Generic name: acetaminophen and tramadol (a SEET a MIN o fen and TRAM a dol)
Brand name: Ultracet
Drug class: Narcotic analgesic combinations
Ultracet contains a combination of tramadol and acetaminophen. Tramadol is an pain medicine similar to an opioid (sometimes called, a narcotic). 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 purposes not listed in this medication guide.
Warnings
MISUSE OF ULTRACET CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.
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.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
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 stomach or intestines; or
- if you have used an MAO inhibitor (such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine) in the past 14 days.
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:
- alcoholism or drug addiction;
- breathing problems, sleep apnea;
- a metabolic disorder;
- a head injury, brain tumor, or seizures; 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, urination problems;
- problems with your pancreas, gallbladder, or thyroid; or
- depression, mental illness, or a suicide attempt.
If you use Ultracet while you are pregnant, your baby could become dependent on tramadol. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.
How should I take Ultracet?
Take Ultracet exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.
Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place 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.
You may take Ultracet with or without food, but take it the same way each time.
You should not stop using this medicine suddenly after long-term use. Follow your doctor's instructions about tapering your dose.
Store Ultracet at room temperature away from moisture and heat. Keep track of your medicine. Keep your medicine in a place where no one can use it improperly.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.
Dosing information
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.
What happens if I miss a dose?
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.
What happens if I overdose?
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.
Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.
Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.
What to avoid
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how Ultracet will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.
Ultracet side effects
Get emergency medical help if you have signs of an allergic reaction to Ultracet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
This medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Stop using this medicine and call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- a slow heart rate or weak pulse;
- a light-headed feeling, like you might pass out;
- seizure (convulsions);
- 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; or
- high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.
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.
Common Ultracet side effects may include:
- dizziness, drowsiness;
- stomach pain, nausea, loss of appetite;
- diarrhea, constipation; or
- sweating.
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.
What other drugs will affect Ultracet?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Acetaminophen and tramadol can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
- opioid medicines;
- a benzodiazepine sedative like Valium, Klonopin, or Xanax;
- sleep medicine, muscle relaxers, or other drugs that make you drowsy; or</ p>
- drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.
This list is not complete. Many 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 here.