What is the most important information I should know about carisoprodol?

Use caution when driving, operating machinery, or performing other hazardous activities. Carisoprodol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness & dizziness while you are taking carisoprodol.

What is carisoprodol?

Carisoprodol is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Carisoprodol is used, along with rest & physical therapy, to treat injuries & other painful muscular conditions.

Carisoprodol may also be used for purposes other than those listed in this medication guide.

Who should not take carisoprodol?

Do not take carisoprodol if you have acute intermittent porphyria.

Before taking carisoprodol, tell your doctor if you have kidney or liver disease. You may need a lower dose or special monitoring during your therapy.

It is not known whether carisoprodol will harm an unborn baby. Do not take carisoprodol without first talking to your doctor if you are pregnant.

It is also not known whether carisoprodol passes into breast milk. Do not take carisoprodol without first talking to your doctor if you are breast-feeding a baby.

Carisoprodol is not approved for use in children younger than 12 years of age.

How should I take carisoprodol?

Take carisoprodol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

The maximum amount of carisoprodol you should take in one day is 1,400 mg (4 tablets).

Store carisoprodol at room temperature away from moisture & heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose & take only your next regularly scheduled dose. Do not take a double dose of this medication. Try to keep your doses at least 4 hours apart.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a carisoprodol overdose include low blood pressure (weakness, fainting, confusion), decreased breathing, & unconsciousness.

What should I avoid while taking carisoprodol?

Use caution when driving, operating machinery, or performing other hazardous activities. Carisoprodol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness & dizziness while you are taking carisoprodol.

What are the possible side effects of carisoprodol?

If you experience any of the following serious side effects, stop taking carisoprodol & seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• paralysis (loss of feeling) or extreme weakness;
• vision loss; or
• agitation or tremor.

Other, less serious side effects may be more likely to occur. Continue to take carisoprodol & talk to your doctor if you experience

• drowsiness or dizziness;
• headache;
• depression;
• blurred vision;
• insomnia; or
• hiccups.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect carisoprodol?

Many drugs can increase the effects of carisoprodol, which can lead to heavy sedation. Before taking this medication, tell your doctor if you are taking any of the following medicines:

• antihistamines such as brompheniramine (Dimetane, Bromfed, others), chlorpheniramine (Chlor-Trimeton, Teldrin, others), azatadine (Optimine), clemastine (Tavist), & many others;
• narcotics (pain killers) such as meperidine (Demerol), morphine (MS Contin, MSIR, others), propoxyphene (Darvon, Darvocet), hydrocodone (Lorcet, Vicodin), oxycodone (Percocet, Percodan), fentanyl (Duragesic), & codeine (Fiorinal, Fioricet, Tylenol #3, others);
• sedatives such as phenobarbital (Solfoton, Luminal), amobarbital (Amytal), & secobarbital (Seconal);
• phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), thioridazine (Mellaril), & trifluoperazine (Stelazine); or
• antidepressants such as doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), phenelzine (Nardil), & tranylcypromine (Parnate).

Drugs other than those listed here may also interact with carisoprodol. Talk to your doctor & pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has more information about carisoprodol written for health professionals that you may read.

What does my medication look like?

Carisoprodol is available with a prescription under the brand name Soma. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Soma 350 mg--white, round tablets

Remember, keep this & all other medicines out of the reach of children, never share your medicines with others, & use this medication only for the indication prescribed

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, & complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners & consumers in the United States & therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients &/or to serve consumers viewing this service as a supplement to, & not a substitute for, the expertise, skill, knowledge & judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

What is the most important information I should know about acetaminophen/butalbital/caffeine?

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital will cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Avoid sleeping pills, antihistamines, sedatives, & tranquilizers except under the supervision of your doctor. These may also make you drowsy.

Avoid alcohol. Alcohol taken during therapy with acetaminophen & butalbital can be very damaging to your liver & can increase drowsiness & dizziness.

Check the acetaminophen content of other over-the-counter & prescription products while taking this medication. You should not exceed 4 grams (4000 mg) of acetaminophen per day.

Never take more acetaminophen/butalbital/caffeine than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

What is acetaminophen/butalbital/caffeine?

Acetaminophen is a pain reliever & fever reducer.

Butalbital is in a class of drugs called barbiturates that slow down your central nervous system (brain & nerve impulses) causing relaxation.

Caffeine is believed to constrict dilated blood vessels that may contribute to tension headaches.

Together, acetaminophen, butalbital, & caffeine are used to relieve complex tension (muscle contraction) headaches although precisely how it works is unknown.

Acetaminophen/butalbital/caffeine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking acetaminophen/butalbital/caffeine?

This medication is habit forming & should only be used under close supervision. Take this drug only for as long as it is prescribed , in the amounts it is prescribed, & no more frequently than prescribed.

Do not take acetaminophen/butalbital/caffeine without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen & butalbital, or you may require a lower dose.

Do not take acetaminophen/butalbital/caffeine if you have porphyria.

Before taking this medication, tell your doctor if you have

• kidney disease, or
• liver disease.

You may not be able to take acetaminophen/butalbital/caffeine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

This drug combination is in the FDA pregnancy category C. This means that its effects on an unborn baby are not known. Do not take this medication without first talking to your doctor if you are pregnant.

This drug combination passes into breast milk & may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Acetaminophen/butalbital/caffeine has not been approved for use in children younger than 12 years of age.

How should I take acetaminophen/butalbital/caffeine?

Take acetaminophen/butalbital/caffeine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Take acetaminophen/butalbital/caffeine with food or milk if it upsets your stomach.

Never take more acetaminophen/butalbital/caffeine than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

Store acetaminophen/butalbital/caffeine at room temperature away from moisture & heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an acetaminophen/butalbital/caffeine overdose include insomnia, restlessness, tremor, nausea, vomiting, diarrhea, abdominal pain, sweating, seizures, drowsiness, decreased breathing, dizziness or fainting, confusion, an irregular heartbeat, & coma.

What should I avoid while taking acetaminophen/butalbital/caffeine?

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital will cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Avoid sleeping pills, antihistamines, sedatives, & tranquilizers except under the supervision of your doctor. These may also make you drowsy.

Avoid alcohol. Alcohol taken during therapy with acetaminophen & butalbital can be very damaging to your liver & can increase drowsiness & dizziness.

Check the acetaminophen content of other over-the-counter & prescription products while taking this medication. You should not exceed 4 grams (4000 mg) of acetaminophen per day.

Avoid taking too much caffeine. Check the caffeine content of other over-the-counter & prescription products as well as beverages (coffee, tea, & colas) while taking this medication

What are the possible side effects of acetaminophen/butalbital/caffeine?

If you experience any of the following serious side effects, stop taking acetaminophen/butalbital/caffeine & seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• slow, weak breathing;
• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue);
• blood problems (easy or unusual bleeding or bruising); or
• low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).

These side effects are very rare & are not likely to occur during proper treatment with acetaminophen & caffeine. If you experience any unusual reactions, stop taking this medicine & seek the advice of your doctor.

Other, less serious side effects may be more likely to occur. Continue to take acetaminophen/butalbital/caffeine & talk to your doctor if you experience

• drowsiness;
• dizziness,, confusion or lightheadedness;
• shortness of breath;
• dry mouth;
• nausea, vomiting, abdominal pain, or decreased appetite;
• tiredness, leg pain, or muscle weakness;
• agitation, irritability, nervousness, anxiety or excitability;
• rash or itching;
• feeling of intoxication;
• headache; or
• constipation.

Butalbital may be habit forming.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect acetaminophen/butalbital/caffeine?

Do not take acetaminophen/butalbital/caffeine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result.

Acetaminophen & butalbital may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, & muscle relaxants. Tell your doctor about all medicines that you are taking, & do not take any medicine unless your doctor approves.

Many other medicines contain acetaminophen, especially over-the-counter pain, fever, cold, & allergy medications. Too much acetaminophen can be very dangerous.

Drugs other than those listed here may also interact with acetaminophen/butalbital/caffeine. Talk to your doctor & pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about acetaminophen/butalbital/caffeine written for health professionals that you may read.

What does my medication look like?

Acetaminophen/butalbital/caffeine is available with a prescription under the brand name Fioricet. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Acetaminophen/butalbital/caffeine strengths are as follows:

• Fioricet 325 mg/50 mg/40 mg--light-blue round tablets
• Esgic 325 mg/50 mg/40 mg--white, round tablets
• Esgic 325 mg/50 mg/40 mg-white capsules
• Esgic Plus 500 mg/50 mg/40 mg-white, capsule shaped tablets

Remember, keep this & all other medicines out of the reach of children, never share your medicines with others, & use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, & complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners & consumers in the United States & therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients &/or to serve consumers viewing this service as a supplement to, & not a substitute for, the expertise, skill, knowledge & judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.