Generic Name: Butabarbital (BUE-ta-BAR-bi-tal)
Brand Name: Butisol Sodium

Butabarbital Elixir is used for:

Treating sleep disorders. It may also be used for other conditions as determined by your doctor.

Butabarbital Elixir is a barbiturate. It works by depressing the central nervous system, causing mild sedation or sleep, depending on the dose.

Do NOT use Butabarbital Elixir if:

• you are allergic to any ingredient in Butabarbital Elixir
• you have the blood disease porphyria
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Butabarbital Elixir:

Some medical conditions may interact with Butabarbital Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems, lung or respiratory tract disease, or a painful condition
• if you are in shock
• if you have a history of substance abuse or dependence, mental or mood problems (eg, depression), or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Butabarbital Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) or sodium oxybate (GHB) because the risk of severe drowsiness may be increased
• Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, micronized estradiol), griseofulvin, metronidazole, oral contraceptives (birth control pills), phenytoin, quinidine, theophylline, or valproic acid because their effectiveness may be decreased by Butabarbital Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Butabarbital Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Butabarbital Elixir:

Use Butabarbital Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Butabarbital Elixir may be taken with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist if you are unsure of how to measure your dose.
• If you miss a dose of Butabarbital Elixir, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Butabarbital Elixir.

Important safety information:

• Butabarbital Elixir may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Butabarbital Elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Butabarbital Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking Butabarbital Elixir for longer than prescribed may be habit-forming.
• If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor.
• Tell your doctor or dentist that you take Butabarbital Elixir before you receive any medical or dental care, emergency care, or surgery.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Butabarbital Elixir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
• Some patients taking sleep medicines have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Butabarbital Elixir. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Butabarbital Elixir. Tell your doctor right away if such an event happens to you.
• Lab tests, including complete blood cell counts and kidney and liver function tests, may be performed while you use Butabarbital Elixir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Butabarbital Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, depression, excitement, or confusion.
• PREGNANCY and BREAST-FEEDING: Butabarbital Elixir has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Butabarbital Elixir while you are pregnant. Butabarbital Elixir is found in breast milk. If you are or will be breast-feeding while you use Butabarbital Elixir, check with your doctor. Discuss any possible risks to your baby.

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Butabarbital Elixir. This is known as DEPENDENCE or addiction. If you suddenly stop taking Butabarbital Elixir, you may experience WITHDRAWAL symptoms. These may include anxiety, dizziness, hallucinations, lightheadedness, nausea, muscle twitching, seizures, sleeplessness, trembling hands and fingers, weakness, or vomiting.

Possible side effects of Butabarbital Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Clumsiness; dizziness; excessive daytime drowsiness; lightheadedness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts or behavior; confusion; fainting; fever; hallucinations; mental or mood changes; nausea or vomiting; new or worsening trouble sleeping; severe dizziness; shortness of breath; swelling or tightness of the throat; very slow breathing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include change in size of pupil; cold, clammy skin; deep sleep; incoordination; loss of consciousness; slowed or fast breathing; slurred speech; trouble walking; unusual eye movements.

Proper storage of Butabarbital Elixir:

Store Butabarbital Elixir between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Butabarbital Elixir out of the reach of children and away from pets.

General information:

• If you have any questions about Butabarbital Elixir, please talk with your doctor, pharmacist, or other health care provider.
• Butabarbital Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Butabarbital Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pronunciation: (byoo-tah-BAR-bih-tahl SO-dee-uhm)
Class: Sedative and hypnotic, Barbiturate

Trade Names:
Butisol Sodium
- Tablets 30 mg
- Tablets 50 mg
- Elixir 30 mg per 5 mL

Pharmacology

Depresses sensory cortex, decreases motor activity, alters cerebellar function, and produces drowsiness, sedation, and hypnosis.

Pharmacokinetics

Absorption

Absorption is increased if taken on an empty stomach.

Distribution

Rapidly distributed to all tissues and fluids with high concentration in the brain, liver, and kidneys. Bound to plasma and tissue proteins.

Metabolism

Metabolized by liver.

Elimination

Excreted in urine; plasma t _½ is 100 h.

Onset

¾ to 1 h.

Duration

6 to 8 h.

Indications and Usage

Short-term use (2 wk) as a sedative or hypnotic.

Contraindications

Hypersensitivity to barbiturates; history of manifest or latent porphyria.

Dosage and Administration

Hypnotic
Adults

PO 50 to 100 mg at bedtime.

Sedative
Adults

PO Daytime sedative: 15 to 30 mg, 3 or 4 times daily. Preoperative sedative: 50  to 100 mg, 60 to 90 min before surgery.

Children

PO Preoperative sedative: 2 to 6 mg/kg (max, 100 mg).

Storage/Stability

Store tablets and elixir at controlled room temperature (68° to 77°F).

Drug Interactions

Alcohol, CNS depressants

CNS depressant effects may be enhanced.

Anticoagulants (eg, warfarin), beta-blockers (eg, metoprolol), corticosteroids, doxycycline, felodipine, griseofulvin, methadone, metronidazole, nifedipine, quinidine, theophyllines, verapamil

Activity of these drugs may be reduced by butabarbital.

Anticonvulsants

Serum levels of carbamazepine, valproic acid, and succinimides may be reduced. Valproic acid may increase butabarbital levels.

Estrogens, estrogen-containing oral contraceptives

May reduce contraceptive effectiveness.

MAOIs

The effects of butabarbital may be prolonged.

Methoxyflurane

Risk of renal toxicity may be increased.

Phenytoin

May increase butabarbital levels while phenytoin levels may increase or decrease.

Laboratory Test Interactions

Decreased serum bilirubin; false-positive phentolamine test results; decreased response to metyrapone.

Adverse Reactions

Cardiovascular

Bradycardia, hypotension, syncope (less than 1%).

CNS

Somnolence (1% to 3%); agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormal thinking, headache (less then 1%).

GI

Nausea, vomiting, constipation (less than 1%).

Hepatic

Liver damage (less than 1%).

Respiratory

Hypoventilation, apnea (less than 1%).

Miscellaneous

Hypersensitivity (angioedema, skin rashes, exfoliative dermatitis), fever (less than 1%).

Precautions

Monitor Ensure CBC with differential, renal function, and hepatic function are evaluated before starting therapy and periodically thereafter during prolonged treatment. Ensure therapy periodically is reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, or discontinuation) is indicated. If being used for sleep induction or maintenance, limit duration of therapy to 2 wk.

Pregnancy

Category D .

Lactation

Excreted in breast milk.

Children

May respond with excitement rather than depression.

Elderly

Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy. May react to barbiturates with marked excitement, depression, and confusion.

Renal Function

Use with caution and in reduced dosage.

Hepatic Function

Use with caution and in reduced dosage.

Special Risk Patients

Use with caution in patients with a history of drug abuse, who are mentally depressed, or who have suicidal tendencies.

Acute or chronic pain

Because paradoxical excitement may be induced, use with caution.

Dependence

May be habit forming; tolerance or psychological and physical dependence may occur with continued use.

Discontinuation

If treatment needs to be discontinued, attempt to gradually taper the dose over at least a 1-wk interval in patient who has been on prolonged therapy. Monitor patient for withdrawal symptoms (eg, increased anxiety, tremor, muscle or abdominal cramps, sweating). If significant withdrawal symptoms develop, reinstitute previous dosing schedule and attempt a less rapid tapering regimen after patient has stabilized.

Overdosage

Symptoms

Unsteady gait, slurred speech, sustained nystagmus, CNS and respiratory depression, Cheyne-Stokes respiration, areflexia, constriction of pupils, oliguria, tachycardia, hypotension, lowered body temperature, coma, shock syndrome (apnea, circulatory collapse, respiratory arrest, and death may occur), pneumonia, pulmonary edema, cardiac arrhythmia, CHF, renal failure, death.

Patient Information

• Advise patients or caregiver to read the patient information leaflet before starting therapy and with each refill.
• Advise patient with anxiety to take as needed and to seek alternative methods for controlling or preventing anxiety (eg, stress, reduction, counseling).
• Advise patient medication usually is started at a low dose and then gradually increased as tolerated until max benefit is obtained.
• Advise patient medication may be habit forming and to take as prescribed and not to stop taking or change dose unless advised by health care provider.
• Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs.
• Advise patient using elixir to measure and administer prescribed dose using dosing syringe, dosing spoon, or dosing cup.
• Advise patient if a dose is missed to skip that dose and take the next dose at the regularly scheduled time. Caution patient never to take 2 doses at same time.
• Advise patient if medication needs to be discontinued after long-term use, it usually will be slowly withdrawn over 1 wk or more unless safety concerns (eg, rash) require a more rapid withdrawal.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Advise patient that drug may impair judgement, thinking, or motor skills, or cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.

Copyright © 2009 Wolters Kluwer Health.

Commonly used brand name(s):

In the U.S.

• Anolor 300
• Cephadyn
• Dolgic LQ
• Esgic
• Esgic-Plus
• Ezol
• Fioricet
• Geone
• Margesic
• Medigesic
• Phrenilin
• Phrenilin Forte

Available Dosage Forms:

• Tablet
• Capsule
• Solution

Uses For butalbital and acetaminophen combination

Butalbital and acetaminophen 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.

When you take butalbital 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 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.

Some butalbital and acetaminophen combinations also contain 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.

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

These medicines are available only with your doctor’s prescription.

Before Using butalbital and acetaminophen combination

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.

Pregnancy

For butalbital:

• Barbiturates such as butalbital have been shown to increase the chance of birth defects in humans. Also, one study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby.
• Butalbital may cause breathing problems in the newborn baby if taken just before or during delivery.

For acetaminophen:

• Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems.

For caffeine:

• Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, use of large amounts of caffeine during pregnancy may cause problems with the heart rhythm and the growth of the fetus. Also, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).

Breast Feeding

For butalbital:

• Barbiturates such as butalbital pass into the breast milk and may cause drowsiness, unusually slow heartbeat, shortness of breath, or troubled breathing in nursing babies.

For acetaminophen:

• Although acetaminophen has not been shown to cause problems in nursing babies, it passes into the breast milk in small amounts.

For caffeine:

• Caffeine (present in some butalbital and acetaminophen combinations) passes into the breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been shown to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use caffeine-containing medicines should probably limit the amount of caffeine they take in from other medicines or from beverages.

Interactions with Medicines

Using medicines in this class 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
• Butabarbital
• Butalbital
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• 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
• Nitrazepam
• Nordazepam
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentobarbital
• Phenindione
• Phenobarbital
• Phenprocoumon
• Prazepam
• Primidone
• Propoxyphene
• Quazepam
• Quetiapine
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Temazepam
• Thiopental
• Triazolam

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 medicines in this class 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 your 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 medicines in this class. 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 may develop. Also, acetaminophen may cause liver damage in people who abuse alcohol.

• Asthma (or history of), emphysema, or other chronic lung disease 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 in some butalbital and acetaminophen combinations can make some kinds of heart disease worse.

Proper Use of butalbital and acetaminophen combination

Take butalbital and acetaminophen combination 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 and acetaminophen combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and acetaminophen combinations 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 and acetaminophen combination may also lead to liver damage or other medical problems.

butalbital and acetaminophen combination 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 and acetaminophen combination 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 medicines in this class 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 these medicines. 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 or tablets):
  • For tension headaches:
    • Adults—One or 2 capsules or tablets every four hours as needed. If your medicine contains 325 or 500 milligrams (mg) of acetaminophen in each capsule or tablet, you should not take more than six capsules or tablets a day. If your medicine contains 650 mg of acetaminophen in each capsule or tablet, you should not take more than four capsules or tablets a day.
    • Children—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of butalbital and acetaminophen combination, 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.

Precautions While Using butalbital and acetaminophen combination

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 and acetaminophen combination. This is especially important if a new headache occurs within 1 day after you took your last dose of butalbital and acetaminophen combination, 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 and acetaminophen combination 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 or acetaminophen, check with your health care professional. Taking them together with butalbital and acetaminophen combination may cause an overdose.

The butalbital in butalbital and acetaminophen combination will add to the effects of alcohol and other 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 and acetaminophen combination may increase the chance of liver damage, especially if you take more of butalbital and acetaminophen combination 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 and acetaminophen combination.

butalbital and acetaminophen combination may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to butalbital and acetaminophen combination 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 and acetaminophen combination. Caffeine (present in some butalbital and acetaminophen combinations) 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 and acetaminophen combinations.

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 and acetaminophen combination. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital.

If you have been taking large amounts of butalbital and acetaminophen combination, 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 and acetaminophen combination, get emergency help at once. Taking an overdose of butalbital and acetaminophen combination or taking alcohol or CNS depressants with butalbital and acetaminophen combination may lead to unconsciousness or possibly death. Signs of butalbital 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 and acetaminophen combination 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
• hive-like swellings (large) on eyelids, face, lips, and/or tongue
• 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)

Symptoms of overdose

• Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
• convulsions (seizures) (for products containing caffeine)
• diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain
• dizziness, lightheadedness, 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)
• muscle trembling or twitching (for products containing caffeine)
• nausea or vomiting, sometimes with blood
• ringing or other sounds in ears (for products containing caffeine)
• seeing flashes of “zig-zag” lights (for products containing caffeine)
• 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

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 lightheadedness (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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Commonly used brand name(s):

In the U.S.

• Fiorinal
• Fortabs
• Laniroif

Available Dosage Forms:

• Tablet
• Capsule

Uses For butalbital and aspirin combination

Butalbital and aspirin 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.

When you use butalbital 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 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.

Some of these medicines also contain 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.

Butalbital and aspirin combination is sometimes also used for other kinds of headaches or other kinds of pain, as determined by your doctor.

These medicines are available only with your doctor’s prescription.

Before Using butalbital and aspirin combination

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 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 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.

Pregnancy

For butalbital:

• Barbiturates such as butalbital have been shown to increase the chance of birth defects in humans. Also, one study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby. Butalbital may cause breathing problems in the newborn baby if taken just before or during delivery.

For aspirin:

• Although studies in humans have not shown that aspirin causes birth defects, it has caused birth defects in animal studies.
• Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor. Some reports have suggested that use of aspirin late in pregnancy may cause a decrease in the newborn’s weight and possible death of the fetus or newborn baby. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects.
• There is a chance that regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn baby. Also, use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn baby. In addition, too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery.

For caffeine:

• Studies in humans have not shown that caffeine causes birth defects. However, use of large amounts of caffeine during pregnancy may cause problems with the heart rhythm and the growth of the fetus. Also, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount in 12 to 24 cups of coffee a day).

Breast Feeding

Although this combination medicine has not been reported to cause problems, the chance always exists, especially if the medicine is taken for a long time or in large amounts.

For butalbital:

• Barbiturates such as butalbital pass into the breast milk and may cause drowsiness, unusually slow heartbeat, shortness of breath, or troubled breathing in nursing babies.

For aspirin:

• Aspirin passes into the breast milk. However, taking aspirin in the amounts present in these combination medicines has not been reported to cause problems in nursing babies.

For caffeine:

• The caffeine in some of these combination medicines passes into the breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been reported to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use caffeine-containing medicines should probably limit the amount of caffeine they take in from other medicines or from beverages.

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Ketorolac

Using medicines in this class 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.

• Acenocoumarol
• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Anisindione
• Aprobarbital
• Beta Glucan
• Bromazepam
• Brotizolam
• Butabarbital
• Butalbital
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Citalopram
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Desirudin
• Desvenlafaxine
• Diazepam
• Dicumarol
• Duloxetine
• Eptifibatide
• Escitalopram
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Fluvoxamine
• Ginkgo
• Halazepam
• Heparin
• Hydrocodone
• Hydromorphone
• Ketazolam
• Ketoprofen
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Methotrexate
• Midazolam
• Milnacipran
• Morphine
• Morphine Sulfate Liposome
• Nefazodone
• Nitrazepam
• Nordazepam
• Oxazepam
• Oxycodone
• Oxymorphone
• Paroxetine
• Pentobarbital
• Phenindione
• Phenobarbital
• Phenprocoumon
• Prazepam
• Primidone
• Propoxyphene
• Quazepam
• Quetiapine
• Remifentanil
• Reteplase, Recombinant
• Secobarbital
• Sertraline
• Sodium Oxybate
• Sufentanil
• Temazepam
• Thiopental
• Ticlopidine
• Triazolam
• Varicella Virus Vaccine
• Venlafaxine
• Warfarin

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.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. 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 may develop.

• Asthma, especially if occurring together with other allergies and nasal polyps (or history of), or
• Emphysema or other chronic lung disease 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 may 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 some of these combination medicines 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 of butalbital and aspirin combination

Take butalbital and aspirin combination with food or a full glass (8 ounces) of water to lessen stomach irritation.

Do not take butalbital and aspirin combination 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 butalbital and aspirin combination 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 and aspirin combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and aspirin combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take butalbital and aspirin combination to relieve frequent headaches. Taking too much of this combination medicine can also lead to stomach problems or to other medical problems.

butalbital and aspirin combination 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 and aspirin combination 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 medicines in this class 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 these medicines. 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 butalbital and aspirin combination
• For oral dosage form (tablets):
  • For tension headaches:
    • Adults—One tablet every four hours as needed. You should not take more than six tablets a day.
    • Children—Dose must be determined by your doctor.

• For butalbital, aspirin, and caffeine combination
• For oral dosage forms (capsules or tablets):
  • For tension headaches:
    • 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.

Missed Dose

If you miss a dose of butalbital and aspirin combination, 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.

Precautions While Using butalbital and aspirin combination

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 butalbital and aspirin combination. 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 butalbital and aspirin combination 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 barbiturate, aspirin, or other salicylates, including diflunisal, check with your health care professional. Taking them together with butalbital and aspirin combination may cause an overdose.

The butalbital in butalbital and aspirin combination will add to the effects of alcohol and other 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 butalbital and aspirin combination.

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

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 and aspirin combination. Serious side effects may occur if your medical doctor or dentist gives you certain other medicines without knowing that you have taken butalbital.

Do not take butalbital and aspirin combination 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 butalbital and aspirin combination. Caffeine (present in some butalbital and aspirin combinations) 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 butalbital and aspirin combinations.

If you have been taking large amounts of butalbital and aspirin combination, 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 butalbital and aspirin combination, get emergency help at once. Taking an overdose of butalbital and aspirin combination or taking alcohol or CNS depressants with butalbital and aspirin combination may lead to unconsciousness or death. Symptoms of overdose of butalbital and aspirin combination include convulsions (seizures); hearing loss; confusion; ringing or buzzing in the ears; severe excitement, nervousness, or restlessness; severe dizziness; severe drowsiness; shortness of breath or troubled breathing; and severe weakness.

butalbital and aspirin combination 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:

Less common or rare – may mean that a serious allergic reaction is occurring

• 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)

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

• Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
• convulsions (seizures, with products containing caffeine)
• diarrhea (severe or continuing)
• dizziness, lightheadedness, 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
• muscle trembling or twitching (for products containing caffeine)
• nausea or vomiting (severe or continuing), sometimes with blood
• 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

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
• muscle cramps or pain
• pinpoint red spots on skin
• swollen or painful glands
• unusual bleeding or bruising
• unusual excitement (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 lightheadedness (mild)
• 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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Brand names: Esgic, Esgic-Plus, Anolor 300, Fioricet

Why is Butalbital, Acetaminophen, Caffeine prescribed?

Fioricet, a strong, non-narcotic pain reliever and relaxant, is prescribed for the relief of tension headache symptoms caused by muscle contractions in the head, neck, and shoulder area. It combines a sedative barbiturate (butalbital), a non-aspirin pain reliever (acetaminophen), and caffeine.

Most important fact about Butalbital, Acetaminophen, Caffeine

Mental and physical dependence can occur with the use of barbiturates such as butalbital when these drugs are taken in higher than recommended doses over long periods of time.

How should you take Butalbital, Acetaminophen, Caffeine?

Take Fioricet exactly as prescribed. Do not increase the amount you take without your doctor’s approval.

• If you miss a dose…
  Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

• Storage instructions…
  Store at room temperature in a tight, light-resistant container.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Fioricet.

• Side effects may include:
  Abdominal pain, dizziness, drowsiness, intoxicated feeling, light-headedness, nausea, sedation, shortness of breath, vomiting

Why should Butalbital, Acetaminophen, Caffeine not be prescribed?

If you are sensitive to or have ever had an allergic reaction to barbiturates, acetaminophen, or caffeine, you should not take Butalbital, Acetaminophen, Caffeine. Make sure that your doctor is aware of any drug reactions that you have experienced.

Unless you are directed to do so by your doctor, do not take Butalbital, Acetaminophen, Caffeine if you have porphyria (an inherited metabolic disorder affecting the liver or bone marrow).

Special warnings about Butalbital, Acetaminophen, Caffeine

Fioricet may cause you to become drowsy or less alert; therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended until you know your response to Butalbital, Acetaminophen, Caffeine.

If you are being treated for severe depression or have a history of severe depression or drug abuse, consult with your doctor before taking Fioricet.

Use Butalbital, Acetaminophen, Caffeine with caution if you are elderly or in a weakened condition, if you have liver or kidney problems, or if you have severe abdominal trouble.

Possible food and drug interactions when taking Butalbital, Acetaminophen, Caffeine

Butalbital slows the central nervous system (CNS) and intensifies the effects of alcohol and other CNS depressants. Use of alcohol with Butalbital, Acetaminophen, Caffeine may also cause overdose symptoms. Avoid alcoholic beverages while taking Fioricet.

If Fioricet is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fioricet with the following:

Antihistamines such as diphenhydramine
Drugs known as monoamine oxidase inhibitors, including the antidepressants phenelzine and tranylcypromine
Drugs to treat depression such as amitriptyline
Major tranquilizers such as chlorpromazine and haloperidol
Muscle relaxants such as cyclobenzaprine
Narcotic pain relievers such as propoxyphene
Sleep aids such as triazolam
Tranquilizers such as alprazolam and diazepam

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor immediately. Fioricet can affect a developing baby. It also appears in breast milk. If Butalbital, Acetaminophen, Caffeine is essential to your health, your doctor may advise you to discontinue breastfeeding your baby until your treatment is finished.

Recommended dosage for Butalbital, Acetaminophen, Caffeine

ADULTS

The usual dose of Fioricet is 1 or 2 tablets taken every 4 hours as needed. Do not exceed a total dose of 6 tablets per day.

The usual dose of Esgic-Plus is 1 tablet every 4 hours as needed. Do not take more than 6 tablets a day.

CHILDREN

The safety and effectiveness of Fioricet have not been established in children under 12 years of age.

OLDER ADULTS

Fioricet may cause excitement, depression, and confusion in older people. Therefore, your doctor will prescribe a dose individualized to suit your needs.

Overdosage

Symptoms of Fioricet overdose can be due to its barbiturate or its acetaminophen component.

• Symptoms of barbiturate poisoning may include:
  Coma, confusion, drowsiness, low blood pressure, shock, slow or troubled breathing

Overdose due to the acetaminophen component of Fioricet may cause kidney and liver damage, blood disorders, or coma due to low blood sugar. Massive doses may cause liver failure.

• Symptoms of liver damage include:
  Excess perspiration, feeling of bodily discomfort, nausea, vomiting

If you suspect an overdose, seek emergency medical treatment immediately.

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

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

Acetaminophen

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Butalbital

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.

Caffeine

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Codeine

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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bue-TAL-bi-tal, AS-pir-in, KOE-deen

Pharmacologic Class: Barbiturate

Chemical Class: Salicylate, Aspirin

Uses For butalbital, aspirin, and codeine

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 butalbital, aspirin, 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, aspirin, and codeine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to butalbital, aspirin, 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 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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Aspirin

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.

Butalbital

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.

Codeine

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using butalbital, aspirin, 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.

• Ketorolac
• Naltrexone

Using butalbital, aspirin, 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.

• Acenocoumarol
• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Anisindione
• Aprobarbital
• Beta Glucan
• Bromazepam
• Brotizolam
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Citalopram
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Desirudin
• Desvenlafaxine
• Dezocine
• Diazepam
• Dicumarol
• Duloxetine
• Eptifibatide
• Escitalopram
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Fluvoxamine
• Ginkgo
• Halazepam
• Heparin
• Hydrocodone
• Hydromorphone
• Ketazolam
• Ketoprofen
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Methotrexate
• Midazolam
• Milnacipran
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Nitrazepam
• Nordazepam
• Opium
• Oxazepam
• Oxycodone
• Oxymorphone
• Paroxetine
• Pentazocine
• Pentobarbital
• Phenindione
• Phenobarbital
• Phenprocoumon
• Prazepam
• Primidone
• Propoxyphene
• Quazepam
• Quetiapine
• Remifentanil
• Reteplase, Recombinant
• Secobarbital
• Sertraline
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Ticlopidine
• Triazolam
• Varicella Virus Vaccine
• Venlafaxine
• Warfarin

Using butalbital, aspirin, 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.

• Anagrelide
• Ardeparin
• Betamethasone
• Cannabis
• Captopril
• Celecoxib
• Certoparin
• Chlorpropamide
• Cortisone
• Dalteparin
• Danaparoid
• Deflazacort
• Delapril
• Dexamethasone
• Diltiazem
• Enalaprilat
• Enalapril Maleate
• Enoxaparin
• Furosemide
• Glyburide
• Ibuprofen
• Imidapril
• Imipramine
• Lisinopril
• Methylprednisolone
• Nadroparin
• Nitroglycerin
• Paramethasone
• Parnaparin
• Prednisolone
• Prednisone
• Probenecid
• Reviparin
• Rofecoxib
• Streptokinase
• Tamarind
• Temocapril
• Tenecteplase
• Tinzaparin
• Tirofiban
• Tolbutamide
• Triamcinolone
• Valproic Acid
• Verapamil
• Warfarin

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using butalbital, aspirin, 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, aspirin, and codeine, 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 butalbital, aspirin, 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/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 of butalbital, aspirin, and codeine

Take butalbital, aspirin, and codeine with food or a full glass (8 ounces) of water to lessen stomach irritation.

Do not take butalbital, aspirin, and codeine 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 butalbital, aspirin, 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 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.

butalbital, aspirin, 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, aspirin, 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, aspirin, 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, aspirin, 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 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.

Missed Dose

If you miss a dose of butalbital, aspirin, 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

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.

Precautions While Using butalbital, aspirin, 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 using butalbital, aspirin, and codeine. 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 butalbital, aspirin, 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]) 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 butalbital, aspirin, 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, aspirin, and codeine:

• Talk to your doctor if you have any questions about taking codeine or about how butalbital, aspirin, 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 the codeine in butalbital, aspirin, 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 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 butalbital, aspirin, and codeine.

butalbital, aspirin, and codeine 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 butalbital, aspirin, 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.

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 butalbital, aspirin, 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.

Do not take butalbital, aspirin, and codeine 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 butalbital, aspirin, and codeine. 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 butalbital, aspirin, and codeine.

If you have been taking large amounts of butalbital, aspirin, and codeine, 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 butalbital, aspirin, and codeine, get emergency help at once. Taking an overdose of butalbital, aspirin, and codeine or taking alcohol or CNS depressants with butalbital, aspirin, and codeine may lead to unconsciousness or death. Signs of overdose of butalbital, aspirin, and codeine 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.

butalbital, aspirin, 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.

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Brand names: Fiorinal

Why is Butalbital, Aspirin, Caffeine prescribed?

Fiorinal, a strong, non-narcotic pain reliever and muscle relaxant, is prescribed for the relief of tension headache symptoms caused by stress or muscle contraction in the head, neck, and shoulder area. It combines a non-narcotic, sedative barbiturate (butalbital) with a pain reliever (aspirin) and a stimulant (caffeine).

Most important fact about Butalbital, Aspirin, Caffeine

Barbiturates such as butalbital can be habit-forming if you take them over long periods of time.

How should you take Butalbital, Aspirin, Caffeine?

For best relief, take Fiorinal as soon as a headache begins.

Take the medication with a full glass of water or food to reduce stomach irritation. Do not take Butalbital, Aspirin, Caffeine if it has a strong odor of vinegar.

Take Fiorinal exactly as prescribed. Do not increase the amount you take without your doctor’s approval, or take the drug for longer than prescribed.

• If you miss a dose…
  If you take Fiorinal on a regular schedule, take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

• Storage instructions…
  Store at room temperature. Keep the container tightly closed.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Fiorinal.

• Side effects may include:
  Dizziness, drowsiness

Why should Butalbital, Aspirin, Caffeine not be prescribed?

If you are sensitive to or have ever had an allergic reaction to barbiturates, aspirin, caffeine, or other sedatives and pain relievers, you should not take Butalbital, Aspirin, Caffeine. The aspirin in Fiorinal, in particular, can cause a severe reaction in someone allergic to it. Make sure your doctor is aware of any drug reactions you have experienced.

Unless you are directed to do so by your doctor, do not take Butalbital, Aspirin, Caffeine if you have porphyria (an inherited metabolic disorder affecting the liver or bone marrow).

Because aspirin, when given to children and teenagers suffering from flu or chickenpox, can cause a dangerous neurological disease called Reye’s syndrome, do not use Fiorinal under these circumstances.

Fiorinal contains aspirin. If you have a stomach (peptic) ulcer or a disorder affecting the blood clotting process, you should not take Fiorinal. Aspirin may irritate the stomach lining and may cause bleeding.

Special warnings about Butalbital, Aspirin, Caffeine

Fiorinal may make you drowsy or less alert; therefore, you should not drive or operate dangerous machinery or participate in any hazardous activity that requires full mental alertness until you know your response to Butalbital, Aspirin, Caffeine.

Taking more of Butalbital, Aspirin, Caffeine than your doctor has prescribed may cause dependence and symptoms of overdose.

Be especially careful with Fiorinal if you are an older person or in a weakened condition, if you have any kidney, liver, or intestinal problems or an enlarged prostate gland, or if you have had a head injury. Also be cautious if you have a thyroid problem, blood clotting difficulties, or a urinary disorder.

Possible food and drug interactions when taking Butalbital, Aspirin, Caffeine

Butalbital decreases the activity of the central nervous system and intensifies the effects of alcohol. Avoid drinking alcohol while you are taking Fiorinal.

If Fiorinal is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fiorinal with the following:

Acetazolamide
Beta-blocking blood pressure drugs such as atenolol and propranolol
Blood-thinning drugs such as warfarin
Drugs known as MAO inhibitors, such as the antidepressants phenelzine and tranylcypromine
Insulin
Mercaptopurine
Methotrexate
Narcotic pain relievers such as oxycodone and propoxyphene
Nonsteroidal anti-inflammatory drugs such as ibuprofen and naproxen
Oral contraceptives
Oral diabetes drugs such as glyburide
Probenecid
Sleep aids such as pentobarbital and triazolam
Steroid medications such as prednisone
Sulfinpyrazone
Theophylline
Tranquilizers such as alprazolam, chlordiazepoxide, and diazepam
Valproic acid

Special information if you are pregnant or breastfeeding

The effects of Fiorinal during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. If you take aspirin late in your pregnancy it could cause bleeding in you or your baby, or could delay the baby’s birth. Aspirin, butalbital, and caffeine appear in breast milk. If Butalbital, Aspirin, Caffeine is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment with Butalbital, Aspirin, Caffeine is finished.

Recommended dosage for Butalbital, Aspirin, Caffeine

ADULTS

The usual dose of Fiorinal is 1 or 2 tablets or capsules taken every 4 hours. You should not take more than 6 tablets or capsules in a day.

CHILDREN

The safety and effectiveness of Fiorinal have not been established in children.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

• Symptoms of an overdose of Fiorinal are mainly attributed to its barbiturate component. These symptoms may include:
  Coma, confusion, drowsiness, low blood pressure, shock, slow or troubled breathing

• Symptoms attributed to the aspirin and caffeine components of Fiorinal may include:
  Abdominal pain, deep, rapid breathing, delirium, high fever, inability to fall or stay asleep, rapid or irregular heartbeat, restlessness, ringing in the ears, seizures, tremor, vomiting