreted into breast milk. Butalbital can cause sedation in the infant. Acetaminophen is generally considered safe in usual doses. Due to butalbital, use with caution; monitor infant for sedation, poor feeding, or unusual lethargy. L3 risk.
Infant Risk:
Moderate risk due to butalbital (sedation, poor feeding). Low risk for acetaminophen.
Pediatric Use
Generally not recommended for children under 12 years of age due to lack of established safety and efficacy, and potential for respiratory depression and other adverse effects.
Geriatric Use
Use with caution in elderly patients. They are more susceptible to the CNS depressant effects of butalbital (drowsiness, dizziness, confusion, falls) and may have reduced hepatic/renal function, increasing the risk of adverse effects and accumulation. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- This combination product carries a risk of dependence and withdrawal symptoms due to butalbital, a barbiturate. It should not be used for prolonged periods.
- Patients should be educated about the risk of medication overuse headache (MOH) or rebound headache with frequent use of butalbital-containing products.
- The acetaminophen component carries a significant risk of hepatotoxicity, especially with doses exceeding 4000mg/day or in patients with underlying liver disease or alcohol use. Patients must be warned about taking other acetaminophen-containing products.
- Due to the long half-life of butalbital (~35 hours), accumulation can occur with frequent dosing, leading to increased sedation and other CNS effects.
- This medication is typically reserved for tension headaches and is not a first-line treatment for migraines.
Alternative Therapies
- NSAIDs (e.g., ibuprofen, naproxen) for tension headaches
- Triptans (e.g., sumatriptan, zolmitriptan) for migraines (not typically used for tension headaches)
- Non-pharmacological treatments for tension headaches (e.g., stress management, biofeedback, physical therapy)
- Other analgesics (e.g., tramadol, opioids - generally avoided for chronic headache)
- Preventive medications for chronic tension headaches (e.g., tricyclic antidepressants, beta-blockers)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic)
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.