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

Uses

What is Acetaminophen-Butalbital-Caffeine-Codeine used for?

Acetaminophen-Butalbital-Caffeine-Codeine is a combination medication used to treat tension headaches. Codeine is an opioid (narcotic) pain reliever that acts on certain centers in the brain to give you pain relief. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative which helps to decrease anxiety and cause sleepiness and relaxation.

How should I take Acetaminophen-Butalbital-Caffeine-Codeine?

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 6 capsules in a 24-hour period. If you have nausea, you may take this medication with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1-2 hours with as little head movement as possible).

The dosage is based on your medical condition, age, 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.

Do not increase your dose or use this drug more often or for longer than prescribed, because your risk of side effects may increase. Properly stop the medication when so directed.

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 runny nose, watery eyes, 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). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

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 Acetaminophen-Butalbital-Caffeine-Codeine?

Acetaminophen-Butalbital-Caffeine-Codeine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Acetaminophen-Butalbital-Caffeine-Codeine in the bathroom or the freezer. There may be different brands of Acetaminophen-Butalbital-Caffeine-Codeine 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 Acetaminophen-Butalbital-Caffeine-Codeine 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 Acetaminophen-Butalbital-Caffeine-Codeine?

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), xanthine derivatives (e.g., theophylline) or opioid pain medications (e.g., morphine); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain enzyme disorder (porphyria), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), disease of the pancreas (e.g., pancreatitis), heart disease (e.g., irregular heartbeat, recent heart attack), liver disease, kidney disease, a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, obesity, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus, stomach ulcer, colitis), adrenal gland problem (e.g., Addison’s disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), recent bowel/abdominal surgery.

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing.

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, and trouble falling asleep. Confusion, dizziness, drowsiness, and trouble falling asleep can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant, such as unusual sleepiness, difficulty feeding, trouble breathing, or unusual limpness. Breast-feeding while using this drug is not recommended. 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 Acetaminophen-Butalbital-Caffeine-Codeine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Acetaminophen-Butalbital-Caffeine-Codeine. Acetaminophen-Butalbital-Caffeine-Codeine is pregnancy risk category N 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 Acetaminophen-Butalbital-Caffeine-Codeine?

Nausea, vomiting, abdominal pain, shaking (tremor), shortness of breath, constipation, dry mouth, lightheadedness, dizziness, drowsiness, or trouble sleeping 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.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

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 you have any serious side effects, including: mental/mood changes, fast/irregular heartbeat, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

Get medical help right away if you have any very serious side effects, including: fainting, seizure.

Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very seriousside effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 Acetaminophen-Butalbital-Caffeine-Codeine?

Some products that may interact with this drug include: anticholinergic medications (e.g., scopolamine), darunavir, drugs affecting liver enzymes that remove this medication from your body (such as cimetidine, disulfiram, valproic acid, fluvoxamine), isoniazid, lithium, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), methoxyflurane, naltrexone, other medications for pain (e.g., pentazocine, nalbuphine, morphine), phenothiazines (e.g., chlorpromazine), sodium oxybate.

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

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as morphine, hydrocodone), alcohol, marijuana, 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 caffeine or ingredients that cause drowsiness. Certain beverages (such as coffee, colas, tea) may also contain caffeine. Ask your pharmacist about using those products safely.

Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), paroxetine, quinidine, rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

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 medical/laboratory tests (including urine 5-HIAA levels, urine VMA levels, urine catecholamine levels, amylase and lipase levels, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Acetaminophen-Butalbital-Caffeine-Codeine 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 Acetaminophen-Butalbital-Caffeine-Codeine?

Acetaminophen-Butalbital-Caffeine-Codeine 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 Acetaminophen-Butalbital-Caffeine-Codeine?

Acetaminophen-Butalbital-Caffeine-Codeine 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 Acetaminophen-Butalbital-Caffeine-Codeine.

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

Usual Adult Dose for Headache

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

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 when nonopioid analgesic and alternative treatments are inadequate.

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 Acetaminophen-Butalbital-Caffeine-Codeine for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Acetaminophen-Butalbital-Caffeine-Codeine available?

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

  • 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 Acetaminophen-Butalbital-Caffeine-Codeine, 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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