Tramadol Capsules (50 mg). Tramadol tablets - instructions for use Tramadol instructions for use tablets 50

In this article, you can read the instructions for using the drug Tramadol. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Tramadol in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Tramadol analogues in the presence of existing structural analogues. Use for the treatment of pain and pain relief in adults, children, and during pregnancy and lactation.

Tramadol- an opioid synthetic analgesic with 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 sedatives.

Activates opioid receptors (mu-, delta-, kappa-) on pre- and postsynaptic membranes of afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

The drug belongs to the list No. 1 of potent substances of the Standing Committee for Drug Control of the Ministry of Health of the Russian Federation.

Compound

Tramadol hydrochloride + excipients.

Pharmacokinetics

Absorption - 90%, bioavailability - 68% (increases with repeated use). Penetrates through the blood-brain and placental barriers, 0.1% is excreted in breast milk. Excreted by the kidneys (25-35% unchanged).

Indications

• pain syndrome of medium and severe intensity of various etiologies (postoperative period, trauma, pain in cancer patients);
• anesthesia during painful diagnostic or therapeutic procedures.

Release form

Capsules 50 mg and 100 mg.

Tablets 50 mg and 100 mg.

Candles for rectal use 100 mg.

Solution or drops for oral administration.

Solution for injection (injections in ampoules).

Instructions for use and dosing regimen

Tablets

Adults and adolescents over 14 years of age: the initial dose is 1 tablet (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 tablet; with severe 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 14 years of age: the initial dose is 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; for 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).

Do not prescribe this dosage form to children weighing less than 25 kg and aged less than 14 years.

Elderly patients, patients with impaired liver and kidney function, if necessary, should 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.

Ampoules

Tramadol is used as 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 justified from a therapeutic point of view.

Tramadol is intended for intravenous (injection slowly), intramuscular or subcutaneous administration. Unless otherwise prescribed, Tramadol should be administered in the following dosages:

For adults and adolescents over 14 years of age, 50-100 mg of tramadol hydrochloride (1-2 ml of injection solution) once. If satisfactory analgesia has not occurred, after 30-60 minutes a repeated single dose of 50 mg (1 ml) may be prescribed. For severe pain, a higher dose (100 mg tramadol hydrochloride) may be given as the starting dose. As a rule, 400 mg of tramadol hydrochloride per day is usually enough to relieve pain.

Higher doses may be used to treat cancer pain and severe postoperative pain.

In elderly patients (aged 75 years and over), due to the possibility of delayed elimination, the interval between injections of the drug may be increased in accordance with individual characteristics.

Candles rectal

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

Adults and adolescents over the age of 14 are prescribed 1 suppository (100 mg of tramadol hydrochloride).

The effect of the drug persists for 4-8 hours. The daily dose should not exceed 400 mg of tramadol hydrochloride (4 suppositories).

In the presence of pain in tumors, higher dosages of the drug are needed, for which other dosage forms are available.

Side effect

• sweating;
• dizziness;
• headache;
• weakness;
• increased fatigue;
• lethargy;
• paradoxical stimulation of the central nervous system (nervousness, agitation, anxiety, tremor, muscle spasms, euphoria, emotional lability, hallucinations);
• drowsiness;
• sleep disturbance;
• confusion;
• violation of coordination of movement;
• depression;
• amnesia;
• unsteady gait;
• dry mouth;
• nausea, vomiting;
• flatulence;
• constipation;
• diarrhea;
• difficulty in swallowing;
• tachycardia;
• orthostatic hypotension;
• hives;
• exanthema;
• difficulty urinating;
• dysuria;
• urinary retention;
• impaired vision, taste;
• violation of the menstrual cycle;
• with prolonged use - the development of drug dependence (narcotic drug).

Contraindications

• conditions accompanied by respiratory depression or severe CNS depression (alcohol poisoning, hypnotics, opioid analgesics, psychotropic drugs);
• severe hepatic and / or renal failure (CC less than 10 ml / min);
• simultaneous use of MAO inhibitors (and 2 weeks after their cancellation);
• children's age (up to 14 years);
• hypersensitivity to the drug and other opioids.

Use during 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.

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.

drug interaction

With the simultaneous use of Tramadol with carbamazepine 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.

Enhances the effect of drugs that have a depressing effect on the central nervous system, and ethanol (alcohol).

Quinidine increases the plasma concentration of Tramadol.

Analogues of the drug Tramadol

Structural analogues for the active substance:

• Protradon;
• Sintradon;
• Tramadol Lannacher;
• Tramadol retard;
• Tramadol Stada;
• Tramadol Akri;
• Tramadol GR;
• Tramadol Plethico;
• Tramadol ratiopharm;
• Tramadol Slovakopharm;
• Tramadol hydrochloride;
• Tramaclosidol;
• Tramal;
• Tramal 50;
• Tramal retard;
• Tramal retard 100;
• Tramal retard 150;
• Tramal retard 200;
• Tramolin;
• Tramundin retard.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

(tramadol | tramadol)

Registration number:

P N 015731/01 dated 06/03/2004

Trade name of the drug: Tramadol

International non-proprietary name:

tramadol

Dosage form:

tablets

Compound:

1 tablet contains:
active substance: tramadol hydrochloride 50 mg
Excipients:
Lactose, microcrystalline cellulose, magnesium stearate, crospovidone, macrogol 4000, sodium saccharin, colloidal silicon oxide, flavor.

Description: round, flat, white with barely noticeable inclusions, slightly rough tablets with a chamfer with a characteristic strawberry odor.

Pharmacotherapeutic group:

Analgesic opioid
ATX code:

Pharmacological properties:

Pharmacodynamics:
An opioid synthetic analgesic that has a central effect and an effect on the spinal cord (promotes the opening of K + and Ca + channels, causes membrane hyperpolarization and inhibits the conduction of pain impulses), enhances the effect of sedatives. Activates specific opioid receptors (mu-, delta-, kappa-) on pre- and postsynaptic membranes of afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

Pharmacokinetics:
After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract (about 90%). The maximum plasma concentration is determined 2 hours after ingestion. Bioavailability with a single oral administration is 68% and increases with repeated use. Penetrates through the blood-brain and placental barriers.
0.1% is excreted in breast milk. The volume of distribution is 306 liters. 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. T ½ in the second phase - 6 hours (tramadol), 7.9 hours (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 of various etiologies (postoperative period, trauma, pain in cancer patients). Anesthesia during painful diagnostic or therapeutic procedures.

Contraindications:

• Hypersensitivity to the drug and other opioids.
• Conditions accompanied by respiratory depression or severe depression of the central nervous system (alcohol poisoning, hypnotics, narcotic analgesics, psychotropic drugs).
• Severe hepatic and / or renal insufficiency (creatinine clearance less than 10 ml / min).
• Simultaneous use of MAO inhibitors (and two weeks after their cancellation).
• During pregnancy and lactation, use is possible only for health reasons and should be limited to a single dose.
• Children's age (up to 14 years).

With caution and under the supervision of a physician, the drug should be used in patients with impaired kidney and liver function, with traumatic brain injury, increased intracranial pressure, patients with epilepsy, also in people with drug dependence on opioids, in patients with abdominal pain of unknown origin (" acute abdomen).

Dosage and administration:

Tramadol is used when a doctor prescribes, the dosage regimen is selected individually, depending on the severity of the pain syndrome and the sensitivity of the patient.
Unless otherwise prescribed, Tramadol should be administered in the following dosages:
For adults and adolescents over the age of 14- 1 tablet (50 mg), if necessary, after 30-60 minutes, you can take another tablet; for severe pain, a single dose may be 100 mg (2 tablets). Tablets are swallowed without chewing, washed down with a small amount of liquid, or previously dissolved in ½ glass of water, regardless of the meal.
The daily dose should not exceed 400 mg (8 tablets).
For the treatment of pain in oncological diseases and severe pain in the postoperative period higher doses may be used.
In elderly patients(at the age of 75 years and more) due to the possibility of delayed excretion, the interval between the administration of the drug can be increased in accordance with individual characteristics.
In patients with kidney and liver disease Tramadol may take longer to work. For such patients, the doctor may recommend an increase in the interval between the introduction of single doses.
Tramadol should not be given for longer than is therapeutically necessary.

Side effects:
From the side of the cardiovascular system: tachycardia, orthostatic hypotension, syncope, collapse.
From the digestive system: dry mouth, nausea, vomiting, flatulence, abdominal pain, constipation, diarrhea, difficulty swallowing.
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, impaired coordination of movement, convulsions central genesis (with intravenous administration in high doses or with the simultaneous appointment of antipsychotics), depression, amnesia, cognitive impairment, paresthesia, gait instability.
Allergic reactions: urticaria, itching, exanthema, bullous rash.
From the urinary system: difficulty urinating, dysuria, urinary retention.
From the sense organs: impaired vision, taste.
From the respiratory system: dyspnea.
Other: violation of the menstrual cycle.

With prolonged use - the development of drug dependence. With a sharp cancellation, the development of the “withdrawal” syndrome is not excluded.

Overdose (intoxication) with the drug:
Symptoms: miosis, vomiting, collapse, coma, convulsions, depression of the respiratory center, apnea.
Treatment: ensuring airway patency, supporting breathing and the activity of the cardiovascular system. Opiate-like effects can be stopped with naloxone, convulsions - benzodiazepine.

Interaction with other drugs:

Enhances the effect of ethanol and agents that have a depressing effect on the central nervous system.
Inducers of microsomal oxidation (including 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 breathing, eliminating analgesia after the use of opioid analgesics. MAO inhibitors, furazolidone, procarbazine, neuroleptics can cause a risk of developing seizures (reducing the seizure threshold).
Quinidine increases the plasma concentration of tramadol and reduces the content of the M1 metabolite due to competitive inhibition of the CYP2D6 isoenzyme.

Special instructions:

With increased time intervals, tramadol is used in elderly patients. Under close medical supervision and in reduced doses, tramadol should be used against the background of the action of anesthetics, hypnotics and psychotropic drugs.
It is forbidden to drink alcohol during treatment.
Do not use for the treatment of the syndrome of "cancellation" of narcotic substances.
In the case of a single dose, there is no need to interrupt breastfeeding.

When using the drug, it is necessary to refrain from driving a car and engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Release form:

10 tablets in Al foil and OPA/Al/PVC combination blisters.
1, 2, 3 or 5 blisters along with instructions for use in a cardboard box.

Storage conditions:

At a temperature not exceeding 25 ° C, out of the reach of children.
The drug belongs to the list No. 1 of potent substances of the Standing Committee for Drug Control of the Ministry of Health of the Russian Federation.

Best before date:

5 years. Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies:

By prescription.

Manufacturing firm:
Geksal AG, manufactured by Salutas Pharma GmbH, Industrialstrasse 25, Holzkirchen, 83607, Germany.

Representative office in Moscow:
121170 Moscow, st. Kulneva, 3

in one milliliter oral solution(corresponding to 40 drops) contains: 100 mg Tramadol hydrochloride, sucrose (Saccharose), (Glicerin), propylene glycol (Propylene glycol), polysorbate 20 (Polysorbate 20), potassium sorbate (Rotassium sorbate), sodium saccharin (Sodium saccharin), oil peppermint (Peppermint oil), anise oil (Oleum anisi), purified water (Aqua purificatae).

One capsule contains: 50 mg Tramadol hydrochloride, lactose monohydrate (Lactose monohydrate), magnesium stearate (Magnesium stearate). The composition of the gelatin capsule contains the dye Brilliant Black PN (E151).

One tablets Tramadol retard the film shell includes 100, 150 or 200 mg Tramadol hydrochloride, hypromellose (Hypromellose), microcrystalline cellulose (Microcrystalline cellulose), colloidal silicon dioxide (Silicii dioxydum colloidale) anhydrous, magnesium stearate (Magnesium stearate).

The composition of the film shell: hypromellose (Hypromellose), lactose monohydrate (Lactose monohydrate), macrogol 6000 (Macrogol 6000), talc (Talcum), titanium dioxide (Titanium dioxide), propylene glycol (Propylene glycol).

One milliliter solution contains 50 mg Tramadol hydrochloride, (Sodium acetate) anhydrous, water for injection (Aqua pro injectionibus).

To make one rectal suppository 100 mg Tramadol hydrochloride, solid fat is required.

Release form

Tramadol is available in the form:

• drops for oral administration;
• capsules;
• tablets;
• prolonged-release tablets (retard);
• solution for injection;
• rectal suppositories.

pharmachologic effect

The INN of the drug is Tramadol. The drug belongs to the group opioid analgesics (painkillers) medicines and is a strong central action .

With an increase in the duration of administration of Tramadol, the analgesic effect of the drug decreases, as a result of which patients who are indicated for long-term therapy need to gradually increase the dose to maintain pain relief.

Pharmacodynamics and pharmacokinetics

Analgesic effect carried out in two ways:

• by binding to opiate receptors (μ-, δ- and κ-) on the presynaptic and postsynaptic membranes of the afferent (centripetal) nerve fibers of the pain perception system (nociceptive system) in the spinal cord and brain, as well as in the digestive tract (due to this property, the intensity of pain);
• by suppressing the reuptake of norepinephrine and stimulating descending noradrenergic effects (as a result, the processes of transmission of pain impulses in the spinal cord are inhibited).

In addition, Tramadol:

• initiates the opening of potassium (K) and calcium (Ca) channels;
• increases the imbalance of ions on both sides of cell membranes;
• slows down transmission nerve impulses ;
• slows down destruction catecholamines (norepinephrine, and others);
• normalizes the level catechoamines in the CNS .

Substance inhibits the activity of the cerebral cortex , as well as respiratory centerR and cough center , thus providing sedative (calming) and antitussive effects; excites the nuclei of the oculomotor nerve and chemoreceptor trigger (starting) zone of the center of vomiting , through which pupillary reflex ; provokes Withspasm of smooth muscle sphincters .

Analgesic action manifests itself 15-30 minutes after oral administration and lasts up to 6 hours. From digestive tract approximately 90% of the dose taken is absorbed. Bioavailability index:

• 68% when taken orally (increases with repeated use of the drug);
• 70% - when using the drug in the form of rectal suppositories;
• 100% - when the solution is injected into the muscle.

Therapeutic concentration reaches its maximum:

• two hours after taking the tablet form of Tramadol;
• 60 minutes after taking the drops;
• 45 minutes after intramuscular injection.

The biotransformation of Tramadol occurs in liver with the formation of 11, one of which (mono-O-desmethyltramadol) is pharmacologically active.

Elimination half-life for Tramadol and its metabolites ranges from 6 to 43.2 hours (very long half-life of the substance in patients with severe forms and CRF ).

Removal of Tramadol and its products metabolism carried out kidneys (from 25 to 35% of the substance is eliminated in pure form), the average cumulative rate of excretion kidneys - 94%. Approximately 7% is excreted using.

Tramadol indications for use

Indications for the use of Tramadol are strong and moderate pain syndrome different nature: post-traumatic pain syndrome (including pain after fractures, surgeries, etc.); pain syndrome associated with ; pain provoked by development, various therapeutic and diagnostic procedures.

Contraindications

The drug is contraindicated in patients with hypersensitivity to Tramadol or auxiliary components of the drug, with acute CNS inhibitors (alcohol, psychotropic drugs ,psycholeptics , sedative and anxiolytic drugs , sleeping pills ).

Tramadol is also not prescribed for an increased risk of suicide, a tendency to abuse PAS (psychoactive substances), severe forms hepatic and/or , in the first 13 weeks, for patients who are being treated with MAOIs (monoamine oxidase inhibitors).

In pediatrics, parenteral administration of the drug and taking drops are contraindicated in children under one year old, capsules and tablets for oral administration are prohibited from prescribing to patients under 14 years of age.

Side effects

The most common side effects of Tramadol are side effects digestive tract and CNS . When taking the drug in therapeutic doses, they are observed in approximately every third to twentieth case out of a hundred.

Adverse reactions, observed in about 5% of cases, are nausea, increased nausea, vomiting, asthenia , increased sweating, increased dry mouth.

More than 1% of patients on the background of the use of Tramadol show the following symptoms:

• increased anxiety, confusion, coordination disorders, emotional lability, sleep disturbances;
• abdominal pain, loss of appetite,;
• the appearance of a rash on the skin;
• urinary retention (ischuria), increased urination;
• changes similar to those that occur during the onset;
• vascular dilatation ;
• visual impairment.

In less than 1% of patients:

• increased seizure activity ;
• impaired cognitive function I (higher functions of the brain), concentration of attention, gait;
• arise and paresthesia ;
• appears;
• develops;
• appears (skin blisters);
• arise urination disorders and menstrual disorders ;
• there are reactions from heart and vascular system (syncope , orthostatic hypotension , palpitation , increased blood pressure , cardiovascular collapse ,);
• increased muscle tone ;
• difficulty swallowing;
• body weight decreases.

Application instruction of Tramadol (Way and dosage)

The treatment regimen is selected depending on the intensity of pain and the general condition of the patient. Tramadol should not be taken longer than the period during which the use of the drug is absolutely justified.

Patients with moderate kidney and/or liver dysfunction , as well as for elderly people, the dose is selected individually. The maximum allowable daily dose for patients over 75 years of age is considered to be a dose of 0.3 g (corresponding to 3 ml or 120 drops).

With a moderate liver failure reduce the dose or increase the interval between capsules.

Patients with renal and/or liver failure It is recommended to take Tramadol at a lower dose and at longer intervals. Patients who have clearance (CC) does not exceed 30 ml per minute, at the initial stages of treatment it is recommended to double the interval between doses of the solution; the maximum daily dose for them should not exceed 0.2 g.

Drops for oral administration: instructions for use

Patients aged 14 years and older for pain relief a single dose of the solution is 20 drops (corresponding to 50 mg). Drops are taken with a small amount of liquid or sugar.

If after half an hour or an hour there is no expected effect, the dose is repeated.

For children aged from one to fourteen years, the drug is prescribed at the rate of 1-2 mg per kilogram of body weight. The daily dose is 4 to 8 mg/kg.

A second dose is allowed to be taken no earlier than 4-6 hours later.

Do not use Tramadol in a daily dose exceeding 0.4 g (corresponding to 4 ml or 160 drops). The exception is cases when pain relief is required for cancer patients with severe postoperative pain syndrome . For this category of patients, the daily dose, if necessary, is increased to 0.6 g.

Instructions for Tramadol capsules

Patients over the age of 14 are prescribed to take one 50 mg capsule (by mouth, with a small amount of liquid, without being attached to the time of the meal). With a strongly pronounced pain syndrome a single dose is allowed to increase to 0.1 g (2 capsules).

The maximum daily dose is 0.4 g (8 capsules).

Tramadol tablets: instructions for use

Tramadol tablets 50 mg are taken in the same way as capsules.

Retard tablets are taken orally at a dose of 0.1-0.2 g every 12 hours. The daily dose is 0.4 g. Reducing the interval between doses to 6 hours and increasing the daily dose is acceptable for patients with cancer.

Tramadol injections: instructions for use

For patients over the age of 14, Tramadol in ampoules is injected into a vein, muscle or under the skin.

A single dose is from 50 mg to 0.1 g (the contents of 1-2 ampoules of 50 mg or 1 ampoule of 0.1 g).

For children aged from one to fourteen years, the dose is selected depending on the weight (1-2 mg / kg). The routes of administration are the same as for older patients. Tramadol IV should be administered very slowly, after diluting it in the infusion solution.

The maximum allowable daily dose is 0.4 g, for patients with oncological diseases - 0.6 g.

Re-Tramadol in / in, in / m or s / c is allowed to enter no earlier than 4-6 hours later.

The instruction on Tramadol in the form of suppositories

For patients over 14 years of age, a single dose is 0.1 g (1 suppository), the intervals between applications are from 4 to 6 hours.

Overdose

A significant excess of the therapeutic dose may be accompanied by the development of symptoms of intoxication:

• impaired consciousness (up to );
• generalized convulsions ;
• hypotension ;
• constriction or dilation of the pupils ;
• respiratory depression ;

With a severe overdose of Tramadol, which is accompanied by damage to the center of consciousness and shallow breathing , as input . For relief of seizures shows the introduction to the patient.

Interaction

Concomitant use of Tramadol with MAO inhibitors . When the drug is combined with drugs that affect CNS , or with alcoholic beverages, may be noted synergistic effect , expressed in an increase in sedation or an increase in analgesic effect.

Increases the drug, as a result - the patient needs an increase in the dose of Tramadol.

Against the background of simultaneous administration of the drug with SSRIs, tricyclic depressants or psycholeptics the patient may be at increased risk of convulsions .

Terms of sale

Prescription drug. Tramadol cannot be bought without a prescription.

Storage conditions

Store in a dry, dark place at room temperature (no more than 25 degrees Celsius).

Best before date

Suitable for use within 5 years from the date of issue.

special instructions

Tramadol - what is it?

Wikipedia states that Tramadol is powerful analgesic from the group of partial agonists of opioid receptors .

Narcopedia (an encyclopedia that describes psychoactive substances ) to the question “What is Tramadol?” replies that this substance is synthetic analogue of opiates (narcotic opium alkaloids ), and produces effects similar to those of opium.

All currently known opioids Depending on the nature of their interaction with receptors, they belong to one of four main classes.

The main group is opioid agonists , which includes Tramadol. The analgesic power of this drug is much weaker than the power of substances such as heroin , pyritramide .

Side effects from taking drugs from this group are associated with depression of stem structures and centers of the medulla oblongata . They appear in the form sedation (may be noted somewhat less often), an increase in general weakness, suppression of the cough reflex .

At higher doses, it may develop bradypnea (rare breathing) and (stopping of respiratory movements), bradycardia , circulatory disorders , hypotension .

Along with the opioid agonists activate activity vomiting centers (which may be accompanied by bouts of nausea and vomiting ) and also affect smooth muscle of hollow internal organs , as a result of which the patient may have impaired motor skills of the latter (against the background of these disorders, it is not uncommon, ischuria , bile stasis , tendency to bronchospasm ).

Tramadol - a drug or not?

All opioid agonists (Tramadol is an exception to this list) are physically and mentally addictive, which is why the International Narcotics Convention classifies them as drugs that must be controlled.

These drugs are subject to special rules for prescribing, dispensing, transportation, reporting, storage, determined by special permits of the Ministry of Health of a particular country.

Among others opioid agonists Tramadol is non-narcotic sole drug , there are no clear data on the development of dependence on it.

A prescription for Tramadol can be written on a prescription form for strong drugs by any doctor after agreement with the head of the department if it is necessary to withdraw from the patient pain syndrome , which cannot be eliminated using non-opioid painkillers .

When and from what tablets, injections and drops should be prescribed with extreme caution

Tramadol should not be administered to patients with a predisposition to the development of alcohol, drug or drug dependence.

During the period of treatment with the drug, as well as for a certain period of time after its completion, special monitoring of the condition of patients with cerebral cramps .

In patients with opioid addiction Tramadol is not used as a replacement therapy.

If it is necessary to use the drug for a long time, the possibility of developing drug dependence is not excluded.

The drug is allowed to be prescribed (but with caution) to patients with increased (for example, with TBI) intracranial pressure and serious lung disease .

High doses can cause gastrointestinal problems.

Patients who are taking drugs that lower the seizure threshold at the same time as tramadol may increase the risk of convulsions .

The solution contains sucrose. Therefore, when prescribing this dosage form, it should be taken into account that with one dose of the drug, from 0.1 to 0.2 g of sucrose enters the body.

The composition of the capsules includes lactose, and therefore they should not be prescribed to patients with fructosemia , insufficiency sucrose-isomaltose , malabsorption glucose and galactose .

Analogues

Coincidence in the ATX code of the 4th level:

Generics of the drug are Tramadol GR (capsules and injection solution), Retard , Shtada (drops, capsules, injection solution), Akri (capsules), Plethico (injection solution), Tramadol-ratiopharm (drops for oral administration, effervescent tablets, capsules, injection solution); Tramaclosidol in tablets and in the form of a solution for injection, Tramal (drops, capsules, injection solution, rectal suppositories), Tramal retard , Tramolin (injection solution).

Tramal and Tramadol: the difference between drugs

And Tramadol are synonyms (or generics). This means that both drugs have the same composition, have the same effect and have the same indications for use, but are produced by different pharmaceutical companies.

A drug Tramal is the trade name for Tramadol, which is produced by Grunenthal GmbH (Grunenthal GmbH). Forms of release of the drug: drops for oral administration, retard tablets, injection solution, capsules, rectal suppositories.

Tramadol analogues according to the mechanism of action: Zaldiar , Prosidol , Forsodol , Ramleps , tramaceta , Palexia .

During pregnancy

Early term (up to 13 weeks) is a contraindication to prescribing the drug.

The category of action on the fetus according to the FDA classification is C. This means that clinical studies have not been conducted in pregnant women, and there are no accurate data on the safety of the drug, however, in experiments on experimental animals, a risk to the fetus has been identified.

Starting at week 14, Tramadol is prescribed if the potential benefit of the drug can outweigh the possible harm.

The drug is characterized by the ability to pass through GEB and placental barrier , 0.1% of the substance entering the body is excreted in the milk of a nursing woman. A single use of the drug, as a rule, does not require discontinuation.

HEXAL HEXAL/ Salyutas Pharma GmbH HEXAL+KANONPHARMA PRODUCTION KRKA LANNACHER POLFA SLOVAKOFARMA STADA Akrikhin KhPK AO BRYNTSALOV-A, CJSC Geksal AG JSC Pranafarm, OOO Salyutas Pharma GmbH FGBU RKNPK of the Ministry of Health and Social Development - EPMBP FGU "RKNPK Rosmedtekhnologii" - EP MBP Hemofarm A.D. Hemofarm D.O.O Hemofarm concern A.D. Shtada Artsneimittel AG EP MBP "RK NPK" FA for high-tech medical science

Country of origin

Austria Austria/Russia Germany Russia Serbia Serbia and Montenegro Yugoslavia

Product group

Painkillers

Opioid analgesic, cyclohexanol derivative

Release form

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

Description of the dosage form

• Capsules Solution for injection solution for injection clear colorless liquid Tablets Tablets

pharmachologic effect

Opioid analgesic, a derivative of cyclohexanol. Non-selective agonist of mu-, delta- and kappa receptors 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 the neuronal uptake 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 a sedative effect. In therapeutic doses, it practically does not depress breathing. It has an antitussive effect.

Pharmacokinetics

Absorption - 90%; bioavailability with intramuscular injection - 100%. The maximum concentration in blood plasma when administered intramuscularly 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 when administered intramuscularly. Communication with blood plasma protein - 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-demethyltramadol (M1) has pharmacological activity. The half-life in the second phase is 6 hours (tramadol), 7.9 hours (M1); in patients older than 75 years - 7.4 hours (tramadol); with cirrhosis of the liver - 13.3 ± 4.9 h (tramadol), 18.5 ± 9.4 h (M1); in chronic renal failure (creatinine clearance less than 5 ml/min) - 11 ± 3.2 h (tramadol), 16.9 ± 3 h (M1). 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 developing 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 anesthetics, hypnotics and psychotropic drugs. The drug should not be combined with narcotic analgesics due to the poor predictability of interaction effects. Not recommended for the treatment of drug withdrawal syndrome. Combination with MAO inhibitors should be avoided. Patients with epilepsy or those susceptible to seizures should only take Tramadol for health reasons. During the period of treatment with the drug, alcohol is not allowed and it is not recommended to engage in activities that require increased attention and a high speed of psychomotor reactions (driving vehicles and operating mechanisms). In the case of a single dose, there is no need to interrupt breastfeeding.

Compound

• Tramadol / tramal semi-finished product for preparation of caps 0.105 g tramadol 50 mg; Auxiliary in-va: sodium acetate, water for injection and tramadol 50 mg; Auxiliary in-va: sodium acetate, water for injection and tramadol g / x 50 mg / ml; Auxiliary in-va: sodium acetate, water for injection of tramadol g / x 50 mg / ml; Auxiliary in-va: sodium acetate, water for injection of tramadol g / x 50 mg; Auxiliary in-va: calcium hydrogen phosphate, 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 insufficiency (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 (of cerebral origin), in patients with abdominal pain of unknown origin, traumatic brain injury, increased intracranial pressure, impaired renal and / or liver function, as well as 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, impaired coordination of movement, convulsions of central origin (with intravenous administration in high doses or with the simultaneous appointment 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. Other: violation of the menstrual cycle. With prolonged use - drug dependence, with a sharp cancellation - "withdrawal" syndrome.

drug interaction

With simultaneous use 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. When used simultaneously with serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics, and other drugs that lower the seizure threshold, the risk of convulsions 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 are described.

Overdose

respiratory depression and convulsions

Storage conditions

• keep away from children
• store in a place protected from light

Information provided by the State Register of Medicines.

Synonyms

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

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

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

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 appoint inside (with a small amount of liquid, regardless of food intake) 1 capsule (50 mg). For severe pain, a 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 renal 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 the possible development of dependence on tramadol, treatment should be short-term and intermittent. The potential benefit of long-term therapy should be carefully reviewed to ensure that it outweighs the risk of dependence.

Side effects

Often:

- increased sweating

- headache

- dizziness

Nausea

• Dry mouth

  Change in appetite

• Flatulence

  Pain in the epigastrium

• Infrequently:

  Tachycardia

  Feeling the heartbeat

  Decreased blood pressure to the point of 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 bronchial asthma

  - bronchospasm

  - menstrual irregularity

  - 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 a withdrawal syndrome (manifestations similar to the symptoms of drug withdrawal: 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

severe liver failure

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

Epilepsy with frequent seizures

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.

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, 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.

With the simultaneous use of Tramadol and warfarin, the risk of side effects from the blood coagulation system increases. Tramadol can 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 concurrent anticonvulsants with Tramadol. Patients with a history of epilepsy and a tendency to epileptic seizures can be prescribed the drug only if absolutely necessary. Use with caution in the treatment of patients with impaired respiratory function or in the case of simultaneous use of agents that depress the activity of the central nervous system, due to 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 requires 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 It is aimed at ensuring the patency of the respiratory tract, maintaining breathing and the function of the cardiovascular 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