When these events 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.
Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Tramadol HCl There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention.
Instruct patients to discontinue Tramadol HCl Do not prescribe Tramadol HCl Administer Tramadol HCl In these patients, alternative non-opioid 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.
Tramadol increases the risk of CNS and respiratory depression in these patients. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in these patients.
Additionally, pupillary changes miosis from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reactions when evaluating altered mental status in these patients if they are receiving Tramadol HCl Tramadol may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
The patient using this drug should be cautioned accordingly. Use Tramadol HCl Animal studies have shown increased deaths with combined administration of MAO inhibitors and tramadol. Concomitant use of tramadol with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome. The use of Tramadol HCl Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, Tramadol HCl Tramadol has mu-opioid agonist activity.
The possibility of illegal or illicit use should be considered when prescribing or dispensing Tramadol HCl Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.
Patients taking tramadol should be warned not to exceed the dose recommended by their physician. Tramadol products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a cause of drug-related deaths.
Patients should be cautioned about the concomitant use of tramadol products and alcohol because of potentially serious CNS additive effects of these agents. Because of its added depressant effects, tramadol should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, tricyclic antidepressants, or other CNS depressant drugs.
Patients should be advised of the additive depressant effects of these combinations. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression, and death. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of tramadol alone or in combination with other drugs.
A serious potential consequence of overdosage with acetaminophen is hepatic centrilobular necrosis, leading to hepatic failure and death. Emergency help should be sought immediately and treatment initiated immediately if overdose is suspected, even if symptoms are not apparent. Withdrawal symptoms may occur if Tramadol HCl Reported symptoms have included anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations.
Other symptoms that have been reported less frequently with Tramadol HCl Clinical experience suggests that withdrawal symptoms may be avoided by tapering Tramadol HCl The recommended dose of Tramadol HCl Do not co-administer Tramadol HCl The safety and effectiveness of Tramadol HCl In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease; and multiple drug therapy.
The administration of Tramadol HCl Experience with tramadol suggests that impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. Caution is advised when Tramadol HCl John's Wort. If concomitant treatment of Tramadol HCl Based on the mechanism of action of tramadol and the potential for serotonin syndrome, caution is advised when Tramadol HCl Patients taking carbamazepine may have a significantly reduced analgesic effect of tramadol.
Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of Tramadol HCl Quinidine is a selective inhibitor of that isoenzyme; so that concomitant administration of quinidine and tramadol results in increased concentrations of tramadol and reduced concentrations of M1.
The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that tramadol has no effect on quinidine metabolism. In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of tramadol.
Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampin and St. John's Wort, with Tramadol HCl In vitro studies indicate that tramadol is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when tramadol is administered concomitantly at therapeutic doses.
Tramadol does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Tramadol is a mild inducer of selected drug metabolism pathways measured in animals. Using alcohol while taking this drug can cause a sedative effect that can be dangerous. It can cause slowed reflexes, poor judgment, and sleepiness. When used with alcohol, this medication can also decrease breathing and cause liver damage.
If you misuse alcohol while taking this drug, you have an increased risk for suicide. For people with kidney disorder. Your kidneys may remove tramadol from your body more slowly.
This increases your risk for dangerous side effects. You may need to take this medication less often each day. For people with liver disease. This medication can increase your risk for liver failure. For people with seizures. This medication can increase your risk for seizure if you have seizures epilepsy or a history of seizures. This can happen if you take normal or higher doses. It can also increase your risk for getting a seizure if you:.
For people with depression. This medication can worsen your depression if you take it with medications that help with antidepressants, sleep sedative hypnotics , tranquilizers, or muscle relaxers. This drug can also increase your risk for suicide if:. They may suggest a pain medication from a different drug class. For people with decreased breathing. This medication can decrease your breathing more if you have decreased breathing or are at risk for decreased breathing.
It may be better for you to take a pain medication from a different drug class. For people with brain pressure or head injury. If you have a head injury or increased pressure on your brain, this medication may:. These effects may hide or make it hard for your doctor to check on your head injury. They may also make it difficult to tell if your medical problems are getting worse or better. For people with a history of addiction.
This medication can increase the risk of overdose or death if you have an addiction disorder, or misuse opioids, narcotics, or other drugs. For people with stomach pain: If you have a condition that causes pain in your abdomen, such as severe constipation or obstruction, this medication may lessen that pain. That could make it more difficult for your doctor to diagnose your condition. For pregnant women. Tramadol, one of the drugs in this medication, is passed to a fetus during pregnancy.
Long-term use of this medication during pregnancy may cause physical dependence and withdrawal symptoms in the baby at birth. Signs of withdrawal in a baby may include:. This drug should only be used during pregnancy if the potential benefit justifies the potential risk.
For women who are breastfeeding. Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:. This list is not complete. Other drugs may affect acetaminophen and tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. This information does not replace the advice of a doctor.
Healthwise, Incorporated, disclaims any warranty or liability for your use of this information. Your use of this information means that you agree to the Terms of Use. Learn how we develop our content. Healthwise, Healthwise for every health decision, and the Healthwise logo are trademarks of Healthwise, Incorporated.
Updated visitor guidelines. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. This site complies with the HONcode standard for trustworthy health information: verify here. This content does not have an English version. This content does not have an Arabic version. See more conditions. Products and services. Description and Brand Names Drug information provided by: IBM Micromedex US Brand Name Ultracet Descriptions Tramadol and acetaminophen combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.
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