Is tramadol a narcotic drug and why do drug addicts use it. Tramadol tablets - instructions for use

Tramadol tablets belong to the group of psychotropic opioid analgesics. This is a very strong drug that provides a quick and long-lasting analgesic effect. However, the drug is several times less effective than morphine, famous representative narcotic analgesics. In Russia, Tramadol is included in the list of essential drugs, but since it is a narcotic drug, its circulation is tightly controlled and regulated by the state drug control service.

Tramadol: description of the principle of action

Tramadol is a synthetic opioid analgesic that provides long-term pain relief. This tool directly affects the central nervous system and spinal cord, blocking the conduction of pain impulses and enhancing the effects of other sedatives. The drug activates opioid receptors in the brain and gastrointestinal tract, prevents the destruction of catecholamines and maintains their concentration in the central nervous system, and also initiates the opening of calcium and potassium channels.

In therapeutic doses, Tramadol does not have a pronounced effect on hemodynamics and respiratory system, does not cause pressure changes in pulmonary artery, but can slightly slow down intestinal motility. In addition to the analgesic effect, the drug has a mild sedative (calming) and antitussive effect.

The therapeutic effect occurs within 15-30 minutes after taking the pill and lasts for 6-8 hours. The danger of this remedy is that with prolonged use of Tramadol, it can provoke the development of drug dependence.

The drug, when taken orally, is rapidly absorbed from the gastrointestinal tract, its bioavailability reaches 68%, and when administered intramuscularly it is 100%. The active substance, tramadol hydrochloride, easily crosses the placenta, the blood-brain barrier and is excreted with breast milk. The drug is metabolized in the liver and excreted by the kidneys.

Tramadol: release forms, composition

Tramadol is available in a variety of dosage forms:

Tablets (50 and 100 mg);
Capsules (50 and 100 mg);
Solution in ampoules (for injection);
Drops for oral administration;
Suppositories rectal (100 mg).

Tramadol tablets are round, flat, white, slightly rough, with subtle inclusions and the smell of strawberries. Contain 50 or 100 mg of the active substance - tramadol + auxiliary components.

Capsules Tramadol - in a hard gelatinous shell of white color with a green cap, filled inside with a white powder. They also contain 50 or 100 mg of the active substance + auxiliary components. Tablets and capsules are packaged in 10 pieces in blisters or blisters and cardboard boxes.

Drops Tramadol - transparent, colorless, intended for oral intake. In addition to the main substance, they contain sucrose, glycerin, anise and mint oil, which gives them a pleasant, refreshing taste.

Tramadol in ampoules is a clear, colorless solution for injection. Produced in glass ampoules of 1 and 2 ml, which contain, respectively, 50 and 100 mg of the active substance + water for injection and sodium acetate.

Indications

Tramadol is designed to relieve pain of moderate to severe intensity. Such painful sensations can occur in the postoperative and post-traumatic period or manifest themselves in vascular, inflammatory disorders or oncological diseases.

In addition, the doctor may prescribe Tramadol before carrying out a diagnostic or therapeutic procedure, accompanied by severe pain.

Contraindications

There are a number of restrictions on the use of the drug. Tramadol is contraindicated in the following conditions:

severe forms of renal and hepatic insufficiency;
period of pregnancy and lactation;
age up to 14 years;
hypersensitivity to the components of the drug;
conditions accompanied by depression of the central nervous system and respiratory functions. These include: alcohol intoxication, poisoning with sleeping pills, any psychotropic drugs or other opioid analgesics.

The drug can not be used simultaneously with MAO inhibitors, Tramadol can be prescribed only 2 weeks after their cancellation. With extreme caution, this medication should be used for various disorders of consciousness, traumatic brain injury, an attack of intracranial hypertension, epileptic syndrome and other conditions accompanied by a loss of control over oneself and the functions of the respiratory system.

Instructions for use

Instructions for use of Tramadol tablets indicate that the doctor should select the optimal dosage of the drug individually, taking into account the intensity and nature of the pain syndrome. The standard dose for adults and adolescents (over 14 years of age) is 50 mg. The tablet is taken orally and washed down with a small amount of liquid, regardless of the meal. If the therapeutic effect is insignificant, after 1 hour you can take another tablet of Tramadol.

With intense pain, the initial dose of the drug can immediately be 100 mg. The analgesic effect after taking the drug persists for 4 to 8 hours. The maximum daily dose for an adult should not exceed 8 tablets (400 mg). For elderly or debilitated patients with diseases associated with impaired functioning of the kidneys and liver, the time interval between doses of the drug should be increased.

Tramadol capsules are taken in the same way as tablets, in the same dosage and under the supervision of a physician. The capsule should be swallowed without chewing with a sufficient amount of liquid.

The initial dose of Tramadol solution for oral administration is 20 drops. They can be dripped into a spoon or on a piece of sugar, taken and washed down with water. If there is no desired effect, after 60 minutes you can drink this dose again. In the future, the interval between taking the next dose of the drug should be 4-8 hours. A day you can take no more than 400 mg (160 drops) of the solution.

The drug in drops is approved for use in young children. The dosage is selected by the doctor individually, at the rate of 1-2 mg of the drug per 1 kg of body weight.

Tramadol in ampoules is intended for subcutaneous, intramuscular or intravenous administration. Intravenously, the drug is administered very slowly, a single dose is 50-100 mg. The maximum daily dose should not exceed 400 mg. The duration of the course of treatment is determined by the specialist individually, taking into account many factors (the patient's condition, the severity of the pain syndrome, the nature of the disease), but the drug should not be used longer than the period justified from a therapeutic point of view, so as not to cause addiction and drug dependence.

For treatment severe pain accompanying oncological diseases or conditions in the postoperative period, the doctor may increase the dose of the drug. In elderly and debilitated patients with chronic diseases the elimination of the drug may be delayed. Therefore, the time interval between injections of Tramadol can be increased.

Adverse reactions

Tramadol is a serious drug, it should be used only according to indications, since the toxic effect of the drug on the body can lead to the development of the following conditions:

From the side of the heart and blood vessels, such a phenomenon as a decrease in pressure (orthostatic hypotension) is often noted, which can provoke fainting, tachycardia, and collapse.
The central nervous system reacts to taking the drug with dizziness, headache, increased nervousness, or, conversely, lethargy. Patients complain of weakness, increased sweating, sleep disturbance, daytime sleepiness, emotional instability, anxiety. Sometimes it is possible to develop depressive states, confusion, manifestations of amnesia, instability of gait. In severe cases, hallucinations, convulsions, and suicidal attempts were noted.
The digestive system reacts with intestinal disorders (constipation or diarrhea), nausea, abdominal pain, flatulence, dry mouth.
Violations of the urinary system are expressed in difficulty urinating, urinary retention, dysuria.
Often there are allergic reactions, which are manifested by itching, bullous rash or urticaria. In addition, narcotic analgesics can cause a change in taste sensations, failure menstrual cycle in women, visual impairment.
The main danger of opiate analgesics is the risk of addiction. Abrupt discontinuation of the drug causes a withdrawal syndrome. This condition is accompanied by a strong craving for an analgesic, the appearance of muscle cramps, a runny nose, sneezing, and lacrimation. There are digestive disorders, nausea, fever, insomnia, tachycardia, increased pressure. To avoid unpleasant consequences, the drug should not be taken for a long time, and it should be canceled gradually.

An overdose of Tramadol can lead to such dangerous conditions as uncontrollable vomiting, convulsions, depression of the respiratory center, respiratory arrest, collapse, coma. In these cases, urgent health care and carrying out therapeutic measures aimed at maintaining the functions of the respiratory and cardiovascular systems. After the condition improves, symptomatic treatment is carried out.

drug interaction

Tramadol should not be administered simultaneously with NSAIDs (indomethacin, diclofenac), nitroglycerin, MAO inhibitors. When taken simultaneously with barbiturates, there is a decrease in the effectiveness of the drug.

Tramadol should not be taken simultaneously with alcoholic beverages, as it enhances the inhibitory effect of ethanol on the central nervous system. It is impossible to combine an opioid analgesic with furazolidone and antipsychotropic drugs, since such an interaction can lead to seizures.

Tramadol belongs to opioid agonists, but its analgesic power is much weaker than other drugs from this group (morphine, heroin, fentanyl). However, it is capable of causing physical and mental dependence, which is why Tramadol belongs to the class of narcotic drugs that are subject to mandatory control. The drugs in this group are subject to special rules for prescribing, dispensing, transporting, storing and reporting.

With extreme caution and under the supervision of a physician, Tramadol can be used in patients with intracranial pressure, with impaired liver and kidney function, craniocerebral brain injuries. This drug should not be given to people who are addicted to opioids.

Against the background of taking psychotropic or hypnotic drugs, Tramadol can be prescribed only in minimal doses and under the supervision of medical staff. While taking the tablets, you should not drive vehicles or dangerous mechanisms, as the medication slows down the speed of psychomotor reactions.

Analogues

Tramadol has a number of analogues containing the same active substance and providing the same therapeutic effect. This list includes the following drugs:

Tramadol Retard;
Sintradon;
Tramal;
Tramal Retard;
Tramilin.

All drugs belong to the group of opioid analgesics and are prescribed by a doctor to relieve severe pain.

Price

The cost of Tramadol in ampoules is on average 60 rubles per pack, in tablets - from 70 rubles per pack. Tramadol cannot just be bought at a pharmacy, the drug is released only on prescription. The medicine is prescribed on a special prescription form for potent medicines, and only in the case when the pain syndrome cannot be eliminated by others medicines.

Many relatives of seriously ill patients are interested in whether it is possible to buy this drug with delivery via the Internet? This is only possible if the drug company is licensed to sell prescription drugs. But even in this case, there is a high probability that the distributors do not have the authority to sell narcotic analgesics.

Tramal® solution for injection 50 mg/ml is intended for intravenous jet, intramuscular, subcutaneous and intravenous drip administration. Intravenous administration of the solution for injection is carried out by slow stream or drip after dilution in the solution for injection. The procedure for preparing Tramal® solution for injection is described in the section "Calculation of the volume of solution for injection". The doses used depend on the severity of the pain syndrome and the individual sensitivity of the patient. It is necessary to select the minimum effective dose of the drug. In the treatment of chronic pain syndrome, a specific schedule for the administration of the drug should be followed.

Adults and teenagers over 12 years old

A single dose for a single injection of 50-100 mg of tramadol (1-2 ml of solution for injection). If satisfactory analgesia has not occurred 30-60 minutes after the first injection, 50 mg (1 ml) of tramadol may be re-administered.

For severe pain, 100 mg of tramadol is recommended as an initial dose. Depending on the intensity of the pain syndrome, the analgesic effect of tramadol lasts 4-8 hours. In the postoperative period, short-term use of tramadol in doses exceeding those indicated is possible. The maximum daily dose of tramadol should not exceed 400 mg, except in certain clinical cases(for example, in the treatment of pain in cancer patients and in the postoperative period).

Children aged 1 to 12 years

Tramal® in the form of a solution for injection is prescribed in a single dose at the rate of 1-2 mg/kg of the child's body weight. It is necessary to select the minimum effective dose. The total daily dose of tramadol should not exceed 8 mg/kg of the child's body weight or not more than 400 mg per day, the calculation is based on the lowest value.

Elderly patients

In elderly patients (under 75 years of age) who do not have clinically significant hepatic or renal insufficiency, dose adjustment is usually not required. In patients older than 75 years, the excretion of the drug may be slowed down. Therefore, if necessary, increase the interval in the appointment of the drug in accordance with the characteristics of the patient.

Patients with kidney failure or on dialysis and patients with liver failure

In case of impaired renal and / or liver function, the excretion of tramadol from the body is slowed down. If necessary, the interval between doses of the drug should be increased.

Calculation of the volume of solution for injection:

1. To calculate the total dose of tramadol (mg), you need: body weight (kg) x dose (mg/kg).

2. The volume (ml) of the diluted solution for administration is calculated as follows: divide the total dose (mg) by the corresponding concentration of the diluted solution (mg/ml; see table below).

Tramal® 50 mg (50 mg/ml - 1 ml) injection + added diluent

Tramal® 100 mg (50 mg/mg - 2 ml) injection + added diluent

Concentration of diluted solution for injection (mg tramadol/ml)

2 ml + 10 ml

2 ml + 12 ml

2 ml + 14 ml

2 ml + 16 ml

2 ml + 18 ml

In accordance with the calculation, dilute the contents of the ampoule by adding a solvent, mix and inject the calculated volume of the finished solution. Dispose of any unused remainder of the solution for injection.

Duration of therapy

Tramadol should under no circumstances be used longer than necessary. With prolonged use of tramadol, due to the intensity or etiology of the pain syndrome, periodic monitoring is necessary (if necessary, with interruptions in taking the drug) to determine the need for further therapy and optimize the dosing regimen.

Recipe for Tramadol in Latin:

An example of how to write a prescription in Latin for tramal is an opioid analgesic. The use of these drugs is permissible in order to relieve intense pain during surgery. Independent use of this drug is unacceptable. The decision on the appointment is made by a medical council signed by three or more specialists.

Tramal recipe in Latin in tablets:

Rep.: Tab. Tramadoli 0.1 D.t.s.N 30 S. 1 tab. * 2 w.d.

Tramadol prescription in Latin in ampoules

Rp.: Sol. Tramadoli 0.05 - 1.0 D.t.d.N 5 in amp. S. 1-2 ml solution for pain relief

Before use, you should consult with a specialist. Self-medication is unacceptable. The information is intended for medical specialists and students of medical universities.

General information:

Active substance : Tramadol (Tramadolum) (INN)
Pharmacological group: Opioid analgesics
Prescription Form: N 148-1/u-88
Trade names:

Tramadol
Tramal
Sintradon

Important!

Narcotic opioid analgesic is used in traumatology and surgery for relief acute pain and chronic pain. Contraindicated in individual sensitivity, the presence of opiate addiction, when used in parallel with MAO inhibitors, with severe CNS depression, substance abuse.

Name:

Tramadol (Tramadolum)

Pharmacological
action:

Possesses strong analgesic (pain-relieving) activity gives a quick and long lasting effect.
Inferior, however, in activity to morphine at the same doses (it is used, respectively, in large doses).

Indications for
application:

Acute and chronic pain syndrome (strong and moderate) in surgery, obstetrics, oncology, rheumatology, orthopedics, dentistry, neurology;
- with myocardial infarction;
- with ischemia lower extremities;
- before surgical operations (for sedation).

During pregnancy and lactation used only under strict indications.

Prescribe with extreme caution sick:
- with drug addiction;
- with confused consciousness;
- dysfunction of the respiratory center;
- increased intracranial pressure;
- convulsive syndrome of cerebral genesis;
- patients with hypersensitivity to opiates.
- with impaired liver and kidney function.

Mode of application:

Dose dependent on the severity of the disease and the individual sensitivity of the patient. The drug is used as prescribed by a doctor, the dosing regimen is selected individually.

Adults and children over the age of 12 years, 50 mg of tramadol is prescribed per reception with a small amount of liquid. If the effect is insufficient, the same dose can be repeated after 30-60 minutes.
Maximum daily dose is 400 mg.
Multiplicity of application- up to 4 times a day.

Children over 1 year of age tramadol can be prescribed at a dose of 1–2 mg/kg body weight; maximum daily dose is 4–8 mg/kg

In / in slowly administered to adults and children over the age of 12 years with a body weight > 50 kg. The initial dose is 50–100 mg; if there is no effect, the administration can be repeated, but not earlier than after 30–60 minutes; maximum daily dose- 400 mg.
In exceptional cases (in oncology), it is possible to reduce the intervals between injections and increase the daily dose.

Infusion administration: an initial dose of 50–100 mg is administered over 20 minutes, then the infusion is continued at a rate of 12 mg / h.

V / m or s / c: initial dose - 50-100 mg, re-introduced as needed, 50 mg, but not more than the maximum daily dose. Children over the age of 1 year are given 1-2 mg / kg, the maximum daily dose is 4-8 mg / kg.

For the elderly (75 years and older) and patients with renal insufficiency individual dosage is required. When Cl creatinine is less than 30 ml / min and in patients with hepatic insufficiency, a 12-hour interval is required between taking successive doses of the drug.

Side effects:

From the CNS:
- dizziness;
- weakness;
- drowsiness;
- confusion of consciousness;
- in some cases - seizures of cerebral genesis (with intravenous administration in high doses or with the simultaneous appointment of antipsychotics).

From the side of cardio-vascular system :
-tachycardia;
- orthostatic hypotension;
- collapse.

From the side digestive system :
- dry mouth;
- nausea;
- vomit.

From the side of metabolism: increased perspiration.
From the musculoskeletal system: miosis.

Contraindications:

Tramadol should not be given:
- in case of acute alcohol intoxication (poisoning);
- patients with hypersensitivity to narcotic analgesics;
- Patients taking MAO inhibitors.
Children under 14 the drug is not prescribed.

FROM caution should be applied in patients with impaired liver and kidney function.
During the treatment period avoid drinking alcohol.

In case of prolonged use the possibility of developing addiction and drug dependence is not ruled out.

During treatment should refrain from:
- from the use of alcohol;
- vehicle management;
- from working with potentially dangerous mechanisms.

Do not apply for the treatment of withdrawal symptoms in drug addiction.

Interaction
other medicinal
by other means:

Incompatible with solutions:
- diclofenac;
- indomethacin;
- phenylbutazone;
- diazepam;
- flunitrazepam;
- nitroglycerin.
Enhances the effect of funds, which have a depressing effect on the central nervous system, and ethanol.

Inducers of microsomal oxidation (including carbamazepine, barbiturates) reduce the severity of the analgesic effect of tramadol and the duration of its action.

Long-term use opioid analgesics or barbiturates stimulates the development of cross-tolerance.
Anxiolytics enhance the analgesic effect, the duration of anesthesia increases when combined with barbiturates.

Naloxone activates breathing, eliminates the opiate effects caused by the use of opioid analgesics.

MAO inhibitors, furazolidone, procarbazine, neuroleptics while prescribing increase the risk of seizures(decrease in seizure threshold).

Quinidine increases the concentration of tramadol in plasma due to competitive inhibition of the CYP 2D6 isoenzyme.

Pregnancy:

Pregnant the appointment must be made with extreme caution.

Long-term use should be avoided during pregnancy tramadol due to the risk of developing addiction in the fetus and the occurrence of withdrawal syndrome in the neonatal period.

pharmachologic effect

Pharmacodynamics

Tramadol is an opioid analgesic with a central mechanism of action. It is a non-selective full agonist of µ-, β- and k-opioid receptors with high affinity for µ-opioid receptors. The second mechanism of action of tramadol, which enhances its analgesic effect, is the suppression of norepinephrine reuptake by neurons and increased release of serotonin.

Tramadol has an antitussive effect. In therapeutic doses, it does not depress breathing and practically does not affect intestinal motility. The effect on the cardiovascular system is weakly expressed. The analgesic potential of tramadol is 1/10-1/6 of the activity of morphine.

Pharmacokinetics

When taken orally, absorption is about 90%. The half-life is about 0.4 hours. After oral administration, bioavailability is about 68%. Compared to other opioid analgesics, the absolute bioavailability of tramadol is high. The time to reach maximum plasma concentration after oral administration is 2 hours.

Communication with plasma proteins is about 20%. Penetrates through the blood-brain and placental barriers. Small amounts of tramadol and its desmethylated derivative (0.1% and 0.02%, respectively) pass into breast milk.

The metabolism of tramadol involves the isoenzymes CYP3A4 and CYP2D6, the suppression of which by other substances can affect the concentration of tramadol and its active metabolite in the blood. To date, clinically significant interactions with other drugs mediated by this mechanism have not been identified.

Tramadol and its metabolites are excreted primarily in the urine, with an average cumulative renal excretion rate of 90%.

The half-life of tramadol (T1 / 2) is approximately 6 hours, regardless of the route of administration. In patients older than 75 years, the half-life can be increased by 1.4 times; with cirrhosis of the liver up to 13.3 ± 4.9 hours (tramadol), 18.5 ± 9.4 hours (O-desmethyltramadol), in severe cases - up to 22.3 hours and 36 hours, respectively.

T1 / 2 in renal failure (creatinine clearance less than 5 ml / min) - 11 ± 3.2 h (tramadol), 16.9 ± 3 h (O-desmethyltramadol), in severe cases - up to 19.5 h and 43.2 h respectively.

In the liver, it is metabolized by N- and O-demethylation, followed by conjugation with glucuronic acid. Only O-desmethyltramadol has pharmacological activity. There are significant individual differences in the concentration of other metabolites. 11 tramadol metabolites were found in the urine.

At therapeutic doses, the pharmacokinetics of tramadol is linear. The ratio of tramadol concentration in blood serum and analgesic effect is dose-dependent, varying in individual individuals. Tramadol serum levels of 100-300 ng/mL are usually effective.

Indications for use

Pain syndrome of moderate and severe degree of various etiologies (for example, pain in cancer patients, with injuries and in the postoperative period). Painful diagnostic and therapeutic procedures.

Mode of application

inside. The tablets are swallowed whole, regardless of the meal, without chewing, with a sufficient amount of liquid.

The dose should be selected individually depending on the intensity of the pain syndrome and the individual sensitivity of the patient. The recommended doses are indicative. The duration of treatment with the drug is determined individually. When treating, it is always necessary to select the minimum effective dose of the drug. In the treatment of chronic pain syndrome, you should adhere to a certain schedule for taking the drug.

Adults and teenagers over 14 years old

A single dose is 50 mg of tramadol. In case of insufficient analgesic effect, 50 mg of tramadol is taken again after 30-60 minutes. For intense pain, the recommended single dose is 100 mg of tramadol.

Depending on the intensity of the pain syndrome, the analgesic effect usually persists for 4-6 hours. In the postoperative period, short-term use of higher doses of the drug is possible (in early dates after operation).

The daily dose of tramadol - 400 mg should not be exceeded, except in special circumstances (for example, cancer pain or severe postoperative pain).

Patients over 75 years of age

In patients over 75 years of age without clinical manifestations hepatic or renal insufficiency usually does not require a change in the dose of tramadol. In patients of this age group, the excretion of tramadol may be slower. Therefore, if it seems necessary, the interval between doses of the drug can be increased according to the condition of the patient.

Patients with renal insufficiency or those on dialysis and patients with hepatic insufficiency

In case of impaired renal and / or liver function, the excretion of tramadol from the body is slowed down. If necessary, the interval between doses of the drug should be increased.

Duration of therapy

Tramadol should under no circumstances be used longer than necessary. With prolonged use of tramadol, due to the intensity or etiology of the pain syndrome, periodic monitoring is necessary (if necessary with interruptions in taking the drug) to determine the need for further therapy and dose optimization.

Side effects

The most common side effects are nausea and dizziness, observed in more than 10% of patients. Frequency is defined as follows: Very common: >1/10; Common: >1/100, 1/1000, 1/10,000,
Frequency not known: cannot be determined from the available data.

From the side of the cardiovascular system

Infrequently: influence on cardiovascular regulation (palpitations, tachycardia, orthostatic hypotension or collapse). These side effects mainly seen in intravenous administration drug or during significant physical exertion.

Seldom: bradycardia, increased blood pressure.

From the side of metabolism and nutrition

Seldom: changes in appetite.

From the respiratory system

Seldom: respiratory depression, shortness of breath.

There was a deterioration in the condition bronchial asthma however, a causal relationship with the use of the drug has not been established.

From the side nervous system

Often: dizziness.

Often: headache, drowsiness.

Seldom: paresthesia, tremor, convulsions, involuntary muscle contractions, impaired coordination, fainting.

Convulsions are possible after the use of high doses of tramadol and with simultaneous use with drugs that lower the seizure threshold.

Frequency unknown: speech disorders.

From the side of the psyche

Seldom: hallucinations, confusion, sleep disturbances, anxiety and nightmares. After the use of tramadol, various rarely observed adverse reactions from the psyche are possible (depending on the personality characteristics of the patient and the duration of treatment). These adverse drug reactions include mood changes (usually euphoria, sometimes dysphoria), changes in motor activity (usually decreased, sometimes increased), cognitive and perceptual impairment (eg, decision-making, perceptual disturbances). Perhaps the development of drug dependence. Possible withdrawal symptoms are similar to those of opioid withdrawal: agitation, anxiety, nervousness, sleep disturbances, hyperkinesia, tremors, and gastrointestinal symptoms.

Other symptoms that are very rare with tramadol withdrawal include: panic attacks, severe anxiety, hallucinations, paresthesias, tinnitus and other very rare symptoms from the central nervous system (disorientation in time and space, hallucinations, depersonalization, derealization, paranoia).

From the organ of vision

Seldom: Blurred vision.

Frequency unknown: mydriasis.

From the digestive system

Often: nausea.

Often: constipation, dry mouth, vomiting.

Infrequently: vomiting, feeling of heaviness in the epigastrium, flatulence, diarrhea.

From the skin and subcutaneous tissue

Often: sweating.

Infrequently: itching, rash, urticaria.

From the musculoskeletal system

Seldom: muscle weakness.

From the side of the liver and biliary tract

In some cases, there was an increase in the activity of "liver" enzymes in time coinciding with tramadol therapy.

From the side of the kidneys and urinary system

Seldom: urinary disorders (difficulty urinating, dysuria and urinary retention).

From the side of the immune system

Seldom: allergic reactions (shortness of breath, bronchospasm, wheezing, angioedema) and anaphylaxis.

General disorders

Often: increased fatigue.

Contraindications

Hypersensitivity to tramadol or other components of the drug. Acute intoxication with alcohol, sleeping pills, analgesics, opioids or other psychotropic drugs.

The simultaneous use of tramadol with monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as within 14 days after the end of their administration. Epilepsy not amenable to adequate medical control. As a drug for the treatment of opioid withdrawal syndrome. Age up to 14 years.

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:

In patients with drug dependence on opioids.

With traumatic brain injury, in patients in a state of shock, in patients with impaired consciousness of unknown origin, in patients with respiratory disorders and impaired activity of the respiratory center, with increased intracranial pressure.

In patients with established severe intolerance to opioids of allergic and non-allergic origin.

In epilepsy that can be adequately controlled by medication, or in patients prone to the development of seizures, tramadol can be used only for health reasons (see section " special instructions").
In patients with a tendency to abuse medicines or opioid dependence treatment with tramadol should be carried out in short courses and under medical supervision (see section "Special Instructions").

During pregnancy and lactation

Tramadol crosses the placental barrier. There is no convincing evidence for the safety of tramadol during pregnancy in humans, so tramadol should not be used during pregnancy. Prolonged use of tramadol during pregnancy can lead to the development of a "withdrawal" syndrome in the newborn.

Tramadol does not affect uterine contractility during labor. In neonates, tramadol may cause a change in respiratory rate, which is usually not clinically significant. About 0.1% of the dose of tramadol administered to the mother is excreted in milk during breastfeeding. Tramadol should not be used during pregnancy and while breastfeeding. After a single dose of tramadol, there is usually no need to interrupt breastfeeding.

Interaction with other drugs

Tramadol should not be used simultaneously or within 14 days after the abolition of MAO inhibitors. In patients treated with MAO inhibitors within 14 days prior to the start of the use of the opioid analgesic pethidine, life-threatening drug interactions have been noted, manifested by symptoms from the central nervous system, respiratory and cardiovascular systems. Similar interactions with MAO inhibitors are possible with the use of tramadol. Concomitant use of tramadol and CNS depressants, including alcohol, may increase adverse reactions from the CNS.

It is noted that with simultaneous or previous use of cimetidine (an inhibitor of microsomal liver enzymes), clinically significant interactions are unlikely. Simultaneous or previous use of carbamazepine (an inducer of microsomal liver enzymes) may reduce the analgesic effect of tramadol and shorten its duration. It is not recommended to combine tramadol with opioid receptor antagonist agonists (eg, buprenorphine, nalbuphine, pentazocine), as the analgesic effect of tramadol as a full opioid receptor agonist may be reduced.

Tramadol can cause seizures and increase the effects of selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, antipsychotics and other drugs that lower the seizure threshold, thus leading to the development of seizures. In some cases, the development of serotonin syndrome associated with the use of tramadol in combination with other serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs) or MAO inhibitors, has been noted. Possible symptoms of serotonin syndrome are confusion, agitation, hyperthermia, sweating, ataxia, hyperreflexia, myoclonus, and diarrhea. Withdrawal of serotonergic drugs causes rapid resolution of symptoms.

Necessary therapy is determined clinical picture and severity of symptoms.

With the simultaneous use of tramadol and indirect anticoagulants - coumarin derivatives (for example, warfarin), it is necessary to carefully monitor patients, as some of them showed an increase in the international normalized ratio (MHO) with the development of bleeding and ecchymosis.

Other inhibitors of the CYP3A4 isoenzyme, such as ketoconazole and erythromycin, can inhibit the metabolism of tramadol (N-demethylation) and possibly active O-desmethyltramadol. The clinical significance of this interaction has not been studied.

There is limited evidence that pre- or postoperative use of antiemetics of the 5-HT3 serotonin receptor blocker group (eg, ondansetron) increased the need for tramadol in patients with postoperative pain syndrome.

Overdose

With an overdose of tramadol, symptoms characteristic of narcotic analgesics should be expected.

Possible symptoms:

miosis, vomiting, collapse, depression of consciousness up to coma, convulsions, depression of the respiratory center to apnea.

Treatment:

patency respiratory tract. Maintenance of breathing and activity of the cardiovascular system, depending on the symptoms. If breathing is disturbed, naloxone is administered. For convulsions, diazepam should be administered intravenously. In case of an overdose of the drug in oral dosage forms, it is necessary to perform a gastric lavage and prescribe activated charcoal within the first two hours after an overdose. After taking especially large doses of the drug in tablets, the removal of stomach contents can be effective at a later date. Hemodialysis and hemofiltration are ineffective.

Release form

Tablets 100 mg - 10, 30 or 50 pcs.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Best before date

3 years.

Composition

1 tablet contains

tramadol hydrochloride 100.0 mg.
Excipients: lactose monohydrate (milk sugar) - 225.0 mg; potato starch - 85.0 mg; magnesium stearate - 5.0 mg; talc - 5.0 mg; microcrystalline cellulose - 60.0 mg; povidone (polyvinylpyrrolidone) - 20.0 mg.