Medicinal reference book geotar. Tramal solution for injection, solution for injection

Tramal injection solution(Solutio Tramal pro injectionibus)

international and chemical name: tramadol; (1RS; 2RS)-2-(dimethylaminomethyl)-1-(m-methoxyphenyl)-cyclohexanol hydrochloride;

Basic physical and chemical characteristics: transparent colorless solution, odorless, free from mechanical impurities;

Compound. 1 ml of solution includes tramadol hydrochloride 50 mg;

other components: sodium acetate, water for injections.

The release form of the drug. Injection.

Pharmacotherapeutic group. Analgesics-opioids. Code PBX N02A X02.

The action of the drug.

Pharmacodynamics. Tramal is a centrally acting analgesic. Possesses mixed mechanism actions. It is a non-selective pure opioid mu-, delta-, and capa-receptor agonist. Other mechanisms that are involved in providing the analgesic effect of Tramal are the inhibition of the reuptake of norepinephrine in neurons and the enhancement of serotonergic response. Tramal also exhibits antitussive activity. When used in therapeutic doses, Tramal does not suppress respiration and does not change intestinal motility.

When administered intravenously, it exhibits an analgesic effect after 5-10 minutes, it acts for 3-5 hours.

Pharmacokinetics. Absorption with intramuscular injection - 100%. Time to reach maximum concentration after intramuscular injection– 45 min. Absolute bioavailability - almost 70%. Binding to blood proteins is about 20%. Penetrates through the blood-brain and placental barriers. 0.1% of the drug is excreted with breast milk. Metabolized in the liver. The half-life is 6 hours. Tramadol and its metabolites are excreted by the kidneys (25-35%) unchanged. Approximately 7% is excreted by hemodialysis.

There was an increase in the half-life in patients older than 75 years.

Indications for use. Acute and chronic pain syndrome of moderate and significant degree of severity (pre- and postoperative periods, malignant tumors, injuries, neuralgia); carrying out painful diagnostic and medicinal manipulations.

Method of use and dosage. Doses are set individually, taking into account the intensity of the pain syndrome.

Adults and children over 14 years of age are administered intravenously (slow drip) at 50-100 mg (1-2 ml of solution), up to 400 mg per day. At the same dose, it is administered intramuscularly or subcutaneously.

For children older than 1 year, the solution for injection may be (in exceptional cases) is prescribed in a single dose of 1-2 mg per kg of body weight of the child. Daily dose- 4 - 8 mg per kg of body weight.

Patients with impaired liver / kidney function, as well as the elderly (75 years and older), may need an individual dose adjustment.

The duration of treatment with Tramal is determined individually. Tramal cannot be used longer term justified from a therapeutic point of view.

Side effect.

From the side nervous system: possible increased sweating, headache, dizziness, weakness, lethargy, decreased reaction rate, sleep disturbance, muscle spasms, euphoria, hallucinations, anxiety, emotional lability, depression, amnesia, paresthesia; in some cases - seizures of convulsions of cerebral origin (with intravenous administration of high doses or with the simultaneous appointment of antipsychotics).

From the side gastrointestinal tract: nausea, vomiting, dry mouth, constipation, flatulence, epigastric pain, diarrhea.

From the side of cardio-vascular system: tachycardia, rarely - palpitations; lowered blood pressure, up to collapse (orthostatic collapse).

allergic reactions: , itching, exanthema, bullous rashes.

From the urinary system: difficulty urinating, dysuria, urinary retention.

From the senses: impaired vision, taste.

From the side respiratory system: dyspnea.

Others: violation menstrual cycle.

Contraindications. Acute alcohol intoxication, acute poisoning sleeping pills, analgesics or psychotropic drugs; severe hepatic / renal insufficiency (creatinine clearance less than 10 ml / min); increased sensitivity to tramadol. Pregnancy, lactation. Children under 1 year old.

Overdose.

Symptoms: vomiting, miosis, collapse, depression of consciousness (up to coma), convulsions, depression of the respiratory center.

Treatment: The main emergency is to ensure patency respiratory tract, support for breathing and the function of the cardiovascular system.

The antidote for depression of the respiratory center is, for convulsions - benzodiazepine.

Features of use. Special care should be taken when prescribing Tramal in case of confusion, dysfunction of the respiratory center, increased intracranial pressure, convulsive syndrome cerebral genesis, as well as patients with hypersensitivity to opiates.

Tramal should not be used to treat withdrawal symptoms. narcotic substances.

Patients who take Tramal should refrain from performing potentially unsafe activities that require increased attention and rapid mental and motor reactions.

During treatment with Tramal, alcohol should not be consumed.

With prolonged use of Tramal, addiction and drug dependence may develop.

Pregnancy and lactation.

During pregnancy, when using Tramal, it must be borne in mind that tramadol crosses the placental barrier. If opioid analgesic therapy is indicated during pregnancy, then the use of Tramal should be limited to single doses. Long term use Tramal should be avoided during pregnancy due to the risk of developing addiction in the fetus and the occurrence of withdrawal syndrome in the neonatal period.

When using Tramal during lactation, it should be borne in mind that tramadol is excreted in breast milk in small quantities. In the case of a single dose of the drug, as a rule, there is no need to interrupt breastfeeding, since the concentration of tramadol in milk is approximately 0.1% of the concentration in plasma.

Impact on driving vehicles or others complex mechanisms.

When using the drug, you should refrain from driving vehicles and working with potentially unsafe mechanisms.

Interaction with others medicines. Tramadol is incompatible with solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, nitroglycerin.

With the simultaneous appointment of Tramal with drugs that suppress the central nervous system, mutual enhancement of central effects, including respiratory inhibition, is possible.

Inducers of microsomal oxidation (carbamazepine, barbiturates) reduce the severity of the analgesic effect and the duration of action. Long-term use of opioid analgesics or barbiturates stimulates the development of cross-tolerance.

Anxiolytics increase the severity of the analgesic effect, the duration of anesthesia increases when combined with barbiturates. Naloxone activates respiration, eliminating analgesia after the use of opioid analgesics. MAO inhibitors, furazolidone, procarbazine, neuroleptics - the risk of convulsions.

Quinidine increases the plasma concentration of tramadol and reduces the content of the M1 metabolite due to competitive inhibition of the CYP2D6 isoenzyme.

Terms and conditions of storage. Keep out of the reach of children at a temperature not exceeding 25°C. Shelf life - 5 years.

Composition and form of release of the drug

10 pieces. - cellular contour packings (2) - packs of cardboard.

pharmachologic effect

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

Causes a sedative effect. In therapeutic doses, it practically does not depress breathing. It has an antitussive effect.

Pharmacokinetics

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract (about 90%). C max in is achieved 2 hours after ingestion. Bioavailability at 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 active substance in plasma. 0.1% is excreted in breast milk.

It is metabolized by demethylation and conjugation to 11 metabolites, of which only 1 is active.

Excreted by the kidneys - 90% and through the intestines - 10%.

Indications

Moderate to severe pain syndrome various genesis(including when malignant tumors, acute infarction myocardium, neuralgia, trauma). Conducting painful diagnostic or therapeutic procedures.

Contraindications

Acute intoxication with alcohol and drugs that have a depressant 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 when taken orally - 50 mg, rectally - 100 mg, intravenously slowly or intramuscularly - 50-100 mg. If the effectiveness of parenteral administration is insufficient, then after 20-30 minutes, oral administration at 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: adults and children over 14 years of age, 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 appointment of antipsychotics).

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

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

From the side of metabolism: increased sweating.

From the side musculoskeletal system: miosis.

drug interaction

At simultaneous application with drugs that have a depressant 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 reuptake inhibitors, tricyclic antidepressants, antipsychotics, and other drugs that reduce the threshold for convulsive readiness, the risk of convulsions increases.

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

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

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

With simultaneous use with sertraline, cases of the development of serotonin syndrome are 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.

Activates breathing, eliminating analgesia after the use of opioid analgesics.

special instructions

Caution should be used in convulsions of central origin, drug dependence, confusion, in patients with impaired renal and hepatic function, as well as in hypersensitivity to other opioid receptor agonists.

Tramadol should not be used longer than is therapeutically justified. In the case of long-term treatment, the possibility of developing drug dependence cannot be ruled out.

Combination with MAO inhibitors should be avoided.

Avoid drinking alcohol during treatment.

Influence on the ability to drive vehicles and control mechanisms

Pregnancy and lactation

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

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

Application in childhood

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

Tramadol in the form dosage forms prolonged action should not be used in children under 14 years of age.

For impaired renal function

Caution should be used in patients with impaired renal function.

For impaired liver function

Caution should be used in patients with impaired liver function.

International non-proprietary name:

Chemical rational name:
(+) trans-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl)-cyclohexanol hydrochloride

Dosage form:

Compound:

Description:
oblong, bicolor (pale green/yellow), shiny hard gelatin capsules with a snap fit closure. Having the Grünenthal logo in black No. 4. The contents of the capsule are small, odorless powder from white to pale yellow.

Pharmacotherapeutic group:

ATS code: N02FX02.

Pharmacological properties:

Pharmacokinetics
Absorption - 90%; bioavailability - 68% (increases with repeated use). The time to reach maximum concentration after i / m administration is 1 hour. Penetrates through the BBB and the placenta, 0.1% is excreted in breast milk. Distribution volume - 306 l. Communication with plasma proteins - 20%. In the liver, it is metabolized by N- and O- demethylation, followed by conjugation with glucuronic acid. 11 metabolites were identified, of which mono-O-desmethyltramadol (M1) has pharmacological activity. T1 / 2 in the second phase - 6 h (tramadol), 7.9 h (mono-O-desmethyltramadol); in patients older than 75 years - 7.4 hours (tramadol); with cirrhosis of the liver - 13.3 ± 4.9 hours (tramadol), 18.5 ± 9.4 hours (mono-O-desmethyltramadol), in severe cases - 22.3 hours and 36 hours, respectively; with chronic renal failure (CC less than 5 ml / min) - 11 ± 3.2 hours (tramadol), 16.9 ± 3 hours (mono-O-desmethyltramadol), in severe cases - 19.5 hours and 43.2 hours, respectively.
Excreted by the kidneys (25-35% unchanged), the average cumulative rate of renal excretion is 94%. About 7% is excreted by hemodialysis.

Indications for use.
Pain syndrome of moderate and severe intensity various etiologies(postoperative period, trauma, pain in cancer patients). Anesthesia during painful diagnostic or therapeutic procedures.

Contraindications.

International name: tramadol; (±)-trans-2-[(dimethylamino)methyl]-1-(m-methoxyphenyl)-cyclohexanol hydrochloride

Basic physical and chemical properties

transparent, colorless solution, without visible mechanical impurities;

1 ml of solution contains 50 mg of tramadol hydrochloride

Excipients: sodium acetate anhydrous, water for injection.

Release form

Injection.

Pharmacological group

Opioid analgesics. ATC code N02A X02.

Pharmacological properties

Pharmacodynamics. Tramadol is a strong centrally acting analgesic. The analgesic effect is carried out in two ways: by binding to opioid receptors, which reduces the sensation of pain, and also by inhibiting the reuptake of norepinephrine and stimulating descending noradrenergic effects, as a result of which the transmission of pain impulses in the spinal cord is inhibited. The analgesic effect is the result of the synergistic activity of both mechanisms of action. Tramadol does not cause respiratory depression and cardiovascular activity. The action comes on quickly and lasts for several hours.

Pharmacokinetics. Plasma protein binding is 20%. Tramodol crosses the placenta, and its concentration in the umbilical blood is 80% of the concentration in the mother's blood.

90% of tramadol and its metabolites are excreted by the kidneys, and the remainder is excreted in the feces. The half-life is 5-6 hours and is the same for tramadol and its metabolites.

In case of impaired renal function, the rate and degree of excretion decrease, therefore, for patients with creatinine clearance less than 30 ml / min, a dose reduction or an increase in the interval between doses is recommended.

In patients older than 75 years, the maximum concentration of the drug in the blood increases slightly, and the half-life is lengthened, so it is necessary to slightly change the dosage.

Indications

Severe and moderate pain of various origins (for example, pain due to trauma (injury, fracture), severe neuralgia, pain due to the presence of a tumor, myocardial infarction, pain after diagnostic and therapeutic procedures).

Dosage and administration

The dose is determined depending on the severity of pain and the condition of the patient.

Adults and children over 14 years of age: 50-100 mg (1-2 ampoules of 50 mg or 1 ampoule of 100 mg), intravenously, intramuscularly or subcutaneously.

Children aged 1 to 14 years: 1 - 2 mg / kg of body weight, intravenously, intramuscularly or subcutaneously. Intravenous injections should be carried out very slowly, and the solution must be diluted in solution for infusion.

Repeated doses can be administered at 4-6 hour intervals.

It is not recommended to use a daily dose of more than 400 mg of tramadol, except in cases of pain relief in patients with cancer and patients with severe postoperative pain, in which the daily dose can be increased to 600 mg.

For patients with renal or liver failure it is recommended to reduce the dose and increase the interval between doses. For patients with creatinine clearance less than 30 ml / min, it is recommended to double the interval between doses at the beginning of treatment.

Side effect

Frequent side effects are reactions from the gastrointestinal tract and the central nervous system. They occur in approximately 5-30% of patients taking tramadol at therapeutic doses.

Adverse effects occurring in more than 5% of patients include dizziness, nausea, constipation, headache, drowsiness, vomiting, itching, asthenia, sweating, shortness of breath, dry mouth, diarrhea.

Other side effects that occur in more than 1% of patients

central nervous system: anxiety, confusion, impaired coordination, euphoria, emotional instability, sleep disturbance;

gastrointestinal tract: abdominal pain, loss of appetite, flatulence;

skin: skin rashes

genitourinary system: urinary retention, frequent urination, menopausal symptoms;

cardiovascular system: vasodilation;

sense organs: blurred vision.

Side effects that occur in less than 1% of patients and which may be associated with the use of tramadol:

central nervous system: convulsions, paresthesia, cognitive impairment, hallucinations, tremor, amnesia, impaired concentration, gait disturbance;

skin: urticaria

genitourinary system: dysuria, menstrual disorders;

cardiovascular system: syncope, orthostatic hypotension, tachycardia, palpitation, hypertension, cardiovascular collapse;

other unwanted effects: increased muscle tone, impaired swallowing, weight loss.

Contraindications

Hypersensitivity to tramadol or other components of the drug. The drug is not recommended for children under 1 year of age. Acute intoxication with central nervous system inhibitors (alcohol, antidepressants, antipsychotics, sedatives, anxiolytics, sleeping pills). Treatment with MAO inhibitors.

Overdose

When using the drug in doses significantly higher than the recommended doses, signs of intoxication may occur: impaired consciousness (including coma), generalized convulsions, hypotension, tachycardia, constriction or dilation of the pupils, respiratory depression. With severe tramadol intoxication, which is accompanied by loss of consciousness and shallow breathing, it is recommended to administer naloxone, and convulsions must be eliminated with intravenous administration diazepam.

Application features

Tramadol can be used to treat patients with hypersensitivity to opioids, but with caution. Tramadol is not recommended for use in patients prone to alcohol, drug and drug abuse.

During treatment, as well as for some time after treatment, it is recommended to carefully monitor patients with cerebral seizures.

Tramadol is not used as replacement therapy with opioid addiction.

With prolonged use of tramadol, the possibility of developing drug dependence cannot be completely excluded.

For patients with renal insufficiency (creatinine clearance less than 30 ml / min), through an increase in the half-life, it is recommended to at least at the beginning of treatment, double the interval between doses.

For patients with hepatic insufficiency, due to reduced hepatic clearance, increased serum concentration and increased half-life, it is recommended to reduce the dose or increase the interval between doses.

Tramadol can be used in patients with increased intracranial pressure (eg, traumatic brain injury) or severe lung disease, but with caution.

Pregnancy and lactation

The safety of the drug during pregnancy has not been established. High doses may have harmful effect on the fetus and newborn. In some urgent cases, the use of the drug is allowed only under close supervision and if the expected benefits of treatment for the mother justify possible risk for the fetus.

When using the drug during lactation, it must be taken into account that approximately 0.1% of the drug passes into breast milk. With a single use of tramadol, it is generally not necessary to stop breastfeeding.

Influence on the ability to drive a car and other mechanisms.

This drug has a strong effect on psychophysical activity. Therefore, during treatment, patients are prohibited from driving or operating machinery.

Interaction with other drugs

Tramadol is not recommended for use with MAO inhibitors. With the simultaneous use of tramadol with drugs acting on the central nervous system (anesthetics, antidepressants, antipsychotics, sedatives, anxiolytics, hypnotics), or with alcoholic drinks a synergistic effect is possible, which manifests itself in an increase in the sedative effect or an increase in the analgesic effect. With simultaneous use with carbamazepine, the metabolism of tramadol increases, which requires an increase in the dose of tramadol. Simultaneous administration of tramadol and specific serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics may increase the risk of seizures.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life - 5 years.

Holiday conditions

On prescription.

Package

1 ml (50 mg / 1 ml) in ampoules No. 5 in a blister in a cardboard box.

2 ml (100 mg / 2 ml) in ampoules No. 5 in a blister in a cardboard box.

Opioid analgesic. It has a pronounced analgesic effect, which is due to the agonistic effect on opioid receptors in the central nervous system. Tramadol is a synthetic opioid, a racemate of (+) and (-) isomers that in a different way participate in analgesic action. The (+) isomer is a pure opioid receptor agonist, the (-) isomer inhibits the neuronal uptake of norepinephrine, activates the central descending noradrenergic system, which disrupts the transmission of pain impulses to the gelatinous substance of the spinal cord, both isomers act synergistically. Causes a sedative effect.

In therapeutic doses, tramadol has practically no effect on hemodynamic parameters, does not depress respiratory function. With controlled use, addiction and drug dependence develop extremely rarely and are less pronounced compared to morphine.

Pharmacokinetics

Suction and distribution

When taking the drug inside, absorption is 90%. Bioavailability - 68% (increases with repeated use). After the / m administration, the time to reach C max is 1 hour. Tramadol penetrates the BBB and the placental barrier, is excreted in breast milk (0.1%). Plasma protein binding - 20%. V d - 306 l.

Metabolism and excretion

Tramadol is biotransformed in the liver by N- and O-desmethylation followed by conjugation with glucuronic acid. 11 metabolites have been identified, of which mono-O-desmethyltramadol (M 1) has pharmacological activity. T 1 / 2 in the second phase for tramadol - 6 hours, for mono-O-desmethyltramadol 7.9 hours. Excreted by the kidneys, 25-35% unchanged, the average cumulative rate of renal excretion is 94%.

Pharmacokinetics in special clinical situations

In patients older than 75 years T 1/2 tramadol - 7.4 hours.

In patients with liver failure T 1/2 tramadol - 13.3 ± 4.9 h, mono-O-desmethyltramadol 18.5 ± 9.4 h, in severe cases 22.3 h and 36 h, respectively.

With chronic kidney failure(CC less than 5 ml / min) T 1/2 tramadol - 11 ± 3.2 h, mono-O-desmethyltramadol 16.9 ± 3 h.

Release form

Excipients: microcrystalline cellulose, sodium carboxymethyl amylopectin, magnesium stearate, colloidal silicon dioxide.

The composition of the capsule shell: indigotine, yellow iron oxide, titanium dioxide, gelatin, water.

10 pieces. - cellular contour packings (2) - packs of cardboard.

Dosage

The solution for injection is prescribed in / in, in / m or s / c.

Inside the drug can be taken before, during and after meals. Capsules should be taken with a small amount of liquid, drops - on a piece of sugar or dissolved in a small amount of liquid.

Suppositories should be injected into the rectum.

Doses are set depending on the intensity of the pain syndrome.

Tramal should not be given for longer than is therapeutically necessary.

For adults and adolescents over 14 years of age, a single dose is 50-100 mg (1-2 capsules, 20-40 drops, 1 suppository, 1-2 ml of injection solution). If after a single application satisfactory analgesia does not occur, then after 30-60 minutes a single dose of 50 mg can be re-assigned.

For severe pain, 100 mg of tramadol hydrochloride can be given as an initial dose. For pain relief, 400 mg/day is usually sufficient.

For the treatment of pain associated with oncological diseases and with severe pain in the postoperative period, the drug can be used in higher doses.

For children over the age of 1 year, the drug in the form of a solution for injections and drops for oral administration is prescribed in a single dose at the rate of 1-2 mg / kg of body weight. A daily dose of 4-8 mg/kg is usually sufficient.

In elderly patients (75 years or more), due to the possibility of delayed elimination, the interval between doses of the drug may be increased in accordance with individual characteristics.

In diseases of the kidneys and liver, prolongation of the action of Tramal is possible. For this category of patients, it is recommended to increase the interval between single doses.

Overdose

Symptoms: from fainting to unconscious state(coma), epileptic convulsions, a drop in blood pressure, palpitations (tachycardia), constriction or dilation of the pupils, difficulty breathing up to a stop.

Treatment: Tramal is an opiate agonist. In this regard, its effects can be stopped with the help of morphine antagonists (for example, naloxone). Convulsions that occur at toxic doses can be eliminated with the help of drugs from the benzodiazepine group.

Interaction

Tramal enhances the effect of drugs that have a depressant effect on the central nervous system, as well as ethanol.

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

Long-term use of opioid analgesics or barbiturates stimulates the development of cross-tolerance.

Anxiolytics increase the severity of the analgesic effect of tramadol, the duration of anesthesia increases when combined with barbiturates. Naloxone activates breathing, eliminating analgesia after the use of opioid analgesics.

With the simultaneous use of MAO inhibitors, furazolidone, procarbazine, neuroleptics with tramadol, there is a risk of developing seizures (reducing the threshold for convulsive readiness).

Quinidine increases the plasma concentration of tramadol and reduces the content of the metabolite mono-O-desmethyltramadol due to competitive inhibition of the CYP2D6 isoenzyme.

Side effects

From the digestive system: nausea, dry mouth are possible; rarely - vomiting, constipation, abdominal pain, bloating; in isolated cases - a change in appetite.

From the nervous system: possible dizziness, fatigue, drowsiness, confusion; rarely - headache, mood changes (mainly improvement, less often - depression), change in activity (mainly suppression, less often - increase), impaired behavioral reactions, impaired sensations; in some cases - cerebral convulsions (observed in almost all cases when tramadol hydrochloride was administered intravenously in high doses, or if antipsychotics were simultaneously prescribed).

From the side of the cardiovascular system: in isolated cases - interruptions heart rate, tachycardia, fainting or collapse (especially if the patient is in vertical position or during exercise).

Dermatological reactions: rarely - redness, rash.

From the musculoskeletal system: in rare cases - muscle weakness(motor weakness).

On the part of the respiratory system: to date, no deterioration in respiratory function has been observed when using Tramal in the form of capsules and rectal suppositories. However, this effect cannot be completely excluded if the recommended dose of Tramal is significantly exceeded, or the patient is simultaneously receiving other drugs that have a depressant effect on the central nervous system.

Others: maybe increased sweating(especially with rapid on / in the introduction); in isolated cases - difficulty in swallowing water.

Indications

Pain syndrome of moderate and severe intensity of various etiologies:

• in the postoperative period;
• with injuries;
• for pain caused by myocardial infarction (for parenteral use);
• in cancer patients;
• during painful diagnostic or therapeutic procedures.

Contraindications

• conditions accompanied by respiratory depression or severe CNS depression (alcohol poisoning, hypnotics, opioid analgesics, psychotropic drugs);
• drug withdrawal syndrome;
• severe renal failure (CC less than 10 ml / min);
• severe liver failure;
• simultaneous use of MAO inhibitors and a 2-week period after their cancellation;
• hypersensitivity to the drug and other opioid analgesics.

Application features

Use during pregnancy and lactation

Application for violations of liver function

Application for violations of kidney function

special instructions

With caution and under the supervision of a physician, the drug should be prescribed to patients with impaired renal and hepatic functions, with traumatic brain injury, increased intracranial pressure, patients with epilepsy, people with drug dependence on opioids, with pain in the abdominal cavity of unknown origin ("acute abdomen") , with confusion of unknown origin, disorders of the respiratory center or respiratory function.

The condition of patients with convulsions of central origin should be carefully monitored during treatment with Tramal.

After prolonged use of Tramal, the possibility of developing drug dependence cannot be completely excluded. Therefore, only the doctor should decide on the duration of treatment and its interruptions. The patient should be warned about the need to strictly adhere to the dose and duration of treatment prescribed by the doctor and not to transfer the drug to other persons. Long term treatment with chronic pain syndrome should be carried out only under strict indications.

The use of alcohol during the period of application of any dosage forms of Tramal should be excluded.

Influence on the ability to drive vehicles and control mechanisms

During treatment with Tramal, the patient must refrain from all activities that require heightened attention and speed of psychomotor reactions (including driving a car, working at a machine tool), because the drug can have a fairly strong effect on psychophysical abilities (including decreased attention, slowing down reactions).