Most Common Adverse Events (%) Reported in Clinical TrialsAdverse Events100 mg QD
(N=403)200 mg QD
(N=400)300 mg QD
(N=400)Placebo
(N=406)Dizziness (excl. vertigo)1620237Nausea1523268Constipation1217214Som nolence81172Flushing81094

• ULTRAM ER is not a scheduled drug
• ULTRAM ER is not an NSAID or COX-2 inhibitor

Indication ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Important Safety Information ULTRAM ER is contraindicated in any situation where opioids are contraindicated, including a history of anaphylactoid reactions to opioids, and in patients who have previously demonstrated hypersensitivity to tramadol.
ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split. Chewing, crushing, or splitting the tablet will result in the uncontrolled delivery of the opioid and could result in overdose and death. This risk is increased with concurrent abuse of alcohol and other substances.
Tramadol, like other opioids used in analgesia, can be abused.
Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking tricyclic antidepressants, selective serotonin reuptake inhibitors, or other opioids.
Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
Do not prescribe ULTRAM ER for patients who are suicidal or addiction-prone.
ULTRAM ER should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, antidepressants or sedative hypnotics. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.
Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients nonopioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use ULTRAM ER cautiously in patients over 65 years of age due to the greater frequency of adverse events observed in this population.
ULTRAM ER should not be used in patients with severe renal (CrCl <30 mL/min) or hepatic (Child-Pugh Class C) impairment.
In clinical trials, the most frequently reported side effects in patients receiving ULTRAM ER and placebo, respectively, were dizziness (not vertigo, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%), constipation (12.2%-21.3% vs 4.2%), somnolence (7.3%-11.3% vs 1.7%), and flushing (7.7%-10.0% vs 4.4%).
ULTRAM ER should not be administered at a dose exceeding 300 mg per day.
Please see full Prescribing Information







Most Common Adverse Events (%) Reported in Clinical TrialsAdverse Events100 mg QD
(N=403)200 mg QD
(N=400)300 mg QD
(N=400)Placebo
(N=406)Dizziness (excl. vertigo)1620237Nausea1523268Constipation1217214Som nolence81172Flushing81094

• ULTRAM ER is not a scheduled drug
• ULTRAM ER is not an NSAID or COX-2 inhibitor

Indication ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Important Safety Information ULTRAM ER is contraindicated in any situation where opioids are contraindicated, including a history of anaphylactoid reactions to opioids, and in patients who have previously demonstrated hypersensitivity to tramadol.
ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split. Chewing, crushing, or splitting the tablet will result in the uncontrolled delivery of the opioid and could result in overdose and death. This risk is increased with concurrent abuse of alcohol and other substances.
Tramadol, like other opioids used in analgesia, can be abused.
Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking tricyclic antidepressants, selective serotonin reuptake inhibitors, or other opioids.
Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
Do not prescribe ULTRAM ER for patients who are suicidal or addiction-prone.
ULTRAM ER should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, antidepressants or sedative hypnotics. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.
Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients nonopioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use ULTRAM ER cautiously in patients over 65 years of age due to the greater frequency of adverse events observed in this population.
ULTRAM ER should not be used in patients with severe renal (CrCl <30 mL/min) or hepatic (Child-Pugh Class C) impairment.
In clinical trials, the most frequently reported side effects in patients receiving ULTRAM ER and placebo, respectively, were dizziness (not vertigo, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%), constipation (12.2%-21.3% vs 4.2%), somnolence (7.3%-11.3% vs 1.7%), and flushing (7.7%-10.0% vs 4.4%).
ULTRAM ER should not be administered at a dose exceeding 300 mg per day.
Please see full Prescribing Information






Analgesic drugs are associated with limitations that may hamper their use. NSAIDs, COX-2 inhibitors, and opioids all play an important role in chronic pain management, but can potentially inhibit successful treatment in certain patient types.


NSAIDS
NSAIDs, which are among the most widely prescribed drugs for a variety of conditions, are associated with gastrointestinal, renal, and cardiovascular-related safety concerns:

• Dyspepsia in a large proportion of patients, as well as more serious adverse events such as upper GI ulcers and bleeding[1]
• Risk for renal toxicity, especially with long-term use[1]
• In patients with a history of heart disease, use of NSAIDs has been found to increase the risk of congestive heart failure 10-fold[2]
• Black box warnings have cautioned that use of NSAIDs in patients may be associated with GI and cardiovascular risk

COX-2 Inhibitors
Although COX-2 inhibitors were developed as gastrointestinally safer alternatives to NSAIDs, their use has raised concerns with other safety issues, as evidenced by the withdrawal of rofecoxib[3]

• Like nonselective NSAIDs, COX-2 specific inhibitors can also cause renal toxicity[1]
• Black box warnings have cautioned that use of COX-2 inhibitors may be associated with GI and cardiovascular risk

Opioids
Opioids are associated with safety risks and prescribing concerns such as:

• Respiratory depression[4]
• Potential dependence/tolerance/abuse/withdrawal[5]
• Stringent regulatory requirements and potential for scrutiny may limit adequate prescribing[5]

Conservative approach to use of NSAIDs may result in suboptimal pain management
In a survey conducted among 2,000 general practitioners in the United Kingdom to determine their prescribing patterns for analgesics in patients with osteoarthritis,[6] the majority of physicians (69%) reported that their main therapeutic objective was to control pain without GI side effects. The findings of this study, however, suggest that a conservative approach to use of NSAIDs may have resulted in suboptimal pain management in patients with OA:

• 73% of physicians reported that breakthrough pain or incomplete pain relief was the most common reason for patient dissatisfaction with their pain medication.
• In contrast, only 23% of physicians reported side effects as being the main reason for patient dissatisfaction.

Reducing NSAIDs, postponing scheduled opioids
The chronic pain treatment ladder below incorporates recommendations by the American Pain Society, the American College of Rheumatology, and the World Health Organization. Patients presenting with moderate chronic pain may already have tried non-prescription analgesics for mild pain (acetaminophen or NSAIDs, such as aspirin or ibuprofen). These patients can be initiated on ULTRAM ER.



Early initiation of ULTRAM ER for the treatment of moderate to moderately severe pain can reduce the number of NSAID rotations that patients experience and provide earlier pain control.

• Use of ULTRAM ER may provide an NSAID-sparing effect
• Use of ULTRAM ER at this stage may postpone the use of scheduled opioids and their potential for dependence

If required, ULTRAM ER can be used concomitantly with drugs on the second step of the pain ladder that target the inflammatory response.
Indication
ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Important Safety Information
ULTRAM ER is contraindicated in any situation where opioids are contraindicated, including a history of anaphylactoid reactions to opioids, and in patients who have previously demonstrated hypersensitivity to tramadol.
ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split. Chewing, crushing, or splitting the tablet will result in the uncontrolled delivery of the opioid and could result in overdose and death. This risk is increased with concurrent abuse of alcohol and other substances.
Tramadol, like other opioids used in analgesia, can be abused.
Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking tricyclic antidepressants, selective serotonin reuptake inhibitors, or other opioids.
Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
Do not prescribe ULTRAM ER for patients who are suicidal or addiction-prone.
ULTRAM ER should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, antidepressants or sedative hypnotics. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.
Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients nonopioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use ULTRAM ER cautiously in patients over 65 years of age due to the greater frequency of adverse events observed in this population.
ULTRAM ER should not be used in patients with severe renal (CrCl <30 mL/min) or hepatic (Child-Pugh Class C) impairment.
In clinical trials, the most frequently reported side effects in patients receiving ULTRAM ER and placebo, respectively, were dizziness (not vertigo, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%), constipation (12.2%-21.3% vs 4.2%), somnolence (7.3%-11.3% vs 1.7%), and flushing (7.7%-10.0% vs 4.4%).
ULTRAM ER should not be administered at a dose exceeding 300 mg per day.
Please see full Prescribing Information



References

1. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee. Arthritis Rheum. 2000;43:1905.
2. Page J, Henry D. Consumption of NSAIDs and the development of congestive heart failure in elderly patients: an underrecognized public health problem. Arch Intern Med. 2000;160:777-784.
3. Caldwell B, Aldington S, Weatherall M, Shirtcliffe P, Beasley. Risk of cardiovascular events and celecoxib: A systematic review and meta-analysis. J R Soc Med. 2006;99:132.
4. Stephens J, Laskin B, Pashos C, Pena B, Wong J. The burden of acute postoperative pain and the potential role of the COX-2-specific inhibitors. Rheumatology. 2003;42(Suppl. 3):iii40.
5. Weinstein SM, Laux LF, Thornby JI, et al. Physicians' attitudes toward pain and the use of opioid analgesics: Results of a survey from the Texas Cancer Pain Initiative. South Med J. 2000;93:479.
6. Crichton B, Green M. GP and patient perspectives on treatment with non-steroidal anti-inflammatory drugs for the treatment of pain in osteoarthritis. Curr Med Res Opin. 2002:18;92-96.

Patients may be eligible to receive UP TO $25 off their out-of-pocket expenses for each of 3 ULTRAM ER prescriptions.

• To obtain this saving, the patient will require a valid prescription for ULTRAM ER and an ULTRAM ER Extended-Savings Card.
• The patient can take the prescription and the ULTRAM ER Extended-Savings Card to any retail pharmacy.
• Cash-paying patients will get up to $25 off their ULTRAM ER prescriptions.
• Patients with authorized 3rd-party coverage will get up to $25 off their ULTRAM ER prescriptions after a $10 out-of-pocket expense.
• Patients can use the same card a total of 3 times during the program period.
• Some eligibility restrictions apply.*
• For questions regarding the ULTRAM ER Extended-Savings Card or to obtain additional cards for your patients, please see your ULTRAM ER sales representative.

ULTRAM ER provides multiple dosing strengths and simple QD dosing. Find out more about the correct starting dose for your patients.


* Eligibility Criteria
(1) The ULTRAM ER Extended-Savings Card is not valid for patients participating in Medicaid, Medicare, or any other federal or state programs (including any state prescription drug program). (2) Card is limited to one (1) per patient for up to 3 uses and is not transferable. (3) Offer good only in the US at retail pharmacies and cannot be redeemed at government-subsidized clinics. This offer is valid in Massachusetts for cash-paying customers only (ie, those who do not have any prescription coverage). (4) Ortho-McNeil, Inc. reserves the right to rescind, revoke, or amend this offer without notice. (5) The selling, purchasing, trading, or counterfeiting of this card is prohibited by federal law, and such activities may result in imprisonment for not more than 10 years or fines not more than $250,000 or both. (6) Patients must understand and agree to comply with the terms and conditions of this offer as set forth above.
Indication ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Important Safety Information ULTRAM ER is contraindicated in any situation where opioids are contraindicated, including a history of anaphylactoid reactions to opioids, and in patients who have previously demonstrated hypersensitivity to tramadol.
ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split. Chewing, crushing, or splitting the tablet will result in the uncontrolled delivery of the opioid and could result in overdose and death. This risk is increased with concurrent abuse of alcohol and other substances.
Tramadol, like other opioids used in analgesia, can be abused.
Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking tricyclic antidepressants, selective serotonin reuptake inhibitors, or other opioids.
Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
Do not prescribe ULTRAM ER for patients who are suicidal or addiction-prone.
ULTRAM ER should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, antidepressants or sedative hypnotics. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.
Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients nonopioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use ULTRAM ER cautiously in patients over 65 years of age due to the greater frequency of adverse events observed in this population.
ULTRAM ER should not be used in patients with severe renal (CrCl <30 mL/min) or hepatic (Child-Pugh Class C) impairment.
In clinical trials, the most frequently reported side effects in patients receiving ULTRAM ER and placebo, respectively, were dizziness (not vertigo, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%), constipation (12.2%-21.3% vs 4.2%), somnolence (7.3%-11.3% vs 1.7%), and flushing (7.7%-10.0% vs 4.4%).
ULTRAM ER should not be administered at a dose exceeding 300 mg per day.
Please see full Prescribing Information



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