What is Ultracet?

Tramadol is a narcotic-like pain reliever.

Acetaminophen is a less potent pain reliever that increases the effects of tramadol.

Ultracet is used to treat moderate to severe pain.

Ultracet may also be used for other purposes not listed in this medication guide.

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

You should not take Ultracet if you are allergic to acetaminophen and tramadol, if you are intoxicated (drunk), or if you have recently used narcotic pain medicine, a sedative or tranquilizer, medicine for depression or mental illness, or any type of street drug.

Do not take more of this medication than is recommended. An Ultracet overdose can be fatal. The maximum amount of Ultracet is 2 tablets per dose, or 8 tablets per day.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Seizures (convulsions) have occurred in some people taking Ultracet. You may be more likely to have a seizure while taking Ultracet if you have a history of seizures or head injury, a metabolic disorder, a brain or spinal cord infection, or if you are taking certain medicines. Talk with your doctor about your individual risk of having a seizure.

Ultracet can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking Ultracet?

You should not take this medication if you are allergic to acetaminophen or tramadol, if you are intoxicated (drunk), or if you have recently used any of the following drugs:

• alcohol;
• narcotic pain medicine;
• sedatives or tranquilizers (such as Valium);
• medicine for depression or anxiety;
• medicine for mental illness (such as bipolar disorder, schizophrenia); or
• street drugs.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Seizures have occurred in some people taking Ultracet. Your risk of a seizure may be higher if you have any of these conditions:

• a history of drug or alcohol addiction;
• a history of epilepsy or other seizure disorder;
• a history of head injury;
• a metabolic disorder;
• an infection of your brain or spinal cord, such as meningitis or encephalitis;
• if you are also taking an antidepressant, mood stabilizer, or another narcotic pain medicine; or
• if you have taken an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Talk with your doctor about your individual risk of having a seizure.

Before taking Ultracet, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• liver disease;
• asthma or other breathing disorder;
• a stomach disorder; or
• a history of depression, mental illness, or suicide attempt.

If you have any of these conditions, you may not be able to use Ultracet, or you may need a dosage adjustment or special tests durinh treatment.

FDA pregnancy category C. It is not known whether Ultracet is harmful to an unborn baby. Tramadol alone may have caused serious or fatal side effects in newborns of mothers who used the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Ultracet. Acetaminophen and tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Ultracet?

Take Ultracet exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not take more Ultracet than is recommended. An Ultracet overdose can be fatal. The maximum amount of Ultracet is 2 tablets per dose, or 8 tablets per day. Take this medicine with a full glass of water.

Ultracet can be taken with or without food, but take it the same way each time.

Do not stop using this medication suddenly or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop taking Ultracet. Store Ultracet at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An Ultracet overdose can be fatal.

Symptoms of an Ultracet overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes, feeling light-headed, fainting, or coma.

What should I avoid while taking Ultracet?

Do not drink alcohol while you are taking Ultracet. Alcohol may cause a dangerous decrease in your breathing when used together with Ultracet.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Ultracet. Tell your doctor if you regularly use any of these medicines.

Ultracet can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Ultracet side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Ultracet and call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);
• a red, blistering, peeling skin rash; or
• shallow breathing, weak pulse.

Less serious Ultracet side effects may include:

• dizziness, drowsiness, weakness;
• nausea, vomiting, constipation, loss of appetite;
• blurred vision;
• flushing (redness, warmth, or tingly feeling); or
• sleep problems (insomnia).

Side effects other than those listed here may also occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ultracet?

Before taking Ultracet, tell your doctor if you also use:

• carbamazepine (Tegretol);
• warfarin (Coumadin);
• digoxin (Lanoxin, Lanoxicaps);
• ketoconazole (Nizoral);
• erythromycin (E-Mycin, E.E.S., Ery-Tab);
• rifampin (Rifadin, Rimactane, Rifater);
• St. John’s wort;
• quinidine (Quinaglute, Quinidex, Cardioquin, Quinora); or
• an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft).

If you are using any of these drugs, you may not be able to use Ultracet or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Ultracet. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Ultracet.

What does my medication look like?

Acetaminophen and acetaminophen and tramadol is available with a prescription under the brand name Ultracet. 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.

• Ultracet 325 mg/37.5 mg – yellow, capsule-shaped, film-coated tablets.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and 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, and 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 and consumers in the United States and 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 and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and 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.