butalbital, acetaminophen, caffeine, and codeine

bue-TAL-bi-tal, a-seet-a-MIN-oh-fen, KAF-een, KOE-deen FOS-fate

Oral route(Capsule)

This product contains butalbital, acetaminophen, caffeine, and codeine phosphate. Acetaminophen has been associated with cases of acute liver failure, including cases of death and transplantation. Most of the cases of liver injury are associated with the use of acetaminophen doses that exceed 4000 milligrams per day and often involve more than one acetaminophen containing product .

Commonly used brand name(s)

In the U.S.

• Fioricet with Codeine


• Phrenilin with Caffeine and Codeine

Available Dosage Forms:

• Capsule

Therapeutic Class: Opioid/Barbiturate Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

Uses For butalbital, acetaminophen, caffeine, and codeine

Butalbital, acetaminophen, caffeine, and codeine combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Codeine is a narcotic analgesic that acts in the CNS to relieve pain. Many of its side effects are also caused by actions in the CNS.

When you take butalbital or codeine for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital and codeine may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

Butalbital, acetaminophen, caffeine and codeine combination may also be used for other kinds of headaches or other kinds of pain as determined by your doctor.

Butalbital, acetaminophen, caffeine, and codeine combination is available only with your doctor's prescription.

Before Using butalbital, acetaminophen, caffeine, and codeine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For butalbital, acetaminophen, caffeine, and codeine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to butalbital, acetaminophen, caffeine, and codeine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

• For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.


• For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.


• For caffeine: There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

• For butalbital: Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.


• For acetaminophen: Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.


• For caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.


• For codeine: Breathing problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of codeine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking butalbital, acetaminophen, caffeine, and codeine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using butalbital, acetaminophen, caffeine, and codeine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Using butalbital, acetaminophen, caffeine, and codeine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Anisindione


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Dicumarol


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Flurazepam


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Phenindione


• Phenobarbital


• Phenprocoumon


• Prazepam


• Primidone


• Propoxyphene


• Quazepam


• Quetiapine


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiopental


• Triazolam

Using butalbital, acetaminophen, caffeine, and codeine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Cannabis


• Carbamazepine


• Imipramine


• Isoniazid


• Phenytoin


• Prednisone


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using butalbital, acetaminophen, caffeine, and codeine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use butalbital, acetaminophen, caffeine, and codeine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using butalbital, acetaminophen, caffeine, and codeine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use butalbital, acetaminophen, caffeine, and codeine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage


• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of butalbital, acetaminophen, caffeine, and codeine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or


• Drug abuse or dependence (or history of)—Dependence on butalbital and codeine may develop; also, acetaminophen may cause liver damage in people who abuse alcohol

• Asthma (or history of), emphysema, or other chronic lung disease or


• Brain disease or head injury or


• Colitis or


• Convulsions (seizures) (history of) or


• Emphysema or other chronic lung disease or


• Enlarged prostate or problems with urination or


• Gallbladder disease or gallstones or


• Hepatitis or other liver disease or


• Hyperactivity (in children) or


• Kidney disease—The chance of serious side effects may be increased

• Type 2 diabetes mellitus or


• Mental depression or


• Overactive thyroid or


• Porphyria (or history of)—Butalbital can make these conditions worse

• Heart disease (severe)—The caffeine can make some kinds of heart disease worse

Proper Use of butalbital, acetaminophen, caffeine, and codeine

Take butalbital, acetaminophen, caffeine, and codeine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital, acetaminophen, caffeine, and codeine combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine can also increase the chance of dependence. Dependence is especially likely to occur in patients who take these medicines to relieve frequent headaches. Taking too much of butalbital, acetaminophen, caffeine, and codeine may also lead to liver damage or other medical problems.

butalbital, acetaminophen, caffeine, and codeine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take butalbital, acetaminophen, caffeine, and codeine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose of butalbital, acetaminophen, caffeine, and codeine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of butalbital, acetaminophen, caffeine, and codeine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules):
  
  • For tension headaches:
    
    • Adults—One or 2 capsules every four hours as needed. You should not take more than six capsules a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of butalbital, acetaminophen, caffeine, and codeine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using butalbital, acetaminophen, caffeine, and codeine

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.


• If you are having headaches more often than you did before you started taking butalbital, acetaminophen, caffeine, and codeine. This is especially important if a new headache occurs within 1 day after you took your last dose of butalbital, acetaminophen, caffeine, and codeine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take butalbital, acetaminophen, caffeine, and codeine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate, acetaminophen, caffeine, or codeine, check with your health care professional . Taking them together with butalbital, acetaminophen, caffeine, and codeine may cause an overdose.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine".Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects . For nursing mothers taking butalbital, acetaminophen, caffeine, and codeine:

• Talk to your doctor if you have any questions about taking codeine or about how butalbital, acetaminophen, caffeine, and codeine may affect your baby.


• Call your doctor if you become extremely tired and have difficulty caring for your baby.


• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.


• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breast-feeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

The butalbital and codeine in butalbital, acetaminophen, caffeine, and codeine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking butalbital, acetaminophen, caffeine, and codeine may increase the chance of liver damage or stomach problems, especially if you take more of butalbital, acetaminophen, caffeine, and codeine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using butalbital, acetaminophen, caffeine, and codeine.

butalbital, acetaminophen, caffeine, and codeine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to butalbital, acetaminophen, caffeine, and codeine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Before you have any medical tests, tell the person in charge that you are taking butalbital, acetaminophen, caffeine, and codeine. Caffeine interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital, acetaminophen, caffeine and codeine combination.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking butalbital, acetaminophen, caffeine, and codeine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital or codeine.

If you have been taking large amounts of butalbital, acetaminophen, caffeine, and codeine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of butalbital, acetaminophen, caffeine, and codeine, get emergency help at once. Taking an overdose of butalbital, acetaminophen, caffeine, and codeine or taking alcohol or CNS depressants with butalbital, acetaminophen, caffeine, and codeine may lead to unconsciousness or possibly death. Signs of butalbital or codeine overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

butalbital, acetaminophen, caffeine, and codeine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Bleeding or crusting sores on lips


• chest pain


• fever with or without chills


• convulsions, hallucinations, trembling, and/or uncontrolled muscle movements


• hive-like swellings (large) on eyelids, face, lips, and/or tongue


• mental depression


• muscle cramps or pain


• red, thickened, or scaly skin


• shortness of breath, troubled breathing, tightness in chest, or wheezing


• skin rash, itching, or hives


• sores, ulcers, or white spots in mouth (painful)


• sore throat

Symptoms of overdose

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe)


• cold and clammy skin


• convulsions (seizures)


• diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain


• dizziness, light-headedness, drowsiness, or weakness, (severe)


• frequent urination


• hallucinations (seeing, hearing, or feeling things that are not there)


• increased sensitivity to touch or pain


• muscle trembling or twitching


• nausea or vomiting, sometimes with blood


• ringing or other sounds in ears


• seeing flashes of "zig-zag" lights


• shortness of breath or unusually slow or troubled breathing


• slow, fast, or irregular heartbeat


• slurred speech


• staggering


• swelling, pain, or tenderness in the upper abdomen or stomach area


• unusual movements of the eyes


• Difficulty breathing


• difficulty nursing


• increased sleepiness (more than usual)


• limpness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Confusion (mild)


• mental depression


• unusual excitement (mild)

Rare

• Bloody or black, tarry stools


• bloody urine


• pinpoint red spots on skin


• swollen or painful glands


• unusual bleeding or bruising


• unusual tiredness or weakness (mild)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloated or "gassy" feeling


• dizziness or light-headedness (mild)


• drowsiness (mild)


• nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: butalbital, acetaminophen, caffeine, and codeine side effects (in more detail)

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