Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Ascomp wCodeine
  2. Fiorinal wCodeine

Canadian Brand Name

  1. Fiorinal-C 12
  2. Fiorinal-C 14

Descriptions


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.

This product is available in the following dosage forms:

  • Capsule

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

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.

Geriatric

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.

Pregnancy

Information about this butalbital-aspirin-caffeine-and-codeine-oral-route
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.

Breastfeeding

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.

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.

  • Influenza Virus Vaccine, Live
  • Ketorolac
  • Naltrexone
  • Riociguat

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.

  • Abciximab
  • Acenocoumarol
  • Adenosine
  • Adinazolam
  • Alfentanil
  • Alipogene Tiparvovec
  • Alprazolam
  • Alteplase, Recombinant
  • Amobarbital
  • Anagrelide
  • Anileridine
  • Anisindione
  • Apixaban
  • Aprobarbital
  • Ardeparin
  • Argatroban
  • Baclofen
  • Beta Glucan
  • Bivalirudin
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Bupropion
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Certoparin
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorzoxazone
  • Cilostazol
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clopidogrel
  • Clorazepate
  • Clovoxamine
  • Clozapine
  • Cobicistat
  • Codeine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Dantrolene
  • Desirudin
  • Desvenlafaxine
  • Dezocine
  • Diazepam
  • Dicumarol
  • Dipyridamole
  • Dipyrone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Duloxetine
  • Elvitegravir
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Estazolam
  • Ethchlorvynol
  • Femoxetine
  • Fentanyl
  • Feverfew
  • Flesinoxan
  • Flunitrazepam
  • Fluoxetine
  • Flurazepam
  • Fluvoxamine
  • Fondaparinux
  • Ginkgo
  • Gossypol
  • Halazepam
  • Heparin
  • Hydrocodone
  • Hydromorphone
  • Ivabradine
  • Ketazolam
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Meadowsweet
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Methotrexate
  • Midazolam
  • Milnacipran
  • Morphine
  • Morphine Sulfate Liposome
  • Nadroparin
  • Nalbuphine
  • Naproxen
  • Nefazodone
  • Nifedipine
  • Nitrazepam
  • Nordazepam
  • Opium
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentazocine
  • Pentobarbital
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Piperaquine
  • Pixantrone
  • Pralatrexate
  • Prasugrel
  • Prazepam
  • Primidone
  • Propoxyphene
  • Protein C
  • Quazepam
  • Regadenoson
  • Remifentanil
  • Reteplase, Recombinant
  • Reviparin
  • Rivaroxaban
  • Secobarbital
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tacrolimus
  • Tapentadol
  • Temazepam
  • Thiopental
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tizanidine
  • Treprostinil
  • Triazolam
  • Ulipristal Acetate
  • Varicella Virus Vaccine
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Warfarin
  • Zimeldine

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
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Anagrelide
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betamethasone
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Cannabis
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celecoxib
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cilazapril
  • Clopamide
  • Cortisone
  • Cyclopenthiazide
  • Deflazacort
  • Delapril
  • Dexamethasone
  • Dilevalol
  • Diltiazem
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Ibuprofen
  • Imidapril
  • Imipramine
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Methylprednisolone
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Nitroglycerin
  • Olmesartan Medoxomil
  • Ospemifene
  • Oxprenolol
  • Paramethasone
  • Penbutolol
  • Pentopril
  • Perampanel
  • Perindopril
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Prednisolone
  • Prednisone
  • Probenecid
  • Propranolol
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Sotalol
  • Spirapril
  • Spironolactone
  • Streptokinase
  • Talinolol
  • Tamarind
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tenecteplase
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamcinolone
  • Triamterene
  • Trichlormethiazide
  • Valproic Acid
  • Valsartan
  • Verapamil
  • Warfarin
  • Xipamide
  • Zofenopril

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.

  • 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.

  • 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:

  • Addison's disease (an adrenal problem) or
  • Alcohol abuse, or history of or
  • Brain disease or
  • Breathing problems (eg, respiratory depression, sleep apnea) 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
  • Porphyria (enzyme problem) or
  • Stomach or bowel problems (eg, 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.
  • 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

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.

Drink plenty of fluids to help avoid constipation.

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 form (capsules):
    • For tension headaches:
      • Adults—One or two capsules every 4 hours as needed. However, the dose is usually not more than 6 capsules per day.
      • Children—Use and dose must be determined by your doctor.

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

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.

Precautions

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.

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. Stop using this medicine and 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.

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

  1. Back, leg, or stomach pains
  2. black, tarry stools
  3. bleeding gums
  4. blistering, peeling, or loosening of the skin
  5. blood in the vomit
  6. bloody urine
  7. blurred vision
  8. chills, fever
  9. confusion
  10. cough
  11. dark urine
  12. decreased frequency or amount of urine
  13. diarrhea
  14. difficulty breathing
  15. difficulty swallowing
  16. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  17. fast, irregular, pounding, or racing heartbeat or pulse
  18. general tiredness and weakness
  19. headache
  20. hives, itching, skin rash
  21. increased thirst
  22. joint or muscle pain
  23. light-colored stools
  24. lower back or side pain
  25. nausea or vomiting
  26. nosebleeds
  27. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  28. red skin lesions, often with a purple center
  29. red, irritated eyes
  30. shakiness in the legs, arms, hands, or feet skin
  31. sores, ulcers, or white spots in the mouth or on the lips
  32. sweating
  33. swelling of the face, fingers, or lower legs
  34. tightness or pain in the chest
  35. trembling or shaking of the hands or feet
  36. upper right abdominal or stomach pain
  37. weight gain
  38. yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Confusion as to time, place, or person
  2. continuing ringing or buzzing or other unexplained noise in the ears
  3. convulsions
  4. difficult or troubled breathing
  5. drowsiness
  6. extremely high fever or body temperature
  7. hallucinations
  8. headache
  9. hearing loss
  10. holding false beliefs that cannot be changed by fact
  11. irregular, fast or slow, or shallow breathing
  12. loss of consciousness
  13. muscle cramps
  14. pale or blue lips, fingernails, or skin
  15. pale, clammy skin
  16. pinpoint pupils (black part of the eyes)
  17. restlessness
  18. trouble sleeping
  19. unusual bleeding or bruising

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:

Rare

  1. Anxiety
  2. blurred vision
  3. burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  4. confusion about identity, place, and time
  5. constricted, pinpoint, or small pupils (black part of the eye)
  6. depression
  7. difficulty having a bowel movement (stool)
  8. dry mouth
  9. feeling of constant movement of self or surroundings
  10. feeling of warmth
  11. feeling that others are watching you or controlling your behavior
  12. feeling that others can hear your thoughts
  13. heartburn
  14. high energy
  15. hyperventilation
  16. irregular heartbeats
  17. irritability
  18. loss in sexual ability, desire, drive, or performance
  19. pain in the legs
  20. redness of the face, neck, arms, and occasionally, upper chest
  21. sensation of spinning
  22. severe mood or mental changes
  23. shaking
  24. sleepiness
  25. sluggishness
  26. slurred speech
  27. trouble sitting still
  28. unexplained weight loss
  29. unusual behavior
  30. weakness

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.