What are tramadol tablets prescribed for? The use of tramadol in cancer. Application for violations of kidney function

Active substance

Tramadol hydrochloride (tramadol)

Release form, composition and packaging

1 ml - ampoules (5) - packs of cardboard.
1 ml - ampoules (10) - packs of cardboard.

Excipients: sodium acetate, water for injection.

2 ml - ampoules (5) - packs of cardboard.
2 ml - ampoules (10) - packs of cardboard.

pharmachologic effect

opioid analgesic with a mixed mechanism of action. Tramadol is a centrally acting analgesic. It has a pronounced analgesic effect.

Indications

- pain syndrome of moderate and severe intensity various etiologies (postoperative period, trauma, pain in cancer patients);

- for the purpose of anesthesia during painful diagnostic or therapeutic procedures.

Contraindications

- conditions accompanied by respiratory depression or severe CNS depression (alcohol poisoning, hypnotic drugs, narcotic analgesics, psychotropic drugs);

- simultaneous use of MAO inhibitors (and 2 weeks after their cancellation);

- pregnancy;

- lactation period (use is possible only for health reasons);

- age up to 1 year;

— hypersensitivity to the drug.

Dosage

The dose and duration of use is determined by the doctor individually, depending on the intensity and nature of the pain.

For moderate pain adults and adolescents over the age of 14 it is recommended to prescribe Tramadol in a single dose of 1 ml (50 mg of tramadol hydrochloride). If after 30-60 minutes the pain does not subside, you can re-enter 1 ml of the drug.

The effect of the drug persists for 4-8 hours. normal use the daily dose should not exceed 400 mg. In the presence of tumors, or during surgical interventions may be necessary much more high boost dosage.

Children aged 1 to 13 it is recommended to prescribe as a single dose of 1-2 mg/kg of body weight. In this case, Tramadol is diluted. It should be taken into account what concentrations should be achieved in this case (1 ml of the drug contains 50 mg of tramadol hydrochloride):

When diluting 1 ml of Tramadol with water for injection, the following concentrations are obtained:

Tramadol is administered intravenously (slowly), intramuscularly and s / c.

If the patient has impaired liver/kidney function, as well as elderly patients in the presence of severe pain Tramadol is prescribed 1 time, or a smaller number of times. If such patients have chronic pain the interval between doses of the drug should be increased due to delayed excretion and the risk of accumulation of Tramadol in the body.

Patients over 75 years of age, even in the absence of visible violations of the liver / kidney function, the interval between drug administrations should be increased.

Side effects

The most characteristic are dizziness, nausea, constipation (in 15-30% of patients), vomiting, pruritus, symptoms of a psychostimulating effect, asthenia, sweating, dyspepsia, dry mouth, diarrhea (in 5.5-15% of patients).

With a frequency of less than 5%, weight loss, hypotension and tachycardia, paresthesia, hallucinations, tremors, abdominal pain, visual disturbances, urinary retention are possible.

Development frequency side effects increases with increasing duration of the drug. With prolonged use in large doses the possibility of developing drug dependence is not ruled out.

About all side effects, incl. not listed above should be reported to your doctor.

Overdose

Symptoms: respiratory depression and convulsions.

Treatment: first aid in case of poisoning - maintaining adequate pulmonary ventilation and symptomatic therapy in a specialized department. In mild cases, gastric lavage is sufficient. Application is not critical, because does not eliminate all symptoms of poisoning and may cause convulsions. Hemodialysis is not very effective. With convulsions, it is advisable to use.

drug interaction

Concomitant use of alcohol or medicines, which have a depressing effect on the central nervous system, can lead to mutual enhancement of central effects, incl. - respiratory depression.

There are isolated reports of development epileptic convulsions when combined with neuroleptics.

May weaken the analgesic effect of Tramadol and reduce the duration of its action.

Tramadol should not be administered concomitantly with MAO inhibitors, tk. in this case, the development of life-threatening phenomena from the central nervous system, the respiratory center and the circulatory system is possible.

It must be remembered that these interactions also occur in the case of short-term use of drugs.

special instructions

In elderly patients, Tramadol is used at extended intervals.

With caution and under the supervision of a physician, the drug should be used in patients with impaired renal and hepatic function, with craniocerebral brain injuries, elevated intracranial pressure, patients with epilepsy, as well as persons with drug dependence on opioids.

Under close medical supervision and in reduced doses, Tramadol should be used against the background of the action of anesthetics, hypnotics and psychotropic drugs, the drug should not be combined with narcotic analgesics due to the poor predictability of the interaction effect.

Against the background of long-term use of carbamazepine, the effect of Tramadol may be weaker.

Influence on the ability to drive vehicles and control mechanisms

When using Tramadol, you should not drive a car or perform other work that requires increased attention.

Tramadol

International non-proprietary name

Tramadol

Dosage form

Capsules 50 mg

Compound

1 capsule contains

active substance- tramadol hydrochloride in terms of 100% substance 50 mg

Excipients: lactose monohydrate, magnesium stearate

composition of the capsule shell: brilliant black PN (E 151), patent blue (E 131), quinoline yellow (E 104), erythrosine (E 127), titanium dioxide

(E 171), gelatin.

Description

Solid gelatin capsules with a green body and cap, cylindrical shape, size No. 2. The contents of the capsule are powder white color.

Pharmacotherapeutic group

Analgesics. Opioids. Opioids are different. Tramadol

ATX code N02A X02

Pharmacological properties

Pharmacokinetics

When taken orally, more than 90% of tramadol is absorbed in the gastrointestinal tract. The maximum plasma concentration is reached after 4.8 hours. Absolute bioavailability - 68%. Binding to plasma proteins - 20%. Penetrates through the blood-brain and placental barriers. 0.1% of the drug passes into breast milk. Metabolized in the liver. The half-life is 6 hours. Tramadol hydrochloride 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.

Pharmacodynamics

Tramadol is a centrally acting analgesic. It has a mixed mechanism of action. It is a non-selective mu-, delta- and kappa-receptor opioid agonist. Other mechanisms that are involved in providing the analgesic effect of tramadol hydrochloride are the inhibition of the reuptake of noradrenaline in neurons and the enhancement of the serotonergic response.

It opens K + and Ca ++ channels, causes membrane hyperpolarization and inhibits the conduction of pain impulses. The analgesic effect is due to a decrease in the activity of the nociceptive and an increase in the antinociceptive system of the body. Tramadol hydrochloride has an antitussive effect. At therapeutic doses, tramadol hydrochloride does not depress respiration and does not affect intestinal motility.

Indications for use

Acute and chronic pain syndrome of moderate and significant severity (pre- and postoperative periods, malignant tumors, injuries, neuralgia)

Dosage and administration

The doctor determines the dose and duration of treatment individually, based on the intensity of the pain syndrome.

Adults administered orally (with a small amount fluids, regardless of food intake) 1 capsule (50 mg). With severe pain one single dose may be 2 capsules (100 mg).

The daily dose should not exceed 5-6 capsules. Dosing frequency should not be more than every 4 hours.

The drug should not be used longer than the period justified from a therapeutic point of view. Patients with moderate hepatic / renal dysfunction, as well as the elderly, doses are selected individually.

In moderate hepatic insufficiency, it is recommended to reduce the dose or increase the interval between doses.

With moderate kidney failure it is advisable to increase the interval between doses. For patients with creatinine clearance less than 30 ml / min, the interval should be increased to 12 hours. In such cases, the maximum recommended daily dose is 200 mg. In connection with possible development Tramadol addiction treatment should be short-term and intermittent. Should be carefully reviewed possible benefit long-term therapy and make sure that it exceeds the risk of addiction.

Side effects

Often:

- increased sweating

- headache

- dizziness

Nausea

Dry mouth

Change in appetite
Flatulence

Pain in the epigastrium
Infrequently:

Tachycardia

Feeling the heartbeat

decline blood pressure up to collapse (orthostatic collapse)

Rarely:

Weakness

lethargy

Reducing the rate of reactions

Sleep disturbance

Nightmares

Euphoria

hallucinations

Anxiety

Emotional lability

Depression

Amnesia

Paresthesia

Drowsiness

epileptiform seizures
Respiratory depression

Impaired coordination and speech

Syncope

Confusion

Anxiety

Visual impairment, taste

midriaz

Bradycardia

Increase in blood pressure

Muscle spasm

Involuntary muscle contraction

muscle weakness

Frequency unknown:

Increased levels of liver enzymes

- hives

- itching

- exanthema

- bullous rash

- angioedema

- anaphylactic reactions

- difficulty urinating

- dysuria

- urinary retention

- dyspnea

- worsening of the course bronchial asthma

- bronchospasm

- violation menstrual cycle

- fatigue

- drug dependence in patients prone to drug abuse, as well as with prolonged use of large doses of the drug.

Abrupt withdrawal after prolonged use of the drug can cause withdrawal syndrome (manifestations similar to withdrawal symptoms of narcotic drugs: psychomotor agitation, anxiety, irritability, insomnia, tremor, paresthesia, phobia attacks, hallucinations, confusion, depersonalization, paranoia, tinnitus, side effects) gastrointestinal tract).

Contraindications

Hypersensitivity to the active substance or to other components of the drug

Acute alcohol intoxication

Acute poisoning with sleeping pills, analgesics or psychotropic drugs

heavy liver failure

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

Epilepsy with frequent attacks

The period of treatment with MAO inhibitors and the next 14 days after their cancellation

Not used to treat opioid dependence

Pregnancy or lactation

Children's age up to 18 years

Drug Interactions

With the simultaneous appointment of Tramadol with drugs that depress the central nervous system, mutual enhancement of central effects, including respiratory depression, is possible.

Microsomal oxidation inducers (carbamazepine, barbiturates) reduce the severity analgesic effect and 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, stopping analgesia after the use of opioid analgesics. When used together with MAO inhibitors and within 14 days after their withdrawal, furazolidone, procarbazine and antipsychotics, there is a 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.

At simultaneous application Tramadol and warfarin increase the risk of side effects from the blood coagulation system. Tramadol may cause seizures and/or the development of potentially life-threatening serotonin syndrome when used in conjunction with serotonergic drugs.

Ketoconazole and erythromycin may interfere with the metabolism of tramadol. The clinical significance of this interaction has not been studied.

Ondansetron increases the need for tramadol in patients with postoperative pain.

special instructions

During treatment with Tramadol, alcohol should not be consumed.

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

Tramadol should not be used to treat drug withdrawal syndrome.

Special care should be taken when prescribing the drug to patients with head injuries, increased intracranial pressure, moderate renal or hepatic impairment, patients with a tendency to convulsions, as well as patients with hypersensitivity to opiates. The risk of seizures may be higher in patients who use drugs that reduce convulsive syndrome. Patients with a history of epilepsy and a tendency to epileptic seizures can be prescribed the drug only if absolutely necessary. Use with caution to treat patients with impaired respiratory function or in the case of simultaneous use of drugs that depress the activity of the central nervous system, because of the risk of further respiratory depression.

The drug contains lactose, so patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.

Application in pediatrics

The drug is not used to treat children under 18 years of age.

Use during pregnancy or lactation

Tramadol crosses the placental barrier, so it is not recommended to use the drug during pregnancy. If there is an indication for opioid analgesic therapy during pregnancy, single use should be limited.

A small amount of Tramadol passes into breast milk, so the drug should not be used during the period of breastfeeding. With a single use, breastfeeding can not be interrupted.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms

When using the drug, you should refrain from driving vehicles and working with other mechanisms, which require increased attention and rapid mental and motor reactions.

Overdose

Symptoms: vomiting, miosis, circulatory disturbances, depression of consciousness (up to coma), convulsions, depression of the respiratory center until complete cessation of breathing.

Treatment aimed at ensuring patency respiratory tract maintaining respiration and cardiovascular function vascular system.

The antidote for depression of the respiratory center is naloxone, for convulsions - benzodiazepine. Tramadol is poorly excreted by dialysis, so the separate use of hemodialysis or hemofiltration is not enough.

Release form and packaging

Tramadol tablets belong to the group of psychotropic opioid analgesics. This is very strong drug, which provides a fast and long-lasting analgesic effect. However, the drug is several times less effective than morphine, the most famous representative of narcotic analgesics. In Russia, Tramadol is included in the list of vital important 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 drug affects directly the central nervous system and spinal cord, blocking the conduction of pain impulses and increasing the impact 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 the respiratory system, does not cause a change in blood pressure. 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 intramuscular injection 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 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 administration. In addition to the main substance, they contain sucrose, glycerin, anise and mint oil giving 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 pain may occur in the postoperative post-traumatic period or manifest 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 associated with CNS depression 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. This medication should be used with extreme caution when various violations consciousness, traumatic brain injury, seizure 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. 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.

To treat severe pain that accompanies cancer 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 - 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:

On the part of the heart and blood vessels, such a phenomenon as a decrease in pressure (orthostatic hypotension) is often noted, which can provoke fainting, tachycardia, collapse.
The central nervous system reacts to taking the drug with dizziness, headache, increased nervousness or vice versa, inhibition. Patients complain of weakness, increased sweating, sleep disturbance, drowsiness in daytime, 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 taste sensations, failure of the 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 analgesics, the appearance of muscle cramps, runny nose, sneezing, lacrimation. Digestive disorders, nausea, feverish conditions, insomnia, tachycardia, increased blood pressure. To avoid unpleasant consequences the drug should not be taken long time and should be phased out 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 holding medical 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. At simultaneous reception with barbiturates, there is a decrease in the effectiveness of the drug.

Tramadol should not be taken at the same time as alcoholic drinks, because 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 addiction, therefore Tramadol belongs to the class drugs which are subject to mandatory control. The drugs in this group are subject to special rules destination, release, transportation, storage 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, and traumatic brain injury. This drug should not be given to people who are addicted to opioids.

While taking psychotropic or sleeping pills 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 other medicines.

many relatives 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.

Active substance

Tramadol hydrochloride (tramadol)

Release form, composition and packaging

Tablets white with barely noticeable inclusions, round, flat, slightly rough, with a chamfer, with a characteristic smell of strawberries.

Excipients: lactose, microcrystalline cellulose, magnesium stearate, crospovidone, macrogol 4000, sodium saccharin, colloidal silicon oxide, flavor.

10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.

Capsules hard gelatin, with body yellow color and green cap the contents of the capsules are white or almost white powder.

Excipients: calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

The composition of the capsule shell: gelatin, titanium dioxide, yellow iron oxide, indigotine (E132).

10 pieces. - cellular contour packings (1) - packs of cardboard.
10 pieces. - cellular contour packings (2) - packs of cardboard.
10 pieces. - cellular contour packings (3) - packs of cardboard.
10 pieces. - cellular contour packings (5) - packs of cardboard.
10 pieces. - cellular contour packings (10) - packs of cardboard.

10 ml - dark glass dropper bottles (1) - packs of cardboard.
20 ml - dark glass dropper bottles (1) - packs of cardboard.
50 ml - dark glass dropper bottles (1) - packs of cardboard.
100 ml - dark glass dropper bottles (1) - packs of cardboard.

pharmachologic effect

Opioid analgesic with a mixed mechanism of action. Refers to analgesics of central action. It has a pronounced analgesic effect. Non-selective opioid mu-, delta- and kappa-receptor antagonist in the CNS with the highest affinity for mu-receptors. Inhibits reverse neuronal uptake and enhances the release of serotonin. It also has an antitussive effect, does not disturb the motility of the gastrointestinal tract.

The duration of action is about 4-8 hours.

Pharmacokinetics

Suction

After taking tramadol, it is rapidly and almost completely absorbed from the gastrointestinal tract (about 90%). C max in the blood is determined after about 2 hours. Bioavailability is about 70%, does not depend on food intake and increases with repeated use of the drug.

Distribution

Plasma protein binding is about 20%. Tramadol crosses the BBB and the placental barrier. Approximately 0.1% is excreted in breast milk.

Metabolism

It is metabolized by demethylation and conjugation to 11 metabolites, only one of which (O-demethyltramadol) has a pronounced pharmacological activity (2-4 times the activity of Tramadol).

breeding

Tramadol and its metabolites are excreted mainly by the kidneys (up to 90%) and through the intestines (about 10%). T 1 / 2, regardless of the route of administration, is about 6 hours. In elderly patients, with and with renal failure, the value of T 1 / 2 increases.

Indications

- pain syndrome of moderate and severe intensity of various etiologies (postoperative period, trauma, pain in cancer patients);

- for the purpose of anesthesia during painful diagnostic or therapeutic procedures.

Contraindications

- conditions accompanied by respiratory depression or severe CNS depression (alcohol poisoning, hypnotics, narcotic analgesics, psychotropic drugs);

- simultaneous use of MAO inhibitors (and 2 weeks after their cancellation);

- pregnancy;

- lactation period (use is possible only for health reasons);

- age up to 14 years;

- Hypersensitivity to the drug.

Dosage

Tablets

initial dose - 1 tab. (50 mg) orally with a small amount of liquid, regardless of food intake; if there is no effect within 30-60 minutes, you can take 1 more tablet; at strong pain a single dose can immediately be 100 mg (2 tablets). The effect, depending on the severity of pain, lasts for 4-8 hours. Do not exceed the daily dose of Tramadol 400 mg (8 tablets).

Duration and scheme of application are determined by the attending physician

Tablets can be swallowed without chewing, with the necessary amount of liquid, regardless of the meal, or pre-dissolved in 1/2 glass of water.

Capsules

The dose of the drug is selected by the doctor individually, depending on the intensity and nature of the pain.

Adults and adolescents over the age of 14: initial dose - 1 capsule (50 mg) orally with a small amount of liquid, regardless of the meal; in the absence of effect within 30-60 minutes, you can take another 1 capsule; at severe pain a single dose can immediately be 100 mg (2 capsules). The effect, depending on the severity of pain, lasts for 4-8 hours. Do not exceed the daily dose of tramadol 400 mg (8 capsules).

This should not be assigned dosage form children weighing less than 25 kg and aged less than 14 years.

Elderly patients, patients with impaired liver and kidney function if necessary, increase the interval between doses of the drug.

Duration and scheme of application are determined by the attending physician.

Capsules should be swallowed without chewing, washing down with the necessary amount of liquid, regardless of the meal.

Solution for oral administration

The dose of the drug is selected by the doctor individually, depending on the intensity and nature of the pain.

Adults and adolescents over the age of 14: the dose is 50 mg (20 drops). In the absence of the desired effect after 30-60 minutes, you can take another 20 drops. If necessary, the drug can be taken again after 4-6 hours. The daily dose should not exceed 400 mg (160 drops).

For children aged 1 to 14 years a single dose is 1-2 mg/kg of body weight. Approximate dosages for children are shown in the table (1 drop of the solution corresponds to approximately 2.5 mg of tramadol g / x).

Elderly

patients, patients with impaired liver and kidney function if necessary, increase the interval between doses of the drug. The prescribed number of drops should be taken with a small amount of liquid or sugar, regardless of food intake. Duration and scheme of application are determined by the attending physician.

The bottle with a dosing device is equipped with a child-resistant cap. To open the bottle, press on the cap and make a rotational movement from left to right.

Side effects

The most characteristic are dizziness, nausea, constipation, headache, drowsiness (in 15-30% of patients), vomiting, skin itching, symptoms of a psychostimulating effect, asthenia, sweating, dyspepsia, dry mouth, diarrhea (5-15% of patients).

With a frequency of less than 5%, weight loss, hypotension and tachycardia, paresthesia, hallucinations, tremors, abdominal pain, visual disturbances, urinary retention are possible.

The incidence of side effects increases with increasing duration of the drug. With prolonged use in large doses, the possibility of developing drug dependence is not ruled out.

About all side effects, incl. not listed above should be reported to your doctor.

Overdose

Symptoms: pupillary constriction, vomiting, respiratory depression and convulsions.

drug interaction

With the simultaneous use of Tramadol with drugs that have a depressant effect on the central nervous system, as well as with ethanol, it is possible to enhance their action.

With the simultaneous use of Tramadol with and other inducers of metabolic enzymes, the analgesic effect of Tramadol may be weakened.

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.

Naloxone activates respiration, eliminating analgesia after the use of opioid analgesics.

special instructions

In elderly patients, Tramadol is used at extended intervals.

With caution and under the supervision of a physician, the drug should be used in patients with impaired renal and hepatic function, with craniocerebral injuries, increased intracranial pressure, patients with epilepsy, as well as persons with drug dependence on opioids.

Under close medical supervision and in reduced doses, Tramadol should be used against the background of the action of anesthetics, hypnotics and psychotropic drugs.

The drug should not be combined with narcotic analgesics due to the poor predictability of the interaction effect.

Against the background of long-term use of carbamazepine, the effect of Tramadol may be weaker.

Influence on the ability to drive vehicles and control mechanisms

When using tramadol, you should not drive a car or perform other work that requires increased attention.

Pregnancy and lactation

During pregnancy, long-term use of Tramadol should be avoided due to the risk of developing addiction in the fetus and the occurrence of withdrawal syndrome in the neonatal period.

If it is necessary to take during lactation, it should be borne in mind that Tramadol is excreted in breast milk in small quantities.

pharmachologic effect

An opioid synthetic analgesic that has a central effect and an effect on the spinal cord (promotes the opening of K + and Ca2 + channels, causes membrane hyperpolarization and inhibits the conduction of pain impulses), enhances the effect of sedative drugs. Activates opiate receptors (mu-, delta-, kappa-) on pre- and postsynaptic membranes of afferent fibers of the nociceptive system in the brain and gastrointestinal tract. Slows down the destruction of catecholamines, stabilizes their concentration in the central nervous system. It is a racemic mixture of 2 enantiomers - dextrorotatory (+) and levorotatory (-), each of which exhibits a different receptor affinity. (+) Tramadol is a selective agonist of mu-opioid receptors, and also selectively inhibits the reuptake of neuronal serotonin. (-) Tramadol inhibits the reuptake of norepinephrine. Mono-O-desmethyltramadol (M1 metabolite) also selectively stimulates mu-opiate receptors. The affinity of tramadol for opioid receptors is 10 times weaker than that of codeine and 6000 times weaker than that of morphine. The severity of analgesic action is 5-10 times weaker than morphine. The analgesic effect is due to a decrease in the activity of the nociceptive and an increase in the antinociceptive systems of the body. In therapeutic doses, it does not significantly affect hemodynamics and respiration, does not change the pressure in the pulmonary artery, slightly slows down intestinal motility, without causing constipation. Provides some antitussive and sedative effect. Inhibits the respiratory center, stimulates the starting zone of the vomiting center, nuclei oculomotor nerve. With prolonged use, tolerance may develop. The analgesic effect develops 15-30 minutes after ingestion and lasts up to 6 hours.

Indications for use

Pain syndrome of strong and moderate intensity with malignant neoplasms, acute myocardial infarction, injuries, during painful diagnostic and therapeutic procedures.

Method of application and dosing regimen

Doses are selected individually (depending on the severity of the pain syndrome and the sensitivity of the patient). The duration of the course of treatment is also determined individually, but the drug should not be prescribed beyond the period justified from a therapeutic point of view.

Adults and teenagers over 14 years old usual dose for a single oral dose is 0.05 g with a small amount of liquid. If necessary, in case of insufficient effect, after 30-60 minutes, you can repeat the intake at the same dose, the frequency of administration is up to 4 doses per day. The maximum daily dose is 0.4 g (400 mg). AT exceptional cases, for example, in cancer patients, it is possible to reduce the interval to 6 hours and increase the daily dose.

The effect lasts an average of 4-8 hours, depending on the nature and intensity of pain.

With increased intervals of time, tramadol is used in elderly patients.

special instructions

With caution, the drug is prescribed to patients with impaired renal and hepatic function, with craniocerebral injuries, increased intracranial pressure, and patients with epilepsy. The use of tramadol may complicate the diagnosis in acute pain syndrome in the abdominal area.

Under close supervision in reduced doses, tramadol should be used against the background of the action of anesthetics, sleeping pills, anxiolytics and antidepressants to avoid excessive depression of the central nervous system and suppression of the activity of the respiratory center.

Influence on the ability to drive a car and potentially dangerous mechanisms: the use of tramadol makes it difficult to perform work that requires a high speed of mental and physical reactions and increased concentration of attention (driving vehicles, operating mechanisms, instruments, etc.).

Side effect

Tramadol is relatively well tolerated, at therapeutic doses it does not cause severe respiratory depression and does not significantly affect the circulatory system and gastrointestinal tract. However, it may cause dizziness, dysphoria, euphoria, hallucinations, cognitive decline, convulsions, nausea, epigastric pain, vomiting, constipation, difficulty urinating, tachycardia, palpitations, lethargy. In rare cases, usually with prolonged use of tramadol, addiction, dependence, "withdrawal" syndrome are possible; severe respiratory depression, hypotension, collapse. When tramadol is used in patients with a burdened allergic history, allergic reactions are possible.

The incidence of side effects increases with increasing duration of the drug.

Contraindications

hypersensitivity, acute poisoning alcohol or CNS depressants, epilepsy, impaired liver and kidney function, pregnancy, breastfeeding, childhood up to 14 years old. The use of tramadol is contraindicated in patients taking MAO inhibitor drugs.

Interaction with other drugs

Enhances the effects of hypnotics, sedatives and anesthetics, anxiolytics, alcohol. Activity is reduced by analeptics and psychostimulants, completely blocked by naloxone and naltrexone (direct antagonists). In combination with neuroleptics and MAO inhibitors, the risk of developing epileptiform seizures increases. In patients receiving long-term carbamazepine, the metabolism of tramadol is significantly increased, which may require an increase in the dose of the analgesic. The drug should not be combined with narcotic analgesics from the group of full (trimeperidine, fentanyl) or partial agonists (buprenorphine), as well as agonist-antagonists (nalbuphine, butorphanol) of opioid receptors. Inducers of microsomal oxidation (including carbamazepine, barbiturates) reduce the duration of the analgesic effect. Long-term use of opioid analgesics and barbiturates stimulates the development of cross-tolerance. Quinidine increases the plasma concentration of tramadol and reduces the concentration of the M1 metabolite due to competitive inhibition of the CYP2D6 coenzyme. There is evidence of a decrease in plasma concentrations of fluoroquinolones (ciprofloxacin, ofloxacin) during premedication with tramadol during surgical interventions.

Overdose

Symptoms: miosis, convulsions, collapse, coma, depression of the respiratory center, apnea.

Treatment: maintaining airway patency, maintaining adequate pulmonary ventilation, maintaining activity of cardio-vascular system, symptomatic therapy (opiate effects can be stopped by naloxone; convulsions - benzodiazepines (diazepam)). At chronic poisoning tramadol may develop withdrawal symptoms.

Release form

Capsules 50 mg in package No. 10.