Call your doctor right away if you become pregnant while taking this drug. For women who are breastfeeding: Tramadol may pass into breast milk and cause serious effects in a child who is breastfed.
These effects can include slowed breathing and death. Talk with your doctor if you breastfeed your child. For seniors: The kidneys or liver of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Seniors 65 years of age and older are at higher risk of side effects from the extended-release forms of this drug. Tramadol oral tablet is used for short-term or long-term treatment.
Your length of treatment depends on how severe your pain is. If you stop taking the drug suddenly, you may have symptoms of withdrawal, which can include:.
For this drug to work well, a certain amount needs to be in your body at all times. If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:. But if your symptoms are severe, call or go to the nearest emergency room right away. What to do if you miss a dose: Take your dose as soon as you remember. If you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once.
This could result in dangerous side effects. A prescription for this medication is refillable. Your doctor will write the number of refills authorized on your prescription. You or your pharmacy may have to contact your doctor for a new prescription if you need this medication refilled. Your doctor should monitor certain health issues. This can help make sure you stay safe while you take this drug. These issues include:. You may need to have blood tests during your treatment with tramadol.
The cost of these tests will depend on your insurance coverage. Many insurance companies require a prior authorization for certain forms or brands of this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription. There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. 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. 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. It's best not to drink alcohol with tramadol as you're more likely to get side effects like feeling sleepy. Tramadol can be taken by adults and children aged 12 and over. Tell your doctor or pharmacist before starting the medicine if you have: had an allergic reaction to tramadol or any other medicines in the past an illness which causes seizures a head injury an addiction to alcohol, strong painkillers or recreational drugs breathing difficulties kidney or liver problems had a reaction to other strong painkillers in the past.
The dose can vary but you should not normally take more than mg a day. Different types of tramadol Tramadol comes as: fast-acting tablets — these contain 50mg of tramadol slow-acting tablets — these contain 50mg, 75mg, mg, mg, mg, mg or mg of tramadol fast-acting capsules — these contain 50mg of tramadol slow-acting capsules — these contain 50mg, mg, mg or mg of tramadol drops that you swallow — these contain mg of tramadol in 1ml of liquid an injection usually given in hospital soluble tablets — these contain 50mg of tramadol tablets that dissolve in the mouth — these contain 50mg of tramadol an injection usually given in hospital Tramadol drops, injections and some tablets and capsules are fast-acting.
How much to take Dosages vary from person to person. Take the tablet out of the blister pack and put it on your tongue. Suck the tablet, do not chew it. After it has melted, swallow or have a drink of water. You can also dissolve the tablet in a glass of water if you prefer.
Important Do not break, crush, chew or suck slow-release tablets and capsules. When to take it When to take it depends on the type of tramadol that you have been prescribed: fast-acting tablets and capsules — usually 3 to 4 times a day drops — usually 3 to 4 times a day slow-release tablets and capsules — usually 1 or 2 times a day If you're 65 and over, or you have liver or kidney problems, you may be asked by your doctor to take tramadol less often.
What if I forget to take it? This will vary depending on which type of tramadol you are taking. Never take 2 doses at the same time to make up for a forgotten one. What will happen if I stop taking it? Tramadol can cause unpleasant withdrawal symptoms if you come off it suddenly, such as: feeling agitated feeling anxious shaking sweating. Important If you have been taking tramadol for more than a few weeks do not stop taking it without speaking to your doctor first. What if I take too much?
Taking too much tramadol can be dangerous. Urgent advice: Contact for advice now if:. Very common side effects Very common side effects of tramadol happen in more than 1 in 10 people and include: feeling sick feeling dizzy Common side effects Common side effects of tramadol happen in more than 1 in people.
They include: headaches feeling sleepy, tired, dizzy or "spaced out" feeling or being sick vomiting constipation dry mouth sweating low energy Serious side effects Serious side effects are rare. Serious allergic reaction In rare cases, it's possible to have a serious allergic reaction anaphylaxis to tramadol. Information: You can report any suspected side effect using the Yellow Card safety scheme. Visit Yellow Card for further information. What to do about: headaches — make sure you rest and drink plenty of fluids.
Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking tramadol. Talk to your doctor if they last longer than a week or are severe. Talk to your doctor if they carry on for longer. Tramadol is a synthetic opioid. Tramadol and hydrocodone are two strong prescription pain medications. They relieve pain but come with side effects. See their differences and…. Here's what you need to know about your treatment options for opioid-induced constipation, from medications to natural remedies and more.
A new study looking into adverse effects from medication use found that anticoagulants and diabetes agents send a significant amount of adults ages 65….
We all experience pain. Fortunately, there are many ways to manage pain, whether that means treating the source of the pain or coping with the pain…. Federal officials have set up locations across the country on National Prescription Drug Take Back Day for people go properly dispose of their old…. Health Conditions Discover Plan Connect. Medically reviewed by Alan Carter, Pharm. How it works Forms and strengths Time in system Factors that affect duration Safety Bottom line Tramadol is a prescription opioid used to treat moderate to severe pain.
Read on to find out how this medication works and how long it typically stays in your system. How does it work? Does it come in different forms and strengths? How long does it stay in your system?
What can affect how long it stays in your body? Safety issues.
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