Tramadol hcl acetaminophen 37 5 325 mg

Apo-Tramadol/Acet

How does this medication work? What will it do for me?

This combination product contains two medications: tramadol and acetaminophen. Tramadol belongs to a group of medications called opioid analgesics and acetaminophen belongs to a group of medications called analgesics. This combination medication is used to manage moderate to moderately severe pain in adults. It decreases pain by working on the central nervous system.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each yellow, capsule-shaped, film-coated tablet, engraved “37.5-325” on one side and “APO” on the other, contains 37.5 mg of tramadol hydrochloride and 325 mg of acetaminophen. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, povidone, stearic acid, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, and yellow ferric oxide.

How should I use this medication?

The usual recommended dose of tramadol – acetaminophen is 1 or 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

The tablets can be taken with or without food.

Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to tramadol, acetaminophen, or any ingredients of the medication
  • are allergic to other opioid medications (e.g., codeine, morphine)
  • are experiencing acute alcoholism or delirium tremens
  • are experiencing acute asthma or other obstructive airway disease
  • are experiencing acute respiratory depression
  • are intoxicated with alcohol or other medications such as hypnotics, other opioids such as codeine or morphine, or psychotropic medications (i.e., medications for mental health conditions)
  • are pregnant, in labour, delivering a baby, or breast-feeding
  • are taking or have taken MAO inhibitors (e.g., phenelzine, tranylcypromine, moclobemide) within the last 14 days
  • have a blockage of the gastrointestinal tract, particularly paralytic ileus
  • have a convulsive (seizure) disorder
  • have a head injury, a brain tumour, or increased pressure inside the head or spinal cord
  • have recently consumed alcohol
  • have severely decreased kidney function
  • have severely decreased liver function

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • dizziness
  • drowsiness
  • headache
  • nausea
  • vomiting

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of taking too much medication, e.g.,:
    • shallow, rapid breathing
    • severe drowsiness
    • decreased coordination
    • seizures
    • unconsciousness
  • signs of a severe allergic reaction, e.g.:
    • difficulty breathing
    • hives
    • swelling of the lips, mouth, throat, or tongue
  • signs of a severe skin reaction, e.g.:
    • high fever
    • painful blisters on the skin, mouth, or eyes
    • rash
    • skin peeling off
    • sores
  • slow or weak breathing
  • symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, high blood pressurerestlessness, shaking, shivering, sudden jerking of muscles, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

July 9, 2015

Health Canada has issued new restrictions concerning the use of acetaminophen. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

Abdominal conditions: Tramadol – acetaminophen may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Acetaminophen overuse: Although acetaminophen is usually considered a safe medication, overuse of acetaminophen can cause liver damage, including liver failure causing death or requiring a liver transplant. It is important that you do not take more of tramadol – acetaminophen than prescribed by your doctor. Acetaminophen can be found in many medications that are available without a prescription. Read the labels carefully to make sure you are not taking more than the recommended adult dose of acetaminophen when you consider the different medications that you are taking. If you have questions about the amount of acetaminophen you are taking, contact your pharmacist or doctor.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Breathing: Tramadol – acetaminophen can suppress breathing. If you have asthma, or are otherwise at risk for breathing problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: Tramadol can cause physical dependence, psychological dependence, and addiction. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. Do not stop taking this medication without talking to your doctor or pharmacist.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.

Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. If you have had a recent head injury, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The kidneys are partially responsible for removing tramadol from the body. Kidney disease or decreased kidney function may cause this medication to build up in the body, causing side effects. If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with severely decreased kidney function.

Liver function: The liver is partially responsible for removing tramadol and acetaminophen from the body. Liver disease or decreased liver function may cause this medication to build up in the body, causing side effects. If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication should not be used by people who are experiencing liver severe failure.

Seizures: Tramadol may cause seizures, especially when higher doses are used or when taken with other medications such as:

The risk of seizures is also higher for people with a history of seizures, or who are at risk of seizures (e.g., people with head trauma). If you have a history of seizures, or are at risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when tramadol is combined with medications used to treat depression. The combination of tramadol and MAO inhibitors must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

Surgery: Tramadol may interact with medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking tramadol – acetaminophen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used by people under 18 years of age.

Seniors: Seniors may be more likely to experience side effects from this medication. Lower doses may be required.

What other drugs could interact with this medication?

There may be an interaction between tramadol – acetaminophen and any of the following:

  • abiraterone acetate
  • aclidinium
  • alcohol
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
  • antiseizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • aprepitant
  • atropine
  • azelastine
  • “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • baclofen
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • belladonna
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • benztropine
  • bicalutamide
  • boceprevir
  • bosentan
  • brimonidine
  • bromocriptine
  • bupropion
  • buspirone
  • butorphanol
  • buprenorphine
  • cabergoline
  • calcium channel blockers (e.g., diltiazem, nifedipine,verapamil)
  • celecoxib
  • chloral hydrate
  • chloroquine
  • cholestyramine
  • cinacalcet
  • cocaine
  • conivaptan
  • darifenacin
  • deferasirox
  • desmopressin
  • desvenlafaxine
  • dextromethorphan
  • disopyramide
  • dronedarone
  • enzalutamide
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • flavoxate
  • glycopyrrolate
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
  • isoniazid
  • ketotifen
  • lithium
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • metoclopramide
  • mirabegron
  • mirtazapine
  • mitotane
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, phenelzine, selegiline, tranylcypromine)
  • muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
  • naltrexone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nefazodone
  • octreotide
  • oxybutynin
  • perampanel
  • pramipexole
  • probenecid
  • quinine
  • quinidine
  • rifabutin
  • rifampin
  • ropinirole
  • rufinamide
  • St. John’s wort
  • scopolamine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • solifenacin
  • tricyclic antidepressants (TCAs; e.g., amitriptyline, clomipramine, desipramine, imipramine)
  • tapentadol
  • terbinafine
  • ticlopidine
  • tiotropium
  • tocilizumab
  • tolterodine
  • trazodone
  • tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
  • “triptan” migraine medications (e.g., eletriptan, sumatriptan)
  • tryptophan
  • umeclidinium
  • valerian
  • venlafaxine
  • warfarin
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apo-TramadolAcet

Ultracet

Generic Name: acetaminophen and tramadol (a SEET a MIN o fen and TRAM a dol)
Brand Names: Ultracet

Medically reviewed by P. Thornton, DipPharm Last updated on Nov 5, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Ultracet?

Ultracet contains a combination of tramadol and acetaminophen. Tramadol is an pain medicine similar to an opioid (sometimes called, a narcotic). Acetaminophen is a less potent pain reliever that increases the effects of tramadol.

Ultracet is used to treat moderate to severe pain.

Ultracet may also be used for purposes not listed in this medication guide.

Important Information

MISUSE OF ULTRACET CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

You should not use Ultracet if you have severe breathing problems, a blockage in your stomach or intestines, or if you have recently used an MAO inhibitor.

Do not give Ultracet to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking Ultracet 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.

Before taking this medicine

You should not use Ultracet if you are allergic to acetaminophen (Tylenol) or tramadol (Ultram), or if you have:

  • 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.

Ultracet 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.

To make sure Ultracet is safe for you, 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 Ultracet 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. Acetaminophen and tramadol can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take Ultracet?

Take Ultracet exactly as prescribed by your doctor. 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 Ultracet 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 Ultracet 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 Ultracet 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.

Ultracet dosing information

Usual Adult Dose of Ultracet for Pain:

Usual dose: 2 tablets orally every 4 to 6 hours as needed for pain
Maximum dose: 8 tablets per day
Maximum duration: 5 days

-Each tablet contains Tramadol 37.5 mg and Acetaminophen 325 mg. Maximum daily doses are Tramadol: 300 mg per day and Acetaminophen 2600 mg per day.
-Use of more than 1 product at time containing acetaminophen is not recommended.
-Due to the risks of addiction, abuse, and misuse, this drug is reserved for patients who have not been or are not expected to tolerate non-opioid pain medications or who have not obtained or are not expected to obtain analgesia with other pain management treatments.
Use: For the short-term (use should be limited to 5 days or less) management of acute pain, severe enough to require an opioid analgesic and for whom alternative treatments are inadequate.

What happens if I miss a dose?

Since Ultracet 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?

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 Ultracet?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how Ultracet 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.

Ultracet side effects

Get emergency medical help if you have signs of an allergic reaction to Ultracet: 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.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Ultracet side effects may include:

  • dizziness, drowsiness;

  • stomach pain, nausea, loss of appetite;

  • diarrhea, constipation; or

  • sweating.

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 other drugs will affect 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.

Acetaminophen and tramadol 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, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;

  • drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

  • 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 interact with acetaminophen and tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ultracet only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 12.01.

Medical Disclaimer

More about Ultracet (acetaminophen / tramadol)

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Español
  • 30 Reviews
  • Generic Availability
  • Drug class: narcotic analgesic combinations
  • FDA Alerts (4)

Consumer resources

  • Ultracet
  • Ultracet (Advanced Reading)

Professional resources

  • Ultracet (FDA)

Related treatment guides

  • Pain

SIDE EFFECTS

The following serious adverse reactions are discussed, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse
  • Life-Threatening Respiratory Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Hepatotoxicity
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Serotonin Syndrome
  • Seizures
  • Suicide
  • Adrenal Insufficiency
  • Severe Hypotension
  • Gastrointestinal Adverse Reactions
  • Hypersensitivity Reactions
  • Withdrawal

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common incidence of treatment-emergent adverse events ( ≥ 3.0%) in subjects from clinical trials was constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.

Table 1 shows the incidence rate of treatment-emergent adverse events reported in ≥ 2.0% of subjects over five days of ULTRACET use in clinical trials (subjects took an average of at least 6 tablets per day).

Table 1: Incidence of Treatment-Emergent Adverse Events ( ≥ 2.0%)

Body System
Preferred Term
ULTRACET
(N=142) (%)
Gastrointestinal System Disorders
Constipation 6
Diarrhea 3
Nausea 3
Dry Mouth 2
Psychiatric Disorders
Somnolence 6
Anorexia 3
Insomnia 2
Central & Peripheral Nervous System
Dizziness 3
Skin and Appendages
Sweating Increased 4
Pruritus 2
Reproductive Disorders, Male*
Prostatic Disorder 2
*Number of males = 62

Incidence at least 1%, causal relationship at least possible or greater:

The following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET.

Body as a Whole – Asthenia, fatigue, hot flushes

Central and Peripheral Nervous System – Dizziness, headache, tremor

Gastrointestinal System – Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting

Psychiatric Disorders – Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence

Skin and Appendages – Pruritus, rash, increased sweating

Selected Adverse events occurring at less than 1%:

The following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET clinical trials.

Body as a Whole – Chest pain, rigors, syncope, withdrawal syndrome

Cardiovascular Disorders – Hypertension, aggravated hypertension, hypotension

Central and Peripheral Nervous System – Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesias, stupor, vertigo

Gastrointestinal System – Dysphagia, melena, tongue edema

Hearing and Vestibular Disorders – Tinnitus

Heart Rate and Rhythm Disorders – Arrhythmia, palpitation, tachycardia

Liver and Biliary System – Hepatic function abnormal

Metabolic and Nutritional Disorders – Weight decrease

Psychiatric Disorders – Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking

Red Blood Cell Disorders – Anemia

Respiratory System – Dyspnea

Urinary System – Albuminuria, micturition disorder, oliguria, urinary retention

Vision Disorders – Abnormal vision

Postmarketing Experience

The following adverse reactions have been identified during post approval use of tramadol-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in ULTRACET.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids .

Eye disorders – miosis, mydriasis

Metabolism and nutrition disorders – Cases of hypoglycemia have been reported very rarely in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients.

Nervous system disorders – movement disorder, speech disorder

Psychiatric disorders – delirium

Other clinically significant adverse experiences previously reported with tramadol hydrochloride:

Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, orthostatic hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis, liver failure, and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures, and coma) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs.

Read the entire FDA prescribing information for Ultracet (Tramadol Hydrochloride and Acetaminophen Tablets)

tramadol/acetaminophen (Rx)

Black Box Warnings

Contains acetaminophen

Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day; take into account all acetaminophen-containing products the patient is taking, including PRN doses and OTC products

Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplant and death

New dosage limit allows no more than 325 mg/dosage unit for prescription medications that contain acetaminophen

Healthcare professionals can direct patients to take 1 or 2 tablets, capsules, or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times daily (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4000 mg/day)

Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death; assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

Serious, life-threatening, or fatal respiratory depression may occur; monitor for respiratory depression, especially during initiation or following a dose increase

Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose

Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts; 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

Effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex; use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1

Risks from concomitant use with benzodiazepines or other CNS depressants; concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant prescribing of this drug combination and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to minimum required; follow patients for signs and symptoms of respiratory depression and sedation

Life-threatening respiratory depression and death have occurred in children who received tramadol; tramadol is subject to variability in metabolism based upon CYP2D6 genotype, which can lead to an increased exposure to active metabolite O-desmethyltramadol (M1), children

Avoid use in adolescents 12-18 years of age who have other risk factors that may increase sensitivity to respiratory depressant effects of tramadol unless benefits outweigh risks; risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression; when prescribing tramadol for adolescents, healthcare providers should choose lowest effective dose for shortest period of time and inform patients and caregivers about risks and the signs of M1 overdose

Opioid analgesic risk evaluation and mitigation strategy (REMS)

  • To ensure that benefits of opioid analgesics outweigh risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products; under requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers
  • Healthcare providers are strongly encouraged to
    • Complete a REMS-compliant education program
    • Counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products
    • Emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist
    • Consider other tools to improve patient, household, and community safety

Contraindications

Hypersensitivity

Obstetric postoperative or post-delivery analgesia

Acute intoxication with alcohol, narcotics, hypnotics, opioids, centrally-acting analgesics, or other psychotropic drugs

Children

Postoperative management in children

Significant respiratory depression

Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment

Known or suspected gastrointestinal obstruction, including paralytic ileus

Previous hypersensitivity to tramadol hydrochloride, acetaminophen, any other component of this product, or opioids

Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

Cautions

Use with caution in hepatitis, liver failure, myocardial ischemia, pulmonary edema, vasodilation

As an opioid, the drug exposes users to risks of addiction, abuse, and misuse; assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing the drug, and monitor all patients for development of addiction behaviors and conditions; reduce risks by prescribing drug in smallest appropriate quantity and advising patient on proper disposal of unused drug risk is greatest during initiation of therapy or following a dosage increase; monitor patients closely for respiratory depression, especially within first 24-72 hours of initiating therapy and following dosage increases; to reduce risk, proper dosing and titration are essential; overestimating; dosage when converting patients from another opioid product can result in fatal overdose with first dose

Monitor for sedation and respiratory depression in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness;. avoid use in patients with impaired consciousness or coma

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper

May cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs; monitor for severe hypotension: during dosage initiation and titration; avoid in patients with circulatory shock

Adrenal insufficiency may occur; if diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid

Monitor closely for life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, particularly during initiation and titration

As of January 2011, the FDA has mandated a dosage limit for all prescription medications that contain acetaminophen, allowing no more than 325 mg/dosage unit

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation or death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)

QT prolongation/torsade de pointes; cases of QT prolongation and/or torsade de pointes have been reported with tramadol use; many cases were reported in patients taking another drug labeled for QT prolongation, in patients with a risk factor for QT prolongation (e.g., hypokalemia), or in overdose setting

Acetaminophen may cause rare serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome, toxic epidermal necrolysis), which can be fatal; discontinued at the first appearance of skin rash

At least one death reported in a nursing infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine; a baby nursing from an ultra-rapid metabolizer mother could potentially be exposed to high levels of M1, and experience life-threatening respiratory depression; for this reason, breastfeeding is not recommended during therapy

Discontinuation of a concomitantly used cytochrome P450 2D6 inhibitor may result in a decrease in tramadol plasma levels and an increase in active metabolite M1 levels, which could increase or prolong adverse reactions related to opioid toxicity and may cause potentially fatal respiratory depression

Do not abruptly discontinue therapy in a patient physically dependent on opioids; when discontinuing therapy, in a physically dependent patient, gradually taper the dosage; rapid tapering in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain

Concomitant use with all cytochrome P450 3A4 inducers or discontinuation of a cytochrome P450 3A4 inhibitor may result in lower tramadol levels; this may be associated with a decrease in efficacy, and in some patients, may result in signs and symptoms of opioid withdrawal

Follow patients receiving any CYP3A4 inhibitor or inducer for risk for serious adverse events including seizures and serotonin syndrome, signs and symptoms that may reflect opioid toxicity and opioid withdrawal when used in conjunction with inhibitors and inducers of CYP3A4

If decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with opioid analgesic, prescribe lowest effective dosages and minimum durations of concomitant use; in patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in absence of an opioid, and titrate based on clinical response; if an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response; follow patients closely for signs and symptoms of respiratory depression and sedation

Life-threatening respiratory depression and death have occurred in children who received tramadol; tramadol is subject to variability in metabolism based upon CYP2D6 genotype, which can lead to an increased exposure to active metabolite M1; children

Avoid use in adolescents 12-18 years of age who have other risk factors that may increase sensitivity to respiratory depressant effects of tramadol unless benefits outweigh risks; risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression; when prescribing tramadol for adolescents, healthcare providers should choose lowest effective dose for shortest period of time and inform patients and caregivers about risks and the signs of opioid overdose

Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range

Do not prescribe therapy to patients who are suicidal or addiction-prone; consideration should be given to use of non-narcotic analgesics in patients who are suicidal or depressed

Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; drug may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

Avoid use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; in these patients, mixed agonist/antagonist and partial agonist analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms

May impair mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery; warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of opioid and know how they will react to the medication

Serotonin syndrome (potentially life-threatening) may develop

  • To ensure that benefits of opioid analgesics outweigh risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products
  • Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed; use the following link to obtain the Patient Counseling Guide (PCG): www.fda.gov/OpioidAnalgesicREMSPCG
  • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them
  • Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities
  • To obtain further information on opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com; the FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint

Off-label use in children

  • Severe respiratory depression reported with off-label use in children
  • Tramadol undergoes extensive hepatic metabolism; it is metabolized by CYP2D6 to the active metabolite O-desmethyltramadol (M1), which has a 200-fold greater affinity for opioid receptors than does tramadol
  • CYP2D6 poor metabolizers have shown a 20% increase in tramadol levels and a 40% decrease in O-desmethyltramadol (M1)

Acetaminophen and tramadol

Generic Name: acetaminophen and tramadol (a SEET a MIN o fen and TRAM a dol)
Brand Name: Ultracet

Medically reviewed by Drugs.com on Oct 14, 2019 – Written by Cerner Multum

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What is acetaminophen and tramadol?

Tramadol is an pain medicine similar to an opioid (sometimes called, a narcotic). Acetaminophen is a less potent pain reliever that increases the effects of tramadol.

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.

MISUSE OF acetaminophen and tramadol 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.

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.

More about acetaminophen / tramadol

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Other brands: Ultracet

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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 , linezolid , phenelzine , selegiline , or tranylcypromine 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).

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 (Stevens-Johnson syndrome). 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, 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 ) 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, 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 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.

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 headaches (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 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.

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.

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 ) medicines and herbal or vitamin supplements.

Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Risk of life-threatening respiratory depression and death related to ultra-rapid metabolizers of tramadol (esp. in children for post-tonsillectomy and/or adenoidectomy pain). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant drugs that cause respiratory depression). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. Avoid in depressed, suicidal, or addiction-prone patients; consider non-narcotic analgesics. Emotional disturbance. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Hepatic impairment: not recommended. Renal impairment. Ultra-rapid metabolizers (due to CYP2D6 polymorphism): avoid. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

The U.S. Food and Drug Administration has approved Ultracet (TM), a new centrally acting prescription pain medication. Ultracet, comprised of 37.5 mg tramadol hydrochloride and 325 mg acetaminophen tablets, reportedly provides long-lasting pain relief and flexible dosing. Ortho-McNeil Pharmaceutical, Inc. will market the product in the United States.

Ultracet combines Ultram (tramadol hydrochloride), a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Clinical trials demonstrated that the combination offers better pain relief over either medication alone. In the trials, Ultracet consistently began working faster than tramadol alone, and pain relief with Ultracet lasted significantly longer than with acetaminophen alone. Ultracet is indicated for the short-term (five days or less) management of acute pain.

“Pain is one of the most prevalent medical symptoms in the United States,” said Warren A. Katz, MD, chief of Rheumatology at Presbyterian Medical Center/University of Pennsylvania Healthcare System in Philadelphia. “Millions of people suffer from acute pain without relief, in part because their medications don’t work or have side-effects that interfere with treatment. With Ultracet we have a product that offers effective relief and a positive side-effect profile.”

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Ultracet is a centrally acting analgesic that controls pain via different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications. Ultracet is not an NSAID, and is not associated with potentially life-threatening gastrointestinal ulcers or bleeding that can occur with NSAIDs and the newer Cox-2 NSAIDs. In addition, Ultracet does not compromise the efficacy of certain antihypertensive agents, like NSAIDs and Cox-2 NSAIDs. Ultracet can also be prescribed in sulfa-sensitive patients. The most frequently reported side effects with Ultracet were constipation, somnolence (sleepiness) and increased sweating.

Ultracet should not be used concomitantly with alcohol. The use of Ultracet in patients with liver disease is not recommended. In addition, acetaminophen may cause liver damage.

Cases of abuse and dependence on tramadol have been reported. Tramadol should not be used in opioid-dependent patients. Since tramadol can reinitiate physical dependence, Ultracet is not recommended for patients with a tendency to drug or alcohol abuse, a history of drug or alcohol dependence or a history of chronic opioid use. Patients with a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids may be at increased risk and therefore should not receive Ultracet.

Please see the full prescribing information for more information on Warnings, Precautions and additional Adverse Reactions that may occur, regardless of drug relationship.

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