5.18 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, ULTRACET should not be used concomitantly with other acetaminophen containing products.
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 ULTRACET. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [see Drug Interactions (7)] .
When discontinuing ULTRACET, in opioid-dependent patients, gradually taper the dosage [see Dosage and Administration (2.4)] . Do not abruptly discontinue ULTRACET [see Drug Abuse and Dependence (9.3)].
ULTRACET 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 ULTRACET and know how they will react to the medication [see Patient Counseling Information (17)] .
The following serious adverse reactions are discussed, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
- Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)]
- Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see Warnings and Precautions (5.3)]
- Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)]
- Hepatotoxicity [see Warnings and Precautions (5.6)]
- Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.7)]
- Serotonin Syndrome [see Warnings and Precautions (5.8)]
- Seizures [see Warnings and Precautions (5.9)]
- Suicide [see Warnings and Precautions (5.10)]
- Adrenal Insufficiency [see Warnings and Precautions (5.11)]
- Severe Hypotension [see Warnings and Precautions (5.13)]
- Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.16)]
- Hypersensitivity Reactions [see Warnings and Precautions (5.17)]
- Withdrawal [see Warnings and Precautions (5.19)]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common incidence of treatment-emergent adverse events (≥3.0%) in subjects from clinical trials was constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.
Table 1 shows the incidence rate of treatment-emergent adverse events reported in ≥2.0% of subjects over five days of ULTRACET use in clinical trials (subjects took an average of at least 6 tablets per day).
|Body System Preferred Term||ULTRACET (N=142) (%)|
|Gastrointestinal System Disorders|
|Central & Peripheral Nervous System|
|Skin and Appendages|
|Reproductive Disorders, Male *|
Incidence at least 1%, causal relationship at least possible or greater:
The following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET.
Body as a Whole – Asthenia, fatigue, hot flushes
Central and Peripheral Nervous System – Dizziness, headache, tremor
Gastrointestinal System – Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting
Psychiatric Disorders – Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence
Skin and Appendages – Pruritus, rash, increased sweating
Selected Adverse events occurring at less than 1%:
The following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET clinical trials.
Body as a Whole – Chest pain, rigors, syncope, withdrawal syndrome
Cardiovascular Disorders – Hypertension, aggravated hypertension, hypotension
Central and Peripheral Nervous System – Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesias, stupor, vertigo
Gastrointestinal System – Dysphagia, melena, tongue edema
Hearing and Vestibular Disorders – Tinnitus
Heart Rate and Rhythm Disorders – Arrhythmia, palpitation, tachycardia
Liver and Biliary System – Hepatic function abnormal
Metabolic and Nutritional Disorders – Weight decrease
Psychiatric Disorders – Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking
Red Blood Cell Disorders – Anemia
Respiratory System – Dyspnea
Urinary System – Albuminuria, micturition disorder, oliguria, urinary retention
Vision Disorders – Abnormal vision
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