Registration number: P No. 014048 / 03-2002
Tradename drug: Tramadol Lannacher

International non-proprietary name:

Tramadol hydrochloride
Chemical rational name: (±) trans-2 - [(dimethylamino) methyl] -1- (3-methoxyphenyl) -cyclohexanol hydrochloride
Dosage form: Solution for injection in ampoules 50 mg / ml and 100 mg / 2 ml.

Composition:

1 ml of solution contains 50 mg of tramadol hydrochloride.

Excipients: sodium acetate, water for injection.

Description: Colorless, transparent liquid.

Pharmacotherapeutic group: An analgesic opioid. PBX code:.

Pharmacological properties

Tramadol hydrochloride belongs to analgesics central action... It has a pronounced analgesic effect.

Indications for use

Pain syndrome of moderate to severe intensity of various etiologies:

postoperative period,

trauma,

myocardial infarction,

neuralgia,

pain in cancer patients,

pain relief during painful diagnostic and therapeutic procedures. Contraindications Hypersensitivity to tramadol hydrochloride or opiates. Conditions accompanied by respiratory depression or pronounced depression of the central nervous system(poisoning with alcohol, sleeping pills, narcotic analgesics, psychotropic drugs). The simultaneous use of MAO inhibitors and a two-week period after their cancellation; Pregnancy and lactation (use is possible only for health reasons) and should be limited to single injections only. Childhood up to 1 year. Warnings Tramadol Lannacher should be used with caution in case of seizures of central origin, drug addiction, confusion, with craniocerebral trauma, increased intracranial pressure, in patients with impaired liver and kidney function, as well as in case of hypersensitivity to other agonists of opioid receptors. Tramadol Lannacher 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 developing drug addiction... Tramadol hydrochloride is used with increased time intervals in elderly patients. Under the close supervision of a physician and in reduced doses, tramadol hydrochloride should be used against the background of the action of drugs for anesthesia, hypnotics and psychotropic drugs. The drug should not be combined with narcotic analgesics due to poor predictability of interaction effects. Not recommended for the treatment of drug withdrawal. Avoid combination with MAO inhibitors. Patients with epilepsy or patients prone to seizures should take Tramadol Lannacher only for health reasons. During the period of drug treatment, alcohol is not allowed and it is not recommended to engage in activities that require increased attention and high speed of psychomotor reactions (driving vehicles and operating mechanisms). Overdose (intoxication) with the drug When using tramadol hydrochloride at a dose of 3 g or more, following signs intoxication: vomiting, nausea, dilated pupils, falling blood pressure... Most dangerous consequences overdoses of tramadol hydrochloride are respiratory depression and convulsions. If you suspect poisoning, you should immediately seek medical attention. First aid for poisoning- maintaining adequate pulmonary ventilation and symptomatic therapy in conditions specialized department... The use of naloxone is not critical, as it does not eliminate all symptoms of poisoning and can cause seizures. Hemodialysis is ineffective. For seizures, it is advisable to use diazepam. Method of administration and dosage Tramadol Lannacher is used when prescribed by a doctor, the dosage regimen of the drug is selected individually, depending on the severity of the pain syndrome and the sensitivity of the patient. The duration of treatment is determined individually; the drug should not be prescribed for more than a period that is justified from a therapeutic point of view. Tramadol hydrochloride is intended for intravenous ( enter slowly!), intramuscular or subcutaneous administration... Usually the drug is prescribed for adults and children over 14 years of age (weighing over 50 kg). Regular single dose for intravenous (enter slowly!) administration is 50-100 mg of tramadol hydrochloride. If necessary, in case of insufficient effect, further injections are possible after 30-60 minutes before the maximum possible daily dose. When carrying out intravenous drip infusion, an initial dose of 50-100 mg of tramadol hydrochloride is administered intravenously slowly (over 20 minutes), then a maintenance drip infusion is started at a rate of 12 mg of tramadol hydrochloride per hour up to the maximum possible daily dose, which is 400 mg. With intramuscular or subcutaneous administration, the initial dose is usually 50-100 mg, further injections are possible, if necessary, at a dose of 50 mg up to the maximum possible daily dose. Maximum daily dose the drug should not exceed 400 mg. For children aged 1 to 14 years, tramadol hydrochloride is recommended to be prescribed in a single dose at the rate of 1-2 mg per 1 kg of the child's body weight, the maximum daily dose should not exceed 4-8 mg per 1 kg of the child's body weight. The drug should be diluted with water for injection, while it is necessary to take into account what concentrations of the drug can be obtained in this case (1 ml of the drug contains 50 mg of tramadol hydrochloride): Breeding: Concentration: 1 ml of the preparation + 1 ml of water for injection 25.0 mg / ml 1 ml of the preparation + 2 ml of water for injection of 16.7 mg / ml 1 ml of the preparation + 3 ml of water for injection of 12.5 mg / ml 1 ml of the preparation + 4 ml of water for injection 10.0 mg / ml 1 ml of the preparation + 5 ml of water for injection of 8.3 mg / ml 1 ml of the preparation + 6 ml of water for injection of 7.1 mg / ml 1 ml of the preparation + 7 ml of water d / in 6.3 mg / ml 1 ml of the drug + 8 ml of water d / in 5.6 mg / ml 1 ml of the drug + 9 ml of water d / in 5.0 mg / ml To dilute the drug, you can use water for injection, saline and 5% glucose solution. It is recommended to use freshly prepared solutions, solutions of tramadol hydrochloride can be used within 24 hours from the moment of preparation, provided that they are stored in a refrigerator at a temperature of 1 to 5 ° C. Side effect The most common are dizziness, nausea, constipation, headache, drowsiness, vomiting is less common, itchy skin symptoms of psychostimulating action, asthenia, sweating, dyspepsia, dry mouth, diarrhea. Rarely, weight loss, hypotension and tachycardia, paresthesia, hallucinations, tremors, abdominal pain, visual impairment, urinary retention are possible. The incidence of side effects increases with the duration of the drug intake. At long-term use in large doses, the possibility of drug dependence is not excluded. About all side effects, including those not mentioned above, should be reported to the attending physician. Interacting with others drugs With the simultaneous use of tramadol hydrochloride with drugs that affect the central nervous system (antidepressants, antipsychotics, sedatives, anxiolytics, sleeping pills and the means used in anesthesiology), as well as with alcohol, it is possible to enhance the action of the latter. The use of carbamazepine and other inducers of metabolic enzymes can lead to a weakening of the analgesic effect of tramadol hydrochloride, respectively, to the need for higher doses of the drug. With the systematic use of barbiturates, especially phenobarbital, 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. Simultaneous administration of tramadol hydrochloride and selective inhibitors seizure of serotonin, tricyclic antidepressants, and antipsychotics may increase the risk of seizures. Naloxone activates breathing, eliminating analgesia after using opioid analgesics. Release form Ampoules of 1 and 2 ml, in a package of 5 ampoules. Storage conditions Store at a temperature not exceeding 25 ° C, protected from light. Keep out of the reach of children. Shelf life 36 months. Do not use after the expiration date printed on the package. Terms of dispensing from pharmacies On prescription.

Treatment of moderate to high intensity pain.

Contraindications Tramadol solution for injection 50mg / ml 2ml

Hypersensitivity to tramadol or any of the components of the drug. Acute intoxication with alcohol, sleeping pills, analgesics, opioids or other psychotropic drugs. Simultaneous use of tramadol with monoamine oxidase (MAO) inhibitors, as well as within 14 days after the end of their intake. Epilepsy not amenable to adequate drug control. The use of tramadol as a drug for the treatment of drug withdrawal syndrome. Pregnancy. During the period breastfeeding the drug can be prescribed only for health reasons. In the case of a single dose of the drug, there is no need to interrupt breastfeeding. Children up to age 1 year. With caution: tramadol should be used with caution: in patients with opioid dependence; with traumatic brain injury, in patients in shock, in patients with impaired consciousness unclear genesis, 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 genesis; with epilepsy, amenable to adequate drug control, or in patients prone to the development of seizures, tramadol can be used only for health reasons; in patients with a tendency to abuse drugs or drug dependence, tramadol treatment should be carried out in short courses and under medical supervision. Pregnancy: Animal studies have shown that, in very high doses, tramadol affects the development of internal organs, ossification and neonatal mortality. Tramadol crosses the placental barrier. Convincing evidence of the safety of using tramadol during pregnancy in humans has not been obtained, therefore, tramadol should not be used during pregnancy. Long-term use of tramadol during pregnancy can lead to the development of withdrawal symptoms in the newborn. Tramadol used before and during labor does not affect uterine contractility during labor. In newborns, tramadol can cause changes in respiratory rate, which is usually not clinically significant. Breastfeeding period: about 0.1% of the dose of tramadol administered to the mother is excreted in milk during breastfeeding. Tramadol should not be used while breastfeeding. After a single use of tramadol, there is usually no need to interrupt breastfeeding. Fertility: Animal studies and post-marketing observations have not shown any effect of tramadol on fertility.

Method of application and dosage Tramadol solution for injection 50mg / ml 2ml

The drug Tramadol, solution for injection, 50mg / ml is intended for intravenous jet, intramuscular, subcutaneous and intravenous drip administration. Intravenous administration of a solution for injection is carried out in a slow stream or drip after dilution in a solution for injection. The method of preparation of the solution for injection is described in the subsection "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. When treating chronic pain syndrome, you should adhere to a specific schedule of drug administration. Adults and adolescents over 12 years of age: a single dose for a single injection - 50-100mg of tramadol (1-2ml of injection solution). If satisfactory analgesia has not occurred within 30-60 minutes after the first injection, 50 mg (1 ml) of tramadol may be re-prescribed. For severe pain, 100mg (2ml) 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. V postoperative period possible short-term use of tramadol in doses exceeding those indicated. The maximum daily dose of tramadol should not exceed 400 mg, with the exception of some clinical cases (for example, in the treatment of pain in cancer patients and in the postoperative period). Children aged 1 to 12 years: Tramadol. 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 (up to 75 years old) who do not have clinically expressed hepatic or renal failure, dose adjustment is usually not required. Elimination of the drug may be slowed down in patients over 75 years of age. Therefore, if necessary, the interval in prescribing the drug is increased in accordance with the characteristics of the patient. Patients with renal failure or on dialysis and patients with hepatic impairment: in case of impaired renal and / or liver function, tramadol excretion 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. To calculate the total dose of tramadol (mg), you need: body weight (kg) x dose (mg / kg). 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). The concentration of the diluted solution for injections - the drug Tramadol 50mg (50mg / ml - 1ml) solution for injections + added solvent, respectively: 25.0mg / ml - 1ml + 1ml; 16.7mg / ml - 1ml + 2ml; 12.5mg / ml - 1ml + 3ml; 10.0mg / ml - 1ml + 4ml; 8.3mg / ml - 1ml + 5ml; 7.1mg / ml - 1ml + 6ml; 6.3mg / ml - 1ml + 7ml; 5.6mg / ml - 1ml + 8ml; 5.0mg / ml - 1ml + 9ml. The concentration of the diluted solution for injections - Tramadol 100mg (50mg / ml - 2ml) solution for injections + added solvent, respectively: 25.0mg / ml - 1ml + 2ml; 16.7mg / ml - 1ml + 4ml; 12.5mg / ml - 1ml + 6ml; 10.0mg / ml - 1ml + 8ml; 8.3mg / ml - 1ml + 10ml; 7.1mg / ml - 1ml + 12ml; 6.3mg / ml - 1ml + 14ml; 5.6mg / ml - 1ml + 16ml; 5.0mg / ml - 1ml + 18ml. In accordance with the calculation, dilute the contents of the ampoule with the addition of solvent, mix and enter the calculated volume of the finished solution. Dispose of any unused leftover injection solution. Duration of therapy: under no circumstances should tramadol 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 dosage regimen.

INN: Tramadol

Manufacturer: Protech Biopharma Pvt. Ltd.

Anatomical-therapeutic-chemical classification: Tramadol

Registration number in the RK: No. RK-LS-5 No. 121793

Registration period: 19.11.2015 - 19.11.2020

ALO (Listed on the Free Outpatient drug supply)

Instructions

Tradename

Tramadol

International non-proprietary name

Tramadol

Dosage form

Capsules 50 mg

Composition

One capsule contains

active substance- tramadol hydrochloride 50 mg,

Excipients: starch, calcium dihydrogen phosphate, lactose, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, polyvinylpyrrolidone (PVP K30), talc,

capsule shell composition: gelatin, iron (III) oxide yellow (E172), brilliant blue (E133).

Description

Size "2" hard gelatin capsules light green / light green. The contents of the capsules are white or almost white powder.

Pharmacotherapeutic group

Analgesics. Opioids. Other opioids. Tramadol.

ATX code N02AX02

Pharmacological properties

Pharmacokinetics

Suction

After oral administration, tramadol is rapidly and almost completely absorbed into gastrointestinal tract... The average oral bioavailability is approximately 68%. Food intake does not significantly affect the rate and extent of absorption. A serum concentration of 100 ng / L (minimum effective analgesic concentration) is reached approximately 0.7 hours after ingestion and lasts for 9 hours.

Distribution Volume of distribution after oral administration and intravenous administration is approximately 306 and 203 liters, respectively. Plasma protein binding is about 20%. Tramadol crosses the placenta and its concentration in the umbilical cord blood is 80% of the concentration in the mother's blood.

Metabolism Approximately 85% of tramadol is metabolized. Tramadol is metabolized by N- and O-demethylation. With the exception of the O-demethylated metabolite (M1), all metabolites are pharmacologically inactive.

Withdrawal

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

In case of impaired renal function, the volume and rate of excretion decreases, therefore, in patients with creatinine clearance less than 0.5 ml / s, it is recommended to reduce the dosage and increase the intervals between dosing.

The metabolism of tramadol and M1 is reduced in patients with severe liver cirrhosis, and therefore the dosage should be adjusted.

In patients over 75 years of age, the peak concentration of tramadol in blood plasma increases slightly and the half-life is longer, therefore dose adjustment is required.

Pharmacodynamics

Tramadol is a central analgesic. It is a non-selective agonist of µ, δ and κ opioid receptors, with a higher affinity for µ-receptors. Tramadol inhibits the neuronal seizure of norepinephrine, and also increases the release of serotonin, which leads to the analgesic effect of the drug.

Tramadol in therapeutic doses has practically no effect on cardiovascular system(does not have a depressing effect and does not increase pressure in pulmonary artery), does not cause spasm of smooth muscles, the release of histamine, therefore, anaphylactic reactions are rare. The effect on respiration is minimal and can only appear at higher doses. The development of addiction and addiction is also very rare.

Indications for use

Pain syndrome of moderate to severe intensity

Method of administration and dosage

The dose is selected individually, depending on the intensity of pain and the sensitivity of the patient. The lowest effective analgesic dose is usually used. The maximum allowable dose of the drug per day is 400 mg.

Unless otherwise indicated, the drug should be taken as follows:

Adults

Acute pain: 1-2 tablets (50-100 mg) 3-4 times a day. For patients with low body weight, the dose is calculated at the rate of 0.7 mg / kg. The duration of treatment depends on the clinical need.

Pain associated with chronic diseases: The recommended starting dose is 50 mg or 100 mg, after which the dose is titrated every 4-6 hours, depending on the intensity of the pain. It is important to regularly assess the need for continued treatment, as there is evidence of withdrawal symptoms and dependence.

Children

The drug is not intended for the treatment of children and adolescents under 18 years of age.

Elderly patients

Usually, when treating patients under 75 years of age, dose adjustment is not required if they do not have clinical manifestations hepatic or renal failure. In patients over 75 years of age, the elimination period may be increased. Therefore, if necessary, the interval between doses of the drug is increased in accordance with the needs of the patient.

Renal failure

In patients with renal insufficiency, elimination of the drug may be slowed down. The starting dose may be standard. These patients need to consider the need to lengthen the interval between doses of the drug in accordance with the individual characteristics of the patient.

For patients with creatinine clearance<30 мл/мин интервал между приемом препарата должен быть увеличен до 12 часов.

Tramadol is not recommended for patients with severe renal failure with creatinine clearance<10 мл/мин. При гемодиализе или гемофильтрации трамадол выводится очень медленно и поэтому пост-диализное назначение трамадола для поддержания анальгезирующего эффекта нецелесообразно.

Liver failure

In patients with impaired liver function, prolonged elimination of the drug is noted. The standard dose should be divided into 2 parts or the interval between doses of the drug should be increased to 12 hours.

These patients need to consider the need to lengthen the interval between doses of the drug in accordance with the individual characteristics of the patient. Tramadol is not recommended for patients with severe hepatic impairment.

Mode of application

The capsules must be taken whole, without breaking or chewing, with a sufficient amount of liquid, with or without food.

Duration of admission

The period of treatment with tramadol, under no circumstances, should exceed the period of urgent need to take it. If it is necessary to take tramadol for a long time for pain relief due to the nature and severity of the disease, regular monitoring should be carried out (if necessary, with interruptions in the treatment process) to determine the further need and scope of therapy.

Side effects

The most common side effects are nausea and vomiting, which develop in 10% of patients.

The following frequency is observed:

Very often: ≥1 / 10

Often: ≥1 / 100,<1/10

Uncommon: ≥1 / 1000,<1/100

Rarely: ≥1 / 10,000,<1/1000

Very rarely:<1/10 000

Cardiovascular disorders:

Infrequently

Palpitations, tachycardia, orthostatic hypotension, cardiovascular collapse. Such undesirable reactions can occur, in particular, with intravenous administration, as well as in physically debilitated patients.

Rarely

Bradycardia, increased blood pressure

Respiratory disorders

Rarely

Respiratory depression, shortness of breath

From the nervous system

Often

Dizziness

Often

Headache, drowsiness

Changes in appetite, speech disorders, paresthesia, tremors, epileptiform seizures, involuntary muscle contractions, coordination disorders, fainting.

Convulsions developed mainly after taking high doses of tramadol or after concomitant use of drugs that lower the seizure threshold.

Mental disorders:

Rarely

Hallucinations, sleep disturbances, delirium, restlessness and nightmares. After the introduction of tramadol, a variety of undesirable mental phenomena may occur, the intensity of which varies in each individual case (depending on the individual characteristics and duration of treatment). These include changes in mood (usually euphoria, in some cases dysphoria), changes in motor activity (usually depression, in some cases increased), and impaired cognitive function and sensory perception (for example, impaired decision-making ability and impaired perception). Drug dependence may develop. Withdrawal symptoms may develop, just as with opiate withdrawal: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremors, and gastrointestinal disturbances. Very rarely, when you stop taking tramadol, symptoms such as: panic attacks, severe anxiety, hallucinations, paresthesia, tinnitus and disturbances in the central nervous system (i.e. confusion, delusional ideas, depersonalization, derealization, paranoia) occur.

Visual impairment

Rarely

Constriction of the pupils, dilated pupils, blurred vision

Gastrointestinal Disorders

Often

Nausea

Often

Constipation, dry mouth, vomiting

Infrequently

Belching, gastrointestinal discomfort (feeling of tightness in the stomach, bloating), diarrhea

Diseases of the skin and subcutaneous fat

Often

Hyperhidrosis

Infrequently

Skin reactions (eg, itching, rash, hives)

Lesions of the musculoskeletal system and connective tissues

Rarely

Motor weakness

From the hepatobiliary system

In several unrelated cases, an increase in the activity of hepatic enzymes was observed, coinciding in time with the intake of tramadol.

Kidney and urinary tract disorders

Difficulty urinating, urinary disorders (dysuria and urinary retention)

Immune system disorders

Rarely

Allergic reactions (eg, difficulty breathing, bronchospasm, wheezing, angioedema) and anaphylactic reaction

Metabolic and nutrient absorption disorders

Unknown

Hypoglycemia

General violations

Often

Fatigue

Contraindications

hypersensitivity to tramadol and / or ancillary ingredients of the drug and other opioid analgesics

acute intoxication with central nervous system depressants

(alcohol, central analgesics, opioids, psychotropic drugs, hypnotics)

severe renal failure (creatinine clearance less than 10 ml / min)

severe liver failure

simultaneous use of MAO inhibitors (and within 14 days

after canceling them)

patients with epilepsy, the course of which cannot be adequately

be monitored

children and adolescents up to 18 years old

pregnancy and lactation

Drug interactions

Tramadol should not be used in combination with MAO inhibitors.

Life-threatening interactions on the central nervous system, respiratory and cardiovascular systems were observed in patients who received MAO inhibitors within 14 days prior to starting opioid analgesics. Such interactions with MAO inhibitors are not excluded with the simultaneous administration of tramadol.

With the simultaneous use of tramadol with drugs that have a depressing effect on the central nervous system, and with ethanol, mutual strengthening of their action is possible.

Application carbamazepine, barbiturates and other inducers of microsomal enzymes can lead to a weakening of the analgesic effect of tramadol.

Long-term use of tramadol stimulates the development of cross-tolerance to other opioid analgesics.

With joint or preliminary using cimetidine (an enzyme inhibitor) clinically significant interactions are unlikely. Combination opioid receptor agonists / antagonists(for example, buprenofine, nalbuphine, pentazocine) and tramadol is not recommended, since the analgesic effect of a pure agonist is reduced under these conditions.

With the simultaneous use of Tramadol with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine serotonin reuptake inhibitors (SNRIs), tri- and tetracyclic antidepressants, antipsychotics and other drugs that lower the seizure threshold , the risk of seizures increases.

Serotonin syndrome may develop when tramadol is used in combination with other serotonergic substances, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline serotonin reuptake inhibitors (SNRIs), MAO inhibitors, tri- and tetracyclic antidepressants. Symptoms of serotonin syndrome: confusion, agitation, hyperthermia, sweating, ataxia, hyperreflexia, myoclonus, and diarrhea.

Serotonin syndrome is possible if one of the following symptoms occurs:

Spontaneous seizures

Induced cramps or twitching of the eye muscles with agitation and sweating

Tremor and hyperreflexia

Hypertension and body temperature> 38 ° C and induced or ocular muscle twitching.

Withdrawal of serotonergic drugs causes rapid relief of symptoms. Treatment depends on the type and severity of the symptoms.

Particular care should be taken with the simultaneous use of tramadol and coumarins ( for example , warfarin) due to the risk of a decrease in prothrombin time with the development of bleeding and bruising.

Other inhibitorsCYP3 A4 , for example , ketoconazole and erythromycin, can inhibit the metabolism of tramadol (N-demethylation) and active O-desmethyltramadol. The clinical significance of this interaction is not well understood.

A limited number of studies have found that pre- or postoperative use of the antiemetic agent, the 5-HT3 antagonist, ondansetron, increased the need for tramadol for postoperative pain.

special instructions

Tramadol should be used with caution and risk / benefit assessment in the following conditions:

Withdrawal symptoms. Therapeutic doses of tramadol may cause withdrawal symptoms (reported rate 1/8000 cases)

Drug addiction. Cases of addiction symptom development are rare and much less frequent than withdrawal symptoms. The clinical need for tramadol treatment should be monitored by a physician. Tramadol has a low potential for developing addiction. However, with prolonged use, addiction, mental and physical dependence may develop. In patients with a tendency to abuse drugs or drug dependence, tramadol treatment should only be carried out for a short period and under the strict supervision of a physician.

Patients with opioid dependence. Tramadol is not useful as a substitute for opioid-dependent patients because it does not suppress morphine withdrawal symptoms.

In opioid-sensitive patients, Tramadol should be used with caution.

Tramadol should be prescribed with caution for head injuries, increased intracranial pressure, liver failure (decreased metabolism of tramadol and its active metabolites) and renal failure (decreased rate and lengthening of excretion of tramadol and its active metabolites), with a reduced level of consciousness and in patients prone to convulsive disorders or in a state of shock.

Patients with convulsive readiness. There have been cases of the development of convulsive symptoms with the appointment of therapeutic doses of tramadol and the risk of developing seizures may increase when the recommended daily dose is exceeded. Tramadol treatment in patients with epilepsy or seizure predisposition should be considered only if there is clinical justification. The risk of developing seizure syndrome increases in patients taking tramadol and drugs that lower the seizure threshold at the same time.

The drug should be administered with caution to patients with respiratory failure or when administered concomitantly with centrally acting depressants or when the doses are significantly higher than the recommended doses. in this case, the development of respiratory depression cannot be ruled out.

Due to reports of deaths from unintentional overdose of tramadol associated with the use of psychoactive drugs and substances, including alcohol, tramadol should be administered with caution to patients with alcohol dependence and receiving any active psychoactive substances.

With prolonged (more than 3 months) use of analgesics, with an interval of every other day or more, headache may develop or worsen. In this case, you should not increase the dose of tramadol. After consulting a doctor, it is necessary to resolve the issue of stopping the use of analgesics.

Pregnancy and lactation

Pregnancy

Animal studies have shown that very high doses of tramadol affect organ development, ossification and neonatal mortality. Tramadol crosses the placenta. There is not enough data on the safety of the use of tramadol for the treatment of people during pregnancy. For this reason, tramadol cannot be used to treat pregnant women.

Administration of tramadol before or during birth does not affect uterine contractility. In newborns, it can cause changes in respiratory rate that are usually not clinically significant.

Chronic use during pregnancy can lead to withdrawal symptoms in the newborn.

Breast-feeding

During lactation, about 0.1% of the dose of the drug taken by the mother is excreted in milk. Do not use the drug during breastfeeding.

Reproductive functions

The results of post-marketing observations did not reveal the effect of tramadol on reproductive functions. The results of studies involving animals did not reveal the effect of tramadol on reproductive functions.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Even when used in accordance with the instructions, tramadol can cause drowsiness and dizziness, as a result of which the reaction of drivers and machine operators may worsen. In particular, this applies to the simultaneous intake of other psychotropic substances, in particular alcohol.

Overdose

Symptoms of an overdose of Tramadol are similar to those that may occur with the use of other centrally acting analgesics (opioids).

Symptoms: constriction or dilation of pupils, vomiting, collapse, drop in blood pressure, palpitations, depression of consciousness (up to a coma), epileptic convulsions, difficulty breathing, up to a stop (apnea).

Treatment:

Maintenance / restoration of vital functions of respiration and blood circulation in a specialized department. The antidote in case of respiratory depression is naloxone; in case of convulsions, it is advisable to use diazepam.

In case of an overdose with oral administration of the drug, it is necessary to take activated charcoal, gastric lavage is recommended in the first 2 hours after taking tramadol. After 2 hours, it is necessary to carry out detoxification measures using a large amount of liquid.

Tramadol is slightly excreted during hemodialysis and hemofiltration, therefore, the treatment of acute intoxication with tramadol with these types of interventions is inappropriate.

Release form and packaging

10 capsules are placed in a blister strip of polyvinyl chloride film and aluminum foil.

1 or 2 blister packs, together with instructions for medical use in the state and Russian languages, are placed in a cardboard box.

Storage conditions

In its original packaging, in a dry place at a temperature not exceeding 30 ° C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date

Terms of dispensing from pharmacies

On prescription

Name and country of the manufacturing organization

Name and country of the packing organization

Protech Biopharma Pvt. Ltd. India

Name and country of the owner of the marketing authorization

Protech Biopharma Pvt. Ltd. India

The address of the organization that accepts claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Denovo Impex LLP, Republic of Kazakhstan, Almaty 050062, st. Utegen batyr, 15

tel .: 727 2437415

fax: 727 2437416

Hexal HEXAL / Salyutas Pharma GmbH OJSC Pranafarm, LLC Salyutas Pharma GmbH Hemofarm D.O. About Hemofarm Concern A.D. Stada Artsnaimittel AG EP MBP "RK NPK" FA for high-tech medical

Country of origin

Austria Austria / Russia Germany Russia Serbia Serbia and Montenegro Yugoslavia

Product group

Pain medications

Opioid analgesic, cyclohexanol derivative

Forms of issue

• 10 - contoured cell packs (1) - cardboard packs. 10 - contoured cell packs (3) - cardboard packs. 10 - contour cell packs (5) - cardboard packs. 10 - contour cell packs (2) - cardboard packs 10 - contour cell packs (2) - cardboard packs. 2 ml - ampoules (5) - cardboard packs. 2 ml - ampoules (10) - cardboard packs. 2 ml - ampoules (5) - contoured cell packs (1) - cardboard packs. 2 ml - ampoules (5) - contour cell packs (2 ml - ampoules (5) - plastic contour packs (1) - cardboard packs. 2 ml - ampoules (5) - plastic contour packs (1) - cardboard packs. 20 - polymer cans (1) - cardboard packs Solution for injection in ampoules of 1 and 2 ml, 5 ampoules in a blister, 1-2 blister packs with instructions for use in a pack.

Description of the dosage form

• Capsules Injection solution Injection solution clear colorless liquid Tablets Tablets

pharmachologic effect

Opioid analgesic, a derivative of cyclohexanol. Non-selective agonist of mu, delta and kappa 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.

Pharmacokinetics

Absorption - 90%; intramuscular bioavailability - 100%. The maximum concentration in blood plasma with intramuscular injection is 45 minutes, the M1 metabolite is 3 hours. It penetrates the blood-brain barrier and the placenta, 0.1% is excreted in breast milk. The volume of distribution is 203 liters with intramuscular injection. The connection with blood plasma protein is 20%. In the liver, it is metabolized by N- and O-demethylation, followed by conjugation with glucuronic acid. 11 metabolites have been identified, of which mono-O-demethyltramadol (M1) has pharmacological activity. The half-life in the second phase is 6 hours (tramadol), 7.9 hours (M1); in patients over 75 years old - 7.4 hours (tramadol); with cirrhosis of the liver - 13.3 ± 4.9 hours (tramadol), 18.5 ± 9.4 hours (M1); in chronic renal failure (creatinine clearance less than 5 ml / min) - 11 ± 3.2 hours (tramadol), 16.9 ± 3 hours (M1). It is excreted by the kidneys (25-35% unchanged), the average cumulative rate of renal excretion is 94%. About 7% is excreted by hemodialysis.

Special conditions

In the case of long-term treatment, the possibility of drug dependence cannot be ruled out. With increased time intervals, tramadol is used in elderly patients. Under the close supervision of a physician and in reduced doses, tramadol should be used against the background of the action of drugs for anesthesia, hypnotics and psychotropic drugs. The drug should not be combined with narcotic analgesics due to poor predictability of interaction effects. Not recommended for the treatment of drug withdrawal. Avoid combination with MAO inhibitors. Patients with epilepsy or those prone to seizures should only take Tramadol for health reasons. During the period of drug treatment, alcohol is not allowed and it is not recommended to engage in activities that require increased attention and high speed of psychomotor reactions (driving vehicles and operating mechanisms). In the case of a single dose, there is no need to interrupt breastfeeding.

Composition

• Tramadol / tramal semi-finished product for preparation of caps 0.105 g tramadol 50 mg; Auxiliary substances: sodium acetate, water d / and tramadol 50 mg; Auxiliary substances: sodium acetate, water d / and tramadol g / x 50 mg / ml; Auxiliary substances: sodium acetate, water for intramadol g / x 50 mg / ml; Auxiliary substances: sodium acetate, water for intramadol g / x 50mg; Auxiliary substances: calcium hydrogen phosphate b / in, magnesium stearate, colloidal silicon dioxide

Tramadol indications for use

• Pain syndrome of moderate and severe intensity of various etiologies: postoperative period, trauma, myocardial infarction, neuralgia, pain in cancer patients, pain relief during painful diagnostic or therapeutic procedures.

Tramadol contraindications

• Hypersensitivity to the drug and other opiates. Conditions accompanied by respiratory depression or severe depression of the central nervous system (alcohol poisoning, hypnotics, narcotic analgesics, psychotropic drugs). Simultaneous use of MAO inhibitors (and two weeks after their cancellation). Severe hepatic and / or renal failure (creatinine clearance less than 10 ml / min). Pregnancy and lactation (use is possible only for health reasons) and should be limited to single injections only. Children's age (up to 1 year). With caution: Convulsions of central origin, drug addiction, confusion, epileptic syndrome (cerebral genesis), in patients with pain in the abdominal cavity of unknown origin, traumatic brain injury, increased intracranial pressure, impaired renal and / or liver function, and hypersensitivity to other opioid receptor agonists

Tramadol dosage

• 100 mg 5% 50 mg 50 mg / ml 50 mg 50 mg / ml

Tramadol side effects

• From the nervous system: sweating, dizziness, headache, weakness, fatigue, lethargy, paradoxical stimulation of the central nervous system (nervousness, agitation, anxiety, tremor, muscle spasms, euphoria, emotional lability, hallucinations), drowsiness, sleep disturbance, confusion, disturbance coordination of movement, convulsions of central origin (with intravenous administration in high doses or with the simultaneous administration of antipsychotics), depression, amnesia, impaired cognitive function, paresthesia, gait instability. From the digestive system: dry mouth, nausea, vomiting, flatulence, abdominal pain, constipation, diarrhea, difficulty swallowing. From the side of the cardiovascular system: manifestations of vasodilation, tachycardia, orthostatic hypotension, syncope, collapse. Allergic reactions: urticaria, itching, exanthema, bullous rash. From the urinary system: difficulty urinating, dysuria, urinary retention. From the senses: impaired vision, taste. From the respiratory system: dyspnea. Others: menstrual irregularities. With long-term use - drug dependence, with abrupt withdrawal - "withdrawal" syndrome.

Drug interactions

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

Overdose

respiratory depression and seizures

Storage conditions

• keep away from children
• store in a dark place

Information provided by the State Register of Medicines.

Synonyms

• Mabron, Protradon, Sintradon, Tradol, Tramagit, Tramadol-Acri, Tramadol Lannacher, Tramadol-Ratiopharm, Tramadol retard, Tramadol-Slovakopharma, Tramadol Stada, Tramal, Tramal retard, Tramalgin, Tramundin retard.

Drug addicts use many pharmaceutical drugs to get high. These medicines include Tramadol. The danger of this drug lies in the fact that in high doses it causes addiction after the first dose and leads to irreversible disorders of the internal organs and psyche.

Tramadol as a drug

Tramadol belongs to the group of narcotic opioid analgesics. Previously, it could be bought in a pharmacy, albeit with difficulty, but now the drug is widely withdrawn from circulation.

Tramadol is available in oral capsules, injection ampoules and rectal suppositories. In Russia, it is prescribed only to mortal patients who experience unbearable pain in the later stages of illness.

In the past, the drug has been used as part of drug addiction treatment. Due to the fact that it has an effect on the central nervous system, it relieves pain in withdrawal symptoms, but only aggravates other manifestations. Therefore, restrictions are now imposed on the use of the medication.

Currently, half of the patients in drug dispensaries are people who are addicted to Tramadol. According to statistics, the drug is used by thousands of schoolchildren.

As part of anti-drug treatment, the body functions damaged as a result of taking Tramadol are restored, the patient's behavior is corrected and the craving for the drug is suppressed. At this stage, antidepressants and antipsychotics are used, in parallel, treatment with nootropic drugs continues.

Also, the patient is influenced by psychotherapeutic methods. Individual and collective classes are held in different centers. Hypnosis with the development of aversion to the drug at the subconscious level, acupuncture, electrical stimulation can be used.

The longest stage is supportive therapy aimed at maintaining the achieved result and preventing breakdowns. After being discharged from the hospital, the patient must continue to attend psychotherapy sessions and take restorative drugs. The duration of anti-relapse treatment can be up to five years.