Brand Names: Ultracet
Generic Name: acetaminophen and tramadol
- What is acetaminophen and tramadol (Ultracet)?
- What are the possible side effects of acetaminophen and tramadol (Ultracet)?
- What is the most important information I should know about acetaminophen and tramadol (Ultracet)?
- What should I discuss with my healthcare provider before taking acetaminophen and tramadol (Ultracet)?
- How should I take acetaminophen and tramadol (Ultracet)?
- What happens if I miss a dose (Ultracet)?
- What happens if I overdose (Ultracet)?
- What should I avoid while taking acetaminophen and tramadol (Ultracet)?
- What other drugs will affect acetaminophen and tramadol (Ultracet)?
- Where can I get more information (Ultracet)?
What is acetaminophen and tramadol (Ultracet)?
Acetaminophen and tramadol is a combination medicine used to treat moderate to severe pain.
Acetaminophen and tramadol may also be used for purposes not listed in this medication guide.
What are the possible side effects of acetaminophen and tramadol (Ultracet)?
Get emergency medical help if you have signs of an allergic reaction: 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); or
- low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Common side effects may include:
- dizziness, drowsiness;
- stomach pain, nausea, loss of appetite, diarrhea, constipation; or
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 is the most important information I should know about acetaminophen and tramadol (Ultracet)?
MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Do not give this medicine to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.
Taking this medicine 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.
What should I discuss with my healthcare provider before taking acetaminophen and tramadol (Ultracet)?
- 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.
Acetaminophen and tramadol 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.
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 this medicine 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.
Do not breastfeed. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.
How should I take acetaminophen and tramadol (Ultracet)?
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 acetaminophen and tramadol 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 this medicine 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 at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
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.
What happens if I miss a dose (Ultracet)?
Since this medicine 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 (Ultracet)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or another person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
What should I avoid while taking acetaminophen and tramadol (Ultracet)?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how this medicine 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.
What other drugs will affect acetaminophen and tramadol (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.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
- medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
- other narcotic medications--opioid pain medicine or prescription cough medicine;
- a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
- drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
- drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may affect acetaminophen and tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Where can I get more information (Ultracet)?
Your doctor or pharmacist can provide more information about acetaminophen and tramadol.
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