Acetaminophen and tramadol

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 symptoms may include shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, seizure, or coma.

Usual Adult Dose 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

Comments:
-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.

• It is used to ease pain.

• If you have an allergy to acetaminophen, tramadol, or any other part of acetaminophen and tramadol.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you have thoughts of suicide or if you have ever had alcohol or other drug abuse or dependence.
• If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
• If you have liver disease.
• If you are taking carbamazepine.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you are taking another drug that has the same drug in it.
• If you are breast-feeding. Do not breast-feed while you take acetaminophen and tramadol.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take acetaminophen and tramadol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

(a seet a MIN oh fen & TRA ma dole)

Hypersensitivity to acetaminophen, tramadol, or any component of the formulation; significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; GI obstruction, including paralytic ileus (known or suspected); concomitant use with or within 14 days following MAO inhibitor therapy

Documentation of allergenic cross-reactivity for opioids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Known or suspected mechanical GI obstruction (eg, bowel obstruction, strictures) or any disease/condition that affects bowel transit; suspected surgical abdomen (eg, acute appendicitis, pancreatitis); severe renal impairment (creatinine clearance <30 mL/minute); severe hepatic impairment (Child-Pugh class C); mild pain that can be managed with other pain medications; acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus; acute respiratory depression, hypercapnia, or cor pulmonale; acute alcoholism, delirium tremens, or seizure disorder; severe CNS depression, increased cerebrospinal or intracranial pressure, or head injury; any situation where opioids are contraindicated (eg, acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs); breastfeeding; pregnancy; use during labor and delivery.

Administer with or without food.

See individual agents.

Applies to acetaminophen / tramadol: oral tablet

General

The most common adverse reactions include nausea, somnolence, and dizziness.[Ref]

Hepatic

Acetaminophen-Tramadol
Uncommon (0.1% to 1%): Increased transaminases, abnormal hepatic function

Acetaminophen:
Frequency not reported: Acute liver failure

Tramadol:
Frequency not reported: Hepatitis, liver failure[Ref]

Psychiatric

A psychic reaction with symptoms of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, and hallucinations has been reported with tramadol use. During clinical trials, tolerance development was mild and the reports of a withdrawal syndrome were rare. Symptoms of a withdrawal syndrome have included: panic attacks, severe anxiety, hallucinations, paresthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalization, derealization, and paranoia).[Ref]

Acetaminophen-Tramadol
Very common (10% or more): Insomnia
Common (1% to 10%): Altered mood (anxiety, nervousness, euphoric mood), sleep disorders
Uncommon (0.1% to 1%): Depression, hallucinations, nightmares, amnesia
Rare (less than 0.1%): Delirium, dependency
Frequency not reported: Depersonalization, paranoia
Postmarketing reports: Abuse

Tramadol:
Frequency not reported: Psychic reactions including mood changes, withdrawal symptoms[Ref]

Gastrointestinal

Acetaminophen-Tramadol
Very common (10% or more): Nausea (up to 18%), constipation (up to 11%)
Common (1% to 10%): Vomiting, dyspepsia, dry mouth, diarrhea, abdominal pain, flatulence
Uncommon (0.1% to 1%): Dysphagia, melena, tongue edema

Tramadol
Frequency not reported: Gastrointestinal bleeding[Ref]

Nervous system

Acetaminophen-Tramadol
Very common (10% or more): Dizziness (up to 15%), Somnolence (up to 12%), headache (up to 11%),
Common (1% to 10%): Tremor, confusion, paresthesia, hypoesthesia
Uncommon (0.1% to 1%): Migraine, hypertonia, stupor, involuntary muscle contractions
Rare (less than 0.1%): Seizures, ataxia, speech disorders

Tramadol:
Frequency not reported: Serotonin syndrome[Ref]

Dermatologic

Common (1% to 10%): Sweating, pruritus, rash
Uncommon (0.11% to 1%): dermal reactions such as rash and urticaria[Ref]

Genitourinary

Uncommon (0.1% to 1%): Albuminuria, micturition disorders (dysuria and urinary retention)
Frequency not reported: Impotence[Ref]

Cardiovascular

Acetaminophen-Tramadol:
Uncommon: Hypertension, palpitations, tachycardia, arrhythmia
Less than 1%: Aggravated hypertension, hypotension, chest pain

Tramadol:
Frequency not reported: Postural hypotension, bradycardia, syncope, vasodilation, myocardial ischemia
Postmarketing reports: QT prolongation/torsade de pointes[Ref]

Postmarketing reports of QT prolongation and/or torsade de pointes have been received for tramadol-containing products. In many cases, patients were taking another drug associated with QT prolongation, had risk factors for QT prolongation such as hypokalemia, or in the overdose setting.[Ref]

Hypersensitivity

Acetaminophen:
Frequency not reported: Allergic reactions (primarily skin rash)

Tramadol:
Rare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, urticarial and Stevens-Johnson syndrome/TENS[Ref]

Respiratory

Acetaminophen-Tramadol:
Uncommon (0.1% to 1%): Dyspnea

Tramadol:
Frequency not reported: Asthma aggravated[Ref]

Other

Common (1% to 10%): Asthenia, fatigue, hot flushes
Uncommon (0.1% to 1%): Tinnitus, shivers[Ref]

Hematologic

Acetaminophen-Tramadol
Frequency not reported: Anemia

Acetaminophen:
Frequency not reported: Blood dyscrasias including thrombocytopenia and agranulocytosis[Ref]

Ocular

Uncommon (0.1% to 1%): Abnormal vision
Rare (less than 0.1%): Blurred vision, mydriasis, miosis[Ref]

Metabolic

Common (1% to 10%): Anorexia
Frequency not reported: Hypoglycemia, decreased weight[Ref]

Endocrine

Common (1% to 10%): Prostatic disorder

Opioids:
Postmarketing reports: Adrenal insufficiency; androgen deficiency[Ref]

Some side effects of acetaminophen / tramadol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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

Comments:
-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.

Use is not recommended unless the benefit outweighs the risk to the fetus AU TGA pregnancy category: C US FDA pregnancy category: Not assigned Comments: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

Tramadol has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83. Animal studies have shown at very high doses, this drug has an effect on organ development, bone growth, and mortality rate. Prolonged maternal use of opioid analgesics during pregnancy may result in respiratory depression and physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. There have been postmarketing reports of neonatal seizures, neonatal withdrawal syndrome, fetal death, and still births with tramadol use. There are no adequate and well-controlled studies in pregnant women. Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and