- Generic Name or Active Ingridient: Tramadol
Doctors prescribe ULTRACET to relieve acute pain expected to last five days or less.
General Drug Information
Each ULTRACET tablet contains 37.5 mg of tramadol and 325 mg of acetaminophen. Tramadol is a powerful opioid analgesic, sometimes called a narcotic pain reliever. Acetaminophen is a non-narcotic pain reliever.
Janssen Ortho, LLC makes ULTRACET in Puerto Rico. Several drug companies distribute ULTRACET in the United States, including Janssen Pharmaceuticals, Ortho-McNeil Pharmaceuticals and Quality Care Products.
ULTRACET is available in a tablet form for oral use.
The usual ULTRACET dose is two tablets every four to six hours as needed to control pain. The maximum dosage is eight tablets in any 24-hour period.
Elderly patients are more sensitive to the effects of ULTRACET and may therefore require smaller doses. Patients with some types of kidney problems should not use more than two ULTRACET tablets in any 12-hour period.
Patients should not use ULTRACET longer than five days.
Tramadol depresses the CNS, or central nervous system, to dull the brain’s perception of pain. Other effects of CNS depression include sedation and a pleasant feeling of euphoria. The tramadol in ULTRACET depresses respiratory centers in the brain to cause slow, shallow and uneven breathing patterns.
Tramadol also inhibits the reuptake, or re-absorption, of serotonin and norepinephrine to cause high levels of these natural hormones. Scientists associate serotonin with mood, sleep and learning; norepinephrine affects parts of the brain responsible for tasks requiring attention and response.
Acetaminophen works differently than tramadol to relieve pain. Acetaminophen reduces the levels of prostaglandin, a hormone responsible for sending pain messages to the brain, inflaming tissue and increasing body temperature. Acetaminophen accomplishes this by inhibiting the production of the COX enzymes responsible for creating prostaglandin. Along with making prostaglandins, COX enzymes also cause blood platelets to stick together in a way that promotes blood clotting to stop bleeding.
The liver metabolizes ULTRACET into smaller components. The kidneys eliminate the majority of ULTRACET and its metabolites through urine. Dysfunction in either the liver or kidneys can slow the elimination of ULTRACET from the body, resulting in high tramadol levels.
Acetaminophen use is associated with hepatotoxicity, or liver damage caused by medications. Hepatotoxicity sometimes results in liver transplant and death. Hepatotoxicity is usually associated with large doses of acetaminophen usually exceeding 4,000 mg in a single day, and is often the result of taking multiple products containing this common analgesic. Anyone who has taken more than 4,000 mg of acetaminophen in any 24-hour period should seek immediate medical care, even if he feels well.
In many cases, the consumer was unaware of the total acetaminophen content in his prescription and over-the-counter remedies. Physicians should instruct patients to check the labels of all medications, including prescription and non-prescription preparations for acetaminophen, which sometimes goes under the name Tylenol or APAP.
The risk for acute liver failure is higher for those people with underlying liver disease and for those who consume alcohol while taking acetaminophen.
The tramadol in ULTRACET depresses CNS respiratory centers to slow breathing patterns. This respiratory depression causes the lungs to do an inadequate job of exchanging spent carbon dioxide for fresh oxygen, causing oxygen starvation and high carbon dioxide levels. Respiratory depression is a serious and sometimes fatal breathing condition.
Physicians should consider a non-opioid pain reliever for patients at high risk for respiratory depression, including those with pre-existing breathing problems. Caretakers should treat respiratory depression as an overdose.
Tramadol inhibits the reuptake of serotonin, causing serotonin levels to rise. Extremely high levels of serotonin may cause the patient to suffer serotonin syndrome, a potentially life threatening condition.
Taking ULTRACET with other drugs that inhibit the uptake of serotonin increases the risk for serotonin syndrome, even at recommended doses. Examples of other drugs that do this are selective serotonin reuptake inhibitors, or SSRIs, and the popular antidepressant and high blood pressure medications, MAOIs. TCAs and triptans also interfere with the reuptake of serotonin.
Some drugs cause serotonin syndrome when taken with ULTRACET because of the way these drugs impair the metabolism of tramadol. Examples of drug classes that do this are CYP2D6 and CYP3A4 inhibitors.
Symptoms of serotonin syndrome include changes in mental status, including agitation, hallucinations and coma. The patient may suffer rapid heartbeat, wild fluctuations in blood pressure and high body temperature. Other symptoms of serotonin syndrome are lack of coordination, diarrhea, nausea and vomiting.
The tramadol in ULTRACET is associated with seizures. Even therapeutic doses of ULTRACET may cause seizures but high doses increases the risk. Using some other medications along with ULTRACET also increases this risk for seizures.
Allergic and Anaphylactic Reactions
Patients who are hypersensitive to tramadol, acetaminophen or other opioids should not use ULTRACET.
Anyone who has taken ULTRACET can suffer an allergic reaction or anaphylaxis to either the tramadol component of ULTRACET or the acetaminophen. Symptoms of an allergic reaction to tramadol include hives, rash and itching, wheezing, swelling and serious, life threatening skin reactions. Someone having an allergic reaction to acetaminophen will likely experience swelling of the face, mouth or throat, breathing problems, hives, rash, itching and vomiting.
Anaphylaxis is a serious and sometimes fatal form of an allergic reaction. Someone can suffer an anaphylactic reaction the first time she takes ULTRACET; in fact, most cases of anaphylaxis occur with the first dose of ULTRACET.
Use in Patients with Head Injury and Increased Intracranial Pressure
Respiratory depression can raise carbon dioxide levels and increase the intracranial fluid pressure surrounding the patient’s brain. Head injuries and pre-existing high intracranial pressure enhance these effects. ULTRACET actions may mimic the effects of a head injury, like causing pinpoint pupils and sleepiness; ULTRACET use may obscure the presence or healing process of head injuries.
Physicians should not prescribe ULTRACET to suicidal patients or to those who are prone to drug addiction. Tramadol-related deaths have occurred in patients with a history of emotional disturbances, suicide attempts or suicidal thoughts, or drug or alcohol abuse.
Using ULTRACET for more than five days increases the consumer’s risk for developing physical dependence on tramadol. An opioid-dependent person experiences unpleasant withdrawal symptoms when he stops taking ULTRACET abruptly.
The tramadol in ULTRACET may impair the consumer’s mental and physical performance. Consumers should not operate heavy machinery or motor vehicles until they know how ULTRACET affects them.
ULTRACET may not be appropriate for everyone. ULTRACET is not suitable wherever opioids are not appropriate, including in cases of respiratory depression outside of monitored settings or in locations without resuscitative equipment.
ULTRACET is not appropriate for patients who are suffering from acute intoxication from alcohol, narcotics, hypnotics, other opioids and other CNS analgesics. ULTRACET may worsen CNS and respiratory depression in these patients.
Pregnancy, Labor and Delivery, Breastfeeding
ULTRACET is an FDA Pregnancy Category C, meaning there are no adequately controlled studies to determine the risk ULTRACET poses to a pregnant woman or fetus, or if it affects the reproductive capabilities for males and females. A pregnant woman should use ULTRACET only when the benefits to her health clearly outweigh the possible risks.
Babies born to women who take ULTRACET during pregnancy may suffer seizures, withdrawal symptoms, stillbirth and death. ULTRACET may pass into human milk and onto a nursing baby; women who breastfeed should discuss the benefits and risks before deciding whether to discontinue ULTRACET or breastfeeding.
ULTRACET may interact with other medications in unsafe or unintended ways.
Some medications increase the risk for seizures, including SSRIs, MAOIs, TCAs and other opioids. Tramadol can increase the risk for seizures in patients who also take anti-seizure medications.
Taking ULTRACET along with the drugs known as CYP2D6 and CYP3A4 inhibitors increases the risk for serotonin syndrome. Drugs in these classes include quinidine, fluoxetine, paroxetine, amitriptyline ketoconazole and erythromycin. Triptans, used for migraines, can interact with ULTRACET to cause serotonin syndrome.
Carbamazepine, the active ingredient in the anti-seizure drug Tegretol, increases the metabolism of tramadol in a way that reduces the analgesic effects of ULTRACET. Furthermore, ULTRACET increases the risk for convulsions in patients with a history of seizure activity, including Tegretol users.
Quinidine, used to treat some types of heart rhythm problems, may increase concentrations of tramadol in the blood.
ULTRACET may cause side effects in some consumers. The most commonly reported side effects include constipation, sleepiness, sweating, diarrhea, nausea, loss of appetite, dizziness and itching.
It is possible to overdose on the tramadol or the acetaminophen in ULTRACET, or both. Overdose of either tramadol or acetaminophen are serious medical emergencies that could result in death.
Overdose of prescription analgesics like tramadol claim the lives of nearly 15,000 Americans yearly.
Other consequences of tramadol overdose are respiratory depression, lethargy, coma, seizures and stopped heartbeat. Symptoms of tramadol overdose are sleepiness that progresses to unconsciousness or coma, limp muscles and cold, clammy skin. The victim may have a slow pulse and low blood pressure.
Acetaminophen overdose is one of the most common poisonings globally; about 60,000 Americans suffer from acetaminophen overdose each year. Acetaminophen overdose is the leading cause of acute liver failure in the United States. Other consequences of acetaminophen overdose are kidney problems, low blood sugar and blood clotting problems.
In the early stages of tramadol overdose, the victim may suffer respiratory depression or seizures, or both. In the first 24 hours after an acetaminophen overdose, the patient may experience loss of appetite, nausea and vomiting, lack of energy, pale complexion and extreme sweating. Laboratory tests and physical examinations may not reveal liver damage for 48 to 72 hours after the ingestion of a hepatotoxic dose of acetaminophen.
ULTRACET overdose patients require immediate medical treatment. Emergency department workers will slide a flexible tube down the patient’s throat to hold his airway open to help him breathe; staff members may connect this tube to a mechanical ventilator to take over breathing responsibilities. Nurses will introduce activated charcoal into the patient’s stomach to absorb excess medication. If it is been less than a few hours since the potentially hepatotoxic overdose, nurses will give the patient the antidote to acetaminophen overdose: N-acetylcysteine. Doctors will order the antidote for tramadol - naloxone - only if the patient suffers respiratory depression as naloxone can cause seizures.
Abuse increases the risk for overdose and death.
Some individuals abuse tramadol products such as ULTRACET because of the way opioids gets them high. ULTRACET abuse can result in side effects, overdose, addiction or physical dependence.
Anyone who uses ULTRACET regularly for more than a few weeks can grow physically dependent on tramadol and suffer withdrawal symptoms when he stops using ULTRACET abruptly.
Someone suffering ULTRACET withdrawal may feel restless and experience watery eyes, runny nose, yawning, sweating, chills, body aches and dilated pupils. The patient may also feel irritable, anxious, weak and nauseated, and suffer backache, joint pain, stomachache, trouble sleeping, and loss of appetite, vomiting and diarrhea. The individual may also show signs of high blood pressure, fast breathing and rapid pulse.
These withdrawal symptoms begin a few hours after the last dose of ULTRACET, a process known as detoxification. Without intervention, these withdrawal symptoms last for five or more days before disappearing; these symptoms will not return unless the individual once again become opioid-dependent. Someone can stop the withdrawal symptoms at any time by taking more ULTRACET, but relapse to tramadol use stops the detoxification process, leaving the individual still dependent on opioids.
To avoid withdrawal symptoms, physicians recommend patients wean themselves from ULTRACET by taking successively smaller doses further apart. This tapering method works for most people but a significant portion of opioid-dependent individuals cannot overcome severe and persistent withdrawal symptoms. Many of these people struggle to return to normal life.
According to the Institute of Addiction Medicine, almost 2 million Americans are physically dependent on opioids like tramadol. Many local healthcare institutions offer detoxification services to help these individuals overcome withdrawal symptoms. Detoxification usually includes drugs to counteract the effects of ULTRACET along with medications to ease the ensuing withdrawal symptoms. Medically assisted detoxification eases the severity of withdrawal symptoms but does not shorten the detoxification process.
Many informed consumers now choose a more humane and efficient approach to detoxification through rapid detox procedures. During rapid detox, anesthesiologists sedate and anesthetize the patient before administering the standard detoxification and anti-withdrawal drugs. The rapid detox patient dozes in a comfortable “twilight sleep” during the difficult detoxification process, awakening a few hours later feeling refreshed and revitalized.