Medical Editor: John P. Cunha, DO, FACOEP
What Is Seglentis?
Seglentis (celecoxib and tramadol hydrochloride) contains an opioid agonist and a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
What Are Side Effects of Seglentis?
Seglentis may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- new or worsening high blood pressure,
- heart failure,
- liver failure,
- low red blood cells (anemia),
- life-threatening skin reactions,
- stomach pain,
- yellowing of the skin or eyes (jaundice),
- vomit that looks like coffee grounds,
- black or tar like stools,
- weight gain,
- skin rash,
- blistering of the skin with fever, and
- swelling of the arms, legs, hands, and feet
Get medical help right away, if you have any of the symptoms listed above.
Side effects of Seglentis include:
- drowsiness, and
- decreased appetite.
Seglentis exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Withdrawal symptoms may occur if Seglentis is suddenly stopped.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Seglentis
The initial dosage of Seglentis is two tablets every 12 hours as needed for pain relief. Use Seglentis for the shortest duration consistent with individual patient treatment goals.
Seglentis In Children
The safety and effectiveness of Seglentis in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Seglentis?
Seglentis may interact with other medicines such as:
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, and bupropion)
- CYP2D6 substrates (e.g., atomoxetine), and celecoxib,
- CYP3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir),
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin),
- mixed agonist/antagonist and partial agonist opioid analgesics (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine),
- drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs]),
- benzodiazepines and other sedatives/hypnotics,
- muscle relaxants,
- general anesthetics,
- other opioids,
- tricyclic antidepressants (TCAs),
- 5-HT3 receptor antagonists,
- drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol),
- monoamine oxidase (MAO) inhibitors,
- angiotensin converting enzyme (ACE) inhibitors,
- angiotensin receptor blockers (ARBs),
- anticholinergic drugs,
- pemetrexed, and
Tell your doctor all medications and supplements you use.
Seglentis During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Seglentis; it may harm a fetus. Use of NSAIDs, including Seglentis, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, the dose and duration of Seglentis use should be limited between about 20 and 30 weeks of gestation and Seglentis use should be avoided at about 30 weeks of gestation and later in pregnancy. Breastfeeding is not recommended while using Seglentis because the safety of tramadol in newborns and infants has not been studied.
Our Seglentis (celecoxib and tramadol hydrochloride) Tablets, For Oral Use, C-IV Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are discussed, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Suicide [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Anaphylaxis and Other Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 550 subjects in 7 clinical studies, from Phase 1 to Phase 3, were exposed to SEGLENTIS during the clinical development program, including 385 subjects exposed to 200 mg of SEGLENTIS, either single or multiple administration.
In a placebo-controlled post-bunionectomy acute pain trial, 637 patients received 200 mg of SEGLENTIS every 12 hours or 50 mg tramadol every 6 hours or 100 mg celecoxib every 12 hours or placebo, orally for 48 hours (blinded period) [see Clinical Studies] and followed up to 7 days post-dose. Table 1 lists the adverse reactions reported by > 5% of patients in any treatment group and greater in SEGLENTIS than placebo. Discontinuation due to adverse events occurred in 1.6% of SEGLENTIS-treated patients (3 out of 183), 1.6% of tramadol-treated patients (3 out of 183), no celecoxib-treated patients, and no placebo-treated patients. The adverse reactions that led to discontinuation of study drug were nausea (1.1%) and pruritus/rash (0.5%) in the SEGLENTIS group, and vomiting (1.1%) and supraventricular tachycardia (0.5%) in the tramadol group.
Table 1: Reported Adverse Reactions in >5% of Patients in Any Treatment Group and greater in SEGLENTIS than Placebo
|System Organ Class
(N = 183)
(N = 183)
(N = 182)
(N = 89)
|Nausea||55 (30.1)||69 (37.7)||30 (16.5)||17 (19.1)|
|Vomiting||29 (15.8)||30 (16.4)||4 (2.2)||2 (2.2)|
|Dizziness||31 (16.9)||34 (18.6)||9 (4.9)||13 (14.6)|
|Headache||21 (11.5)||33 (18.0)||20 (11.0)||6 (6.7)|
|Somnolence||15 (8.2)||10 (5.5)||4 (2.2)||3 (3.4)|
|Metabolism and nutritional disorders|
|Decreased appetite||6 (3.3)||11 (6.0)||1 (0.5)||0|
|Total daily dose: 400 mg of SEGLENTIS (200 mg twice a day); 200 mg of tramadol (50 mg four times a day); 200 mg of celecoxib (100 mg twice a day); or placebo.
Note: Acetaminophen 1 g IV and oxycodone hydrochloride 5 mg Immediate Release (IR) tablets were permitted as rescue medication.
The following adverse reactions have been identified during post approval use of either tramadol or celecoxib-containing products. 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.
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
QT Prolongation/Torsade De Pointes
Cases of QT prolongation and/or torsade de pointes have been reported with tramadol use. 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.g., hypokalemia), or in the overdose setting.
Metabolism And Nutrition Disorders
Cases of hypoglycemia have been reported very rarely in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients.
Cases of severe hyponatremia and/or SIADH have been reported in patients taking tramadol, most often in females over the age of 65, and within the first week of therapy [see WARNINGS AND PRECAUTIONS].
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].
Nervous System Disorders
Movement disorder, speech disorder.
Vasculitis, deep venous thrombosis.
Anaphylactoid reaction, angioedema.
Liver And Biliary
Liver necrosis, hepatitis, jaundice, hepatic failure.
Hemic And Lymphatic
Agranulocytosis, aplastic anemia, pancytopenia, leucopenia.
Aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage.
Table 2: Clinically Significant Drug Interactions with SEGLENTIS
|Inhibitors of CYP2D6|
|Clinical Impact:||The concomitant use of SEGLENTIS and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1. Since M1 is a more potent μ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol. 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 which could increase or prolong therapeutic effects but also increase adverse reactions related to opioid toxicity and may cause potentially fatal respiratory depression [see CLINICAL PHARMACOLOGY].
|Intervention:||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 follow patients closely for adverse events including respiratory depression and sedation.|
|Examples:||Quinidine, fluoxetine, paroxetine, and bupropion.|
|Clinical Impact:||In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6 (e.g., atomoxetine), and celecoxib, which may enhance the exposure and toxicity of CYP2D6 substrate drugs.|
|Intervention:||If concomitant use of a CYP2D6 substrate drug is necessary, follow patients closely for adverse events of that CYP2D6 substrate drug. Evaluate each patient's medical history when consideration is given to prescribing SEGLENTIS [see CLINICAL PHARMACOLOGY].|
|Inhibitors of CYP3A4|
|Clinical Impact:||The concomitant use of SEGLENTIS 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.
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease [see CLINICAL PHARMACOLOGY], resulting in decreased opioid efficacy and possibly signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol.
|Intervention:||If concomitant use is necessary, follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, follow patients for efficacy maintenance and for signs and symptoms of opioid withdrawal.|
|Examples:||Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir).|
|Clinical Impact:||The concomitant use of SEGLENTIS and CYP3A4 inducers can decrease the plasma concentration of tramadol [see CLINICAL PHARMACOLOGY], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to tramadol.
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase [see CLINICAL PHARMACOLOGY], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures and serotonin syndrome, and potentially fatal respiratory depression.
|Intervention:||If concomitant use is necessary, follow patients for efficacy maintenance and for signs of opioid withdrawal.
If a CYP3A4 inducer is discontinued, 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 SEGLENTIS and carbamazepine is not recommended.
|Examples:||Rifampin, carbamazepine, phenytoin.|
|CYP2C9 Inhibitors or inducers|
|Clinical Impact:||Celecoxib metabolism is predominantly mediated via CYP2C9 in the liver. Coadministration of celecoxib with drugs that are known to inhibit CYP2C9 (e.g., fluconazole) may enhance the exposure and toxicity of celecoxib whereas co-administration with CYP2C9 inducers (e.g., rifampin) may lead to compromised efficacy of celecoxib.|
|Intervention:||If concomitant use with CYP2C9 inhibitor drugs is necessary, follow patients for adverse events of celecoxib from SEGLENTIS.
If concomitant use with CYP2C9 inducer drugs is necessary, follow patients for efficacy maintenance of SEGLENTIS.Evaluate each patient's medical history when consideration is given to prescribing SEGLENTIS.
|Drugs That Interfere with Hemostasis|
|Clinical Impact:||Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
|Intervention:||Monitor patients with concomitant use of SEGLENTIS with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
In two studies in healthy volunteers, and in patients with osteoarthritis and established heart disease respectively, celecoxib (200-400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100-325 mg).
|Intervention:||Concomitant use of SEGLENTIS and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS].
SEGLENTIS is not a substitute for low dose aspirin for cardiovascular protection.
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of celecoxib with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].|
|Intervention:||The concomitant use of SEGLENTIS with other NSAIDs or salicylates is not recommended.|
|Benzodiazepines and Other Central Nervous System (CNS) Depressants|
|Clinical Impact:||Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of respiratory depression, profound sedation, coma, and death.|
|Intervention:||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].|
|Examples:||Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.|
|Clinical Impact:||The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.|
|Intervention:||If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation. Discontinue SEGLENTIS if serotonin syndrome is suspected.|
|Examples:||Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).|
|Monoamine Oxidase Inhibitors (MAOIs)|
|Clinical Impact:||MAOI interactions with opioids may manifest as serotonin syndrome [see WARNINGS AND PRECAUTIONS] or opioid toxicity (e.g., respiratory depression, coma) [see WARNINGS AND PRECAUTIONS].|
|Intervention:||Do not use SEGLENTIS in patients taking MAOIs or within 14 days of stopping such treatment.|
|Examples:||Phenelzine, tranylcypromine, linezolid.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|Clinical Impact:||NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
|Intervention:||During concomitant use of SEGLENTIS and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
During concomitant use of SEGLENTIS and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS]. When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
|Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics|
|Clinical Impact:||May reduce the analgesic effect of SEGLENTIS and/or precipitate withdrawal symptoms.|
|Intervention:||Avoid concomitant use.|
|Examples:||Butorphanol, nalbuphine, pentazocine, buprenorphine.|
|Clinical Impact:||Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.|
|Intervention:||Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of the muscle relaxant as necessary.|
|Clinical Impact:||Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
|Intervention:||Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. During concomitant use of SEGLENTIS with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity.
The concomitant use of celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
|Intervention:||During concomitant use of SEGLENTIS and digoxin, monitor serum digoxin levels. Follow patients for signs of digoxin toxicity and adjust the dosage of digoxin as needed.|
|Clinical Impact:||The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.|
|Intervention:||Monitor patients for signs of urinary retention or reduced gastric motility when SEGLENTIS is used concomitantly with anticholinergic drugs.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of SEGLENTIS and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Post-marketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times.|
|Intervention:||Monitor the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Celecoxib has no effect on methotrexate pharmacokinetics.|
|Intervention:||During concomitant use of SEGLENTIS and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of celecoxib and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of SEGLENTIS and cyclosporine, monitor patients for signs of worsening renal function.|
|Clinical Impact:||Concomitant use of celecoxib and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of SEGLENTIS and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.
NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
|Clinical Impact:||Concomitant use of corticosteroids with celecoxib may increase the risk of GI ulceration or bleeding.|
|Intervention:||Monitor patients with concomitant use of SEGLENTIS with corticosteroids for signs of bleeding [see WARNINGS AND PRECAUTIONS].|
Drug Abuse And Dependence
SEGLENTIS contains tramadol, a Schedule IV controlled substance.
SEGLENTIS contains tramadol, a substance with a high potential for abuse similar to other opioids and can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS AND PRECAUTIONS].
All patients treated with opioids require careful monitoring for signs of abuse and addiction, since 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.
“Drug seeking” behavior is very common in persons with substance use disorders. Drug seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. 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. Health care 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.
SEGLENTIS, 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.
Risks Specific to Abuse of SEGLENTIS
SEGLENTIS is for oral use only. Abuse of SEGLENTIS poses a risk of overdose and death. The risk is increased with concurrent abuse of SEGLENTIS 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 opioid therapy. Tolerance is the need for increasing doses of opioids 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.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
Do not abruptly discontinue SEGLENTIS in a patient physically dependent on opioids. Rapid tapering of SEGLENTIS in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
When discontinuing SEGLENTIS, gradually taper the dosage using a patient-specific plan that considers the following: the dose of SEGLENTIS 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, WARNINGS AND PRECAUTIONS]. If SEGLENTIS is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
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].
Read the entire FDA prescribing information for Seglentis (Celecoxib and Tramadol Tablets)
© Seglentis Patient Information is supplied by Cerner Multum, Inc. and Seglentis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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