Tramacet

Name: Tramacet

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Commonly used brand name(s)

In the U.S.

Ultracet

In Canada

Tramacet

Available Dosage Forms:

Tablet

Therapeutic Class: Analgesic Combination

Chemical Class: Tramadol

Before Using Tramacet

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. Safety and efficacy have not been established.

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.

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.

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
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.

Acepromazine
Alfentanil
Almotriptan
Alprazolam
Amineptine
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Anileridine
Aripiprazole
Asenapine
Baclofen
Benperidol
Benzphetamine
Bromazepam
Bromopride
Bromperidol
Brompheniramine
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butorphanol
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Ceritinib
Chloral Hydrate
Chlordiazepoxide
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Citalopram
Clarithromycin
Clobazam
Clomipramine
Clonazepam
Clorazepate
Clozapine
Cobicistat
Cocaine
Codeine
Cyclobenzaprine
Darunavir
Desipramine
Desmopressin
Desvenlafaxine
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Dibenzepin
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diphenhydramine
Diphenoxylate
Dolasetron
Donepezil
Dothiepin
Doxepin
Doxylamine
Droperidol
Duloxetine
Eletriptan
Enflurane
Escitalopram
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fentanyl
Flibanserin
Fluconazole
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Fospropofol
Frovatriptan
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Idelalisib
Imatinib
Imipramine
Isoflurane
Isoniazid
Ketamine
Ketazolam
Ketobemidone
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lorazepam
Lorcaserin
Loxapine
Meclizine
Melitracen
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methocarbamol
Methohexital
Methotrimeprazine
Metoclopramide
Midazolam
Milnacipran
Mirabegron
Mirtazapine
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nalbuphine
Naratriptan
Nefazodone
Nicomorphine
Nitrazepam
Nitrous Oxide
Nortriptyline
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Palonosetron
Papaveretum
Paregoric
Paroxetine
Peginterferon Alfa-2b
Pentazocine
Pentobarbital
Perampanel
Periciazine
Perphenazine
Phenobarbital
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Pixantrone
Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
Prazepam
Primidone
Prochlorperazine
Promethazine
Propofol
Protriptyline
Quazepam
Quetiapine
Ramelteon
Remifentanil
Remoxipride
Rizatriptan
Secobarbital
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
St John's Wort
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Trazodone
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Tryptophan
Venlafaxine
Vilazodone
Vortioxetine
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine

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
Fosphenytoin
Lixisenatide
Phenytoin
Quinidine
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
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

Precautions While Using Tramacet

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®) within the past 14 days.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain acetaminophen or tramadol, check with your doctor. Taking them together with this medicine may cause an overdose.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, shortness of breath, or yellow eyes or skin.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Ultracet® may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet.

Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures (convulsions). It may also cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression (eg, citalopram, fluoxetine, sertraline, Cymbalta®, Effexor®, Lexapro®, Pristiq®) or medicine to treat migraine headache (eg, eletriptan, frovatriptan, rizatriptan, zolmitriptan). Check with your doctor right away if you have the following symptoms of serotonin syndrome: agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching.

This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has tried to commit suicide.

This medicine may cause some people to become dizzy, drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble sleeping.

Analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Tramacet 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
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
tightness in the chest
trouble breathing
unusual tiredness or weakness
vomiting

Incidence not known

Blistering, peeling, or loosening of the skin
chills
diarrhea
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
noisy breathing
red skin lesions, often with a purple center
red, irritated eyes
sore throat
sores, ulcers, or white spots in the mouth or on the lips

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

Symptoms of overdose

Abdominal or stomach pain
black, tarry stools
chest pain or discomfort
dark urine
difficulty with sleeping
disorientation
drowsiness to profound coma
fever
headache
irregular, fast or slow, or shallow breathing
lethargy
light-colored stools
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
unpleasant breath odor
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

Acid or sour stomach
anxiety
belching
bloated or full feeling
constipation
dry mouth
excess air or gas in the stomach or intestines
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 pain or weakness
numbness or tingling of the hands, legs, and feet
painful or difficult urination
redness of the face, neck, arms, and occasionally the upper chest
sleepiness or unusual drowsiness
soft stools
stomach discomfort
weight loss