In vitro drug interaction studies in human liver microsomes indicate that tramadol has no effect on quinidine metabolism. Use with Digoxin Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity. Use with Warfarin-like Compounds Post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect, including elevation of prothrombin times. Administration of tramadol may enhance the seizure risk in patients taking: 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.
Anaphylactoid Reactions Serious and rarely, fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. When these rare reactions 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 drug has been associated with craving, drug-seeking behaviour and tolerance development.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
The following are considered to be the essential components of the Risk Management strategy: Abuse and addiction are separate and distinct from physical dependence and tolerance. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.
Tolerance as well as both physical and psychological dependence may develop upon repeated administration of opioids, and are not by themselves evidence of an addictive disorder or abuse.
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. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
The judicious prescribing of tramadol is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non- narcotic analgesics. 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, antidepressants, or other CNS-depressant drugs.
Patients should be advised of the additive depressant effects of these combinations. 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. In these patients, alternative non-opioid analgesics should be considered. Respiratory depression should be treated as an overdose. The patient using this drug should be cautioned accordingly.
Animal studies have shown increased deaths with combined administration of MAO inhibitors and tramadol. The maximum recommended dose is milligrams per day. If you are older than 75 years, the maximum recommended dose is milligrams per day. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. Pain medications work best if they are used as the first signs of pain occur.
If you wait until the pain has worsened, the medication may not work as well. If you have ongoing pain such as due to arthritis , your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden breakthrough pain only as needed. Other pain relievers such as acetaminophen , ibuprofen may also be prescribed.
Ask your doctor or pharmacist about using tramadol safely with other drugs. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. There is a theoretical possibility that tramadol could interact with lithium due to their respective mechanisms of action. Tramadol can induce convulsions and increase the potential for selective serotonin reuptake inhibitors SSRIs , serotonin-norepinephrine reuptake inhibitors SNRIs , tricyclic anti-depressants, anti-psychotics and other seizure threshold lowering medicinal products such as bupropion, mirtazapine, tehrahydrocannabinol to cause convulsions.
Concomitant therapeutic use of tramadol and serotonergic drugs, such as selective serotonin reuptake inhibitors SSRIs , serotonin-norepinephrine reuptake inhibitors SNRIs , MAO inhibitors see section 4. Serotonin syndrome is likely when one of the following is observed: Treatment depends on the nature and severity of the symptoms. Caution should be exercised during concomitant treatment with tramadol and coumarin derivatives e.
Other active substances known to inhibit CYP3A4, such as ketoconazole and erythromycin, might inhibit the metabolism of tramadol N-demethylation probably also the metabolism of the active O-demethylated metabolite. The clinical importance of such an interaction has not been studied see section 4. In a limited number of studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirement of tramadol in patients with postoperative pain.
Tramadol crosses the placenta. There is inadequate evidence available on the safety of tramadol in human pregnancy. Therefore Tramadol should not be used in pregnant women. Tramadol - administered before or during birth - does not affect uterine contractility.
In neonates it may induce changes in the respiratory rate which are usually not clinically relevant. Chronic use during pregnancy may lead to neonatal withdrawal symptoms. Breast-feeding During lactation about 0. Tramadol is not recommended during breast-feeding. After a single administration of tramadol it is not usually necessary to interrupt breast-feeding.
Fertility Post marketing surveillance does not suggest an effect of tramadol on fertility. Animal studies did not show an effect of tramadol on fertility. Ambulant patients should be warned not to drive or operate machinery if affected.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When prescribing this medicine, patients should be told: The frequencies are defined as follows:
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