Butalbital, aspirin, caffeine, and codeine (Oral route)
bue-TAL-bi-tal, AS-pir-in, KAF-een, KOE-deen FOS-fate
- Ascomp w/Codeine
- Fiorinal w/Codeine
- Fiorinal-C 1/2
- Fiorinal-C 1/4
Addiction, abuse, and misuse may lead to overdose and death. Assess risk before prescribing and regularly monitor for signs of these behaviors and conditions. Serious and potentially fatal respiratory depression may occur. Monitor for respiratory depression, particularly when initiating or increasing dosage. Accidental ingestion of one dose or more can lead to fatal overdose, especially in children. Prolonged use of butalbital/aspirin/caffeine/codeine phosphate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with butalbital/aspirin/caffeine/codeine phosphate requires careful consideration of the effects on codeine, and the active metabolite, morphine. Concomitant use of benzodiazepines or other CNS depressants and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation .
Uses of This Medicine:
Butalbital, aspirin, caffeine, and codeine combination is used to relieve symptoms of tension (or muscle contraction) headaches. Extended and repeated use of this product is not recommended.
Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
Aspirin is used to relieve pain and reduce fever in patients. It belongs to the group of medicines known as salicylates and acts on the immune system to reduce inflammation. It is also known as an anti-inflammatory analgesic.
Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
When butalbital or codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. 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.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of butalbital, aspirin, caffeine, and codeine combination in the pediatric population. Safety and efficacy have not been established.
Use of Fiorinal® with codeine should not be used to relieve pain after surgery to remove of tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital, aspirin, caffeine, and codeine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
|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.|
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.
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.
- Influenza Virus Vaccine, Live
- Methylene Blue
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.
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amtolmetin Guacil
- Chloral Hydrate
- Choline Salicylate
- Dabigatran Etexilate
- Doxorubicin Hydrochloride Liposome
- Ethacrynic Acid
- Flufenamic Acid
- Mefenamic Acid
- Morphine Sulfate Liposome
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Nitrous Oxide
- Opium Alkaloids
- Peginterferon Alfa-2b
- Pentosan Polysulfate Sodium
- Protein C
- Reteplase, Recombinant
- Salicylic Acid
- Sodium Oxybate
- Sodium Salicylate
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolonium Chloride
- Varicella Virus Vaccine
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.
- Enalapril Maleate
- Valproic Acid
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.
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.
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:
- Addison's disease (an adrenal problem) or
- Alcohol abuse, or history of or
- Brain tumor or
- Breathing problems (eg, COPD, cor pulmonale, hypercapnia, hypoxia, sleep apnea) or
- Depression, or history of or
- Drug abuse or dependence, or history of or
- Enlarged prostate or
- Head injury, or history of or
- Hypothyroidism (underactive thyroid) or
- Stomach problems or
- Trouble urinating or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Asthma with nasal polyps and rhinitis, history of or
- Hemophilia (bleeding problem) or
- Hypoprothrombinemia (low prothrombin in the blood) or
- Liver damage, severe or
- Lung or breathing problems (eg, asthma, respiratory depression), severe or
- Porphyria (enzyme problem) or
- Reye's syndrome or
- Stomach or bowel problems (eg, paralytic ileus, peptic ulcer, lesions) or
- Surgery (eg, nasopharyngeal tonsils, tonsils) or
- Thrombasthenia (a platelet disorder) or
- Thrombocytopenia (low platelets in the blood) or
- Vitamin K deficiency or
- von Willebrand's disease (blood clotting disorder)—Should not be used in patients with these conditions.
- Chicken pox or
- Flu—Use with caution. May increase risk to have a condition called Reye's syndrome.
- Gallbladder problems or
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation of the pancreas) or
- Seizures, history of or—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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 too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Drink plenty of fluids to help avoid constipation.
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 form (capsules):
- For tension headaches:
- Adults—1 or 2 capsules every 4 hours as needed. Do not take more than 6 capsules per day.
- Children—Use and dose must be determined by your doctor.
- For tension headaches:
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.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a safe and secure place. Do not throw unused medicine in the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®) within the past 14 days.
Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate, aspirin, caffeine, or codeine, check with your doctor. 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. Children may be especially sensitive to this effect.
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 2 to 3 hours and should not sleep more than 4 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 breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Aspirin may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine may make you dizzy or drowsy. 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 not alert.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include convulsions, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or trouble sleeping.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Side Effects of This Medicine:
- Back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the vomit
- bloody urine
- blurred vision
- chills, fever
- dark urine
- decreased frequency or amount of urine
- difficulty breathing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- general tiredness and weakness
- hives, itching, or skin rash
- increased thirst
- joint or muscle pain
- light-colored stools
- lower back or side pain
- nausea or vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- shakiness in the legs, arms, hands, or feet skin
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the face, fingers, or lower legs
- tightness or pain in the chest
- trembling or shaking of the hands or feet
- upper right abdominal or stomach pain
- weight gain
- yellow eyes and skin
- Symptoms of overdose
- Confusion as to time, place, or person
- continuing ringing or buzzing or other unexplained noise in the ears
- difficult or troubled breathing
- extremely high fever or body temperature
- hearing loss
- holding false beliefs that cannot be changed by fact
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- muscle cramps
- pale or blue lips, fingernails, or skin
- pale, clammy skin
- pinpoint pupils (black part of the eyes)
- trouble sleeping
- unusual bleeding or bruising
- blurred vision
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- confusion about identity, place, and time
- constricted, pinpoint, or small pupils (black part of the eye)
- difficulty having a bowel movement (stool)
- dry mouth
- feeling of constant movement of self or surroundings
- feeling of warmth
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- high energy
- irregular heartbeats
- loss in sexual ability, desire, drive, or performance
- pain in the legs
- redness of the face, neck, arms, and occasionally, upper chest
- sensation of spinning
- severe mood or mental changes
- slurred speech
- trouble sitting still
- unexplained weight loss
- unusual behavior
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 9/4/2017