|A FDA ruling has recently changed the status of this medication. As of 8/18/14, federal law will require that doctors can only prescribe Tramadol and Ultracet upon
seeing the patient in-person. To comply with the recent FDA ruling, this medication will no longer be available through
TeleConsults and/or eConsults.
Combination medicines containing opioid analgesics (nar-KOT-ik an-al-JEE-zicks ) such as tramadol (TRA-ma-dole) and acetaminophen (a-seat-a-MIN-oh-fen ) are used to relieve pain. An opioid analgesic and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.
are used to relieve pain. An opioid analgesic and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.
Opioid analgesics act in the central nervous system (CNS) to relieve pain. Many of their side effects are also caused by actions in the CNS. When opioids are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when opioids are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine.
Acetaminophen does not become habit-forming when taken for a long time but it may cause other unwanted effects, when taken in large doses including liver damage, if too much is taken.
This medicine is available only with your doctor's prescription, in the following dosage form:
What is the most important information I should know about Ultracet?
Seizures have been reported as a rare side effect of treatment with acetaminophen and tramadol. The risk of seizures may be increased in patients who take more than the prescribed dose, have a history of seizures or epilepsy, have head trauma, have a metabolic disorder, have a central nervous system infection, are experiencing alcohol or drug withdrawal, or are taking certain medications. Talk to your doctor about factors that may increase the risk of seizures during treatment.
Avoid the consumption of alcoholic beverages while taking the combination of acetaminophen and tramadol. Alcohol may cause a dangerous decrease in breathing and/ or liver problems when used during treatment with Ultracet.
Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen and tramadol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
Do not take more of this medication than is prescribed for you. If the pain is not being controlled, talk to your doctor. Taking more than the prescribed amount of this medication could result in seizures or decreased breathing.
Do not take other prescription or over-the-counter medicines that contain acetaminophen (Tylenol, pain relievers, cold and flu medicines, others) during treatment with acetaminophen and tramadol. Taking too much acetaminophen may be harmful.
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tramadol and acetaminophen, the following should be considered:
Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to tramadol, other opioid analgesics or acetaminophen. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy - Tramadol and acetaminophen has not been studied in pregnant women. However, studies in animals have shown that tramadol and acetaminophen causes birth defects and other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.
Too much use of an opioid during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Newborn seizures, symptoms of withdrawal from opioids, death of the fetus and still birth have been reported.
Breast-feeding - Tramadol and acetaminophen pass into breast milk and may cause unwanted side effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.
Children - Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tramadol and acetaminophen in children up to 16 years of age with use in other age groups.
Elderly adults - This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tramadol and acetaminophen, it is especially important that your health care professional know if you are taking any of the following:
Tramadol and acetaminophen
- Anticoagulants (e.g., Coumadin [blood thinners]) - Ultracet may increase the amount of blood thinners in your blood, which can cause problems with bleeding.
- Alcohol and products with alcohol in them - Taking these medicines with tramadol and acetaminophen may cause problems with your liver.
- Acetaminophen-containing products (e.g., Tylenol, Nyquil, Chlor-Trimeton Sinus) - Consuming additional acetaminophen may increase the risk of liver problems.
- Analgesics, opioid (e.g., codeine, morphine) or
- Antidepressants such as tricyclic antidepressants (e.g., amitriptyline [Elavil], doxepin [Sinequan]), and selective serotonin reuptake inhibitors (e.g., citalopram [Celexa], fluvoxamine [Luvox], sertraline [Zoloft]), and medicines with Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) or
- Neuroleptics (e.g., Thorazine, Prolixin) - Taking these medicines with tramadol may increase the possibility of seizures or convulsions.
- Alcohol and products with alcohol in them or
- Anesthetic medicines or
- Central nervous system (CNS) depressants such as , narcotic pain relievers (e.g., Codeine, Darvon), phenothiazines (e.g., Thorazine, Prolixin), sedative hypnotics (e.g., Valium, Xanax), tranquilizers (e.g., Ativan, Haldol - Taking these medicines with tramadol may increase the chance of serious side effects.
- Carbamazepine (e.g., Tegretol) - May decrease the blood levels of Tramadol, which increases the chance of serious side effects
- Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) (taken currently or within the past 2 weeks) - Taking tramadol with these medicines may cause more of a chance for seizures. It may also cause high blood pressure, unusual heartbeats, or headache
- Selective serotonin reuptake inhibitors (SSRI) (citalopram [e.g., Celexa], fluvoxamine [e.g., Luvox], and sertraline [e.g., Zoloft] - Taking these medicines with tramadol and acetaminophen may increase the possibility of seizures or convulsions
Other medical problems -
The presence of other medical problems may affect the use of tramadol and acetaminophen. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol and/or other drug abuse, or history of, or
- Convulsions (seizures), history of, or
- Head injury, or
- Hormonal problems or
- Infections of the central nervous system or
- Kidney disease or
- Liver disease, or
- Respiratory difficulty or troubled breathing, or
- Severe abdominal problems - The chance of serious side effects may be increased
Proper Use of This Medicine
Take this medicine only as directed by your medical doctor or dentist. Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who may be more sensitive than other people to the effects of analgesics. If too much of a analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Taking too much acetaminophen may cause liver damage.
The dose of tramadol and acetaminophen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tramadol and acetaminophen. If your dose is different, do not change it unless your doctor tells you to do so.
The number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking tramadol and acetaminophen
- For oral dosage form (tablets):
- For pain:
- Adults and adolescents 16 years and older - Take 2 tablets every 4-6 hours as needed for up to 5 days.
- Children under 16 years of age should consult with their phycisian to determine the appropriate usage and dosage.
To store this medicine:
- Keep Ultracet out of the reach of children. Overdose of tramadol and acetaminophen is very dangerous in young children.
- Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.
Side Effects of Ultracet
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects appear:
- Burning, itching, and redness of skin; vomiting ;
cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing;
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.
- Abdominal pain;
aches, pains or weakness of muscles; numbness or tingling of hands, legs, and feet;
acid or sour stomach; belching; heartburn; indigestion; stomach discomfort ;
bloated full feeling; excess air or gas in stomach or intestines;
false or unusual sense of well-being;
feeling of warmth; redness of the face, neck, arms, and occasionally the upper chest;
increase in bowel movements; loose stools; soft stools;
loss of appetite; weight loss;
loss of strength or energy; muscle pain or weakness;
mood or mental changes;
painful or difficult urination;
sleepiness or unusual drowsiness;
sleeplessness; trouble sleeping; unable to sleep;
unusual tiredness or weakness;
- Abnormal thinking;
bloody or black, tarry stools; vomiting of blood or material that looks like coffee grounds; sever stomach pain; constipation;
blurred vision; dizziness; severe or continuing, dull headache; pounding in the ears; slow or fast heartbeat;
change in vision;
chills; cold sweats; confusion; dizziness; faintness, or light-headedness when getting up from lying or sitting position;
continuing ringing or buzzing or other unexplained noise in ears;
crying; depersonalization; dysphoria; euphoria; mental depression; paranoia; quick to react or overreact emotionally; rapidly changing moods ;
decreased awareness or responsiveness;
decrease in amount of urine;
decrease in urine volume; decrease in frequency of urination; difficulty in passing urine [dribbling]; painful urination;
dizziness or lightheadedness; feeling of constant movement of self or surroundings; sensation of spinning;
drug abuse and dependence ;
fainting; fast, pounding, or irregular heartbeat or pulse; palpitations;
feeling unusually cold; shivering ;
high or low blood pressure; dizziness; lightheadedness ;
increased muscle tone;
involuntary muscle contractions;
loss in sexual ability, desire, drive, or performance; decreased interest in sexual intercourse; inability to have or keep an erection;
loss of memory; problems with memory;
loss of sense of reality;
seeing, hearing, or feeling things that are not there;
shakiness and unsteady walk; clumsiness, unsteadiness, trembling, or other problems with muscle control or coordination;
shortness of breath; difficult or labored breathing; tightness in chest; wheezing ;
swelling of tongue;
trouble in holding or releasing urine; painful urination;
unusual tiredness or weakness;
yellow eyes or skin
After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on which of these medicines you were taking, the amount of medicine you were using, and how long you used it. During this time check with your doctor if you notice any of the following side effects:
fever, runny nose, or sneezing ;
nausea or vomiting;
nervousness, restlessness, or irritability;
seeing, hearing, or feeling things that are not there;
shivering or trembling;
trouble in sleeping
Other side effects of Ultracet not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
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