Butalbital-Acetaminophen

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Generic Name: Butalbital-Acetaminophen Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: C

Uses

What is Butalbital-Acetaminophen used for?

Butalbital-Acetaminophen is a combination medication used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

How should I take Butalbital-Acetaminophen?

Take this medication by mouth with or without food, usually every 4 hours as needed or as directed by your doctor. Do not take more than 300 milligrams of butalbital in a 24-hour period.

The dosage is based on your medical condition and response to therapy. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

Inform your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

How do I store Butalbital-Acetaminophen?

Butalbital-Acetaminophen is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Butalbital-Acetaminophen in the bathroom or the freezer. There may be different brands of Butalbital-Acetaminophen that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Butalbital-Acetaminophen down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Butalbital-Acetaminophen?

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen or butalbital; or to other barbiturates (e.g., phenobarbital); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., bronchopneumonia), a certain enzyme disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, abdominal/intestinal problems.

Before having surgery, tell your doctor or dentist that you are using this medication.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness. This side effect can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor right away if you notice any of these symptoms in your newborn.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Butalbital-Acetaminophen during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Butalbital-Acetaminophen. Butalbital-Acetaminophen is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Butalbital-Acetaminophen?

Nausea, vomiting, abdominal pain, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: shortness of breath, mental/mood changes, fainting, seizure, fast heartbeat.

Tell your doctor right away if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Butalbital-Acetaminophen?

Some products that may interact with this drug include: darunavir, sodium oxybate, anti-seizure drugs (e.g., phenytoin), drugs affecting liver enzymes that remove this medication from your body (such as disulfiram, valproic acid, MAO inhibitors including isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), isoniazid, methoxyflurane, phenothiazines (e.g., chlorpromazine).

This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include “blood thinners” (e.g., warfarin), corticosteroids such as prednisone, estrogen, felodipine, quinidine, certain beta blockers such as metoprolol, theophylline, doxycycline.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain laboratory tests (including urine 5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Butalbital-Acetaminophen may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Butalbital-Acetaminophen?

Butalbital-Acetaminophen may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

What health conditions may interact with Butalbital-Acetaminophen?

Butalbital-Acetaminophen may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Butalbital-Acetaminophen.

What is the dose of Butalbital-Acetaminophen for an adult?

Usual Adult Dose for Headache

Butalbital 50 mg/acetaminophen 300 or 325 mg:

1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:

2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

-Due to high rate of physical dependence, the extended use of this drug is not recommended.

-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

Dose Adjustments

Elderly: Dose selection should be cautious generally starting at the low end of the dosing range.

The drug should not be abruptly discontinued in the physically dependent person.

What is the dose of Butalbital-Acetaminophen for a child?

Usual Pediatric Dose for Headache

12 years or older:

Butalbital 50 mg/acetaminophen 300 or 325 mg:

1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:

2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

-Due to high rate of physical dependence, the extended use of this drug is not recommended.

-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

How is Butalbital-Acetaminophen available?

Butalbital-Acetaminophen is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral capsule.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Butalbital-Acetaminophen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: November 6, 2018 | Last Modified: November 6, 2018

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