Tramadol Hydrochloride and Acetaminophen
FULL PRESCRIBING INFORMATION: CONTENTS*
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacodynamics
CLINICAL PHARMACOLOGY, Pharmacokinetics
Pharmacokinetics
Absorption
Food Effects
Distribution
Metabolism
PRECAUTIONS, Drug Interactions
WARNINGS
Elimination
Special Populations
Renal
DOSAGE AND ADMINISTRATION
Hepatic
PRECAUTIONSDOSAGE AND ADMINISTRATION
Geriatric
PRECAUTIONS, Geriatric Use
Gender
Pediatric
Clinical Studies
Single Dose Studies for Treatment of Acute Pain
INDICATIONS & USAGE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN CONTRAINDICATIONS
WARNINGS
Seizure RiskSeizures 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:
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● Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics),
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● Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
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● Other opioids.
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● MAO inhibitors (see alsoWARNINGS, Use with MAO Inhibitors and Serotonin Re-uptake Inhibitors),
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● Neuroleptics, or
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● Other drugs that reduce the seizure threshold.
Suicide Risk
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● Do not prescribe tramadol hydrochloride and acetaminophen tablets for patients who are suicidal or addiction-prone.
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● Prescribe tramadol hydrochloride and acetaminophen tablets with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess and who suffer from emotional disturbance or depression.
WARNINGS, Risk of Overdosage
Serotonin Syndrome Risk
The development of a potentially life-threatening serotonin syndrome may occur with the use of tramadol products, including tramadol hydrochloride and acetaminophen tablets, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose (seeCLINICAL PHARMACOLOGY, Pharmacokinetics).
Serotonin syndrome 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) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Anaphylactoid Reactions
CONTRAINDICATIONS
Respiratory Depression
WARNINGS, Seizure RiskOVERDOSAGE
Interaction With Central Nervous System (CNS) Depressants
Interactions with Alcohol and Drugs of Abuse
Increased Intracranial Pressure or Head Trauma
WARNINGS, Respiratory Depression
Use in Ambulatory Patients
Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors
Use With Alcohol
Use With Other Acetaminophen-containing Products
Misuse, Abuse and Diversion
DRUG ABUSE AND DEPENDENCEOVERDOSAGE
Risk of Overdosage
OVERDOSAGE
Withdrawal
DRUG ABUSE AND DEPENDENCE
PRECAUTIONS
GeneralWARNINGS, Use With Other Acetaminophen-containing Products and Risk of Overdosage
Pediatric Use
Geriatric Use
Acute Abdominal Conditions
Use in Renal Disease
Use in Hepatic Disease
WARNINGS, Use With Alcohol
INFORMATION FOR PATIENTS
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● Patients should be informed that tramadol hydrochloride and acetaminophen tabletsmay cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SSRIs, SNRIs, and triptans) or drugs that significantly reduce the metabolic clearance of tramadol.
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● Tramadol hydrochloride and acetaminophen tablets may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
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● Tramadol hydrochloride and acetaminophen tablets should not be taken with alcohol containing beverages.
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● The patient should be instructed not to take tramadol hydrochloride and acetaminophen tablets in combination with other tramadol or acetaminophen-containing products, including over-the-counter preparations.
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● Tramadol hydrochloride and acetaminophen tablets should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
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● The patient should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant (seePRECAUTIONS, Labor and Delivery).
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● The patient should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures, hepatic toxicity and death.
DRUG INTERACTIONS
CYP2D6 and CYP3A4 InhibitorsCLINICAL PHARMACOLOGY, Pharmacokinetics
Serotonergic Drugs
WARNINGS, Serotonin Syndrome
Triptans
WARNINGS, Serotonin Syndrome
Use With Carbamazepine
Use With Quinidine
Potential for Other Drugs to Affect Tramadol
Potential for Tramadol to Affect Other Drugs
Use With Cimetidine
Use With Digoxin
Use With Warfarin Like Compounds
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic Effects: Pregnancy Category CNon-teratogenic Effects:
LABOR & DELIVERY
DRUG ABUSE AND DEPENDENCENURSING MOTHERS
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ADVERSE REACTIONS
Body as a Whole
Central and Peripheral Nervous System
Gastrointestinal System
Psychiatric Disorders
Skin and Appendages
Body as a Whole
Cardiovascular Disorders
Central and Peripheral Nervous System
Gastrointestinal System
Hearing and Vestibular Disorders
Liver and Biliary System
Metabolic and Nutritional Disorders
Psychiatric Disorders
Red Blood Cell Disorders
Respiratory System
Urinary System
Vision Disorders
DRUG ABUSE AND DEPENDENCE
AbuseTramadol has mu-opioid agonist activity. Tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion.
Dependence
WARNINGS, Withdrawal
OVERDOSAGE
Tramadol
WARNINGS, Misuse, Abuse, and Diversion
to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period..
Acetaminophen
DOSAGE & ADMINISTRATION
Individualization of Dose
HOW SUPPLIED
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
