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- What is tramadol and acetaminophen, and how does it work (mechanism of action)?
- What brand names are available for tramadol and acetaminophen?
- Do I need a prescription for tramadol and acetaminophen?
- What are the side effects of tramadol and acetaminophen?
- What is the dosage for tramadol and acetaminophen?
- Which drugs or supplements interact with tramadol and acetaminophen?
- Is tramadol and acetaminophen safe to take if I'm pregnant or breastfeeding?
- What else should I know about tramadol and acetaminophen?
What is tramadol and acetaminophen, and how does it work (mechanism of action)?
Ultracet is a combination of two drugs, tramadol (Ultram) and acetaminophen (Tylenol) that is used to relieve moderate, acute pain such as pain following dental or surgical procedures. Tramadol and acetaminophen each relieve pain, but they do so by different mechanisms. Tramadol achieves pain relief in two ways. It binds to the -opioid receptor on nerves (the same mechanism that is responsible for the effectives of narcotics, such as morphine), and it also inhibits the reuptake by nerves of two neurotransmitters, serotonin and norepinephrine, that the nerves use to communicate with one another. This inhibition may lead to reduced transmission of pain signals from nerve to nerve in the spinal cord and brain. Acetaminophen achieves pain relief in the spinal cord and brain by increasing the threshold to pain, that is, by increasing the strength of the painful stimulus that is necessary in order to give rise to the sensation of pain. It does this by inhibiting an enzyme that makes prostaglandins. Ultracet was approved by the FDA in 2001.
What are the side effects of tramadol and acetaminophen?
Ultracet usually is well-tolerated. The most common side effects are:
Because tramadol is chemically related to the narcotic class of drugs such as morphine and hydrocodone (Vicodin ES, Anexsia, Lorcet, Lorcet Plus, Norco), it can cause psychological or physical dependence. Some patients who received tramadol have reported seizures.
Abrupt withdrawal of tramadol may result in the following side effects:
An overdose of acetaminophen can result in severe liver damage.
Quick GuideChronic Pain Syndrome: Treatment and Management for CPS
What is the dosage for tramadol and acetaminophen?
The usual dose of Ultracet is two tablets every four to six hours as needed for the relief of pain. Patients should not take more than two tablets at a time nor more than 8 tablets per day.
Which drugs or supplements interact with tramadol and acetaminophen?
Carbamazepine (Tegretol) or rifampin can increase the rate of metabolic breakdown of tramadol, thus making tramadol less effective. Concomitant administration of quinidine, fluoxetine (Prozac), paroxetine (Paxil) and amitriptyline (Elavil, Endep), ketoconazole (Nizoral, Extina, Xolegel, Kuric), or erythromycin may reduce elimination of tramadol, increasing the risk for serious side effects from tramadol.
Combining tramadol with monoamine oxidase inhibitors (for example, Parnate), selective serotonin inhibitors (SSRIs, for example, fluoxetine [Prozac]), linezolid (Zyvox), St. John's wort, triptans (for example sumatriptan [Imitrex, Alsuma]) may result in severe side effects such as seizures or a condition called serotonin syndrome. Tramadol may increase central nervous system and respiratory depression when combined with alcohol, anesthetics, narcotics, tranquilizers, or sedative hypnotics.
Is tramadol and acetaminophen safe to take if I'm pregnant or breastfeeding?
Tramadol is excreted in breast milk. Safe use in nursing mothers has not been established.
What else should I know about tramadol and acetaminophen?
What preparations of tramadol and acetaminophen are available?
Tablets: tramadol, 37.5 mg and acetaminophen, 325 mg.
How should I keep tramadol and acetaminophen stored?
Ultracet should be stored at room temperature, between 15 and 30 C (59-86 F). It should be kept out of the reach of children.
Ultracet is a combination of the drugs tramadol (Ultram) and acetaminophen. Ultracet is prescribed for the short-term relief of moderately to severe acute pain. Side effects, drug interactions, dosing, pregnancy safety, and warnings and precautions should be reviewed prior to taking this medication.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Top tramadol and acetaminophen Related Articles
Acetaminophen is a drug that reduces fever and relieves pain. It is available alone, or in combination with hundreds of other drugs available both over-the-counter (without a prescription) or that that may require a prescription from your doctor, for example, acetaminophen and hydrocodone (Vicodin, Norco) or acetaminophen and oxycodone (Percocet).
Acetaminophen treats a variety of diseases or other medical problems that cause pain or fever. Examples of conditions acetaminophen treats include, headache, minor arthritis pain, back pain, tooth pain, menstrual cramps, PMS, osteoarthritis, common cold, tension headache, chronic pain, hip pain, shoulder and neck pain, sore throat, sinus infection, teething, TMJ, bites and stings, and sprains and strains.
Acetaminophen generally has no side effects when taken as prescribed. When side effects are experienced, the most common are headache, rash, and nausea.
In 2014, the FDA recommended that doctors and other health care professionals only prescribe acetaminophen in doses of 325 mg or less. This warning highlights the potential for allergic reactions, for example, face, mouth, and throat swelling, difficulty breathing, itching, or rash. This action also will help reduce the risk of severe liver injury and serious allergic reactions associated with this drug. Other possible serious side effects adverse effects include anemia, kidney damage, thrombocytopenia (a reduced number of platelets in the blood), and liver problems.
Other patient information. Do not take more than one product that contains acetaminophen at the same time. Do not take more than one acetaminophen-containing drug than directed. Do not drink alcohol while taking medicine that contains acetaminophen due to severe liver damage.
REFERENCE: FDA Prescribing Information.
Acetaminophen vs Ibuprofen Side Effects
Acetaminophen (Tylenol and many other brand names is an pain reliever (analgesic) and fever reducer (antipyretic ). Scientists do not know the exact mechanism of action of acetaminophen. Ibuprofen (Advil) is an NSAID (nonsteroidal inti-inflammatory drug) used for the treat inflammation, fever, and mild pain. Ibuprofen works in relieving mild pain, inflammation, and fever by blocking an enzyme that makes chemicals released in the body that promote inflammation (prostaglandins). Prostaglandins promote inflammation in the body.
Common side effects of both acetaminophen and ibuprofen include rash, nausea, and headache.
Side effects specific to acetaminophen include kidney damage, anemia, thrombocytopenia, serious skin reactions, and liver failure.
Side effects of specific to ibuprofen include tinnitus (ringing in the ears), dizziness, drowsiness, stomach pain, constipation, and heartburn.
Dosage depends upon whether the person using acetaminophen or ibuprofen.
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Chronic PainChronic pain is pain (an unpleasant sense of discomfort) that persists or progresses over a long period of time. In contrast to acute pain that arises suddenly in response to a specific injury and is usually treatable, chronic pain persists over time and is often resistant to medical treatments.
Fibromyalgia FactsFibromyalgia is a chronic pain condition characterized by symptoms such as fatigue, sleep disturbances, and tender points. Stress reduction, exercise, and medication are the standard treatments for fibromyalgia.
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Oxycodone vs Tramadol for Pain
Oxycodone and tramadol are prescription medications used to manage acute and chronic moderate to severe pain. Oxycodone is an opiate (narcotic) derived drug whereas tramadol is a man-made synthetic drug. Tramadol is not a narcotic, and it is not a nonsteroidal anti-inflammatory drug (NSAIDs). Some of the side effects of oxycodone and tramadol are the same, for example:
- Dry mouth
Serious side effects for oxycodone and tramadol differ. Oxycodone and tramadol are habit forming drugs and patients may become addicted. Withdrawal symptoms include:
Drug interactions, dosing, and pregnancy and breastfeeding safety information differs for these drugs and should be reviewed prior to administration.
Pain ManagementPain management and treatment can be simple or complex, according to its cause. There are two basic types of pain, nociceptive pain and neuropathic pain. Some causes of neuropathic pain include:
- complex regional pain syndrome,
- interstitial cystitis,
- and irritable bowel syndrome.
Tramadol hydrochloride (Ultram) is a centrally acting opioid painkiller (analgesic) indicated for the management of moderate to moderately severe pain in adults. Pain relief (analgesia) begins approximately within one hour after administration and reaches a peak in approximately two to three hours. Apart from analgesia, tramadol administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, tramadol has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.
Side effects of tramadol include:
- Dizziness/spinning sensation (vertigo)
- Central nervous system (CNS) stimulation
- Weakness/lack of energy
- Dry Mouth
The dosage of tramadol should be started at 25 mg/day in the morning, and adjusted in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg four times daily). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 20days to reach 200 mg/day (50 mg four times daily). After adjustment, tramadol 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day. Tramadol is supplied in 50 mg tablets.
Withdrawal symptoms may occur if tramadol is discontinued abruptly. Reported withdrawal symptoms have included:
- Upper respiratory symptoms
- Goose bumps (piloerections)
- Rarely hallucinations
There are reports of acute overdosage with tramadol. Signs and symptoms can manifest by respiratory depression, sleepiness progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, slow heart rate, low blood pressure (hypotension), cardiac arrest, and death. Deaths due to overdose have been reported with abuse and misuse of tramadol.
Tramadol may interact with quinidine, fluoxetine, paroxetine, amitriptyline, ketoconazole, erythromycin, SSRIs, MAOIs, triptans, linezolid, lithium, St. John's wort, carbamazepine, rifampin, and digoxin. There are no adequate and well-controlled studies of tramadol in pregnant women. Tramadol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported during post-marketing. Tramadol 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.
Other drugs in the same class as tramadol include codeine hydrocodone (Zohydro ER), oxycodone (OxyContin, Roxicodone), methadone hydromorphone (Dilaudid, Exalgo), morphine (Avinza, Kadian, MSIR, MS Contin), fentanyl (Actiq, Duragesic). If you have questions about this drug talk to your doctor, pharmacist, or other medical professional.
REFERENCE: FDA Prescribing Information for tramadol.