With immediate-release pain medications, patients often have to chase their pain with multiple daily doses.
Patients only need to take ULTRAM ER once daily for around-the-clock treatment of their moderate to moderately severe chronic pain. This is due to the pharmacokinetic profile that allows ULTRAM ER to maintain relatively steady drug levels throughout the course of a day.
Clinical studies have also shown that the pain relief provided by ULTRAM ER helped improve chronic pain-related sleep problems, such as trouble falling asleep or waking up in the middle of the night due to pain.
Mean steady-state tramadol plasma concentrations on Day 8 postdose after administration of 200 mg ULTRAM ER once daily and 50 mg ULTRAM every 6 hours.
The gradual increase in plasma concentration may be associated with improved patient adaptability.
In a 12-week, flexible-dose clinical trial, ULTRAM ER demonstrated efficacy in chronic osteoarthritis pain1
- Demonstrated analgesic efficacy at each assessment point
- Significant improvements in pain intensity VAS vs placebo
- The average ULTRAM ER daily dose in the intent-to-treat (ITT) population was between 200 mg and 300 mg
{mosimage}Study involved 246 patients with osteoarthritis of the knee who had:
- A baseline visual analog scale (VAS) pain intensity score of ≥40 mm in the index joint
- Knee pain requiring analgesic therapy for ≥75 days of 90 days prior to study
- Following a 2- to 7-day washout, patients were randomized to receive either ULTRAM ER or placebo. Patients were evaluated at Weeks 1, 2, 4, 8, and 12 or at exit of study. The primary efficacy endpoint was the mean change from baseline in Arthritis Pain Intensity VAS scores averaged over 12 weeks.
Indication
ULTRAM ER Extended-Release Tablets are 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 Extended-Release Tablets are 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%), headache (11.5% – 15.5% vs 10.6%), and somnolence (7.3%-11.3% vs 1.7%).
ULTRAM ER should not be administered at a dose exceeding 300 mg per day.
Reference
Babul N, Noveck R, Chipman H, Roth SH, Gana T, Albert K. Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee. J Pain Symptom Manage. 2004;28:59-71.
