Renal Dose Adjustment (Based on CrCl)
- <30 mL/min: 2 tabs PO q12 hrs; Max: 4 tabs/day
- Hemodialysis: Dose adjustments not defined
Hepatic Dose Adjustment
- Hepatic impairment: Avoid use
See Supplemental Patient Information
- Tramadol component of this combination drug is associated with increased risk of seizures within the recommended dosage range. Risk of seizures increase with doses of tramadol above the recommended range. Concomitant use with selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine) or other opioids increases risk of seizures
- Administration of tramadol component in patients taking MAO inhibitors/serotonin re-uptake inhibitors/neuroleptics/or other drugs lowering the seizure threshold also enhances risk of seizure
- Patients with epilepsy, those with a history of seizures, or patients with a recognized risk for seizure are more susceptible to risk of convulsions
- Avoid prescribing this combination drug for patients who are suicidal or addiction-prone. Prescribe with caution in patients using tranquilizers or antidepressant drugs, alcoholic patients and those suffering from emotional disturbances or depression. Consider use of non-narcotic analgesics in patients who are depressed or suicidal
- Tramadol component of this drug is associated with fatalities in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active agents
- Life-threatening serotonin syndrome have occurred particularly with concurrent use of serotonergic drugs such as TCAs, SSRIs, SNRIs, MAOIs and triptans, with drugs impairing metabolism of serotonin (including MAOIs), and with drugs impairing metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). Serotonin syndrome include mental-status changes, autonomic instability, neuromuscular aberrations and/or gastrointestinal symptoms
- Serious and rare cases of fatal anaphylactoid reactions have occurred in patients receiving therapy with tramadol. Allergic reactions including pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome have occurred. Avoid use in patients having history of anaphylactoid reactions to codeine and other opioids
- Consider alternative non-opioid analgesics in patients having risk for respiratory depression. Respiratory depression has occurred on administration of large doses with anesthetic medications or alcohol. Treat respiratory depression has as an overdose
- Administer reduced doses in patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics as risk of CNS and respiratory depression increases
- Tramadol component of this combination drug is associated with additive effects when used concomitantly with alcohol, other opioids, or illicit drugs that cause CNS depression
- Severe carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure is markedly exaggerated in patients with increased intracranial pressure or head injury. Miosis might obscure the existence, extent, or course of intracranial pathology. Maintain a high degree of suspicion for adverse drug reaction during evaluation of altered mental status in these patients
- Avoid concomitant use with alcohol. Using this combination drug in patients with liver disease is not recommended
- Avoid concomitant use with other acetaminophen-containing products
- This combination drug exhibits potential for abuse and criminal diversion. Consider possibility of illegal or illicit use while considering prescribing this drug. Misuse or abuse is associated with overdose and death
- Prescribe with caution for patients whose medical condition requires concurrent administration of sedatives, tranquilizers, muscle relaxants, tricyclic antidepressants, or other CNS depressant drugs
- Hepatic (centrilobular) necrosis, leading to hepatic failure and death has occurred on overdosage with acetaminophen. Immediately sought emergency help and initiate therapy on suspection of overdosage
- Abrupt discontinuation leads to withdrawal symptoms. Anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rare cases of hallucinations have occurred. Taper dose at the time of discontinuation to avoid withdrawal symptoms
- Avoid exceeding recommended dose and avoid co-administering with other tramadol or acetaminophen-containing products
Cautions: Use cautiously in
- Renal impairment
- History of seizure
- Risk of seizure
- Use of CNS depressant
- Use of alcohol
- Psychiatric disorder
- Head injury
- Respiratory depression
- Use of respiratory depressant
- Increased ICP
- Acute abdomen
- G6PD deficiency
- Geriatrics
Supplemental Patient Information
- Warn patients to avoid exceeding recommended dose prescribed by their physician
- Caution patients about the concomitant use of tramadol products and alcohol as potential for serious CNS additive effects of these agents exists
- Caution patients against engaging in activities requiring mental or physical abilities such as driving a car or operating machinery
Pregnancy Category:C
Breastfeeding: Safety unknown; low levels of tramadol are excreted in milk. Unlikely to produce adverse effects in breastfeed infants, monitor premature infants for increased sleepiness, difficulty breastfeeding, breathing difficulties ,limpness, and contact a physician immediately on occurrence of these events. Acetaminophen is good choice for analgesia, and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. This data is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 February 2011). According to manufacturer's data this combination drug is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers as its safety in infants and newborns has not been established.
US Trade Name(s)
US Availability
acetaminophen/tramadol (generic)
Ultracet
Canadian Trade Name(s)
Canadian Availability
acetaminophen/tramadol (generic)
Tramacet
UK Trade Name(s)
UK Availability
Tramacet
- TABS: 325 mg/37.5 mg
- EFFER TABS: 325 mg/37.5 mg
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Ultracet 37.5-325 MG TABS [Bottle] (JANSSEN)
30 mg = $63.99
90 mg = $157.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
