TRAMADOL IN-HOME WITHDRAWAL AND TAPERING PROGRAM

In 1995 Tramadol was relea sed in the United States and used primarily as a pain reliever for acute and chronic pain. While Tramadol was initially considered to have a low abuse potential, it was popular in China since the early 1990s, particularly for opiate addicts. Studies have shows that Tramadol does have a high risk potential for addiction.

Tramadol can cause physical dependence and a withdrawal syndrome with symptoms associated with SSRI withdrawal, including numbness, anxiety, tingling, tinnitus, stomach upset, insomnia and many others. Symptoms generally surface 12-20 hours after the last dose but this can vary depending on drug metabolism. Tramadol withdrawals last longer than those of opiates and follow the withdrawal syndrome length of antidepressants.

Tramadol was isolated from the root bark of N. latifolia, an African medical plant and synthesized into a chemical structure similar to Effexor, an SNRI (Serotonin-Norepinephrine Reuptake Inhibitor).  Tramadol can be associated with Serotonin Syndrome, a serious condition caused by excess Serotonin activity. As a result, Tramadol should never be combined with St. John’s Wort, 5HTP, Antidepressants or any other item that increases Serotonin. Alcohol should not be consumed while taking Tramadol.

Tramadol has a relatively short half-life that helps to explain the severity of the withdrawals frequently experienced by patients.  Tramadol should be tapered slowly to minimize withdrawal symptoms. 

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TRAMADOL WITHDRAWAL SYMPTOMS MAY INCLUDE:

abdomnial cramping, anxiety, backache, diarrhea, insomnia, chills, irritability, joint pain, muscle pain, vomiting, weakness, perspiration, nausea, increased heart rate, increased blood pressure, confusion, hallucination, numbness, panic attacks, paranoia, tingling 

TRAMADOL SIDE EFFECTS MAY INCLUDE: 

vertigo, nausea, constipation, headache, somnolence, vomitting, cns stimulation, sweating, dry mouth, insomnia, menstrual issues, sinusitis, cough, rash 

TRAMADOL ADVERSE REACTIONS MAY INCLUDE: per PDR   

Severe: visual impairment, hepatic failure, pancreatitis, GI bleeding, bradycardia, serotonin syndrome, seizures, suicidal ideation, Stevens-Johnson syndrome, toxic epidermal necrolysis, proteinuria, cholecystitis, hearing loss, myocardial infarction, pulmonary embolism, pulmonary edema, torsade de pointes, bronchospasm, anaphylactoid reactions, angioedema, fetal death, neonatal opioid withdrawal syndrome, SIADH 

Moderate: constipation, euphoria, hallucinations, orthostatic hypotension, peripheral vasodilation, hypertension, hypertonia, depression, dyspnea , urinary retention, hyperglycemia, peripheral edema, hot flashes, blurred vision, confusion, withdrawal , dysphagia, hepatitis, stomatitis, hypotension, amnesia, ataxia, impaired cognition, migraine, dysuria, hematuria, cystitis, anemia, thrombocytopenia, elevated hepatic enzymes, cholelithiasis, cataracts, impotence (erectile dysfunction), palpitations, sinus tachycardia, gout, QT prolongation, dysphonia, respiratory depression, physiological dependence, psychological dependence, hyponatremia, infertility, adrenocortical insufficiency

Mild: nausea, vertigo, dizziness, headache, drowsiness, vomiting, flushing, agitation, tremor, anxiety, emotional liability, xerostomia, dyspepsia, asthenia, pruritus, insomnia, diarrhea, diaphoresis, anorexia, arthralgia, malaise, syncope, paresthesias, increased urinary frequency, infection, fever, weight loss, myalgia, flatulence, abdominal pain, fatigue, weakness, lethargy, sneezing, nasal congestion, rhinorrhea, cough, hypoesthesia, miosis, restlessness, rash, chills , rhinitis, pharyngitis, sinusitis, influenza, back pain, gastroesophageal reflux, yawning, hyperkinesis, night sweats, irritability, pallor, urticaria, menstrual irregularity , tinnitus, libido decrease, ecchymosis, muscle cramps, gonadal suppression, amenorrhea

TRAMADOL BOXED WARNINGS: per PDR

Accidental exposure, acute intoxication of CNS depressants, ethanol ingestion, ethanol intoxication, potential for overdose or poisoning 

Use of tramadol is associated with a significant potential for overdose or poisoning. Tramadol in excessive doses, either alone or in combination with other CNS depressants such as alcohol, is a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. Many of the tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of tramadol alone or in combination with other drugs. Tramadol should be kept out of the reach of pediatric patients, others for whom the drug was not prescribed, and pets as accidental exposure or improper use may cause respiratory failure and a fatal overdose. The use of immediate-release tramadol, tramadol orally disintegrating tablets (Rybix), and extended-release tablets (specifically Ultram ER and generic equivalents) is contraindicated in cases of acute intoxication of CNS depressants including ethanol intoxication and/or intoxication with opiate agonists, hypnotics, centrally-acting analgesics, or psychotropic drugs. Note that while Ryzolt extended-release tablets (and generic equivalents) and extended-release capsules are not specifically contraindicated, use during acute intoxication is not recommended. Tramadol may worsen central nervous system depression and decrease the respiratory rate in these patients. Tell patients not to exceed the recommended tramadol dose and to avoid ethanol ingestion during tramadol therapy. Advise patients of the additive depressant effects of tramadol and alcohol. 

Asthma, coadministration with other CNS depressants, respiratory depression
As with other opioid agonists, tramadol should be avoided in patients with severe pulmonary disease. Additionally, avoid coadministration with other CNS depressants unless no other alternatives are available, as this significantly increases the risk for respiratory depression, low blood pressure, and death. As tramadol use is contraindicated in any situation where opioid agonist are contraindicated, do not use in patients with severe respiratory depression. Further, the manufacturers of dual-matrix extended-release tablets (e.g., Ryzolt) and extended-release capsules (e.g., ConZip) specifically contraindicate use in patients with acute or severe asthma or hypercapnia in unmonitored care settings or in the absence of resuscitate equipment. Consider alternative non-opioid analgesics instead of tramadol. Respiratory depression is possible with large doses of tramadol, especially when given concurrently with ethanol and anesthetic agents. Concurrent administration with other respiratory depressants exacerbates this risk. If respiratory depression occurs, treat as an overdose; however, administer naloxone cautiously in these situations due to an increased risk of seizures.

Alcoholism, depression, substance abuse, suicidal ideation
Do not prescribe tramadol for patients who have depression, suicidal ideation, or addiction problems such as patients with alcoholism. Consider use of non-narcotic analgesics in these patients. Tramadol is an opioid agonist and therefore has abuse potential and risk of fatal overdose from respiratory failure. Addiction may occur in patients who obtain tramadol illicitly or in those appropriately prescribed the drug. The risk of addiction in any individual is unknown. However, patients with mental illness (e.g., major depression) or a family history of substance abuse (including alcoholism) have an increased risk of opioid abuse. Assess patients for risks of addiction, abuse, or misuse before drug initiation, and monitor patients who receive opioids routinely for development of these behaviors or conditions. A potential risk of abuse should not preclude appropriate pain management in any patient, but requires more intensive counseling and monitoring. Abuse and addiction are separate and distinct from physical dependence and tolerance; patients with addiction may not exhibit tolerance and symptoms of physical dependence. The misuse of tramadol extended-release tablets or extended-release capsules by splitting, breaking, crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery and can result in overdose and death. To discourage abuse, the smallest appropriate quantity of tramadol should be dispensed, and proper disposal instructions for unused drug should be given to patients.

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According to the FDA:

Discontinuation of Treatment
Withdrawal symptoms may occur if tramadol hydrochloride extended-release capsules is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering tramadol hydrochloride extended-release capsules [see WARNINGS AND PRECAUTIONS (5.10) and DRUG ABUSE AND DEPENDENCE ( 9.3)].

Dependence
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). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist.

REFERENCES:

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/tramadol-information

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022370s000lbl.pdf

https://clinicaltrials.gov/ct2/show/NCT00142896

https://www.ncbi.nlm.nih.gov/pubmed/14723474