Tramadol and acetaminophen

The usual dose of Ultracet is two tablets every four to six hours as needed for the relief of pain. Patients should not take more than two tablets at a time nor more than 8 tablets per day.

In the U.S.

• Ultracet

In Canada

• Tramacet

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic Combination

Chemical Class: Tramadol

Tramadol and acetaminophen combination is used to relieve pain. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine. Since tramadol and acetaminophen is only used for the short-term relief of pain, physical dependence will probably not occur.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

tramadol and acetaminophen is available only with your doctor's prescription.

Take tramadol and acetaminophen 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 tramadol and acetaminophen is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

tramadol and acetaminophen should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

The dose of tramadol and acetaminophen 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 tramadol and acetaminophen. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For acute pain:
    • Adults—2 tablets every 4 to 6 hours as needed for up to 5 days. Do not take more than 8 tablets per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of tramadol and acetaminophen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Tramadol Hydrochloride and Acetaminophen Tablets are available as:

37.5 mg/325 mg tablets: Orange, film-coated capsule shaped, debossed “083” on one side and “KALI” on the other side.

Addiction, Abuse, and Misuse

Tramadol hydrochloride and acetaminophen tablets contain tramadol, a Schedule IV controlled substance. As an opioid, tramadol hydrochloride and acetaminophen tablets expose users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)].

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed tramadol hydrochloride and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing tramadol hydrochloride and acetaminophen tablets, and monitor all patients receiving tramadol hydrochloride and acetaminophen tablets for the development of these behaviors and conditions.  Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as tramadol hydrochloride and acetaminophen tablets, but use in such patients necessitates intensive counseling about the risks and proper use of tramadol hydrochloride and acetaminophen tablets along with intensive monitoring for signs of addiction, abuse, and misuse.

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.  Consider these risks when prescribing or dispensing tramadol hydrochloride and acetaminophen tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)].  Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.  Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of tramadol hydrochloride and acetaminophen tablets, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage increases of tramadol hydrochloride and acetaminophen tablets.

To reduce the risk of respiratory depression, proper dosing and titration of tramadol hydrochloride and acetaminophen tablets are essential [see Dosage and Administration (2)]. Overestimating the tramadol hydrochloride and acetaminophen tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

Accidental ingestion of even one dose of tramadol hydrochloride and acetaminophen tablets, especially by children, can result in respiratory depression and death due to an overdose of tramadol.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of tramadol hydrochloride and acetaminophen tablets during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations (8.1), Patient Counseling Information (17)].

Risks of Interactions with Drugs Affecting Cytochrome P450 Isoenzymes

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors on levels of tramadol and M1 from tramadol hydrochloride and acetaminophen tablets are complex.  Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride and acetaminophen tablets requires careful consideration of the effects on the parent drug, tramadol, which is a weak serotonin and norepinephrine reuptake inhibitor and µ-opioid agonist, and the active metabolite, M1, which is more potent than tramadol in µ-opioid receptor binding [see Drug Interactions (7)].

Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors 

The concomitant use of tramadol hydrochloride and acetaminophen tablets with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in tramadol plasma levels and a decrease in the levels of the active metabolite, M1. A decrease in M1 exposure in patients who have developed physical dependence to tramadol, may result in signs and symptoms of opioid withdrawal and reduced efficacy. The effect of increased tramadol levels may be an increased risk for serious adverse events including seizures and serotonin syndrome.

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.

Follow patients receiving tramadol hydrochloride and acetaminophen tablets and any CYP2D6 inhibitor for the risk of serious adverse events including seizures and serotonin syndrome, signs and symptoms that may reflect opioid toxicity, and opioid withdrawal when tramadol hydrochloride and acetaminophen tablets are used in conjunction with inhibitors of CYP2D6 [see Drug Interactions (7)].

Cytochrome P450 3A4 Interaction

The concomitant use of tramadol hydrochloride and acetaminophen tablets with cytochrome P450 3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir) or discontinuation of a cytochrome P450 3A4 inducer such as rifampin, carbamazepine, and phenytoin, may result in an increase in tramadol plasma concentrations, which could increase or prolong adverse reactions, increase the risk for serious adverse events including seizures and serotonin syndrome, and may cause potentially fatal respiratory depression.

The concomitant use of tramadol hydrochloride and acetaminophen tablets 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 tramadol hydrochloride and acetaminophen tablets and any CYP3A4 inhibitor or inducer for the risk for serious adverse events including seizures and serotonin syndrome, signs and symptoms that may reflect opioid toxicity and opioid withdrawal when tramadol hydrochloride and acetaminophen tablets are used in conjunction with inhibitors and inducers of CYP3A4 [see Drug Interactions (7)].

Hepatotoxicity

Tramadol hydrochloride and acetaminophen tablets contain tramadol hydrochloride and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride and acetaminophen tablets with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone.  Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions (7)].

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the 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 the 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.

Advise both patients and caregivers about the risks of respiratory depression and sedation when tramadol hydrochloride and acetaminophen tablets are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.  Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions (7), Patient Counseling Information (17)].

Serotonin Syndrome Risk

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported with the use of tramadol, including tramadol hydrochloride and acetaminophen tablets, during concomitant use with serotonergic drugs.

Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including MAO inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) [see Drug Interactions (7)]. This may occur within the recommended dosage range.

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue tramadol hydrochloride and acetaminophen tablets if serotonin syndrome is suspected.

Increased Risk of Seizures

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.

Concomitant use of tramadol increases the seizure risk in patients taking: [see Drug Interactions (7)].

• Selective serotonin re-uptake inhibitors (SSRIs) and Serotonin-norepinephrine re-uptake inhibitors (SNRIs) antidepressants or anorectics, • Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), • Other opioids, • MAO inhibitors [see Warnings and Precautions (5.7), Drug Interactions (7)] • Neuroleptics, or • Other drugs that reduce the seizure threshold.

Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).

In tramadol overdose, naloxone administration may increase the risk of seizure.

Suicide Risk

• Do not prescribe tramadol hydrochloride and acetaminophen tablets for patients who are suicidal or addiction-prone. Consideration should be given to the use of non-narcotic analgesics in patients who are suicidal or depressed [see Drug Abuse and Dependence (9)]. • Prescribe tramadol hydrochloride and acetaminophen tablets with caution for patients with a history of misuse and/or are currently taking CNS-active drugs including tranquilizers, or antidepressant drugs, or alcohol in excess, and patients who suffer from emotional disturbance or depression [see Drug Interactions (7)]. • Inform patients not to exceed the recommended dose and to limit their intake of alcohol [see Dosage and Administration (2), Warnings and Precautions (5.5, 5.6)].

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.  If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

The use of tramadol hydrochloride and acetaminophen tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [see Contraindications (4)].

Patients with Chronic Pulmonary Disease:  Tramadol hydrochloride and acetaminophen tablets-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of tramadol hydrochloride and acetaminophen tablets [see Warnings and Precautions (5.2)].

Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics, or altered clearance, compared to younger, healthier patients [see Warnings and Precautions (5.2)].

Monitor such patients closely, particularly when initiating and titrating tramadol hydrochloride and acetaminophen tablets and when tramadol hydrochloride and acetaminophen tablets are given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.6), Drug Interactions (7)]. Alternatively, consider the use of non-opioid analgesics in these patients.

Severe Hypotension

Tramadol hydrochloride and acetaminophen tablets 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 (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7)]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of tramadol hydrochloride and acetaminophen tablets. In patients with circulatory shock, tramadol hydrochloride and acetaminophen tablets may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of tramadol hydrochloride and acetaminophen tablets in patients with circulatory shock.

Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

n patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), tramadol hydrochloride and acetaminophen tablets may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with tramadol hydrochloride and acetaminophen tablets.

Opioids may also obscure the clinical course in a patient with a head injury.  Avoid the use of tramadol hydrochloride and acetaminophen tablets in patients with impaired consciousness or coma.

Serious Skin Reactions

Rarely, acetaminophen   may   cause   serious   skin   reactions   such   as   acute   generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity

Risk of Use in Patients with Gastrointestinal Conditions

Tramadol hydrochloride and acetaminophen tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Contraindications (4)].

The tramadol in tramadol hydrochloride and acetaminophen tablets may cause spasm of the sphincter of Oddi.  Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Anaphylaxis and Other Hypersensitivity Reactions

Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with tramadol. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride and acetaminophen tablets. If anaphylaxis or other hypersensitivity occurs, stop administration of tramadol hydrochloride and acetaminophen tablets immediately, discontinue tramadol hydrochloride and acetaminophen tablets permanently, and do not rechallenge with any formulation of tramadol.  Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction [see Contraindications (4), Information for Patients (17)].

There have been postmarketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue tramadol hydrochloride and acetaminophen tablets immediately and seek medical care if they experience these symptoms. Do not prescribe tramadol hydrochloride and acetaminophen tablets for patients with acetaminophen allergy.

Increased Risk of Hepatotoxicity with Concomitant Use of Other Acetaminophen-containing Products

Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, tramadol hydrochloride and acetaminophen tablets should not be used concomitantly with other acetaminophen containing products.

Withdrawal

Avoid the 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, including tramadol hydrochloride and acetaminophen tablets.  In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms [see Drug Interactions (7)].

When discontinuing tramadol hydrochloride and acetaminophen tablets, in opioid-dependent patients, gradually taper the dosage [see Dosage and Administration (2.4)]. Do not abruptly discontinue tramadol hydrochloride and acetaminophen tablets [see Drug Abuse and Dependence (9.3)].

Driving and Operating Machinery

Tramadol hydrochloride and acetaminophen tablets may impair the 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 tramadol hydrochloride and acetaminophen tablets and know how they will react to the medication [see Patient Counseling Information (17)].

Tramadol Hydrochloride and Acetaminophen Tablets combines two analgesics, tramadol hydrochloride and opioid agonist, and acetaminophen.

The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder.  

The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is:

The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.

Tramadol Hydrochloride and Acetaminophen Tablets contain 37.5 mg tramadol hydrochloride and 325 mg of acetaminophen and are orange in color. Inactive ingredients in the tablet are crospovidone, magnesium stearate, microcrystalline cellulose, OPADRY® II Orange, povidone, pregelatinized starch, purified water, and stearic acid.  OPADRY® II Orange contains: FD&C red #40; FD&C yellow #6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose; polyethylene glycol; titanium dioxide; and triacetin.

Single-Dose Studies for Treatment of Acute Pain

In single-dose studies in acute pain, two tablets of tramadol hydrochloride and acetaminophen administered to patients with pain following oral surgical procedures provided greater relief than placebo or either of the individual components given at the same dose. The onset of pain relief after tramadol hydrochloride and acetaminophen tablets was faster than tramadol alone. Onset of analgesia occurred in less than one hour. The duration of pain relief after tramadol hydrochloride and acetaminophen tablets was longer than acetaminophen alone. Analgesia was generally comparable to that of the comparator, ibuprofen

Medication Guide Tramadol Hydrochloride and Acetaminophen Tablets, CIV (TRAM-a-dol HYE-droe-KLOR-ide and a-SEET-a-MIN-oh-fen)

Tramadol Hydrochloride and Acetaminophen Tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used for the short-term (five days or less) management of acute pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Tramadol Hydrochloride and Acetaminophen Tablets: • Get emergency help right away if you take too much Tramadol Hydrochloride and Acetaminophen Tablets (overdose). When you first start taking Tramadol Hydrochloride and Acetaminophen Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Tramadol Hydrochloride Extended-release Tablets can cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with benzodiazepines or other medicines that depress consciousness. • Never give anyone else your Tramadol Hydrochloride and Acetaminophen Tablets. They could die from taking it. Store Tramadol Hydrochloride and Acetaminophen Tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away Tramadol Hydrochloride and Acetaminophen Tablets is against the law. • Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking Tramadol Hydrochloride and Acetaminophen Tablets with other products that contain acetaminophen can lead to serious liver problems and death.

Do not take Tramadol Hydrochloride and Acetaminophen Tabletsif you have: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowing of the stomach or intestines. • An allergy to any of its ingredients (e.g., tramadol hydrochloride or acetaminophen). • Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

Before taking Tramadol Hydrochloride and Acetaminophen Tablets, tell your healthcare provider if you have a history of: • head injury, seizures● liver, kidney, thyroid problems • problems urinating● pancreas or gallbladder problems • abuse of street or prescription drugs, alcohol addiction, or mental health problems. Tell your healthcare provider if you are: • pregnant or planning to become pregnant. Prolonged use of Tramadol Hydrochloride and Acetaminophen Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. • breastfeeding. Tramadol Hydrochloride and Acetaminophen Tablets passes into breast milk and may harm your baby. • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Tramadol Hydrochloride and Acetaminophen Tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Tramadol Hydrochloride and Acetaminophen Tablets: • Do not change your dose. Take Tramadol Hydrochloride and Acetaminophen Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. • Take your prescribed dose: 2 tablets every 4 to 6 hours as needed for pain relief for a maximum of 5 days. Do not take more than your prescribed dose and do not take more than 8 tablets per day. If you miss a dose, take your next dose at your usual time. • Call your healthcare provider if the dose you are taking does not control your pain. • If you have been taking Tramadol Hydrochloride and Acetaminophen Tablets regularly, do not stop taking Tramadol Hydrochloride and Acetaminophen Tablets without talking to your healthcare provider. • After you stop taking Tramadol Hydrochloride and Acetaminophen Tablets, ask your pharmacist how to dispose of any unused tablets.

While taking Tramadol Hydrochloride and Acetaminophen TabletsDO NOT: • Drive or operate heavy machinery, until you know how Tramadol Hydrochloride and Acetaminophen Tablets affect you. Tramadol Hydrochloride and Acetaminophen Tablets can make you sleepy, dizzy, or lightheaded. • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Tramadol Hydrochloride and Acetaminophen Tablets may cause you to overdose and die.

The possible side effects of Tramadol Hydrochloride and Acetaminophen Tablets: • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help if you have: • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of Tramadol Hydrochloride and Acetaminophen Tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

This Medication Guide has been approved by the U.S. Food and Drug Administration.        

Issued: 09/2017