Author: Charles Frank

Ultram Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting ULTRAM or when the dosage is increased, and that it can occur even at recommended dosages. “Drug-seeking” behavior is very common in persons with substance use disorders. “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction.

Your risk of seizures is higher if you’re taking certain other medications. These drugs include other opioid pain drugs or certain medications for depression, other mood disorders, or psychosis. This means it can only be used with a doctor’s close supervision. These types of drugs require a doctor’s close supervision based on their medical use in treatment, potential for misuse, and potential for dependence if misused. In patients with severe hepatic impairment, adjustment of the dosing regimen is recommended [see DOSAGE AND ADMINISTRATION]. Steady-state plasma concentrations of both tramadol and M1 are achieved within two days with four times per day dosing.

In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see DOSAGE AND ADMINISTRATION]. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counselling Information]. Contact local state professional licensing board or state controlled substances authority for information on how toprevent and detect abuse or diversion of this product. Tramadol has a risk for abuse and addiction, which can lead to overdose and death.

In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of ULTRAM beincreased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with ULTRAM [see WARNINGS AND PRECAUTIONS, Patient Counseling Information]. Tolerance is the need for increasing doses of drugs to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Accidental ingestion of even one dose of ULTRAM, especially by children, can result in respiratory depression and death due to an overdose of tramadol.

Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resultingin withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may beprecipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physicaldependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

Report Problems to the Food and Drug Administration

It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist. Part of the class of drugs known as opioid analgesics, Ultram is a prescription drug used to treat moderate to severe pain symptoms.

Inform female patients of reproductive potential that ULTRAM may cause fetal harm and to inform the healthcare providerof a known or suspected pregnancy [see Use In Specific Populations]. ULTRAM may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a caror operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects ofULTRAM and know how they will react to the medication [see Patient Counselling Information]. Our Ultram Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Good pain management practice dictates that the dose of Ultram be individualized according to patient need using the lowest beneficial dose.

1. ULTRAM contains tramadol, a substance with a high potential for abuse similar to other opioids.
2. The tablets are imprinted “ULTRAM” on one side and “06 59” on the scored side.
3. In studies including geriatric patients, treatment-limiting adverse events were higher in subjects over 75 years of age compared to those under 65 years of age.
4. Advise caregivers of children ages 12 to 18 years of age receiving ULTRAM to monitor for signs of respiratory depression [see WARNINGS AND PRECAUTIONS].
5. You should not drive, use heavy machinery, or perform any dangerous activities until you know how this drug affects you.

The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent opioid agonists. The minimum effective analgesic concentration of tramadol for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance [see DOSAGE AND ADMINISTRATION]. If infants are exposed to ULTRAM through breast milk, they should be monitored for excess sedation and respiratorydepression.

Important considerations for taking tramadol

Concomitant therapy withinhibitors of CYP2D6 such as fluoxetine, paroxetine and quinidine could result in significant drug interactions. Concomitant use of serotonin re-uptake inhibitors and MAO inhibitors may enhance the risk of adverse events, including seizure and serotonin syndrome [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in respiratory depressionand physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with ULTRAM. When the seevents do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.

The safety and effectiveness of ULTRAM in pediatric patients have not been established. ULTRAM is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. The tablets are imprinted “ULTRAM” on one side and “06 59” on the scored side.

Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.

5 Safe Reduction or Discontinuation of ULTRAM

ULTRAM has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving ULTRAM. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Inpatients with creatinine clearances of less than 30 mL/min, adjustment of the dosing regimen is recommended [see DOSAGE AND ADMINISTRATION]. The total amount of tramadol and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose. Tramadol is extensively metabolized after oral administration by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites.

2 Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

If you take too much tramadol, you may be treated with a medication called naloxone. If you use tramadol with certain drugs, you may have more side effects. This is because the amount of tramadol in your body may be increased. If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist. A class of drugs is a group of medications that work in a similar way.

The absolute bioavailability of tramadol was 73% in males and 79% in females. The plasma clearance was 6.4 mL/min/kg inmales and 5.7 mL/min/kg in females following a 100 mg IV dose of tramadol. Following a single oral dose, and after adjusting for body weight, females had a 12% higher peak tramadol concentration and a 35% higher area under the concentration-time curve compared to males. The analgesic activity of ULTRAM is due to both parent drug and the M1 metabolite [see CLINICAL PHARMACOLOGY]. Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation.

You should not drive, use heavy machinery, or perform any dangerous activities until you know how this drug affects you. Tramadol is similar to substances in your brain called endorphins. Endorphins bind to receptors (parts of cells that receive a certain substance). The receptors then decrease the pain messages your body sends to your brain.

Both tramadol and hydrocodone attach to receptors in your brain to change your perception of pain. However, tramadol also allows the chemical messengers norepinephrine and serotonin to remain available to your brain for a longer period. It is believed that this helps block pain signals in your spinal cord. Call your healthcare provider if you have any of these symptoms and they are severe.