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What is tramadol taken for: Common and Rare Side Effects for tramadol oral

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Common and Rare Side Effects for tramadol oral

The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:

Conditions:

  • decreased function of the adrenal gland
  • symptoms from alcohol withdrawal
  • suicidal behavior
  • suicidal thoughts
  • alcoholism
  • alcohol intoxication
  • drug abuse
  • depression
  • serotonin syndrome, a type of disorder with high serotonin levels
  • a low seizure threshold
  • asthma
  • decreased lung function
  • blockage of the stomach or intestine
  • hardening of the liver
  • seizures
  • opioid overdose
  • a mother who is producing milk and breastfeeding
  • benzodiazepine overdose
  • high pressure within the skull
  • nervous system infection of brain and spinal cord
  • inherited dysfunction of autonomic nerve function
  • chronic obstructive pulmonary disease
  • CYP2D6 ultrarapid metabolizer
  • CYP2D6 poor metabolizer
  • sleep apnea due to airway obstruction
  • surgical removal of the adenoids in pediatric patient
  • surgical removal of the tonsils in pediatric patient
  • kidney disease with likely reduction in kidney function

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Effectiveness, Ease of Use, and Satisfaction

Most voted positive review

121 People found this comment helpful

Here’s the deal with Tramadol, folks. It can be a miracle drug for one person and a complete waste of time for another. Many people report poor results and they blame the drug, when they should be blaming their own body chemistry. I am in the miracle drug category. Thanks to Tramadol, I am now able to live pain free (Extremely rare testicular disorder requiring several surgeries). If you are …

Most voted negative review

12 People found this comment helpful

I got a prescription for Tramadol from the emergency room. I took one dose and from there the entire night was AWFUL. It started off with mild irritability and anxiety which turned into a strange sense of impending doom and I could not get myself calm. I tried to lay down but didn’t sleep, rather I blacked out and when I came to consciousness I couldn’t talk or move my body at all for several minu…

Shared reviews and ratings

Condition: Pain EffectivenessEase of UseSatisfaction

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Approved medicines without prescription Kindly place your orders here with heavy discounts available. 1(775)-773-5306, Whatsapp, Call and Text. Email: [email protected], Ambien, Valium, Xanax, Klonopin, Tramadol, and Soma. We have available stocks for Oxycontin, Hydrocodone, Adderall and Ativan etc. No Script and Health Insurance needed to get your orders. Also, Customer Satisfaction is what we believe in. We do overnight Delivery also on request. Feel free to contact us for any queries.

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Approved medicines without prescription Kindly place your orders here with heavy discounts available. 1(775)-773-5306, Whatsapp, Call and Text. Email: [email protected], Ambien, Valium, Xanax, Klonopin, Tramadol, and Soma. We have available stocks for Oxycontin, Hydrocodone, Adderall and Ativan etc. No Script and Health Insurance needed to get your orders. Also, Customer Satisfaction is what we believe in. We do overnight Delivery also on request. Feel free to contact us for any queries.

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Approved medicines without prescription Kindly place your orders here with heavy discounts available. 1(775)-773-5306, Whatsapp, Call and Text. Email: [email protected], Ambien, Valium, Xanax, Klonopin, Tramadol, and Soma. We have available stocks for Oxycontin, Hydrocodone, Adderall and Ativan etc. No Script and Health Insurance needed to get your orders. Also, Customer Satisfaction is what we believe in. We do overnight Delivery also on request. Feel free to contact us for any queries.

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Tramadol Interactions – Drugs.com Interactions Checker

A total of 542 drugs are known to interact with
tramadol
categorized as 293 major, 246 moderate, and 3 minor interactions.

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Most frequently checked interactions

View interaction reports for tramadol and the medicines listed below.

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Tramadol alcohol/food interactions

There is 1 alcohol/food interaction with tramadol

Tramadol disease interactions

There are 10 disease interactions with tramadol which include:

More about tramadol

Related treatment guides

Drug Interaction Classification
These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

What are the side effects of tramadol? An overview

Tramadol is a prescription pain medication that can help with moderate to severe pain. It has a number of side effects, however, including dizziness, nausea, sweating, and heartburn. Less common side effects include confusion and hives.

Doctors only prescribe tramadol to people over 12 years old. Adolescents with certain risk factors should speak with their doctors about the risks of taking tramadol.

Some people take tramadol for premature ejaculation and restless legs syndrome, but the Food and Drug Administration (FDA) have not approved these uses of it.

As an opioid drug, tramadol acts on the brain to relieve pain. However, tramadol is not as effective as morphine, which is another opioid. Because of its opioid activity, people can become dependent on tramadol.

In this article, we discuss the side effects of tramadol. We will also take a look at tramadol dependence.

Ultram and Ultram ER are the brand names of the drug tramadol. They are available in the form of immediate and extended release tablets. Tramadol is also combined with acetaminophen in the drug Ultracet.

The following table lists the available dosages of tramadol in milligrams (mg).

Brand name Active ingredient and dosage Type of release
Ultram tramadol 50 mg immediate release
Ultram ER tramadol 100 mg
tramadol 200 mg
tramadol 300 mg
extended release
Ultracet acetaminophen 325 mg
tramadol 37.5 mg
immediate release

Tramadol acts on two compounds associated with the sensation of pain: serotonin and norepinephrine. Tramadol helps relieve pain by decreasing the amount of these two compounds in brain cells.

Liver enzymes break down tramadol into another compound called O-desmethyltramadol, which binds to the opioid receptor. This is the same receptor that morphine binds to, but tramadol is not as strong as morphine; its efficacy is “about one-tenth that of morphine.”

The FDA classify tramadol as a schedule IV drug because of its potential for misuse and addiction. It belongs to the same schedule as Xanax, Soma, and Valium.

Doctors should choose the lowest effective dosage for the shortest period and educate people on the possible risks of taking tramadol.

Tramadol can cause side effects in some people. They occur more often when people first start taking tramadol and can wear off over time.

Common side effects

The most common side effects of tramadol affect the abdominal tract and the brain.

The following list provides common side effects that occur in 5% or more of people who take tramadol:

Less common side effects

People may experience other side effects that occur with an incidence of less than 5%, such as:

  • whole body discomfort
  • allergic reactions
  • suicidal tendencies
  • weight loss
  • rapid heartbeat
  • drop in blood pressure upon standing up
  • confusion
  • disturbance in coordination
  • constriction of the pupil
  • fainting
  • rash
  • hives
  • visual disturbance
  • menopausal symptoms
  • retention of urine
  • difficulty breathing
  • frequent urination
  • serotonin syndrome

Serious side effects

Serious side effects may also occur in some people.

Some serious side effects include:

  • respiratory depression
  • serotonin syndrome
  • heart rhythm problems called QT prolongation

The following sections discuss these serious side effects.

Respiratory depression

Respiratory depression is a serious side effect that may occur in people taking tramadol. If a person has difficulty breathing while taking tramadol, they must seek emergency medical attention.

People can experience respiratory depression with usual dosages of tramadol. Respiratory depression usually occurs when the person starts taking tramadol or when they increase their dosage.

People who overdose on tramadol are at an even greater risk of respiratory depression. Combining certain drugs with tramadol can also increase the risk of respiratory depression.

Some people are more at risk than others. Some people’s bodies break down tramadol into O-desmethyltramadol much more quickly and completely. This can result in higher levels of this compound in the bloodstream and lead to respiratory depression.

Adolescents aged 12–18 years may have additional risk factors for respiratory depression:

  • obesity
  • severe lung disease
  • neuromuscular disease

Some adolescents may be taking other medicines that put them at greater risk of respiratory depression. In these situations, tramadol can cause life threatening respiratory depression.

Serotonin syndrome

Serotonin syndrome develops when there is too much serotonin accumulating in the body. This can cause mild to fatal symptoms.

In rare cases, people can experience serotonin syndrome when taking tramadol alone or with other drugs.

The symptoms of serotonin syndrome may include:

  • agitation
  • hallucinations
  • coma
  • rapid heartbeat
  • fluctuating blood pressure
  • high body temperature
  • muscle rigidity
  • nausea
  • vomiting
  • diarrhea

Heart rhythm problems

QT prolongation is a serious condition affecting the heart rhythm. On an electrocardiogram of the heart, the QT interval represents a portion of the electrical activity during the heartbeat.

Some drugs, such as tramadol, can cause QT prolongation. When a person has a prolonged QT interval, they may experience serious heart problems. They may have an irregular heartbeat, which can become life threatening.

In most cases of QT prolongation related to tramadol, a person has taken tramadol with other drugs that prolong the interval.

Although the combination of QT-prolonging drugs can be dangerous, some people are born with long QT syndrome. These people should let their doctor know about their condition before taking tramadol.

People who overdose on tramadol also have an increased risk of QT prolongation.

Tramadol can interact with several medications, such as benzodiazepines and serotonergic drugs.

Benzodiazepines

Benzodiazepines are drugs that reduce anxiety and relax the muscles. People use them to treat anxiety and insomnia.

If someone is already taking a benzodiazepine medication such as lorazepam or alprazolam, also taking tramadol can result in sedation, respiratory depression, coma, and even death.

Serotonergic drugs

Serotonergic drugs affect serotonin levels in the body. People use them to treat depression.

People who are taking serotonergic drugs should use tramadol carefully because of the risk of serotonin syndrome.

The following table lists serotonergic drug classes:

Drug class Drugs
selective serotonin reuptake inhibitors (SSRIs) citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
serotonin and norepinephrine reuptake inhibitors (SNRIs) venlafaxine, duloxetine, desvenlafaxine
tricyclic antidepressants amitriptyline, imipramine, clomipramine
triptans almotriptan, eletriptan, frovatriptan, rizatriptan, sumatriptan
5-HT3 receptor antagonists granisetron, ondansetron
monoamine oxidase inhibitors (MOIs) phenelzine, selegiline

People taking tramadol should report any side effects to their doctor. By discussing the benefits and risks of the medication, a doctor can help a person find the most appropriate medicine at the lowest effective dosage.

Severe allergic reactions require emergency medical attention.

Anyone having difficulty breathing or experiencing any symptoms of serotonin syndrome must seek immediate medical care.

Share on PinterestPeople may become dependent on tramadol when taking it for more than a few weeks or months.

According to a World Health Organization (WHO) report on tramadol, clinical data in adults suggests that the drug has a low potential for dependence.

People may, however, become dependent on tramadol when taking it for more than a few weeks or months. People with a history of drug misuse are more at risk of developing a dependence on tramadol.

In one case study, a 39-year-old male with no history of substance misuse went to the emergency room to get help for tramadol addiction. His tramadol treatment began about 2 years earlier. He was taking up to 600 mg per day and was unable to stop taking it without experiencing withdrawal symptoms.

So, in rare cases, tramadol dependence can affect people without a history of drug misuse.

Tramadol is an opioid pain medication. It also acts on brain chemicals called serotonin and norepinephrine to relieve moderate to severe pain.

Tramadol is not safe for everyone. Children under 12 years old should not take tramadol, and those aged 12–18 should use caution when taking it.

Some people may experience mild to severe side effects when taking tramadol. Some drug interactions can occur with tramadol, and the effects can be severe.

Although it has a low potential for dependence, the Drug Enforcement Administration (DEA) control the distribution of tramadol.

Tramadol: Uses, Interactions, Mechanism of Action

Summary

Tramadol is a centrally-acting opioid agonist and SNRI (serotonin/norepinephrine reuptake inhibitor) used for the management of moderate to severe pain in adults.

Brand Names

Conzip, Durela, Qdolo, Ralivia, Ryzolt, Tridural, Ultracet, Ultram, Zytram

Generic Name
Tramadol
DrugBank Accession Number
DB00193
Background

Tramadol is a centrally acting synthetic opioid analgesic and SNRI (serotonin/norepinephrine reuptake-inhibitor) that is structurally related to codeine and morphine. Due to its good tolerability profile and multimodal mechanism of action, tramadol is generally considered a lower-risk opioid option for the treatment of moderate to severe pain. It is considered a Step 2 option on the World Health Organization’s pain ladder and has about 1/10th of the potency of morphine.

Tramadol differs from other traditional opioid medications in that it doesn’t just act as a μ-opioid agonist, but also affects monoamines by modulating the effects of neurotransmitters involved in the modulation of pain such as serotonin and norepinpehrine which activate descending pain inhibitory pathways. 13 Tramadol’s effects on serotonin and norepinephrine mimic the effects of other SNRI antidepressants such as duloxetine and venlafaxine.

Tramadol exists as a racemic mixture consisting of two pharmacologically active enantiomers that both contribute to its analgesic property through different mechanisms and are also themselves metabolized into active metabolites: (+)-tramadol and its primary metabolite (+)-O-desmethyl-tramadol (M1) are agonists of the μ opioid receptor while (+)-tramadol inhibits serotonin reuptake and (-)-tramadol inhibits norepinephrine reuptake. These pathways are complementary and synergistic, improving tramadol’s ability to modulate the perception of and response to pain.12,25

Tramadol has also been shown to affect a number of other pain modulators within the central nervous system as well as non-neuronal inflammatory markers and immune mediators.17,18,20,26,16 Due to the broad spectrum of targets involved in pain and inflammation, it’s not surprising that the evidence has shown that tramadol is effective for a number of pain types including neuropathic pain, post-operative pain, lower back pain, as well as pain associated with labour, osteoarthritis, fibromyalgia, and cancer. Due to its SNRI activity, tramadol also has anxiolytic, antidepressant, and anti-shivering effects which are all frequently found as comorbidities with pain.16

Similar to other opioid medications, tramadol poses a risk for development of tolerance, dependence and abuse. If used in higher doses, or with other opioids, there is a dose-related risk of overdose, respiratory depression, and death.22,30 However, unlike other opioid medications, tramadol use also carries a risk of seizure and serotonin syndrome, particularly if used with other serotonergic medications.23,24

Type
Small Molecule
Groups
Approved, Investigational
Structure
Weight
Average: 263.3752
Monoisotopic: 263.188529049
Chemical Formula
C16H25NO2
Synonyms
External IDs
Indication

Tramadol is approved for the management of moderate to severe pain in adults. 29,30

Tramadol is also used off-label in the treatment of premature ejaculation.8

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Associated Conditions
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Pharmacodynamics

Tramadol modulates the descending pain pathways within the central nervous system through the binding of parent and M1 metabolite to μ-opioid receptors and the weak inhibition of the reuptake of norepinephrine and serotonin. 7,6

Apart from analgesia, tramadol may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids.

Central Nervous System

In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, tramadol has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.29

Tramadol produces respiratory depression by direct action on brain stem respiratory centres. The respiratory depression involves both a reduction in the responsiveness of the brain stem centres to increases in CO2 tension and to electrical stimulation.

Tramadol depresses the cough reflex by a direct effect on the cough centre in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia.

Tramadol causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but
are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce
similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of
oxycodone overdose.30

Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures
or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders,
alcohol and drug withdrawal, CNS infections), or with concomitant use of other drugs known to reduce the seizure threshold.30

Tramadol can cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs (e.g., anti-depressants, migraine medications). Treatment with the serotoninergic drug should be discontinued if such events (characterized by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated. Tramadol should not be used in combination with MAO inhibitors or serotonin-precursors (such as L-tryptophan, oxitriptan) and should be used with caution in combination with other serotonergic drugs (triptans, certain tricyclic antidepressants, lithium, St. John’s Wort) due to the risk of serotonin syndrome.30

Gastrointestinal Tract and Other Smooth Muscle

Tramadol causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of the sphincter of Oddi, and transient elevations in serum amylase.30

Endocrine System

Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical signs and symptoms may be manifest from these hormonal changes.30

Hyponatremia has been reported very rarely with the use of tramadol, usually in patients with predisposing risk factors, such as elderly patients and/or patients using concomitant medications that may cause hyponatremia (e.g., antidepressants, benzodiazepines, diuretics). In some reports, hyponatremia appeared to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and resolved with discontinuation of tramadol and appropriate treatment (e. g., fluid restriction). During tramadol treatment, monitoring for signs and symptoms of hyponatremia is recommended for patients with predisposing risk factors.30

Cardiovascular

Tramadol administration may result in severe hypotension in patients whose ability to maintain adequate blood pressure is compromised by reduced blood volume, or concurrent administration of drugs such as phenothiazines and other tranquillizers, sedative/hypnotics, tricyclic antidepressants or general anesthetics. These patients should be monitored for signs of hypotension after initiating or titrating the dose of tramadol.30

QTc-Interval Prolongation

The maximum placebo-adjusted mean change from baseline in the QTcF interval was 5.5 ms in the 400 mg/day treatment arm and 6.5 ms in the 600 mg/day mg treatment arm, both occurring at the 8h time point. Both treatment groups were within the 10 ms threshold for QT prolongation. Post-marketing experience with the use of tramadol containing products included rare reports of QT prolongation reported with an overdose. Particular care should be exercised when administering tramadol to patients who are suspected to be at an increased risk of experiencing torsade de pointes during treatment with a QTc-prolonging drug.30

Abuse and Misuse

Like all opioids, tramadol has the potential for abuse and misuse, which can lead to overdose and death. Therefore, tramadol should be prescribed and handled with caution.30

Dependence/Tolerance

Physical dependence and tolerance reflect the neuroadaptation of the opioid receptors to chronic exposure to an opioid and are separate and distinct from abuse and addiction. Tolerance, as well as physical dependence, may develop upon repeated administration of opioids, and are not by themselves evidence of an addictive disorder or abuse. Patients on prolonged therapy should be tapered gradually from the drug if it is no longer required for pain control. Withdrawal symptoms may occur following abrupt discontinuation of therapy or upon administration of an opioid antagonist. Some of the symptoms that may be associated with abrupt withdrawal of an opioid analgesic include body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, anxiety, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, palpitations, unexplained fever, weakness and yawning.30

Mechanism of action

Tramadol is a centrally acting μ-opioid receptor agonist and SNRI (serotonin/norepinephrine reuptake-inhibitor) that is structurally related to codeine and morphine. Tramadol binds weakly to κ- and δ-opioid receptors and to the μ-opioid receptor with 6000-fold less affinity than morphine.16

Tramadol exists as a racemic mixture consisting of two pharmacologically active enantiomers that both contribute to its analgesic property through different mechanisms: (+)-tramadol and its primary metabolite (+)-O-desmethyl-tramadol (M1) are agonists of the μ opioid receptor while (+)-tramadol inhibits serotonin reuptake and (-)-tramadol inhibits norepinephrine reuptake. These pathways are complementary and synergistic, improving tramadol’s ability to modulate the perception of and response to pain.12

In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding.29

Tramadol has also been shown to affect a number of pain modulators including alpha2-adrenoreceptors, neurokinin 1 receptors, the voltage-gated sodium channel type II alpha subunit17, transient receptor potential cation channel subfamily V member 1 (TRPV1 – also known as the capsaicin receptor)18, muscarinic receptors (M1 and M3), N-methyl-D-aspartate receptor (also known as the NMDA receptor or glutamate receptor)19, Adenosine A1 receptors20, and nicotinic acetylcholine receptor.26

In addition to the above neuronal targets, tramadol has a number of effects on inflammatory and immune mediators involved in the pain response. This includes inhibitory effects on cytokines, prostaglandin E2 (PGE2), nuclear factor-κB, and glial cells as well as a change in the polarization state of M1 macrophages.16

Absorption

Oral Administration

Tramadol is administered as a racemate, with both the [-] and [+] forms of both tramadol and the M1 metabolite detected in circulation. Following administration, racemic tramadol is rapidly and almost completely absorbed, with a bioavailability of 75%. This difference in absorption and bioavailability can be attributed to the 20-30% first-pass metabolism. Peak plasma concentrations of tramadol and the primary metabolite M1 occur at two and three hours, respectively.30 Following a single oral dose of 100mg of tramadol, the Cmax was found to be approximately 300μg/L with a Tmax of 1.6-1.9 hours, while metabolite M1 was found to have a Cmax of 55μg/L with a Tmax of 3 hours.12,29

Steady-state plasma concentrations of both tramadol and M1 are achieved within two days of dosing. There is no evidence of self-induction.30 Following multiple oral doses, Cmax is 16% higher and AUC is 36% higher than after a single dose, demonstrating a potential role of saturable first-pass hepatic metabolism in increasing bioavailability.12

Intramuscular Administration

Tramadol is rapidly and almost completely absorbed following intramuscular administration. Following injection of 50mg of tramadol, Cmax of 166μg/L was found with a Tmax of 0.75 hours.12

Rectal Administration

Following rectal administration with suppositories containing 100mg of tramadol, Cmax of 294μg/L was found with a Tmax of 3.3 hours. The absolute bioavailability was found to be higher than oral administration (77% vs 75%), likely due to reduced first-pass metabolism with rectal administration compared to oral administration.12

Volume of distribution

The volume of distribution of tramadol is reported to be in the range of 2.6-2.9 L/kg.29,30 Tramadol has high tissue affinity; the total volume of distribution after oral administration was 306L and 203L after parenteral administration.16 Tramadol crosses the blood-brain barrier with peak brain concentrations occurring 10 minutes following oral administration. It also crosses the placental barrier with umbilical concentrations being found to be ~80% of maternal concentrations.12

Protein binding

About 20% of the administered dose is found to bind to plasma proteins. Protein binding appears to be independent of concentrations up to 10μg/mL. Saturation only occurs at concentrations outside of the clinical range.30

Metabolism

Tramadol undergoes extensive first-pass metabolism in the liver by N- and O- demethylation and conjugation. From the extensive metabolism, there have been identified at least 23 metabolites. There are two main metabolic pathways: the O-demethylation of tramadol to produce O-desmethyl-tramadol (M1) catalyzed by CYP2D6 and the N-demethylation to N-desmethyl-tramadol (M2) catalyzed by CYP3A4 and CYP2B6.12,29,30

The wide variability in the pharmacokinetic properties between patients can partly be ascribed to polymorphisms within the gene for CYP2D6 that determine its enzymatic activity. CYP2D6*1 is considered the wild-type allele associated with normal enzyme activity and the “extensive metabolizer” phenotype; 90-95% of Caucasians are considered “extensive metabolizers” (with normal CYP2D6 function) while the remaining 5-10% are considered “poor metabolizers” with reduced or non-functioning enzyme.14 CYP2D6 alleles associated with non-functioning enzyme include *3, *4, *5, and *6 while alleles associated with reduced activity include *9, *10, *17, and *41.21

Poor metabolizers have reduced activity of the CYP2D6 enzyme and therefore less production of tramadol metabolites M1 and M2, which ultimately results in a reduced analgesic effect as tramadol interacts with the μ-opioid receptor primarily via M1.12

There are also large differences in the frequency of these alleles between different ethnicities: *3, *4, *5, *6, and *41 are more common among Caucasians while *17 is more common in Africans for example.21 Compared to 5-10% of Caucasians, only ~1% of Asians are considered poor metabolizers, however Asian populations carry a much higher frequency (51%) of the CYP2D6*10 allele, which is relatively rare in Caucasian populations and results in higher exposure to tramadol.14

Some individuals are considered “ultra-rapid metabolizers”, such as those carrying CYP2D6 gene duplications (CYP2D6*DUP) or multiplications. These individuals are at risk of intoxication or exaggerated effects of tramadol due to higher concentrations of its active metabolite (M1).15 The occurrence of this phenotype is seen in approximately 1% to 2% of East Asians (Chinese, Japanese, Korean), 1% to 10% of Caucasians, 3% to 4% of African-Americans, and may be >10% in certain racial/ethnic groups (ie, Oceanian, Northern African, Middle Eastern, Ashkenazi Jews, Puerto Rican). The FDA label recommends avoiding the use of tramadol in these individuals.29,30

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Route of elimination

Tramadol is eliminated primarily through metabolism by the liver and the metabolites are excreted primarily by the kidneys, accounting for 90% of the excretion while the remaining 10% is excreted through feces.29,30,6 Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% of the dose is excreted as metabolites.11

The mean terminal plasma elimination half-lives of racemic tramadol and racemic M1 are 6.3 ± 1.4 and 7.4 ± 1.4 hours, respectively. The plasma elimination half-life of racemic tramadol increased from approximately six hours to seven hours upon multiple dosing.29,30

Half-life

Tramadol reported a half-life of 5-6 hours while the M1 metabolite presents a half-life of 8 hours.6

Clearance

In clinical trials, the clearance rate of tramadol ranged from 3.73 ml/min/kg in renal impairment patients to 8.50 ml/min/kg in healthy adults.29,30

Adverse Effects

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Toxicity

The reported LD50 for tramadol, when administered orally in mice, is 350 mg/kg.11

In carcinogenic studies, there are reports of murine tumors which cannot be concluded to be carcinogenic in humans. On the other hand, tramadol showed no evidence to be mutagenic in different assays and does not have effects on fertility. However, there are clear reports of embryotoxicity and fetotoxicity.29,30

Pathways
Pharmacogenomic Effects/ADRs
Interacting Gene/Enzyme Allele name Genotype(s) Defining Change(s) Type(s) Description Details
Cytochrome P450 2D6 CYP2D6*3 Not Available C allele ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*4 Not Available C allele ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*5 Not Available Whole-gene deletion ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*6 Not Available 1707delT ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*7 Not Available 2935A>C ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*8 Not Available 1758G>T ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*11 Not Available 883G>C ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*12 Not Available 124G>A ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*13 Not Available CYP2D7/2D6 hybrid gene structure ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*14A Not Available 1758G>A ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*15 Not Available 137insT, 137_138insT ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*19 Not Available 2539_2542delAACT ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*20 Not Available 1973_1974insG ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*21 Not Available 2573insC ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*31 Not Available -1770G>A / -1584C>G  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*36 Not Available 100C>T / -1426C>T  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*38 Not Available 2587_2590delGACT ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*40 Not Available 1863_1864ins(TTT CGC CCC)2 ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*42 Not Available 3259_3260insGT ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*44 Not Available 2950G>C ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*47 Not Available 100C>T / -1426C>T  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*51 Not Available -1584C>G / -1235A>G  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*56 Not Available 3201C>T ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*57 Not Available 100C>T / 310G>T  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*62 Not Available 4044C>T ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*68A Not Available -1426C>T / -1235A>G  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*68B Not Available Similar but not identical switch region compared to CYP2D6*68A. Found in tandem arrangement with CYP2D6*4. ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*69 Not Available 2988G>A / -1426C>T  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*92 Not Available 1995delC ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*100 Not Available -1426C>T / -1235A>G  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*101 Not Available -1426C>T / -1235A>G  … show all ADR Inferred Effect Poor drug metabolizer. This results in reduced analgesic efficacy and decreased risk of opioid toxicity as well as increased risk of seizures and serotonin syndrome. Consider alternative therapies. Details
Cytochrome P450 2D6 CYP2D6*10 Not Available 100C>T (but also appears in other variants) ADR pgx review This mutation leads to an unstable CYP2D6 enzyme with lower metabolic activity. Details

Find out Why and How It’s Used

What Is Tramadol?

Tramadol is a medication veterinarians commonly dispense to manage pain in dogs. Physicians also frequently prescribe tramadol for human aches and pains, and it is one of the few human painkillers that is safe to give to dogs under the guidance of a veterinarian.

Scientifically speaking, tramadol is a member of the opioid family, which means it alters the transmission and perception of pain in humans and animals. In addition, tramadol inhibits the reuptake of norepinephrine and serotonin in the dog’s brain, which increases the level of these chemicals in the bloodstream, and creates that feeling of euphoria and well-being that human patients sometimes experience.

What Is Tramadol Used for in Veterinary Medicine?

Like most opioids, tramadol is used to treat pain. The Merck Veterinary Manual recommends using tramadol to treat “acute and chronic pain of moderate to severe intensity,” which could mean anything from helping your dog recover from surgery or as a way to help manage the pain associated with osteoarthritis when taken with other medications.

Your veterinarian might prescribe tramadol if your dog has any of the following causes of pain:

  • Osteoarthritis
  • Nonsurgical intervertebral disc disease
  • Cancer
  • Lameness
  • Post-operative pain
  • General pain from an injury or another condition

Other uses includes treating:

  • Anxiety
  • Coughing
  • Canine degenerative myelopathy (progressive disease of the spinal cord)

Tramadol does not have the anti-inflammatory properties associated with nonsteroidal anti-inflammatory drugs (NSAIDs). It does not treat the underlying cause of the pain. Instead, it alters the way the body perceives pain, giving the patient some relief. As a result, it is often used in conjunction with another drug, such as the NSAID carprofen (Rimadyl), or as an additional pain management strategy for chronic conditions.

Side Effects of Tramadol in Dogs

Like most medications, tramadol has side effects. Most dogs tolerate tramadol well, as long as the dosage instructions are followed properly, but there are a few adverse reactions you should be aware of.

These reactions range in severity, but play it safe and call your veterinarian if your dog experiences any of these tramadol side effects.

Overdose of Tramadol In Dogs

Adverse reactions aren’t the only thing owners need to worry about when it comes to medications. Overdoses happen. Sometimes dogs get into things that they should not, like medication, or well-meaning pet sitters or family members accidentally give dogs a higher dose than prescribed. These reactions are serious. Here are the symptoms of a tramadol overdose that you need to be aware of:

  • Respiratory depression
  • Lethargy
  • Vomiting
  • Decreased heart rate
  • Tremors
  • Sleepiness
  • Seizures
  • Excessive drooling
  • Sedation
  • Agitation
  • Dilated pupils
  • Ataxia (uncontrollable movement)
  • Loss of consciousness
  • Coma

If you notice any of these symptoms, stop giving tramadol and call your veterinarian immediately.

Tramadol Dosage for Dogs

Tramadol requires a prescription and is a class 4 controlled substance. The only way to get tramadol for your dog is a prescription from your veterinarian. As tempting as it might be to pop your dog a pill from a human tramadol prescription, remember that dosages for dogs differ greatly from those for humans, and giving your dog tramadol outside of the guidance of a veterinarian could result in a tramadol overdose.

Owners should never attempt to calculate the dosage of tramadol for their dogs without a veterinarian. Veterinarians calculate tramadol dosages based on weight, but they also take into consideration other components of your dog’s health, such as pre-existing conditions and liver values, and the cause of the pain itself. The dosage for chronic pain, for instance, might be different from the dosage used to treat acute pain.

What Dogs Should Not Take Tramadol?

Most drugs have counter-indications, drug interactions, and safety restrictions. While tramadol is relatively safe, there are some exceptions.

Tramadol’s effects on serotonin uptake means that some dogs should avoid tramadol unless a veterinarian states otherwise, as it can result in drug interactions. Tramadol can also pass from a mother to her pups, and there have been instances of tramadol increasing seizure activity in dogs with pre-existing conditions.

Ask your veterinarian if tramadol is right for your dog, if your dog meets the following criteria:

  • Dogs taking monoamine oxidase inhibitors (MAOIs), like the drug selegiline, used to treat canine cognitive dysfunction and pituitary dependent hyperadrenocorticism (Cushing’s Disease)
  • Dogs taking selective serotonin reuptake inhibitors (SSRIs), like fluoxetine, sertraline, paroxetine, and fluvoxamine
  • Dogs with a history of recent seizures
  • Pregnant or nursing dogs
  • Dogs with liver or kidney disease

Tramadol can help manage your dog’s pain levels and improve his quality of life. Now that you know a little more about tramadol for dogs, don’t hesitate to bring up any questions or concerns you still have with your veterinarian.

Tramadol tablets

What is this medicine?

TRAMADOL (TRA ma dole) is a pain reliever. It is used to treat moderate to severe pain in adults.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Ultram

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • brain tumor
  • depression
  • drug abuse or addiction
  • head injury
  • if you frequently drink alcohol containing drinks
  • kidney disease or trouble passing urine
  • liver disease
  • lung disease, asthma, or breathing problems
  • seizures or epilepsy
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • an unusual or allergic reaction to tramadol, codeine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medication with any of the following medicines:

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

  • alcohol
  • antihistamines for allergy, cough and cold
  • certain medicines for anxiety or sleep
  • certain medicines for depression like amitriptyline, fluoxetine, sertraline
  • certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
  • certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, primidone
  • certain medicines that treat or prevent blood clots like warfarin
  • digoxin
  • furazolidone
  • general anesthetics like halothane, isoflurane, methoxyflurane, propofol
  • linezolid
  • local anesthetics like lidocaine, pramoxine, tetracaine
  • medicines that relax muscles for surgery
  • other narcotic medicines for pain or cough
  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
  • procarbazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care provider if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

There are different types of narcotic medicines (opiates). If you take more than one type at the same time or if you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase or decrease the effects of this medicine. Avoid alcoholic drinks.

You may have constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care provider.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • confusion
  • redness, blistering, peeling or loosening of the skin, including inside the mouth
  • seizures
  • signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
  • trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation
  • dry mouth
  • nausea, vomiting
  • tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

90,000 Does preoperative tramadol provide effective and safe postoperative analgesia in children?

Children experience pain after surgery (“postoperative pain”) and management of this pain is a major challenge in recently published trials. Combining drugs may be the best way to treat postoperative pain, for example drugs called “opioids” such as morphine and codeine. However, there is concern about severe side effects (adverse events) with opioid use.Tramadol is a weak opioid used worldwide to treat children with moderate to severe pain or chronic pain. Tramadol can be given to children before surgery to help relieve postoperative pain. It is believed that the use of tramadol may be associated with a lower risk of respiratory or hemodynamic depression, and therefore tramadol may be an ideal pain reliever for children in the perioperative period. In this review, we attempted to assess the efficacy and adverse events of tramadol versus placebo or other opioids.In July 2014, we found 20 small randomized controlled trials involving 1170 people. These small trials have limited data, but perhaps tramadol may be better than placebo. In five studies, mostly preschool children who underwent minor surgeries (eg, tonsillectomy) received tramadol or placebo prior to surgery. Tramadol-administered children required fewer drugs in the postoperative care unit, indicating better analgesia with tramadol.Due to the small amount of data that could be used for comparing tramadol with other opioids (eg, morphine, nalbuphine, pethidine, fentanyl), the evidence for comparative efficacy is not clear at this time. In general, adverse events identified during trials were poorly reported, so there is no clarity about side effects.

Order of the Ministry of Health of Russia approved the list of medicines for medical use subject to quantitative accounting


The new list has been published and will come into effect on August 16 this year. The previous list has been in effect since 2005 and will be canceled by the same Order (Order of the Ministry of Health of Russia dated April 22, 2014 No. 183n “On approval of the list of medicines for medical use subject to quantitative accounting”).

The new list includes a group of potent and poisonous drugs. At the same time, all medicinal products for medical use listed in the list are subject to quantitative accounting, regardless of their trade name.

Dosage forms for external use – creams, ointments, gels containing snake venom, bee venom, 1-testosterone and its isomer – were removed from the order.

Thus, the List includes three groups of medicines. The first group included pharmaceutical substances and medicinal preparations containing narcotic drugs, psychotropic substances and their precursors (their salts, isomers, stereoisomers) included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation. Federation, in combination with pharmacologically inactive substances.

The second group includes pharmaceutical substances and drugs containing potent and poisonous substances (their salts, isomers, ethers and esters, mixtures and solutions, regardless of concentration) included in the lists of potent and poisonous substances for the purposes of Article 234 and other articles of the Criminal of the Code of the Russian Federation, in combination with pharmacologically inactive substances, as well as one combined medicinal product containing the potent substance Tramadol in an amount of 37.5 mg in combination with the pharmacologically active substance Paracetamol.

The third group consists of combined medicinal preparations containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances, and dispensed according to prescriptions written out on prescription forms of registration form No. 148-1 / u-88.

At the same time, the procedure for dispensing drugs of the 1st and 3rd groups does not change, only their accounting is introduced, since the drugs have already been dispensed on special forms of forms No. 148-1 / y-88.And drugs of the 2nd group, which until now have been dispensed with a prescription written on prescription forms No. 107-1 / y, must be released if there is a prescription form No. 148-1 / u-88, as required by the Order of the Ministry of Health of Russia dated 20.12. .2012 No. 1175n “On approval of the procedure for prescribing and prescribing medicinal products, as well as forms of prescription forms for medicinal products, the procedure for preparing these forms, recording and storing them.”

In particular, this applies to a number of hormonal drugs, drugs used for obesity and in gynecology (for example, drugs containing sibutramine, danazol, gestrinone).The Ministry of Health of Russia pays special attention to this fact of the regional executive authorities in the field of health care and medical workers and asks to take this into account in their work. The relevant information letters (No. 1152, No. 1119) were posted by the Russian Ministry of Health on the procurement portal for seven costly nosologies.

“It is important to note, – comments Elena Maksimkina, Director of the Department of Pharmaceutical Provision and Regulation of the Circulation of Medical Devices, – that the List will be supplemented in connection with proposals to include other medicines, the circulation of which must be controlled.They will be included in accordance with the regulations prescribed in the Order of the Ministry of Health of Russia dated January 20, 2014 No. 30n “On approval of the procedure for including drugs for medical use in the list of drugs for medical use subject to quantitative accounting” by the decision of the interdepartmental commission, which includes representatives of the Ministry of Health of Russia, the Ministry of Industry and Trade of Russia, Roszdravnadzor and the Federal Drug Control Service ”.

In addition, in accordance with the new Order, the following are recognized as invalid: Appendix No. 1 to the Procedure for the Dispensing of Medicines, approved by order of the Ministry of Health and Social Development of Russia dated December 14, 2005 No.No. 785, and other orders of the Ministry of Health and Social Development of Russia (dated October 13, 2006 No. 703, dated February 12, 2007 No. 109, dated August 6, 2007 No. 521), amending the above Appendix.

Violation of the requirements for maintaining subject-quantitative accounting is a gross violation of licensing requirements in the implementation of pharmaceutical activities and entails administrative liability in accordance with Article 14.1 (clause 4) of the Code of Administrative Offenses of the Russian Federation.

Link to published order: http://www.rg.ru/2014/08/05/lekarstva-dok.html

Categories: List of Medicines; circulation of medicines.

TRAMADOL tablets – instructions for use, price, dosages, analogs, contraindications, reviews

Active ingredient

– tramadol hydrochloride (tramadol)

Composition and release form of the drug

Tablets white or almost white, round, flat-cylindrical, chamfered and scored.

1 tab.
tramadol hydrochloride 50 mg

Excipients: potato starch 50 mg, lactose monohydrate 147.5 mg, magnesium stearate 2.5 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Pharmacological action

Opioid analgesic, cyclohexanol derivative. Non-selective agonist of μ-, Δ- and κ-receptors in the central nervous system. It is a racemate of (+) and (-) isomers (50% each), which are involved in various ways in the analgesic effect. Isomer (+) is a pure agonist of opioid receptors, has a low tropism and does not have a pronounced selectivity in relation to various receptor subtypes. Isomer (-), inhibiting the neuronal seizure of norepinephrine, activates descending noradrenergic influences.Due to this, the transmission of pain impulses to the gelatinous substance of the spinal cord is disrupted.

Causes sedation. In therapeutic doses, it practically does not depress respiration. It has an antitussive effect.

Related news

Pharmacokinetics

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract (about 90%). C max in plasma is achieved 2 hours after oral administration. Bioavailability with a single dose is 68% and increases with repeated use.

Plasma protein binding – 20%. Tramadol is widely distributed in tissues. V d after oral administration and intravenous administration is 306 liters and 203 liters, respectively. Penetrates through the placental barrier at a concentration equal to the concentration of the active substance in the plasma. 0.1% is excreted in breast milk.

Metabolized by demethylation and conjugation of up to 11 metabolites, of which only 1 is active.

It is excreted by the kidneys – 90% and through the intestines – 10%.

Indications

Moderate and severe pain syndrome of various origins (including with malignant tumors, acute myocardial infarction, neuralgia, trauma). Carrying out painful diagnostic or therapeutic procedures.

Contraindications

Acute alcohol intoxication and drugs that have a depressing effect on the central nervous system, children under 1 year of age, hypersensitivity to tramadol.

Dosage

For adults and children over 14 years of age, a single dose for oral administration is 50 mg, rectally – 100 mg, intravenously slowly or intramuscularly – 50-100 mg.If, with parenteral administration, the effectiveness is insufficient, then after 20-30 minutes, oral administration in a dose of 50 mg is possible.

For children aged 1 to 14 years, the dose is set at the rate of 1-2 mg / kg.

The duration of treatment is determined individually.

Maximum dose: for adults and children over 14 years old, regardless of the route of administration – 400 mg / day.

Side effects

From the side of the central nervous system: dizziness, weakness, drowsiness, confusion; in some cases – seizures of cerebral genesis (with intravenous administration in high doses or with the simultaneous administration of antipsychotics).

From the cardiovascular system: tachycardia, orthostatic hypotension, collapse.

From the digestive system: dry mouth, nausea, vomiting.

From the side of metabolism: increased sweating.

From the musculoskeletal system: muscle weakness.

Drug interaction

With simultaneous use with drugs that have a depressing effect on the central nervous system, with ethanol, an increase in the inhibitory effect on the central nervous system is possible.

With simultaneous use with MAO inhibitors, there is a possibility of developing serotonin syndrome.

With simultaneous use with serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics, and other drugs that reduce the seizure threshold, the risk of seizures increases.

With simultaneous use, the anticoagulant effect of warfarin and phenprocoumon is enhanced.

With simultaneous use with carbamazepine, the concentration of tramadol in the blood plasma and its analgesic effect decrease.

With simultaneous use with paroxetine, cases of the development of serotonin syndrome, seizures have been described.

With simultaneous use with sertraline, fluoxetine, cases of the development of serotonin syndrome have been described.

With simultaneous use, there is a possibility of a decrease in the analgesic effect of opioid analgesics. Long-term use of opioid analgesics or barbiturates stimulates the development of cross-tolerance.

Naloxone activates respiration, eliminating analgesia after using opioid analgesics.

Special instructions

It should be used with caution in case of seizures of central origin, drug addiction, confusion, in patients with impaired renal and hepatic function, as well as in case of hypersensitivity to other agonists of opioid receptors.

Tramadol should not be used for longer than the period justified from a therapeutic point of view. In the case of long-term treatment, the possibility of the development of drug dependence cannot be ruled out.

Not recommended for the treatment of drug withdrawal.

Combinations with MAO inhibitors should be avoided.

Avoid drinking alcohol during treatment.

Tramadol in the form of extended-release dosage forms should not be used in children under the age of 14.

Influence on the ability to drive vehicles and mechanisms

During the period of use of tramadol, it is not recommended to engage in activities that require increased attention, high speed of psychomotor reactions.

Pregnancy and lactation

During pregnancy, prolonged use of tramadol should be avoided due to the risk of developing addiction in the fetus and the occurrence of withdrawal syndrome in the neonatal period.

If it is necessary to use it during lactation (breastfeeding), it should be borne in mind that tramadol is excreted in small quantities in breast milk.

Use in children

Contraindicated in children under 1 year of age.For children aged 1 to 14 years, the dose is set at the rate of 1-2 mg / kg.

Tramadol in the form of extended-release dosage forms should not be used in children under the age of 14.

In case of impaired renal function

Use with caution in patients with impaired renal function.

In case of impaired liver function

Use with caution in patients with impaired liver function.

The description of the TRAMADOL preparation is based on the officially approved instructions for use and approved by the manufacturer.

The price information provided for the drugs does not constitute an offer to sell or buy a product. The information is intended solely for comparing prices in inpatient pharmacies operating in accordance with Article 55 of the Federal Law “On Circulation of Medicines”.

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The potent substance tramadol did not get to the Trans-Baikal Territory – Customs News of Siberia dated 01.21.2016

News of Siberia

The weight of the detained drugs was 6.860 grams.At this time, the goods have been seized and placed in the evidence storage room.

The Trans-Baikal customs post initiated a criminal case under Part No.1 article 226.1 of the Criminal Code of the Russian Federation “Smuggling of potent, poisonous, poisonous substances …” in relation to a Russian citizen who imported drugs from China to Russia – 20 tablets, manufactured in China. The examination established that the detained drugs are a potent substance – tramadol (tramal). The weight of the detained drugs was 6.860 grams. At this time, the goods have been seized and placed in the evidence storage room.

Reference: Tramadol is a centrally acting synthetic opioid analgesic widely used for pain relief in therapy and surgery.Large doses of tramadol cause drug intoxication. The constant use of tramadol leads to increased intracranial pressure, epilepsy, and renal dysfunction. Tramadol is a potent substance that is prohibited for free distribution on the territory of the Russian Federation.

Chita customs

90,000 Tramadol is a drug.The effects of addiction | “Narcological Center No. 1” in Nizhny Novgorod

In order to experience euphoria, drug addicts use various medical devices. A pharmacy drug called Tramadol is very popular. This drug in large doses is addictive and addictive. The first use of the drug disrupts the work of the psyche and internal organs. For this reason, it is very dangerous to use Tramadol. A large number of people whose relatives have encountered drug addiction with this drug apply to our Narcological Center No. 1 in Nizhny Novgorod.

Pharmacy drug belongs to the group of narcotic opioid analgesics. Once upon a time, people purchased it freely in pharmacies. Today, this tool is gradually disappearing from circulation. The medicine is available in several forms: capsules, ampoules, rectal suppositories and injections. Doctors prescribe Tramadol to patients with severe pain in the last stages of the disease. If earlier a medicine was used to treat drug addiction, today half of the patients in drug addiction institutions come with a dependence on this drug.Unfortunately, most of them are schoolchildren. Today Tramodol has categorical restrictions.

Tramadol is a synthetic opiate for heroin that causes overdose. As a result, the addict can suffer paralysis, amputation of limbs, serious damage to the central nervous system and even death. The specialists of our center state the fact that many drug addicts use this drug when they cannot get heroin.

Composition of Tramadol and its action

The composition of the preparation may differ from each other.This is due to the different form of release. The active ingredient in Tramadol is hydrochloride. The auxiliary components of the medicine are magnesium stearate, milk sugar, distilled water, sodium acetate.

After the substance enters the bloodstream, it begins to affect the nervous system. Tramadol dulls pain, stimulates receptors. As a result, the pain syndrome stops. The use of a medicine on the recommendation of a specialist cannot lead to side effects.

In case of excessive use of Tramadol, a person experiences drug intoxication.Among the side effects of the drug:

  • Hallucinations;
  • Arrhythmia;
  • Headaches;
  • Inhibition.

The drug Tarmadol, being a narcotic drug, can have a powerful analgesic effect. The agent dissolves in the human body very quickly, literally in a couple of minutes, and acts for a long time. The activity of the drug is much less than morphine, so drug addicts use it in large doses. A person feels a state of euphoria for 36 hours.But the more often the patient uses the remedy, the more rapidly the effect weakens. After a while, narcotic intoxication disappears after 5 minutes.

Most drug addicts use the drug in capsules, less often injections. The state of narcotic intoxication is accompanied by:

  • Impression;
  • Excessive responsiveness;
  • Goodwill towards everyone around you, even enemies;
  • Cheerfulness;
  • Swagger.

Prolonged use of Tramadol leads to fear of loneliness, nightmares, paranoia, persecution mania.After just one week of taking the drug, the person begins to see hallucinations. During the examination, specialists learn that patients have seen unusual creatures. Such hallucinations are perceived by drug addicts as a fun adventure.

How does Tramadol addiction develop?

The use of Tramadol in therapeutic doses does not lead to dependence. But when the dose is increased, the person begins to feel changes at the psychological and physical levels. Three months of use becomes a real drug for the addict.It will be very difficult for a patient to overcome the craving for Tramadol without outside help. The specialists of the Novgorod center specialize in the treatment of tramadol addiction. The experience of our doctors shows that the complete cleansing of the addict’s body takes place for many years.

Inpatient treatment takes place quite rapidly – from one week to a month. If a person is not supported after treatment, the likelihood of a return to addiction is very high. Highly qualified specialists devote a lot of time to this issue.

Abrupt rejection of Tramadol leads a person to severe withdrawal. It can last from 20 to 30 days. Our experts characterize withdrawal symptoms as increased hallucinations. The patient sees more and more terrible pictures. After a while, the addict develops such mental disorders as:

  • Suicidal thoughts, depression;
  • Unreasonable aggression;
  • Hysterics;
  • Irritability.

The state of withdrawal syndrome for a patient is a heightened sense of guilt and shame.A person is afraid of his actions, both real and imaginary. Because of this, the patient begins to show aggression and anger towards relatives and friends. The patient experiences physically excruciating symptoms. These include:

  • Headache;
  • High blood pressure;
  • Chills, fever;
  • Excessive sweating;
  • Body aches;
  • Soreness in the muscles;
  • Arrhythmia.

Specialists observe severe weakness in drug addicts.Many have difficulty in doing anything, so they need outside help. Also, our doctors note a complete loss of appetite and sleep. Almost all abstinence a person lies in bed. In the evenings and at night, patients experience an aggravation of all symptoms.

Signs of using Tramadol

Due to the fact that the drug belongs to psychoactive drugs, it manifests itself in strange behavior. They are all individual. Specialists of the Novgorod Narcological Center No. 1 distinguish the following:

  • Lethargy, excessive activity;
  • Insomnia;
  • Apathy;
  • Seclusion;
  • Memory degradation;
  • Aggravated reaction;
  • Mood variability;
  • Deceit;
  • Untidiness;
  • Questionable environment;
  • Debts;
  • Theft.

You can also notice in drug addicts:

  • Dilated pupils;
  • Cloudy look;
  • Red eyes;
  • Pale or red skin color;
  • Rash;
  • Excessive thinness or excessive fatness;
  • Fast or very slow speech;
  • Gesturing;
  • Drunken gait.

Consequences of the use of Tramadol

The extensive experience of the specialists of our institution suggests that the bone tissue of drug addicts is very weak after just one year of using the drug Tramadol.This can lead to serious consequences such as multiple fractures and injuries, hair and teeth loss.

An addict who uses Tramadol and does not want to be treated can die in 3-4 years. Successful rehabilitation cannot completely heal a person, the consequences persist throughout life.

After two years of taking a narcotic drug, experts identify the patient with the most serious diseases: epilepsy, hepatitis, dementia, cirrhosis of the liver. There are also deviations in the psyche.The doctors of our center refer to them: obsession, paranoia, irritability, euphoria, depression. If you do not turn to specialists in time, the consequences of addiction will be very serious.

Statistics from the Narcological Center # 1 show that many drug addicts die from overdose during breakdowns. About 9% of patients using Tramadol commit suicide at the time of withdrawal. Some drug addicts die from damage to internal organs. Drug intoxication also often leads to accidents leading to death.

Overdose and poisoning from Tramadol

An overdose of the drug leads to severe intoxication, which is characterized by certain symptoms. The specialists of the narcological center No. 1 refer to them as:

  • Vomiting;
  • Difficulty swallowing;
  • Breathing severity;
  • Visual impairment;
  • Rashes;
  • Blue lips and skin;
  • Decrease in pain threshold;
  • Fainting;
  • Epileptic seizures;
  • Slow heartbeat.

If you or your loved one is poisoned by the drug Tramadol, you should immediately contact our Narcological Center No. 1 in Nizhny Novgorod. Clinic specialists urgently hospitalize a drug addict in an institution. During the time when a person enters the walls of our center, qualified doctors will perform a pulmonary ventilation procedure, as well as select the most effective symptomatic therapy for a particular case.

How is Tramadol addiction treated?

In the process of treating addiction in patients from the drug Tramadol, the specialists of our center use the same methods as for opium addiction.Rehabilitation in a specialized institution is an obligatory stage of complete healing.

Doctors of our center carry out addiction treatment in several stages:

  • Detoxification;
  • Firming therapy;
  • Active healing process;
  • Supportive care.

The detoxification process takes three to four weeks. At this stage, the patient takes the necessary vitamins, glucose, nootropics, blood substitutes.Also, doctors pay special attention to symptomatic treatment. In necessary cases, analeptics and medicines are prescribed to the patient. Thanks to them, the respiratory function is normalized, the work of the heart is restored.

The main condition that our specialists set for patients is a complete and categorical refusal to take the drug Tramadol. Withdrawal symptoms caused by this drug are relieved by pyrroxan and clonidine. In order to eliminate psychosis, the doctors of the Narcological Center No. 1 resort to tranquilizers.

During the rehabilitation process, the specialists of our center reveal in the ward the restoration of all body functions, behavior correction, suppression of craving for Tramadol. At this stage, the wards of our center use antipsychotics and antidepressants, as well as nootropics. Specialists also influence the patient through psychotherapeutic methods. These include group and individual lessons.

The final stage – anti-relapse – is the longest and most difficult.Supportive therapy is aimed at keeping the achieved result. After being discharged from our Narcological Center No. 1 in Nizhny Novgorod, the patient will have to continue treatment and attend psychotherapeutic sessions. Also, the patient must follow all the instructions of our doctors. The anti-relapse stage can last up to 5 years.

Novgorod Narcological Center No. 1 works to help people.

Do not postpone treatment until tomorrow, call us today!

8 (831) 281-60-30

8 (952) 453-12-13

Tramadol (Ultram) – pain reliever for dogs: dosage, side effects

Tramadol (Ultram) is a powerful synthetic pain reliever that has an analgesic (opioid) effect by binding to mu opioid receptors and inhibiting the reuptake of chemicals known as serotonin and norepinephrine in the brain.

The drug is used to treat dogs with moderate to moderately severe pain, both in the short and long term, as well as in the postoperative period to reduce pain. Tramadol is often prescribed for older dogs who are in severe pain.

What is it used for?

Veterinarians sometimes prescribe Tramadol for dogs with arthritis or pain in general (which can be caused by surgery, dental problems, cancer, etc.).

The drug is used to treat:

  • disturbances,
  • degenerative myelopathy (severe progressive neurodegenerative disease that leads to paralysis of the lower limbs),
  • cough.

It is rarely used in anxiety, as there are safer alternatives such as Zilken and Benadryl for this purpose.

Recommended dosage of tramadol for dogs

Tramadol is a prescription drug that can have serious consequences if misused. Never give a drug to a dog without a veterinarian’s prescription.

An experienced specialist will help you choose the most appropriate form of drug administration and correctly calculate the dosage.

The recommended dose for dogs is 1.1 mg / kg to 9.9 mg / kg given orally every 8-12 hours. It is possible to adjust the doses of the drug taking into account the clinical picture.

For example , for pain associated with cancer, a higher dose is recommended, while a dose of about 2.2 mg / kg is recommended for relief of moderate pain.

Adding medicine to food can help mask the bitter taste and prevent vomiting.

Pain relief effects may not develop immediately and may take up to 2 weeks in chronic conditions such as degenerative joint disease and cancer.

The best results are observed when the drug is administered with non-steroidal anti-inflammatory drugs (NSAIDs), such as firocoxib, or other drugs, such as gabapentin or amantadine (depending on the condition being treated).

Sustained-release capsules are not given to animals, but if they are used for any reason, it is important that the capsules are swallowed whole.If they are broken or chewed, overdose symptoms may occur.

It is possible to use the drug both intravenously (into the bloodstream) and subcutaneously (under the skin). Both injection methods are equally effective, but the intravenous injection starts to work faster.

Will my dog ​​get addicted to Tramadol?

If the drug is used for long periods of time, the regular dose may become ineffective. In this case, it is recommended to prescribe additional medications (such as NSAIDs) together.
As a rule, it is recommended to use Tramadol for short-term pain relief – for example, after surgery.

Double action of the drug


Some Tramadol products, especially those formulated for humans, contain additional active ingredients. Plain Tramadol is most effective for treating dogs, as some of the more common added ingredients (such as the acetaminophen in Ultracet) can be dangerous if taken in inappropriate doses.

Example: acetaminophen is dosed from 9.9 to 14.3 mg / kg. Ultracet contains Tramadol at 37.5 mg and acetaminophen at 325 mg (a dose that would be above the recommended range for dogs up to 22.7 kg).

How to wean from a medicine?

Although physical dependence is less common, the drug should be weaned gradually after prolonged periods of use.

Example: 2.2 mg / kg to a 22.7 kg dog can be given 50 mg every 12 hours.In other words, one 50 mg tablet twice a day.

Is it safe?

Well tolerated in dogs, with sedation being the most common side effect.

This medicine can cause serious side effects if used improperly.

Tramadol is not suitable for dogs with liver and kidney disease (in rare cases it can be prescribed, but the dosage must be adjusted), since these organs are responsible for the metabolism of the drug.

Dogs with insufficient lung function, seizures or sensitivity to other opioids are also contraindicated.

Tramadol should not be given to dogs taking MAOs (monoamine oxidase inhibitors) or SSRIs (antidepressants). Dogs taking medications that lower the seizure threshold or depress the central nervous and respiratory systems are at a higher risk of side effects.

May not be suitable for severely debilitated or elderly dogs.

Pregnancy and nursing

Tramadol passes into milk in small quantities and has been shown to be embryotoxic and fetotoxic (congenital malformations, growth disorders, intrauterine death) at high doses.
It is not suitable for pregnant or lactating dogs.

Safety Rules

The drug is dispensed strictly according to the prescription of a veterinarian. Tell the healthcare professional about any medical conditions your pet is suffering from, and any medications or supplements your pet is taking.

In particular, MAO and SSRIs should be avoided during treatment, and the use of digoxin with Tramadol is associated with toxicity.

What if my pet is not responding well?

Using Tramadol only as directed by your veterinarian can help reduce the chance of serious reactions, although it is important to be able to recognize the signs of a bad reaction and act quickly.

If your pet develops problems such as difficulty breathing or an irregular heartbeat, you should contact your veterinarian immediately.Overdose can be especially dangerous.

Side effects

Tramadol is generally well tolerated and does not cause hazardous reactions when used correctly.

Common side effects when using Tramadol include:

  • nausea / vomiting,
  • loss of coordination,
  • sedation;

rare:

  • diarrhea,
  • pruritus,
  • rash,
  • blurred vision,
  • heart rhythm disturbance,
  • loss of appetite,
  • constipation,
  • dizziness,
  • fainting,
  • seizures,
  • anxiety,
  • shortness of breath.

Most side effects are the result of Tramadol’s central nervous system effects, while other symptoms such as constipation are less common and are more common with long-term treatment.

Serious adverse reactions such as breathing difficulties or allergy symptoms (diarrhea, itching, rash, irregular heartbeat) require immediate veterinary attention.

Overdose

Become familiar with overdose symptoms as they can quickly become life threatening.

The first sign of an overdose is usually respiratory depression, which can cause your pet to breathe harder or have trouble breathing.

As this progresses, breathing may become less frequent and chest movements decrease, with pauses of more than 10 seconds between each breath. There will also be signs of drowsiness that can go into a coma. In the worst cases, cardiac arrest and death can occur.

Overdose symptoms include:

  • vomiting,
  • sedation,
  • Howl

  • ,
  • excessive salivation,
  • impaired coordination of movement,
  • respiratory depression,
  • loss of consciousness,
  • cardiac arrest,
  • convulsions,
  • vomiting,
  • shiver.

Overdose is a veterinary emergency.

90,000 Chronicle supply. Mikhail Golichenko – about substitution therapy

At the end of last year, TASS published an article “Skvortsova: Substitution Therapy Creates the Illusion of Safe Drug Use”, where, with reference to the words of the Russian Minister of Health, it was said that “an experiment to introduce substitution therapy in the Russian Federation showed that it creates the illusion of safe drug use ”.This publication again sparked a discussion about whether any experiments on the use of substitution therapy were carried out in Russia.

As defined by the World Health Organization, substitution therapy (most commonly methadone and buprenorphine) is “the administration of rigorously and comprehensively assessed opioid agonists to individuals with opioid dependence, conducted by certified professionals in an approved medical practice, in order to achieve stated treatment goals.”Of the 47 member states of the Council of Europe, this method of drug addiction treatment has been banned only in Russia. In addition to Europe, substitution therapy is successfully used in China, Iran, USA, Canada, Australia. Of the CIS countries, only Russia, Uzbekistan and Turkmenistan still do not use substitution therapy.

Have any experiments with substitution therapy been carried out in Russia? For the first time, the experience of using opiates for the maintenance treatment of drug addiction in the USSR was reported in the March notebook of the journal “Soviet Neurology”, it was about the method of Dr. Kantorovich, about a successful six-year experiment in Leningrad.However, two decades later, the USSR Ministry of Health banned the “system of dispensing drugs to drug addicts.” Historiographic research suggests that the ban was not associated with the emergence of any scientific evidence about the ineffectiveness of the Kantorovich method. Rather, the ban on the distribution of drugs gave way to the main method of Stalin’s work with representatives of objectionable social groups, sending them to the GULAG.

In the period from 1953 to 1994, there were no studies or pilot projects that could directly or indirectly be attributed to substitution therapy in the USSR and Russia.In September 1994, the Russian Federal Service for Intellectual Property, Patents and Trademarks registered a patent on the use of tramal maintenance therapy at a dose of 100–300 mg per day for up to 6–12 months as a way to relieve withdrawal symptoms in patients with opium addiction. Among the authors is Evgeny Brun, the current chief freelance psychiatrist-narcologist of the Russian Ministry of Health.

Soviet Russia may have been one of the first countries in the world where the method of substitution therapy was successfully tested

However, in August 1995, an order of the Ministry of Healthcare and Medical Industry reaffirmed the ban on the use of drugs for therapeutic purposes in the treatment of drug addiction, including the issuance of drugs to drug addicts (“drug rations”) in any form.In 1998, a federal law, and 12 years later, a decree of the President of Russia confirmed this ban. Tramadol is currently on the list of drugs for use in specialized medical care for withdrawal symptoms caused by the use of psychoactive substances. According to the testimony of patients with experience of participating in substitution maintenance therapy programs abroad, the appointment of tramadol cannot be considered an analogue of substitution therapy.

There is evidence that in 2005, on the basis of the National Scientific Center for Addictions, a study of the method of drug addiction treatment with the use of nalbuphine was carried out.However, according to the testimony of a participant in this project, the experiments were ineffective. There is also information about attempts by some narcologists to use the antiepileptic drug pregabalin (trade name in Russia – “Lyrica”) to relieve withdrawal symptoms. These experiments also had low efficiency.

At the same time, in the United States and European countries, since the 1960s, the method of substitution maintenance therapy has become widespread and has become the subject of numerous scientific studies that have confirmed its effectiveness for the treatment of opium addiction.Since the mid-1980s, substitution therapy has gained wider acceptance as the most effective method of preventing HIV infection among injecting drug users. Soviet Russia may have been one of the first countries in the world (along with Great Britain) where the method of substitution therapy (“supplying the chronicles”) was successfully tested and recommended for use. However, from about the 1950s to the 1960s, Soviet and then Russian psychiatry and narcology banned the method of substitution therapy, while this method continued to develop in foreign countries.There are no data on any scientific research or pilot projects of substitution therapy in Soviet and post-Soviet Russia after 1936. It can be argued with a high probability that they did not exist for ideological and political reasons.

The author thanks the coordinator of the Eurasian Network of People Who Use Drugs Alexander Levin and the coordinator of the Berlin Network of People Who Use Drugs Larisa Solovieva for the help in preparing the material

Mikhail Golichenko – lawyer, candidate of legal sciences

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