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Tramadol and acetaminophen (Oral route)

Pronunciation:

TRA-ma-dole hye-droe-KLOR-ide, a-seet-a-MIN-oh-fen

Brand Names:

Ultracet
Counteract Children's Pain Reliever
Tramacet

Dosage Forms:

Tablet

Classifications:

Therapeutic—

Analgesic Combination

Chemical—

Tramadol

Uses of This Medicine:

Combination medicines containing narcotic analgesics such as tramadol and acetaminophen 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.

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:

Allergies—

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.

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.

Older 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.

Pregnancy—

Pregnancy Category Explanation
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.

Breast-feeding—

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.

Other medicines—

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.

Rasagiline
Selegiline

Other interactions—

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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.

Ethanol

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 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.

Dosing—

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 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–use and dose must be determined by your doctor.

Storage—

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:

The analgesic in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; opioids; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. 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 are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

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.

If you have been taking this medicine regularly , do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects. This will depend on which of these medicines you have been taking, and the amount you have been taking every day.

Side Effects of This Medicine:

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:

Rare: Burning, itching, and redness of skin; vomiting; chest pain; 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; seizures

Symptoms of Overdose: Chest pain or discomfort; convulsions; difficulty breathing

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:

Less common: 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; anxiety; bloated full feeling; excess air or gas in stomach or intestines; confusion; constipation; dizziness; dry mouth; false or unusual sense of well-being; feeling of warmth; redness of the face, neck, arms, and occasionally the upper chest; headache; increased sweating; increase in bowel movements; loose stools; soft stools; itching skin; loss of appetite; weight loss; loss of strength or energy; muscle pain or weakness; mood or mental changes; nausea; nervousness; painful or difficult urination; rash; sleepiness or unusual drowsiness; sleeplessness; trouble sleeping; unable to sleep; unusual tiredness or weakness; vomiting

Rare: 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; depression; difficulty swallowing; 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; morbid dreaming; migraine headache; 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; weight loss; yellow eyes or skin

Anxiety

diarrhea

fever, runny nose, or sneezing

gooseflesh

increased sweating

nausea or vomiting

nervousness, restlessness, or irritability

pain

seeing, hearing, or feeling things that are not there

shivering or trembling

trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Last Updated: 7/4/2008