Tramadol and acetaminophen (Oral route)
TRAM-a-dol hye-droe-KLOR-ide, a-seet-a-MIN-oh-fen
Tramadol hydrochloride/acetaminophen has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of tramadol hydrochloride/acetaminophen, especially in children, can result in fatal overdose of tramadol hydrochloride. Prolonged use of tramadol hydrochloride/acetaminophen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use or discontinuation of concomitantly used cytochrome P450 3A4 inducers or inhibitors or cytochrome P450 2D6 inhibitors may affect the plasma levels of tramadol and its active metabolite and lead to fatal respiratory depression, profound sedation, opioid toxicity, and/or opioid withdrawal; monitor patients carefully when used concurrently. Acetaminophen has been associated with acute liver failure, resulting in liver transplant and death. Most cases were with the use of doses that exceeded 4000 mg per day and involved more than 1 acetaminophen-containing product. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation .
Uses of This Medicine:
Tramadol and acetaminophen combination is used to relieve pain. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.
Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine. Since this medicine is only used for the short-term relief of pain, physical dependence will probably not occur.
Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.
This medicine is available only with your doctor's prescription.
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of tramadol and acetaminophen combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tramadol and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems which may require caution and an adjustment in the dose for patients receiving tramadol and acetaminophen combination.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Peginterferon Alfa-2b
- Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, or history of or
- Brain tumor or
- Breathing or lung problems (eg, COPD, hypercapnia, hypoxia) or
- Depression, history of or
- Drug dependence, especially narcotic abuse or dependence, or history of or
- Head injuries or
- Increased pressure in the head or
- Mental illness, history of—Use with caution. The chance of side effects may be increased.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease—Use is not recommended in patients with this condition.
- Lung or breathing problems, severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
- Seizures, history of or
- Stomach problems, severe—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, 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 using the medicine.
- For oral dosage form (tablets):
- For acute pain:
- Adults—2 tablets every 4 to 6 hours as needed for up to 5 days. Do not take more than 8 tablets per day.
- Children—Use and dose must be determined by your doctor.
- For acute pain:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®) within the past 14 days.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain acetaminophen or tramadol, check with your doctor. Taking them together with this medicine may cause an overdose.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, shortness of breath, or yellow eyes or skin.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Ultracet® may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet.
Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures (convulsions). It may also cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression (eg, citalopram, fluoxetine, sertraline, Cymbalta®, Effexor®, Lexapro®, Pristiq®) or medicine to treat migraine headache (eg, eletriptan, frovatriptan, rizatriptan, zolmitriptan). Check with your doctor right away if you have the following symptoms of serotonin syndrome: agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching.
This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has tried to commit suicide.
This medicine may cause some people to become dizzy, drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble sleeping.
Analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Side Effects of This Medicine:
- Burning, itching, and redness of the skin
- chest pain
- difficulty with swallowing
- fast heartbeat
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash, hives, or itching skin
- tightness in the chest
- trouble breathing
- unusual tiredness or weakness
- Incidence not known
- Blistering, peeling, or loosening of the skin
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- noisy breathing
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- Symptoms of overdose
- Abdominal or stomach pain
- black, tarry stools
- chest pain or discomfort
- dark urine
- difficulty with sleeping
- drowsiness to profound coma
- irregular, fast or slow, or shallow breathing
- light-colored stools
- loss of appetite
- mood or other mental changes
- pale or blue lips, fingernails, or skin
- seeing, hearing, or feeling things that are not there
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
- Less common
- Acid or sour stomach
- bloated or full feeling
- dry mouth
- excess air or gas in the stomach or intestines
- false or unusual sense of well-being
- feeling of warmth
- increase in bowel movements
- increased sweating
- loose stools
- loss of strength or energy
- muscle pain or weakness
- numbness or tingling of the hands, legs, and feet
- painful or difficult urination
- redness of the face, neck, arms, and occasionally the upper chest
- sleepiness or unusual drowsiness
- soft stools
- stomach discomfort
- weight loss
- Abnormal thinking
- blurred vision
- change in vision
- clumsiness, unsteadiness, trembling, or problems with muscle control or coordination
- cold sweats
- continuing ringing, buzzing, or unexplained noise in the ears
- decrease in the frequency or amount of urination
- decreased awareness or responsiveness
- decreased interest in sexual intercourse
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- feeling of constant movement of self or surroundings
- feeling unusually cold
- headache, severe or continuing
- increased muscle tone
- involuntary muscle contractions
- loss of memory
- loss of sense of reality
- loss of sexual ability, desire, drive, or performance
- migraine headache
- morbid dreaming
- pounding in the ears
- problems with memory
- quick to react or overreact emotionally
- rapidly changing moods
- sensation of spinning
- severe stomach pain
- shakiness and unsteady walk
- swelling of the tongue
- vomiting of blood or material that looks like coffee grounds
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 occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017