Reliance on any information provided by the National Drug Codes List website or other visitors to this website is solely at your own risk. Before using Tramadol Injection, inform your doctor about your current list of medications, over the counter products (e.g. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 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.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and drugs that impair metabolism of serotonin (including MAO inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) [see Drug Interactions (7)]. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor. Concomitant therapy with inhibitors of CYP2D6 such as fluoxetine, paroxetine and quinidine could result in significant drug interactions. Tramadol hydrochloride may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Color: White. Action: How Tramal works Tramadol hydrochloride is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. In general, both enantiomers of tramadol and M1 follow a parallel time course in the body following single and multiple doses although small differences (~ 10%) exist in the absolute amount of each enantiomer present. When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. Both tolerance and physical dependence can develop during chronic opioid therapy. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals, Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse, Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with tramadol hydrochloride tablets and adjust the dosage accordingly, all children younger than 12 years of age, postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy, Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, Known or suspected gastrointestinal obstruction, including paralytic ileus, Hypersensitivity to tramadol, any other component of this product or opioids, Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days. Avoid the use of tramadol hydrochloride in patients with circulatory shock. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. An opioid pain medicine that can put you at risk for overdose and death. Tramadol is extensively metabolized after oral administration by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. For oral dosage form (extended-release capsules): AdultsâAt first, 100 milligrams (mg) once a day. Do not change your dose. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride USP and are a white, crystalline powder. The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors on levels of tramadol and M1 from tramadol hydrochloride are complex. Consider these risks when prescribing or dispensing tramadol hydrochloride. Tramadol/acetaminophen has a risk for abuse and addiction, which can lead to overdose and death. Tramadol was not mutagenic in the in vitro bacterial reverse mutation assay using Salmonella and E. coli (Ames), the mouse lymphoma assay in the absence of metabolic activation, the in vitro chromosomal aberration assay, or the in vivo micronucleus assay in bone marrow. Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism. Life-threatening respiratory depression and death have occurred in children who received tramadol. 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). Tramadol is extensively metabolized after oral administration by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. Mixing tramadol with alcohol or other drugs that slow your heart rate and breathing can substantially increase a personâs overdose risk. tramadol. Postmarketing surveillance of tramadol has revealed rare reports of digoxin toxicity. 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 is achieved. 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