Ultracet contains a combination of tramadol and acetaminophen. Tramadol is an pain medicine similar to an opioid (sometimes called, a narcotic)and may be habit-forming. Acetaminophen is a less potent pain reliever that increases the effects of tramadol.

Ultracet is used for the short term (5 days or less) treatment of severe acute pain.

Ultracet is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep Ultracet where others cannot get to it.

Fatal side effects may occur if you also drink alcohol or use other drugs that cause drowsiness or slow breathing.

You should not use Ultracet if you have severe breathing problems, a blockage in your stomach or intestines, or if you have recently used an MAO inhibitor.

Do not give Ultracet to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking Ultracet during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Before taking this medicine

You should not use Ultracet if you are allergic to acetaminophen (Tylenol) or tramadol (Ultram), or if you have:

• severe asthma or breathing problems, a blockage in your digestive tract (stomach or intestines); or

• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Ultracet is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have ever had:

• a metabolic disorder;

• breathing problems, sleep apnea, a head injury, brain tumor, seizures; or

• alcoholism or drug addiction, or if you have recently used sedatives, tranquilizers, or narcotic medications.

To make sure Ultracet is safe for you, tell your doctor if you have ever had:

• liver disease, or if you drink alcohol;

• kidney disease (or if you are on dialysis), urination problems;

• problems with your pancreas, gallbladder, or thyroid; or

• depression, mental illness, or a suicide attempt.

Using Ultracet during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Ask a doctor before using Ultracet if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Take Ultracet exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Ultracet in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share Ultracet with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

The maximum amount of Ultracet is 2 tablets per dose, or 8 tablets per day. Do not take this medicine for longer than 5 days in a row. Do not take more than 4000 mg of acetaminophen in 24 hours.

You may take Ultracet with or without food, but take it the same way each time.

You should not stop using Ultracet suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

Do not keep leftover Ultracet. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

Usual Adult Dose of Ultracet for Pain:

Usual dose: 2 tablets orally every 4 to 6 hours as needed for pain
Maximum dose: 8 tablets per day
Maximum duration: 5 days

Comments:
-Each tablet contains Tramadol 37.5 mg and Acetaminophen 325 mg. Maximum daily doses are Tramadol: 300 mg per day and Acetaminophen 2600 mg per day.
-Use of more than 1 product at time containing acetaminophen is not recommended.
-Due to the risks of addiction, abuse, and misuse, this drug is reserved for patients who have not been or are not expected to tolerate non-opioid pain medications or who have not obtained or are not expected to obtain analgesia with other pain management treatments.

Use: For the short-term (use should be limited to 5 days or less) management of acute pain, severe enough to require an opioid analgesic and for whom alternative treatments are inadequate.

You should not use Ultracet if you are allergic to acetaminophen (Tylenol) or tramadol (Ultram), or if you have:

• severe asthma or breathing problems, a blockage in your digestive tract (stomach or intestines); or

• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Ultracet is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have ever had:

• a metabolic disorder;

• breathing problems, sleep apnea, a head injury, brain tumor, seizures; or

• alcoholism or drug addiction, or if you have recently used sedatives, tranquilizers, or narcotic medications.

To make sure Ultracet is safe for you, tell your doctor if you have ever had:

• liver disease, or if you drink alcohol;

• kidney disease (or if you are on dialysis), urination problems;

• problems with your pancreas, gallbladder, or thyroid; or

• depression, mental illness, or a suicide attempt.

Using Ultracet during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Ask a doctor before using Ultracet if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since Ultracet is used for pain, you are not likely to miss a dose. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or person using this medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

In case of an overdose, make sure any person caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid driving or hazardous activity until you know how Ultracet will affect you.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP).

Get emergency medical help if you have signs of an allergic reaction to Ultracet (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Ultracet can slow or stop your breathing, and death may occur. A person caring for you should administer naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Ultracet may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, sleep apnea (breathing stops during sleep), a light-headed feeling, like you might pass out, seizures;

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop), chest pain;

• liver problems - upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness;

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, diarrhea;

• low blood sodium - headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or

• low blood sugar> - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Ultracet side effects may include:

• dizziness, drowsiness, sweating; or

• stomach pain, nausea, loss of appetite, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

You may have a fatal Ultracet overdose if you start or stop using certain other medicines. Tell your doctor about all your medications.

Many other drugs can be dangerous when used with Ultracet. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• sleep medicine, muscle relaxers, or other drugs that make you drowsy or a benzodiazepine sedative like Valium, Klonopin, or Xanax; or

• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Other drugs may interact with acetaminophen and tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.