Description
Butalbital, aspirin, and codeine combinations are used to relieve headaches and other kinds of pain. These combination medicines may provide better pain relief than either aspirin or codeine used alone. In some cases, relief of pain may come at lower doses of each medicine.
Codeine is a narcotic analgesic that acts in the central nervous system (CNS) to relieve pain. Many of its side effects are also caused by actions in the CNS. Butalbital belongs to the group of medicines called barbiturates. Barbiturates also act in the CNS to produce their effects.
When you use butalbital or codeine for a long time, your body may get used to the medicine 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 they are used for a long time or in large doses. Physical dependence may lead to withdrawal symptoms when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.
This combination also contains caffeine. 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.
Aspirin is not a narcotic and does not cause physical dependence. However, it may cause other unwanted effects if too much is taken.
This combination medicine is available only with your doctor's prescription
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 butalbital often causes drowsiness, some children become excited after taking it.
For aspirin: Do not give a medicine containing aspirin to a child with fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.
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: Confusion, depression, or excitement may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of butalbital.
For aspirin: Elderly patients are more sensitive than younger adults to the effects of aspirin. This may increase the chance of side effects during treatment.
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.
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.
Breastfeeding
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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.
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Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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 this medicine, 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 this medicine 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.
- Abrocitinib
- Defibrotide
- Dichlorphenamide
- Influenza Virus Vaccine, Live
- Isocarboxazid
- Ketorolac
- Linezolid
- Mavorixafor
- Methylene Blue
- Moclobemide
- Naltrexone
- Ozanimod
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Samidorphan
- Selegiline
- Tranylcypromine
Using this medicine 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.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acarbose
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Acepromazine
- Acetazolamide
- Aclidinium
- Adagrasib
- Alclometasone
- Aldosterone
- Alfentanil
- Alipogene Tiparvovec
- Almotriptan
- Alosetron
- Alprazolam
- Alteplase, Recombinant
- Amantadine
- Amcinonide
- Amifampridine
- Amikacin
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amphotericin B
- Amprenavir
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Anisindione
- Apalutamide
- Apixaban
- Aprepitant
Using this medicine 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.
- Acebutolol
- Atenolol
- Betaxolol
- Bisoprolol
- Carteolol
- Carvedilol
- Celiprolol
- Delapril
- Esmolol
- Imidapril
- Labetalol
- Levobunolol
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Nitroglycerin
- Ospemifene
- Oxprenolol
- Penbutolol
- Pindolol
- Prednisone
- Probenecid
- Propranolol
- Sotalol
- St John's Wort
- Streptokinase
- Tamarind
- Temocapril
- Tenecteplase
- Timolol
- Warfarin
Other Interactions
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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Using this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. 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/or codeine may develop.
- Asthma, especially if occurring together with other allergies and nasal polyps (history of), 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
- Hyperactivity (in children) or
- Kidney disease or
- Liver disease—The chance of serious side effects may be increased.
- Diabetes mellitus (sugar diabetes) or
- Mental depression or
- Overactive thyroid or
- Porphyria (or history of)—Butalbital can make these conditions worse.
- Gout—Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout.
- Heart disease (severe)—The caffeine in the butalbital, aspirin, and codeine combination can make some kinds of heart disease worse.
- Hemophilia or other bleeding problems or
- Vitamin K deficiency—Aspirin increases the chance of serious bleeding.
- Stomach ulcer, especially with a history of bleeding, or other stomach problems—Aspirin can make your condition worse.
Proper Use
Take this medicine with food or a full glass (8 ounces) of water to lessen stomach irritation.
Do not take this medicine if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional.
Take this medicine 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 or codeine is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). Regular use of caffeine can also cause physical dependence. Dependence is especially likely to occur in people who take these medicines to relieve frequent headaches. Also, taking too much of this combination medicine may cause stomach problems or other medical problems.
This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine 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 this medicine 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 this medicine. 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 and tablets):
- For relieving pain:
- Adults—One or 2 capsules or tablets every four hours as needed. You should not take more than six capsules or tablets a day.
- Children—Dose must be determined by your doctor.
- For relieving pain:
Missed Dose
If you miss a dose of this medicine, 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
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm .
Precautions
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 using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, 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 headache medicine. Continuing to take this medicine 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]) and prescription medicines you now take. If any contain a narcotic, a barbiturate, aspirin, or other salicylates, including diflunisal, check with your doctor or pharmacist. Taking them together with this medicine 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 this medicine:
- Talk to your doctor if you have any questions about taking codeine or about how this medicine 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 the codeine in this medicine 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 or narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.
This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
Dizziness, light-headedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Lying down for a while may relieve these effects.
Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital or codeine.
Do not take this medicine for 5 days before any planned surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.
Before you have any medical tests, tell the person in charge that you are taking this medicine. The caffeine in this combination 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 some other tests may also be affected by this medicine.
If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects.
If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Signs of overdose of this medicine include convulsions (seizures); hearing loss; confusion; ringing or buzzing in the ears; severe excitement, nervousness, or restlessness; severe dizziness; severe drowsiness; unusually slow or troubled breathing; and severe weakness.
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.
The following side effects may mean that a serious allergic reaction is occurring. Check with your doctor or get emergency help immediately if they occur, especially if several of them occur at the same time.
Less common or rare
- Bluish discoloration or flushing or redness of skin (occurring together with other effects listed in this section)
- coughing, shortness of breath, troubled breathing, tightness in chest, or wheezing
- difficulty in swallowing
- dizziness or feeling faint (severe)
- hive-like swellings (large) on eyelids, face, lips, or tongue
- skin rash, itching, or hives
- stuffy nose (occurring together with other effects listed in this section)
Also check with your doctor immediately if any of the following side effects occur, especially if several of them occur together:
Rare
- Bleeding or crusting sores on lips
- chest pain
- fever with or without chills
- red, thickened, or scaly skin
- sores, ulcers, or white spots in mouth (painful)
- sore throat (unexplained)
- tenderness, burning, or peeling of skin
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, especially with products containing caffeine)
- cold, clammy skin
- convulsions (seizures)
- diarrhea (severe or continuing)
- dizziness, light-headedness, drowsiness, or weakness (severe)
- frequent urination (for products containing caffeine)
- hallucinations (seeing, hearing, or feeling things that are not there)
- increased sensitivity to touch or pain (for products containing caffeine)
- increased thirst
- low blood pressure
- muscle trembling or twitching (for products containing caffeine)
- nausea or vomiting (severe or continuing), sometimes with blood
- pinpoint pupils of eyes
- ringing or buzzing in ears (continuing) or hearing loss
- seeing flashes of "zig-zag'' lights (for products containing caffeine)
- slow, fast, or irregular heartbeat
- slow, fast, irregular, or troubled breathing
- slurred speech
- staggering
- stomach pain (severe)
- uncontrollable flapping movements of the hands (especially in elderly patients)
- unusual movements of the eyes
- vision problems
- 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 or rare
- Bloody or black, tarry stools
- bloody urine
- confusion or mental depression
- pinpoint red spots on skin
- skin rash, hives, or itching (without other signs of an allergic reaction to aspirin listed above)
- sore throat and fever
- stomach pain (severe)
- swollen or painful glands
- trembling or uncontrolled muscle movements
- unusual bleeding or bruising
- unusual excitement (mild)
- 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, light-headedness, or drowsiness (mild)
- heartburn or indigestion
- 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.
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