Serotonergic drugs include selective serotonin reuptake inhibitors SSRIs , serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system e. This may occur within the recommended dosage range. Serotonin syndrome symptoms may include mental status changes e.
The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue tramadol hydrochloride tablets if serotonin syndrome is suspected. Seizures have been reported in patients receiving tramadol hydrochloride tablets within the recommended dosage range.
Spontaneous postmarketing reports indicate that seizure risk is increased with doses of tramadol hydrochloride tablets above the recommended range.
Concomitant use of tramadol hydrochloride tablets increase the seizure risk in patients taking [see Drug Interactions 7 ] :. Risk of seizure 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.
In tramadol hydrochloride tablets overdose, naloxone administration may increase the risk of seizure. Do not prescribe tramadol hydrochloride tablets for patients who are suicidal or addiction-prone. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.
If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
The use of tramadol hydrochloride tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Tramadol hydrochloride tablets -treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosage of tramadol hydrochloride tablets [see Warnings and Precautions 5.
Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions 5.
Monitor such patients closely, particularly when initiating and titrating tramadol hydrochloride tablets and when tramadol hydrochloride tablets are given concomitantly with other drugs that depress respiration [see Warnings and Precautions 5. Alternatively, consider the use of non-opioid analgesics in these patients.
Tramadol hydrochloride tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e. Monitor these patients for signs of hypotension after initiating or titrating the dosage of tramadol hydrochloride tablets.
In patients with circulatory shock, tramadol hydrochloride tablets may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of tramadol hydrochloride tablets in patients with circulatory shock. In patients who may be susceptible to the intracranial effects of CO 2 retention e. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with tramadol hydrochloride tablets.
Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of tramadol hydrochloride tablets in patients with impaired consciousness or coma. Tramadol hydrochloride tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Contraindications 4 ]. The tramadol in tramadol hydrochloride tablets may cause spasm of the sphincter of Oddi.
Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms. Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with tramadol hydrochloride tablets.
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 hypersensitivity reactions to tramadol and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride tablets [see Contraindications 4 ].
If anaphylaxis or other hypersensitivity occurs, stop administration of tramadol hydrochloride tablets immediately, discontinue tramadol hydrochloride tablets permanently, and do not rechallenge with any formulation of tramadol. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction.
Do not abruptly discontinue tramadol hydrochloride tablets in a patient physically dependent on opioids. When discontinuing tramadol hydrochloride tablets in a physically dependent patient, gradually taper the dosage. Rapid tapering of tramadol in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain [see Dosage and Administration 2. Tramadol hydrochloride tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of tramadol hydrochloride tablets and know how they will react to the medication [see Patient Counselling Information 17 ]. Most cases of hyponatremia occurred in females over the age of 65 and within the first week of therapy.
In some reports, hyponatremia resulted from the syndrome of inappropriate antidiuretic hormone secretion SIADH. Monitor for signs and symptoms of hyponatremia e. If signs and symptoms of hyponatremia are present, initiate appropriate treatment e. Cases of tramadol-associated hypoglycemia have been reported, some resulting in hospitalization. In most cases, patients had predisposing risk factors e. If hypoglycemia is suspected, monitor blood glucose levels and consider drug discontinuation as appropriate [see Dosage and Administration: Safe Reduction or Discontinuation of Tramadol Hydrochloride Tablets 2.
The following serious adverse reactions are described, or described in greater detail, in other sections:. Urogenital : Menopausal symptoms, Urinary frequency, Urinary retention. Body as a Whole : Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma.
A causal relationship between tramadol hydrochloride tablets and these events has not been determined. However, the most significant events are listed below as alerting information to the physician. Gastrointestinal : Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.
Laboratory Abnormalities : Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria. The following adverse reactions have been identified during post-approval use of tramadol hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology Many of these cases were reported in patients taking another drug labeled for QT prolongation, in patients with a risk factor for QT prolongation e. Hypoglycemia: Cases of hypoglycemia have been reported in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients [see Warnings and Precautions 5.
The concomitant use of tramadol hydrochloride tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride tablets is achieved. Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome. After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase.
This could increase or prolong therapeutic effects but also increase adverse reactions related to opioid toxicity, such as potentially fatal respiratory depression [see Clinical Pharmacology If concomitant use of a CYP2D6 inhibitor is necessary, follow patients closely for adverse reactions including opioid withdrawal, seizures and serotonin syndrome.
If a CYP2D6 inhibitor is discontinued, consider lowering tramadol hydrochloride tablets dosage until stable drug effects are achieved. Follow patients closely for adverse events including respiratory depression and sedation. The concomitant use of tramadol hydrochloride tablets and CYP3A4 inhibitors can increase the plasma concentration of tramadol and may result in a greater amount of metabolism via CYP2D6 and greater levels of M1.
Follow patients closely for increased risk of serious adverse events including seizures and serotonin syndrome, and adverse reactions related to opioid toxicity including potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride tablets is achieved.
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease [see Clinical Pharmacology If concomitant use is necessary, consider dosage reduction of tramadol hydrochloride tablets until stable drug effects are achieved.
Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the tramadol hydrochloride tablets dosage until stable drug effects are achieved and follow patients for signs and symptoms of opioid withdrawal.
Macrolide antibiotics e. The concomitant use of tramadol hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of tramadol [see Clinical Pharmacology After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase [see Clinical Pharmacology If concomitant use is necessary, consider increasing the tramadol hydrochloride tablets dosage until stable drug effects are achieved.
Follow patients for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider tramadol hydrochloride tablets dosage reduction and monitor for seizures and serotonin syndrome, and signs of sedation and respiratory depression. Patients taking carbamazepine, a CYP3A4 inducer, 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 hydrochloride tablets and carbamazepine is not recommended.
Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions 5. The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment.
Discontinue tramadol hydrochloride tablets immediately if serotonin syndrome is suspected. Do not use tramadol hydrochloride tablets in patients taking MAOIs or within 14 days of stopping such treatment. Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Due to the risk of respiratory depression with concomitant use of. Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor patients for signs of urinary retention or reduced gastric motility when tramadol hydrochloride tablets are used concomitantly with anticholinergic drugs. Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity.
Follow patients for signs of digoxin toxicity and adjust dosage of digoxin as needed. Post-marketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times.
Monitor the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
Available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1. Tramadol decreased pup body weight and increased pup mortality at 1. Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in respiratory depression and physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Neonatal opioid withdrawal syndrome can present as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.
Observe newborns for symptoms and signs of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions 5. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during postmarketing. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate.
Tramadol hydrochloride tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including tramadol hydrochloride tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor.
Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.
The effect of tramadol hydrochloride tablets, if any, on the later growth, development, and functional maturation of the child is unknown.
Embryo and fetal toxicity consisted primarily of decreased fetal weights, decreased skeletal ossification and increased supernumerary ribs at maternally toxic dose levels.
Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. The dosages listed for mouse, rat and rabbit are 1.
Tramadol was evaluated in pre- and post-natal studies in rats. Tramadol hydrochloride tablets are 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.
Tramadol and its metabolite, O-desmethyltramadol M1 , are present in human milk. There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The M1 metabolite is more potent than tramadol in mu opioid receptor binding [ see Clinical Pharmacology 12 ]. Published studies have reported tramadol and M1 in colostrum with administration of tramadol to nursing mothers in the early post-partum period. Women who are ultra-rapid metabolizers of tramadol may have higher than expected serum levels of M1, potentially leading to higher levels of M1 in breast milk that can be dangerous in their breastfed infants.
In women with normal tramadol metabolism, the amount of tramadol secreted into human milk is low and dose-dependent. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with tramadol hydrochloride tablets [ see Warnings and Precautions 5. If infants are exposed to tramadol hydrochloride tablets through breast milk, they should be monitored for excess sedation and respiratory depression.
Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Following a single IV mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post dose was mcg of tramadol 0. Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [ see Adverse Reactions 6.
The safety and effectiveness of tramadol hydrochloride tablets in pediatric patients have not been established. Life-threatening respiratory depression and death have occurred in children who received tramadol [see Warnings and Precautions 5. Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of tramadol.
Avoid the use of tramadol hydrochloride tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.
A total of elderly 65 years of age or older subjects were exposed to tramadol hydrochloride tablets in controlled clinical trials. Of those, subjects were 75 years of age and older. 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. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Titrate the dosage of tramadol hydrochloride tablets slowly in geriatric patients starting at the low end of the dosing range and monitor closely for signs of central nervous system and respiratory depression [ see Warnings and Precautions 5.
Tramadol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. Metabolism of tramadol and M1 is reduced in patients with severe hepatic impairment based on a study in patients with advanced cirrhosis of the liver.
In patients with severe hepatic impairment, dosing reduction is recommended [see Dosage and Administratio n 2. With the prolonged half-life in these conditions, achievement of steady-state is delayed, so that it may take several days for elevated plasma concentrations to develop. Tramadol hydrochloride tablets contain tramadol, a substance with a high potential for abuse similar to other opioids.
Tramadol hydrochloride tablets can be abused and is subject to misuse, addiction, and criminal diversion [ see Warnings and Precautions 5. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful, or potentially harmful, consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.
In addition, abuse of opioids can occur in the absence of true addiction. Tramadol hydrochloride tablets, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.
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. Tramadol hydrochloride tablets are intended for oral use only. Abuse of tramadol hydrochloride tablets pose a risk of overdose and death. The risk is increased with concurrent abuse of tramadol hydrochloride tablets with alcohol and other central nervous system depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Both tolerance and physical dependence can develop during chronic opioid therapy. 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.
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. Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Rapid tapering of tramadol hydrochloride tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain and suicide. When discontinuing tramadol hydrochloride tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of tramadol hydrochloride tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient.
To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper [see Dosage and Administration 2.
Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations 8. Acute overdosage with tramadol hydrochloride tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, seizures, and death.
Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. Deaths due to overdose have been reported with abuse and misuse of tramadol [ see Warnings and Precautions 5. Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids. In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.
Employ other supportive measures including oxygen and vasopressors in the management of circulatory shock and pulmonary edema as indicated. These are not all the side effects of tramadol. For a full list see the leaflet inside your medicines packet. In early pregnancy, it's been linked to some problems for your unborn baby. If you take tramadol at the end of pregnancy there's a risk that your newborn baby may get withdrawal symptoms.
However, it's important to treat pain in pregnancy. For some pregnant women with severe pain, tramadol might be the best option. Your doctor is the best person to help you decide what's right for you and your baby.
It's safe to breastfeed while taking tramadol. Tramadol passes into breast milk in small amounts but it's unlikely to harm your baby. However, if your baby is premature, had a low birthweight or has an illness, talk to your doctor before breastfeeding. Some medicines and tramadol interfere with each other and increase the chances of you having side effects.
Tell your doctor if you're taking:. Do not take medicines called monoamine oxidase inhibitors or MAOIs which are used to treat depression with tramadol. It's not known if complementary medicines and herbal teas are safe to take with tramadol. They're not tested in the same way as pharmacy and prescription medicines.
They're generally not tested for the effect they have on other medicines. Tell your doctor or pharmacist if you're taking any other medicines, including herbal medicines, vitamins or supplements. It acts on pain receptors in the central nervous system and the brain to block pain signals to the rest of the body.
It also works in your brain to stop you feeling pain messages. Tramadol does not stop the pain from happening, but you will not be able to feel it as much.
You will feel less pain 30 to 60 minutes after taking fast-acting tramadol. The pain relief wears off after 4 to 6 hours. Slow-acting tramadol tablets and capsules can take a day or two to start working but the pain relief will last for longer. Depending on why you're taking tramadol, you may only need to take it for a short time.
For example, if you're in pain after an injury or operation, you may only need to take tramadol for a few days or weeks at most. Talk to your doctor if you're unsure how long you need to take tramadol for. Yes, tramadol is addictive. For this reason, your dose will be reviewed to make sure you are only taking the amount you need to control your pain.
Your treatment plan may include details of how and when you will stop taking tramadol. If you need to take it for a long time your body can become tolerant to it.
That means you need higher doses to control your pain over time. Some people can become more sensitive to pain hyperalgesia. If this happens, your doctor will reduce your dose gradually to help these symptoms. Speak to your doctor if you are worried about tolerance, hyperalgesia or becoming addicted. If you're addicted to tramadol, you may find it difficult to stop taking it or feel you need to take it more often than necessary.
And if you stop taking tramadol suddenly you may suffer from withdrawal reactions. These include agitation, anxiety, nervousness, panic attacks, difficulty sleeping, shaking, over-activity, pins and needles or ringing in the ears. Talk to your doctor if you're worried about addiction or if you want to know more about how to prevent withdrawal symptoms. The type of painkiller that's best depends on what type of pain you have and the cause of your pain.
If tramadol doesn't get rid of your pain or works less well, talk to your doctor. Tramadol doesn't affect any type of contraception including the combined pill and emergency contraception. There's no firm evidence to suggest that taking tramadol will reduce fertility in men. Speak to a pharmacist or your doctor if you're trying to get pregnant.
They may want to review your treatment. Drinking alcohol while you're taking tramadol can make you feel more sleepy or increase the risk of serious side effects. Stop drinking alcohol during the first few days of treatment until you see how the medicine affects you.
If you feel sleepy with tramadol, it may be best to stop drinking alcohol while you're taking it. Do not drive a car or ride a bike if tramadol makes you sleepy during the daytime, gives you blurred vision or makes you feel dizzy, clumsy or unable to concentrate or make decisions.
This may be more likely when you first start taking tramadol but could happen at any time - for example when starting another medicine. It's an offence to drive a car if your ability to drive safely is affected. It's your responsibility to decide if it's safe to drive. If you're in any doubt, do not drive. UK has more information on the law on drugs and driving.
Talk to your doctor or pharmacist if you're unsure whether it's safe for you to drive while taking tramadol. If you take recreational drugs, such as cannabis, cocaine and heroin, while you are taking tramadol, you're more likely to get serious side effects. These include breathing difficulties, heart problems, seizures fits and even going into a coma.
Some recreational drugs, such as cannabis, will also increase tramadol side effects such as sleepiness and dizziness. Serotonin syndrome occurs when the levels of a chemical in your brain called serotonin become too high. Tell your doctor if you think you may take recreational drugs while you're on tramadol. Page last reviewed: 26 November Next review due: 26 November Tramadol On this page About tramadol Key facts Who can and can't take tramadol How and when to take it Taking tramadol with other painkillers Side effects How to cope with side effects Pregnancy and breastfeeding Cautions with other medicines Common questions.
About tramadol Tramadol is a strong painkiller. Help us improve our website Can you answer a quick question about your visit today? The most common side effects of tramadol are feeling sick and dizzy. It's possible to become addicted to tramadol, but your doctor will explain how to reduce the risks of becoming addicted.
If you need to take tramadol for more than a few weeks, your treatment plan may include details of how and when to stop taking this medicine. However, data are not available to establish the true incidence of addiction in chronic pain patients. Risk of Overdosage 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, 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 hydrochloride tramadol hydrochloride tablets 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.
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 hydrchloride discontinuation include panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering tramadol hydrochloride at the time of discontinuation. Acute Abdominal Conditions The administration of tramadol hydrochloride may complicate the clinical assessment of patients with acute abdominal conditions.
Use in Renal and Hepatic Disease Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. With the prolonged half-life in these conditions, achievement of steady-state is delayed, so that it may take several days for elevated plasma concentrations to develop.
Caution is advised when tramadol hydrochloride is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as SSRIs, MAOIs, triptans, linezolid an antibiotic which is a reversible non-selective MAOI , lithium, or St. John's Wort. If concomitant treatment of tramadol hydrochloride with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases see WARNINGS, Serotonin Syndrome.
Triptans Based on the mechanism of action of tramadol and the potential for serotonin syndrome, caution is advised when tramadol hydrochloride is coadministered with a triptan. If concomitant treatment of tramadol hydrochloride with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases see WARNINGS, Serotonin Syndrome.
Use With Carbamazepine Patients taking carbamazepine may have a significantly reduced analgesic effect of tramadol hydrochloride. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of tramadol hydrochloride and carbamazepine is not recommended.
Quinidine is a selective inhibitor of that isoenzyme, so that concomitant administration of quinidine and tramadol hydrochloride 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. Potential for Other Drugs to Affect Tramadol 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 hydrochloride may affect the metabolism of tramadol leading to alteted tramadol exposure. Potential for Tramadol to Affect Other Drugs 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. Use With Cimetidine Concomitant administration of tramadol hydrochloridewith cimetidine does not result in clinically significant changes in tramadol pharmacokinetics.
Therefore, no alteration of the tramadol hydrochloride dosage regimen is recommended. Use With Digoxin and Warfarin Post-marketing surveillance has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.
A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. This finding is not believed to suggest risk in humans. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans.
These dosages are 1. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. The dosages listed for mouse, rat and rabbit are 1. Non-teratogenic Effects Tramadol was evaluated in peri- and post-natal studies in rats. There are no adequate and well-controlled studies in pregnant women.
Tramadol Hydrochloride 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 still birth have been reported during post-marketing. Tramadol hydrochloride should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks.
Safe use in pregnancy has not been established. Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0. The effect of tramadol hydrochloride, if any, on the later growth, development, and functional maturation of the child is unknown.
Tramadol hydrochloride 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. Following a single IV mg dose of tramadol, the cumulative excretion in breast milk within 16 hours postdose was of tramadol 0. The safety and efficacy of tramadol hydrochloride in patients under 16 years of age have not been established.
The use of tramadol hydrochloride in the pediatric population is not recommended. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
A total of elderly 65 years of age or older subjects were exposed to tramadol hydrochloride in controlled clinical trials. Of those, subjects were 75 years of age and older.
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.
Tramadol hydrochloride was administered to patients during the double-blind or open-label extension periods in U. Of these patients, were 65 years old or older. The most frequently reported events were in the central nervous system and gastrointestinal system.
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