Tramadol and acetaminophen

Generic name: Tramadol And Acetaminophen
Drug class: Narcotic analgesic combinations

Usage of Tramadol and acetaminophen

Tramadol and acetaminophen combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. 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). Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to side effects when you suddenly stop taking the medicine. Since this medicine is only used for short-term relief of pain, mental and 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 under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

Tramadol and acetaminophen side effects

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 the skin

chest pain or tightness

cough

difficulty with swallowing

dizziness

fast heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

skin rash, hives, or itching skin

trouble breathing

unusual tiredness or weakness

vomiting

Incidence not known

Agitation

anxiety

bigger, dilated, or enlarged pupils

blistering, peeling, or loosening of the skin

blurred vision

chills

cold sweats

coma

confusion

confusion as to time, place, or person

constricted, pinpoint, or small pupils

cool, pale skin

darkening of the skin

decreased urine output

depression

diarrhea

fainting

fever

hallucinations

headache

holding false beliefs that cannot be changed by fact

increased hunger

increased sensitivity of the eyes to light

increased thirst

irregular or slow heart rate

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of appetite

muscle cramps

nausea

nervousness

nightmares

noisy breathing

overactive reflexes

poor coordination

red skin lesions, often with a purple center

red, irritated eyes

shakiness

shivering

slurred speech

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sweating

swelling of the face, ankles, or hands

talking or acting with excitement you cannot control

trembling or shaking

twitching

unusual excitement, nervousness, or restlessness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Black, tarry stools

dark urine

depression

disorientation

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness to profound coma

fever

headache

irregular, fast or slow, or shallow breathing

lightheadedness

loss of appetite

mood or other mental changes

nausea

pale or blue lips, fingernails, or skin

seeing, hearing, or feeling things that are not there

stomach pain

trouble sleeping

unpleasant breath odor

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

vomiting of blood

yellow eyes or skin

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

Anxiety

belching

bloated or feeling of fullness

constipation

dry mouth

excess air or gas in the stomach or bowels

false or unusual sense of well-being

feeling of warmth

heartburn

increase in bowel movements

increased sweating

indigestion

loose stools

loss of strength or energy

muscle 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

Rare

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

crying

decrease in the frequency or amount of urination

decreased awareness or responsiveness

decreased interest in sexual intercourse

delusions of persecution, mistrust, suspiciousness, or combativeness

difficulty in passing urine (dribbling)

false or unusual sense of well-being

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

shivering

vomiting of blood or material that looks like coffee grounds

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.

Before taking Tramadol and acetaminophen

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tramadol and acetaminophen combination in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.

This medicine should not be used to relieve pain after surgery removal of tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

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.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with 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 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.

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Methylene Blue

Moclobemide

Nalmefene

Naltrexone

Nialamide

Phenelzine

Procarbazine

Rasagiline

Safinamide

Samidorphan

Selegiline

Tranylcypromine

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.

Abiraterone Acetate

Acepromazine

Alfentanil

Almotriptan

Alprazolam

Amifampridine

Amineptine

Amiodarone

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Amprenavir

Anileridine

Aprepitant

Aripiprazole

Armodafinil

Asenapine

Atazanavir

Baclofen

Benperidol

Benzhydrocodone

Benzphetamine

Boceprevir

Bosentan

Bromazepam

Bromopride

Bromperidol

Brompheniramine

Butorphanol

Calcium Oxybate

Cannabis

Carphenazine

Ceritinib

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorpheniramine

Chlorpromazine

Chlorzoxazone

Cimetidine

CinaCalcet

Ciprofloxacin

Citalopram

Clarithromycin

Clobazam

Clomipramine

Clonazepam

Clopidogrel

Clorazepate

Clozapine

Cobicistat

Cocaine

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Daridorexant

Darunavir

Delavirdine

Desipramine

Desmopressin

Desvenlafaxine

Dexamethasone

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Dezocine

Diazepam

Dibenzepin

Dichloralphenazone

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dolasetron

Donepezil

Dothiepin

Doxepin

Doxylamine

Dronedarone

Droperidol

Duloxetine

Efavirenz

Eletriptan

Enflurane

Enzalutamide

Erythromycin

Escitalopram

Esketamine

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etravirine

Fedratinib

Fenfluramine

Fentanyl

Flibanserin

Fluconazole

Fluoxetine

Fluphenazine

Flurazepam

Fluspirilene

Fluvoxamine

Fosamprenavir

Fosaprepitant

Fosphenytoin

Fospropofol

Frovatriptan

Gabapentin

Gabapentin Enacarbil

Gepirone

Granisetron

Halazepam

Haloperidol

Halothane

Hexobarbital

Hydrocodone

Hydromorphone

Hydroxyamphetamine

Hydroxytryptophan

Hydroxyzine

Idelalisib

Imatinib

Imipramine

Indinavir

Isoflurane

Isoniazid

Itraconazole

Ivacaftor

Ketamine

Ketazolam

Ketobemidone

Ketoconazole

Lacosamide

Lasmiditan

Lemborexant

Lenacapavir

Levocetirizine

Levoketoconazole

Levomilnacipran

Levorphanol

Lisdexamfetamine

Lithium

Lofepramine

Lofexidine

Lomitapide

Lopinavir

Lorazepam

Lorcaserin

Loxapine

Lumacaftor

Magnesium Oxybate

Meclizine

Melitracen

Melperone

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methamphetamine

Methocarbamol

Methohexital

Methotrexate

Methotrimeprazine

Metoclopramide

Mibefradil

Midazolam

Mifepristone

Milnacipran

Mirabegron

Mirtazapine

Mitotane

Modafinil

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Naratriptan

Nefazodone

Nelfinavir

Nevirapine

Nicomorphine

Nilotinib

Nitrazepam

Nitrous Oxide

Nortriptyline

Olanzapine

Ondansetron

Opipramol

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Ozanimod

Palbociclib

Palonosetron

Papaveretum

Paregoric

Paroxetine

Peginterferon Alfa-2b

Pentazocine

Pentobarbital

Perampanel

Periciazine

Perphenazine

Phenobarbital

Phenytoin

Pimozide

Piperacetazine

Pipotiazine

Piritramide

Pixantrone

Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate

Posaconazole

Potassium Oxybate

Prazepam

Prednisone

Pregabalin

Primidone

Prochlorperazine

Promethazine

Propofol

Protriptyline

Quazepam

Quetiapine

Quinidine

Quinine

Ramelteon

Ranitidine

Ranolazine

Remifentanil

Remimazolam

Remoxipride

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rizatriptan

Rolapitant

Ropeginterferon Alfa-2b-njft

Saquinavir

Scopolamine

Secobarbital

Sertindole

Sertraline

Sibutramine

Sodium Oxybate

St John's Wort

Sufentanil

Sulpiride

Sumatriptan

Suvorexant

Tapentadol

Telaprevir

Telithromycin

Temazepam

Terbinafine

Thiethylperazine

Thiopental

Thiopropazate

Thioridazine

Tianeptine

Tilidine

Tizanidine

Tolonium Chloride

Topiramate

Trazodone

Triazolam

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Trimipramine

Tryptophan

Venlafaxine

Verapamil

Vilazodone

Voriconazole

Vortioxetine

Zaleplon

Ziprasidone

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Zuranolone

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.

Acenocoumarol

Carbamazepine

Digoxin

Fosphenytoin

Lixisenatide

Phenytoin

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

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.

Ethanol

Grapefruit Juice

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.

Cabbage

Relate drugs

How to use Tramadol and acetaminophen

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. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of tramadol and acetaminophen combination. This medicine should come with a Medication Guide. Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it.

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), as this may increase the risk for serious liver problems.

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 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 12 years of age and older—Use and dose must be determined by your doctor.

Children younger than 12 years of age—Should not be used in these patients.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Warnings

It is very important that your doctor check your or your child's progress at regular visits, especially within the first 24 to 72 hours of treatment, to make sure the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] within the past 14 days.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Check with 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. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Tramadol is highly metabolized in the body. Some people change tramadol to a stronger product (O-desmethyltramadol) more quickly than others. These individuals are called "ultra-rapid metabolizers of tramadol". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of tramadol." As a result, there is too much O-desmethyltramadol in the body and more side effects of O-desmethyltramadol than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to:

Children younger than 12 years of age.

Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.

Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby and cause very serious side effects.

For nursing mothers using this medicine

Talk to your doctor if you have any questions about taking tramadol or about how this medicine may affect your baby.

Call your doctor if you become extremely tired and have difficulty caring for your baby.

Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.

Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, 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 (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing or swallowing, unusual tiredness or weakness, 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.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you or your child are taking this medicine. Serious side effects can occur if your doctor or dentist gives you certain medicines without knowing that you have been taking this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose. Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, 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 cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

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. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure your doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also, 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hypoglycemia (low blood sugar level).

Do not change the dose or suddenly 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, melted bits of ice in your mouth, or 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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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