5.3 Neonatal Opioid Withdrawal Syndrome
5.4 Risks of Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
5.5 Hepatotoxicity
5.6 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
5.7 Serotonin Syndrome Risk
5.8 Increased Risk of Seizures
5.9 Suicide Risk
5.10 Adrenal Insufficiency
5.11 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
5.12 Severe Hypotension
5.13 Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
5.14 Serious Skin Reactions
5.15 Risk of Use in Patients with Gastrointestinal Conditions
5.16 Anaphylaxis and Other Hypersensitivity Reactions
5.17 Increased Risk of Hepatotoxicity with Concomitant Use of Other Acetaminophen-containing Products
5.18 Withdrawal
5.19 Driving and Operating Machinery
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
8.8 Sex
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
Single-Dose Studies for Treatment of Acute Pain
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Tramadol hydrochloride and acetaminophen tablets are not approved for use for more than 5 days.
Do not exceed the recommended dose of tramadol hydrochloride and acetaminophen tablets. Do not co-administer tramadol hydrochloride and acetaminophen tablets with other tramadol or acetaminophen containing products [see WARNINGS AND PRECAUTIONS (5.17)].
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS (5.1)].
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse |
