1142-03,06 | TRAMADOL HYDROCHLORIDE [H.J. Harkins Company, Inc.] | BioPortfolio

13:08 EST 27th January 2019 | BioPortfolio

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Tramadol hydrochloride extended-release tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow tramadol hydrochloride extended-release tablets intact, and not to cut, break, chew, crush, or dissolve the tablets to avoid exposure to a potentially fatal dose of tramadol. (5.2) Accidental ingestion of tramadol hydrochloride extended-release tablets, especially by children, can result in a fatal overdose of tramadol. (5.2) Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism (5.3). Tramadol hydrochloride extended-release tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (4). Avoid the use of tramadol hydrochloride extended-release 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. [see Warnings and Precautions (5.3)] Prolonged use of tramadol hydrochloride extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.4) The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride extended-release tablets requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1 (5.5, 7) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.6, 7)

Tramadol hydrochloride is an opioid agonist indicated for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1) Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1) Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. (1)

To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain. (2.1) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (2.1). Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1) Do not exceed a daily dose of 300 mg tramadol. Do not use with other tramadol products.(2.1) For opioid-naïve and opioid non-tolerant patients, initiate tramadol hydrochloride extended-release tablets at a dose of 100 mg once daily, then titrate up by 100 mg increments every 5 days according to need and tolerance. (2.2) For patients currently on tramadol IR, calculate total 24-hr IR dose, and initiate tramadol hydrochloride extended-release tablets at a dose rounded down to next lower 100 mg increment; then adjust dose according to need and tolerance. See full prescribing information for instructions on conversion, titration, and maintenance of therapy. (2.2, 2.3) Do not abruptly discontinue tramadol hydrochloride extended-release tablets in a physically-dependent patient. (2.4)

Children younger than 12 years of age (4) Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (4) Significant respiratory depression (4) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment (4) Known or suspected gastrointestinal obstruction, including paralytic ileus (4) Hypersensitivity to tramadol (4) Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days (4)

Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue tramadol hydrochloride extended-release tablets if serotonin syndrome is suspected. (5.7) Risk of Seizure: Present within recommended dosage range. Risk is increased with higher than recommended doses and concomitant use of SSRIs, SNRIs, anorectics, tricyclic antidepressants and other tricyclic compounds, other opioids, MAOIs, neuroleptics, other drugs that reduce seizure threshold, in patients with epilepsy or at risk for seizures. (5.8, 7) Risk of Suicide: Do not use tramadol hydrochloride extended-release tablets in suicidal or addiction-prone patients. Use with caution in those taking tranquilizers, antidepressants or abuse alcohol. (5.9) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.10) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.11) Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of tramadol hydrochloride extended-release tablets in patients with circulatory shock. (5.12) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of tramadol hydrochloride extended-release tablets in patients with impaired consciousness or coma. (5.13)

Most common adverse reactions (≥10% and ≥2 x placebo rate): Dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, dry mouth. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with tramadol hydrochloride extended-release tablets because they may reduce analgesic effect of tramadol hydrochloride extended-release tablets or precipitate withdrawal symptoms. (5.16,7)

Advise the patient to read the FDA-approved patient labeling (Medication Guide).


H.J. Harkins Company, Inc.

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Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets

The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®. In o...

An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain

The purpose of this study is to find the clinical dose range of an active ingredient of JNS013 - Tramadol hydrochloride in chronic-pain patients who cannot attain a sufficient analgesic ef...

Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac

The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combinatio...

Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants

The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in ...

A Comparative Study on Tramadol 37.5mg/Acetaminophen 325mg Tablets Maintenance Versus Non-steroidal Anti-inflammatory Drugs(NSAIDs) Maintenance in Patients With Knee Osteoarthritis

The purpose of this study is to compare the effectiveness of tramadol 37.5mg/acetaminophen 325mg maintenance with that of NSAID maintenance in patients whose pain was relieved after the ad...

PubMed Articles [243 Associated PubMed Articles listed on BioPortfolio]

Tramadol hydrochloride: An alternative to conventional local anaesthetics for intraoral procedures- a preliminary study.

To evaluate and compare the soft tissue anaesthesia produced by tramadol hydrochloride on gingival tissues in maxilla.

Postoperative Tramadol administration at home after ambulatory surgery in children.

Since the withdrawal of codeine in children, rescue analgesia is usually usually performed using tramadol. This compound is metabolized (by the P2D6 cytochrome the same enzyme that transforms codeine ...

A Disposition Kinetic Study of Tramadol in Intoxicated Rats Induced by Ethanol and Acetaminophen in Perfused Rat Liver Model.

Damage to the liver can lead to changes in the metabolism of tramadol. In this study, the rate of tramadol metabolites in rats with damaged liver induced by ethanol and acetaminophen were assessed in ...

Serotonin and norepinephrine transporter occupancy of tramadol in non-human primate using positron emission tomography.

Tramadol, a centrally acting analgesic drug, has relatively high affinity to serotonin transporter (5-HTT) and norepinephrine transporter (NET) in addition to μ-opioid receptor. Based on this charact...

Seizures in tramadol overdoses reported in the ToxIC registry: predisposing factors and the role of naloxone.

Tramadol prescriptions have increased as fewer schedule II and III drugs are prescribed. There has been a concomitant increase in overdoses and adverse events recorded in the National Poison Data Syst...

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