Acetaminophen and tramadol

Name: Acetaminophen and tramadol

What is acetaminophen and tramadol?

Tramadol is a narcotic-like pain reliever. 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.

What should I discuss with my healthcare provider before taking acetaminophen and tramadol?

You should not use this medicine 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.

Acetaminophen and tramadol is not approved for use by anyone younger than 18 years old.

Seizures have occurred in some people taking this medicine. Your risk of a seizure may be higher if you have ever had:

  • alcoholism or drug addiction;

  • epilepsy or other seizure disorder;

  • a metabolic disorder;

  • a head injury or brain tumor; or

  • if you have recently used sedatives, tranquilizers, or narcotic medications.

To make sure acetaminophen and tramadol 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;

  • depression, mental illness, or a suicide attempt; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

If you use this medicine 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. Tell your doctor if you are pregnant.

Do not breast-feed. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take acetaminophen and tramadol?

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

The maximum amount of acetaminophen and tramadol is 2 tablets per dose, or 8 tablets per day. Do not take this medicine for longer than 5 days in a row.

This medicine may be habit forming, even at regular doses. Never share it with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away this medicine is against the law.

You may take this medicine 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 at room temperature away from moisture and heat.

Keep track of your medicine. Acetaminophen and tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What should I avoid while taking acetaminophen and tramadol?

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

Avoid driving or operating machinery until you know how this medicine 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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Very bad dizziness or passing out.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Noisy breathing.
  • Feeling very sleepy.
  • Very hard stools (constipation).
  • Very bad belly pain.
  • Feeling very tired or weak.
  • Chest pain or pressure or a fast heartbeat.
  • Feeling confused.
  • Not able to pass urine or change in how much urine is passed.
  • Pale skin.
  • Change in eyesight.
  • Seizures.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Use Labeled Indications

Pain management: Short-term (≤5 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of use: Reserve tramadol/acetaminophen for use in patients for whom alternative treatment options (eg, nonopioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Dosing Adult

Pain management: Oral: Acetaminophen 325 mg/tramadol 37.5 mg: Two tablets every 4 to 6 hours as needed for pain relief (maximum: 8 tablets/day [acetaminophen 2,600 mg/tramadol 300 mg per day]); do not exceed 5 days of therapy

Dosing Geriatric

Refer to adult dosing. Use with caution.

Precautions

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYP450 ISOENZYMES; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS:
-Addiction, Abuse, and Misuse: Use of this drug exposes patients and other users to the risks of opioid addiction 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.
-Life-Threatening Respiratory Depression including 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 one dose, especially by children, can result in a fatal overdose of tramadol.
-Neonatal Opioid Withdrawal Syndrome, a potentially life-threatening condition if not recognized and treated, may result from prolonged maternal opioid use during pregnancy; it 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 appropriate treatment be available.
-Concomitant use or discontinuation of CYP450 isoenzymes including CYP450 3A4 inducers/inhibitors, or CYP450 2D6 inhibitors are complex; concomitant use requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
-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 4000 mg per day, and often involve more than one acetaminophen-containing product.
-Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

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