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Description

Tablets are white, almost white or white with a yellowish tint, flat-cylindrical, with a bevel. Marbling is allowed on the surface of the tablets.

Compound

Each tablet contains active substance- tramadol hydrochloride - 50 mg; Excipients- lactose monohydrate, povidone K-25, calcium stearate, microcrystalline cellulose.

Pharmacotherapeutic group

Analgesics, other opioids.

ATS code: N02AX02.

pharmachologic effect

Tramadol is a centrally active opioid analgesic. Has a mixed mechanism of action. It is a non-selective pure agonist of opioid µ, d and k receptors, has maximum affinity for µ receptors. Other mechanisms involved in the analgesic effects of tramadol include inhibition of neuronal norepinephrine reuptake and increased serotonin release. Tramadol also has an antitussive effect. Unlike morphine, analgesic doses of tramadol over a wide range do not depress respiration; gastrointestinal motility is less inhibited. The effect on the cardiovascular system is usually weak. The activity of tramadol is estimated to range from 1/10 to 1/6 of the activity of morphine.

Indications for use

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

Directions for use and dosage regimen

The tablets should be swallowed whole with a little water or the tablet should be dissolved in one glass of water. The drug is taken regardless of meals.

The dose of the drug should be adjusted depending on the intensity of the pain syndrome and the sensitivity of the patient. For pain relief, the minimum effective therapeutic dose should be selected. 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. If long-term treatment with tramadol is necessary, the patient's condition and the justification for continued use of the drug should be carefully and regularly assessed at short intervals.

For adults and adolescents over 14 years of age, the usual dose for a single oral dose is 50 mg (1 tablet), repeated every 4-6 hours if necessary. If pain relief does not occur within 30-60 minutes, you can repeat the dose at the same dose. For severe pain, an initial dose of 100 mg (2 tablets) may be required. Do not exceed the maximum daily dose of 400 mg (8 tablets). Depending on the nature and intensity of the pain, the duration of action of the drug is 4-8 hours.

Elderly patients

There is usually no need to adjust the dose in patients under 75 years of age without clinical evidence of hepatic/renal impairment. In patients over 75 years of age, tramadol elimination may be prolonged. Therefore, if necessary, the interval between doses of the drug should be extended in accordance with the patient's need for pain relief.

Patients with impaired renal/liver function

In patients with renal/liver failure, the elimination of the drug is slowed down. Therefore, prolongation of the interval between doses of the drug must be carefully monitored in accordance with the patient's pain relief needs.

In patients with creatinine clearance

Because very little tramadol is removed by hemodialysis, it is usually not necessary to take an additional dose of tramadol after the hemodialysis procedure.

Side effect

The frequency of possible side effects is classified as follows:

Often (≥ 1/10)

Often (≥ 1/100 to

Infrequently (≥ 1/1000 to

Rarely (≥ 1/10000 to

Very rarely (

Unknown (frequency cannot be estimated from available data).

The most common side effects that may occur during treatment with tramadol are nausea and dizziness, occurring in more than 1 in 10 patients.

From the outsidecardiovascularsystems: infrequently: rapid heartbeat, weakness, vascular collapse. These side effects may occur especially in an upright position and during physical activity. Rarely: bradycardia, arterial hypertension.

From the central nervous system: very often: dizziness; often: headache; rarely: loss of coordination, fainting, speech disorders, changes in appetite, paresthesia, tremor, decreased breathing, epileptic seizures.

Epileptiform seizures have been observed mainly after the administration of high doses of tramadol or after the simultaneous use of drugs that can provoke seizures or lower the seizure threshold.

From the mental side: rarely: hallucinations, confusion, insomnia and nightmares.

Mental disorders may vary in manifestation (depending on the individual and duration of use of the drug). These may include changes in mood (usually high spirits, sometimes irritability), changes in cognitive and sensory abilities (changes in sensory perception and consciousness, which can lead to errors in decision making).

Dependence, abuse and withdrawal reactions may develop. Withdrawal reactions after stopping the drug are typical for opiates and include: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor, gastrointestinal symptoms. Very rarely, attacks of panic, anxiety, hallucinations, paresthesia, tinnitus, confusion, delirium, depersonalization, loss of sense of reality, and paranoia are observed.

From the organ of vision: rarely: blurred vision, miosis, mydriasis.

From the gastrointestinal tract: very often: nausea; often: vomiting, constipation, dry mouth; infrequently: diarrhea, stomach problems (for example, feeling of fullness in the stomach, flatulence).

From the respiratory system and mediastinal organs: rarely: shortness of breath, respiratory depression; unknown: worsening of existing asthma, although a cause-and-effect relationship has not been established.

From the skin: often: sweating; infrequently: itching, rash, redness of the skin.

From the musculoskeletal system: rarely: decreased muscle strength.

From the liver and biliary tract: very rarely: increased transaminases.

From the outsideurinarysystems: rarely: difficulty urinating, dysuria, urinary retention.

From the reproductive system: unknown: decreased libido, impotence, erectile dysfunction, lack of menstruation, infertility. If these adverse reactions develop, it is necessary to evaluate the level of sex hormones.

Other: rarely: allergic reactions (such as difficulty breathing, wheezing, swelling of the skin) and shock reactions (sudden circulatory failure).

When taking tramadol simultaneously with serotonergic drugs, you should immediately consult a doctor if the following symptoms develop: agitation, hallucinations, rapid heartbeat, fever, increased sweating, chills or tremors, muscle twitching (muscle cramps) or rigidity (stiffness), loss of coordination, nausea, vomiting or diarrhea (see section "Precautions" - Serotoninsyndrome).

If the above adverse reactions or adverse reactions not listed in this instruction occur, you should consult a doctor.

Contraindications

Hypersensitivity to tramadol or to any of the excipients; porphyria; asthma attack; acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs; simultaneous use of MAO inhibitors (and 2 weeks after their discontinuation); epilepsy; drug withdrawal syndrome; dysfunction of the liver and kidneys; pregnancy; lactation; children up to 14 years of age.

Overdose

Symptoms: specific miosis, vomiting, cardiovascular collapse, impaired consciousness up to coma, convulsions and respiratory depression up to respiratory arrest.

Treatment: General first aid measures should be taken. Ensure airway patency (aspiration is possible), respiratory and circulatory support depending on symptoms.

In case of overdose with oral forms, gastric lavage and the use of activated charcoal are recommended within 2 hours after taking tramadol; at a later date, cleansing the digestive system may be useful only if high doses are used.

The antidote for respiratory depression is naloxone. In animal studies, naloxone was found to have no effect on seizures. In this case, diazepam is administered.

Tramadol is excreted only in minimal quantities from the blood serum by hemodialysis or hemofiltration. Therefore, treatment of acute tramadol overdose with hemodialysis or hemofiltration is not sufficient to eliminate intoxication.

Precautionary measures

The drug is prescribed with caution for opioid addiction, traumatic brain injury, shock, loss of consciousness of unknown origin, dysfunction of the respiratory center, increased intracranial pressure in traumatic brain injury, brain diseases, impaired renal and liver function, and patients with epilepsy. The use of tramadol may complicate the diagnosis of acute pain in the abdominal region.

Tramadol is used with extreme caution in patients sensitive to opiates. Seizures have been reported in patients receiving tramadol at the recommended dosage. The risk may increase with doses greater than the recommended maximum daily dose (400 mg). When used together with drugs that lower the seizure threshold, tramadol may increase the risk of epileptic seizures. In patients with epilepsy or prone to epileptic seizures, tramadol is used only for health reasons.

In patients with respiratory depression or concomitant use of CNS depressants, or if the maximum recommended daily dose is significantly exceeded, the drug is prescribed with caution as respiratory depression may occur. Tramadol has a low addiction potential. With prolonged use, tolerance, mental and physical dependence may develop. In patients prone to drug abuse or dependence, treatment with tramadol should be carried out only for a short period and under strict medical supervision.

Tramadol is not suitable for replacement therapy in opioid-dependent patients. Although tramadol is an opioid agonist, it does not suppress morphine withdrawal symptoms.

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.

Serotoninsyndrome: When taking tramadol simultaneously with serotonergic drugs, you should immediately consult a doctor if the following symptoms develop: agitation, hallucinations, rapid heartbeat, fever, increased sweating, chills or tremors, muscle twitching (muscle cramps) or rigidity (stiffness), loss of coordination, nausea, vomiting or diarrhea. Symptoms typically develop within hours to several days of starting concomitant opioid therapy with other drugs. However, symptoms may develop later, especially after increasing the dose of drugs. If serotonin syndrome is suspected, discontinue opioids and/or other concomitant medications.

Adrenal insufficiency: You should consult your doctor if you notice symptoms of adrenal insufficiency, such as nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, diagnostic testing should be performed. If necessary, if the test result is positive, it is necessary to prescribe treatment with corticosteroids and discontinue opioids. If opioids are discontinued, a follow-up evaluation of adrenal function should be performed to determine the need to continue or discontinue corticosteroid therapy.

Androgenicfailure: Chronic use of opioids can affect the hypothalamic-pituitary-gonadal axis, which can lead to androgen deficiency, which manifests as low libido, impotence, erectile dysfunction, amenorrhea and infertility. If symptoms or signs of androgen deficiency occur, laboratory testing should be performed.

Applicationduring pregnancy and lactation

Contraindicated.

Impact on the ability to drive vehicles and other 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 (driving a vehicle, operating machinery, devices, etc.), so during treatment you should refrain from such activities.

Interaction with other drugs

Tramadol should not be taken together with MAO inhibitors. Life-threatening reactions affecting the central nervous, respiratory, and cardiovascular systems have been observed in patients receiving MAO inhibitors within 14 days of use of the opioid pethidine. A similar interaction with MAO inhibitors when using tramadol cannot be excluded.

The simultaneous use of tramadol and drugs that depress the central nervous system, including alcohol, may enhance their effect on the central nervous system.

The results of pharmacokinetic studies have shown that concomitant or prior use of cimetidine (an enzyme inhibitor) is unlikely to lead to a clinically significant interaction. Concomitant or prior use of carbamazepine (an enzyme inducer) may reduce the analgesic effect and shorten the duration of action of tramadol.

The combination of mixed agonists/antagonists (eg, buprenorphine, nalbuphine, pentazocine) and tramadol is not recommended because the combination may theoretically reduce the analgesic effect of the pure agonist.

Caution should be used when using tramadol with coumarin derivatives (eg, warfarin) as there are reports of increased INR (INR) with severe bleeding and hemorrhage in some patients.

Drugs that inhibit CYP3A4, including ketoconazole and erythromycin, may inhibit the metabolism of tramadol (O-demethylation) and its active O-demethylated metabolite. The clinical significance of this interaction has not been studied.

A small number of studies have shown that pre- or postoperative use of selective 5-HT3 serotonin receptor antagonists (ondansetron) increases the need for tramadol in patients with postoperative pain.

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 coenzyme CYP2D6. There is evidence of a decrease in plasma concentrations of fluoroquinolones (ciprofloxacin, ofloxacin) when premedicated with tramadol during surgical interventions.

Tramadol may stimulate the development of seizures and increase the ability of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, antipsychotics and other drugs that lower the seizure threshold, such as bupropion, mirtazapine, tetrahydrocannabinol, to cause seizures.

Concomitant use of tramadol and serotonergic drugs, such as selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, MAO inhibitors and mirtazapine, may contribute to the development of serotonin syndrome (see section "Precautions" - Serotoninsyndrome).

There is a risk of developing serotonin syndrome when one of the following symptoms occurs:

Spontaneous muscle clonus; inducible or ocular clonus with agitation or sweating; tremor and hyperreflexia; hypertension, body temperature >38°C, inducible or ocular clonus.

Package

10 tablets per blister pack. One or two contour packages along with instructions for use are placed in a cardboard pack.

Vacation conditions

On prescription.

Manufacturer

RUE "Belmedpreparaty"

Republic of Belarus, 220007, Minsk,

st. Fabricius, 30, t./f.: (+375 17) 220 37 16,

e-mail: [email protected]

Active substance

Tramadol hydrochloride (tramadol)

Release form, composition and packaging

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

Excipients: sodium acetate, water for injection.

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

pharmachologic effect

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

Indications

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

— for the purpose of pain relief during painful diagnostic or therapeutic procedures.

Contraindications

- conditions accompanied by respiratory depression or severe depression of the central nervous system (poisoning with alcohol, sleeping pills, narcotic analgesics, psychotropic drugs);

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

- 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 are determined by the doctor individually, depending on the intensity and nature of the pain.

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

The effect of the drug lasts for 4-8 hours. With normal use, the daily dose should not exceed 400 mg. In the presence of tumors, or during surgical interventions, a significantly higher dosage increase may be necessary.

Children aged 1 to 13 years It is recommended to administer 1-2 mg/kg body weight as a single dose. In this case, Tramadol is diluted. It is necessary to take into account what concentrations should be achieved (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 subcutaneously.

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

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

Side effects

The most common symptoms are dizziness, nausea, constipation (in 15-30% of patients), vomiting, itching, symptoms of psychostimulant action, 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, tremor, abdominal pain, visual disturbances, and urinary retention are possible.

The incidence of side effects increases with increasing duration of drug use. With long-term use in large doses, the possibility of developing drug dependence cannot be 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 for poisoning is maintaining adequate pulmonary ventilation and symptomatic therapy in a specialized department. In mild cases, gastric lavage is sufficient. The application is not decisive, because does not eliminate all symptoms of poisoning and may cause convulsions. Hemodialysis is not very effective. For convulsions it is advisable to use.

Drug interactions

Simultaneous intake of alcohol or drugs that have a depressant effect on the central nervous system can lead to mutual enhancement of central effects, incl. - respiratory depression.

There are isolated reports of the development of epileptic seizures when combined with antipsychotics.

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

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

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

special instructions

In elderly patients, Tramadol is used at increased intervals.

The drug should be used with caution and under the supervision of a physician in patients with impaired renal and liver function, with traumatic brain 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 effects of anesthesia, hypnotics and psychotropic drugs; the drug should not be combined with narcotic analgesics due to the poor predictability of the interaction effect.

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

Impact on the ability to drive vehicles and operate machinery

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

(tramadol | tramadol)

Registration number:

P N 015731/01 dated 06/03/2004

Trade name of the drug: Tramadol

International nonproprietary name:

tramadol

Dosage form:

pills

Compound:

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

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

Pharmacotherapeutic group:

Analgesic opioid drug
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 hyperpolarization of membranes and inhibits the conduction of pain impulses), enhances the effect of sedatives. Activates specific opioid receptors (mu-, delta-, kappa-) on the pre- and postsynaptic membranes of afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

Pharmacokinetics:
After oral administration, it is quickly and almost completely absorbed from the gastrointestinal tract (about 90%). The maximum concentration in blood plasma is determined 2 hours after oral administration. Bioavailability after a single oral dose is 68% and increases with repeated use. Penetrates through the blood-brain and placental barriers.
0.1% is excreted in breast milk. Distribution volume – 306 l. Communication with plasma proteins - 20%.
Metabolized in the liver by N- and O-demethylation followed by conjugation with glucuronic acid. 11 metabolites have been 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 over 75 years old – 7.4 hours (tramadol); for liver cirrhosis – 13.3 + 4.9 hours (tramadol), 18.5 + 9.4 hours (mono-O-desmethyltramadol), in severe cases – 22.3 hours and 36 hours, respectively; for chronic renal failure (creatinine clearance 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 renal excretion rate is 94%. About 7% is eliminated 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 (poisoning with alcohol, sleeping pills, narcotic analgesics, psychotropic drugs).
• Severe liver and/or renal failure (creatinine clearance less than 10 ml/min).
• Simultaneous use of MAO inhibitors (and two weeks after their discontinuation).
• 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).

The drug should be used with caution and under the supervision of a physician in patients with impaired renal and liver function, with traumatic brain injury, increased intracranial pressure, patients with epilepsy, as well as persons with drug addiction to opioids, in patients with abdominal pain of unknown origin (“ acute stomach").

Directions for use and dosage:

Tramadol is used when prescribed by a doctor; 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 prescribed in the following dosages:
For adults and teenagers over 14 years of age- 1 tablet (50 mg), if necessary, after 30-60 minutes you can take another tablet; for severe pain, a single dose can be 100 mg (2 tablets). The tablets are swallowed without chewing, washed down with a small amount of liquid, or pre-dissolved in ½ glass of water, regardless of meals.
The daily dose should not exceed 400 mg (8 tablets).
For the treatment of pain due to cancer and severe pain in the postoperative period Higher doses may be used.
In elderly patients(aged 75 years or more) due to the possibility of delayed elimination, the interval between administration of the drug can be increased in accordance with individual characteristics.
In patients with kidney and liver diseases Tramadol may last longer. For such patients, the doctor may recommend increasing the interval between single doses.
Tramadol should not be prescribed for longer than therapeutically necessary.

Side effects:
From 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, increased fatigue, lethargy, paradoxical stimulation of the central nervous system (nervousness, agitation, anxiety, tremors, muscle spasms, euphoria, emotional lability, hallucinations), drowsiness, sleep disturbance, confusion, poor coordination of movements, convulsions central origin (with intravenous administration in high doses or with simultaneous administration of antipsychotic drugs), depression, amnesia, impaired cognitive function, paresthesia, gait instability.
Allergic reactions: urticaria, itching, exanthema, bullous rash.
From the urinary system: difficulty urinating, dysuria, urinary retention.
From the senses: disturbance of vision, taste.
From the respiratory system: dyspnea.
Other: menstrual irregularities.

With prolonged use - the development of drug dependence. In case of abrupt withdrawal, the development of withdrawal syndrome is possible.

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

Interaction with other drugs:

Strengthens the effect of ethanol and drugs that have a depressant effect on the central nervous system.
Inducers of microsomal oxidation (including carbamazepine, barbiturates) reduce the severity of the 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 breathing, eliminating analgesia after the use of opioid analgesics. MAO inhibitors, furazolidone, procarbazine, and antipsychotics may cause a risk of developing seizures (lowering 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:

Tramadol is used at increased intervals in elderly patients. Under close medical supervision and in reduced doses, tramadol should be used against the background of the effects of anesthesia, hypnotics and psychotropic drugs.
It is prohibited to drink alcohol during treatment.
Not used for the treatment of drug withdrawal syndrome.
In the case of a single dose, there is no need to interrupt breastfeeding.

When using the drug, you must refrain from driving a car and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form:

10 tablets each in blisters made of Al foil and OPA/Al/PVC combination.
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 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. The drug should not be used after the expiration date.

Conditions for dispensing from pharmacies:

By doctor's prescription.

Company manufacturer:
Hexal AG, manufactured by Salutas Pharma GmbH, Industrialstrasse 25, Holzkirchen, 83607, Germany.

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

Tramadol in ampoules is an opioid synthetic analgesic that not only has a central effect, but also acts on the spinal cord. While taking the drug, the effect of synthetic drugs is enhanced. This is a potent medicine, injections of which are used only as prescribed by a doctor.

Composition and release form

The main component of the drug is tramadol. The medicine is also prepared using excipients - anhydrous sodium acetate and water for injection. The production of the medicine is carried out in ampoules. Tramadol is a colorless and clear solution. One ampoule of the drug contains 1 milliliter of medicine.

Pharmacokinetics and pharmacokinetics

Tramadol is a potent opioid analgesic that has central action. If you increase the duration of taking the medication, this will lead to a decrease in its analgesic effect. If there is a need for long-term therapy, a gradual increase in dosage is recommended.

There are two ways to achieve an analgesic effect. The first is that the nerve fibers of the pain perception system bind to opioid receptors in the spinal cord, brain, and digestive tract, which leads to a decrease in pain. The second way is that L-1-2-aminoethanol is reuptaken and descending noradrenergic effects are stimulated. As a result, inhibition of the transmission of pain impulses in the spinal cord is observed.

During the period of use of the drug, potassium and calcium channels open, and the imbalance of ions on both sides of the cells increases. The action of the medication is aimed at inhibiting the transmission of nerve impulses. With its help, the amount of catecholamines in the nervous system is normalized. After intramuscular injection, the maximum concentration of the active substance in the blood is observed within 45 minutes.

Indications for use of Tramadol in ampoules

The administration of Tramadol must be carried out in strict accordance with the indications. The drug is recommended for severe and moderate pain syndromes of various origins:

• for severe pain resulting from injuries;
• surgical intervention;
• for fractures;
• for neuralgia with pain syndrome.

Tramadol is a highly effective medication that provides pain relief of various etiologies. Thanks to the special method of administering the solution, the drug works quickly. The use of Tramadol is recommended only in the presence of severe pain. The medication is characterized by the presence of contraindications, which must be taken into account by the doctor before prescribing. Otherwise, the development of undesirable effects may occur.

Contraindications

Despite the high effect of Tramadol injection solution, it has certain contraindications. If the patient has an individual intolerance to the main or auxiliary components of the drug, then its use is strictly prohibited. Experts do not recommend using the drug in acute forms of intoxication with CNS inhibitors such as:

• Sleeping pills;
• Psychotropic medications;
• Sedatives;
• Psycholeptics;
• Anxiolytic drugs.

If the patient has suicidal tendencies, then the use of the medicine is also not recommended for him. A contraindication to the use of the drug is substance abuse. If there are severe problems with the kidneys or liver, administering Tramadol is strictly prohibited.

In the first trimester of pregnancy, the drug is not used to relieve pain. If a person is undergoing therapy with monoamine oxidase inhibitors, then using Tramadol for therapy is prohibited. If the patient's age is less than 14 years, then the use of the medication is also strictly prohibited. If there are contraindications, it is recommended to use analogues.

Analogs

Side effects

If Tramadol is used or administered incorrectly, if there are contraindications, side effects may occur. In most cases, they manifest themselves in the digestive and nervous systems.

• Patients complain of disturbances in the digestive tract, which manifest themselves in the form of:
  • nausea;
  • vomiting;
  • constipation;
  • diarrhea.
• In some cases, after administration of the solution, the following may be observed:
  • headache;
  • dizziness;
  • dyspnea;
  • drowsiness;
• During long-term treatment with Tramadol, patients complain of:
  • increased anxiety;
  • euphoria;
  • confusion;
  • emotional lability;
  • insomnia;
  • disturbances in coordination of movements.

Taking the drug may be accompanied by urine retention or increased urination. Patients also complain that they have no appetite and appear.

Side effects of taking the medicine include a rash on the skin. Representatives of the fairer sex may experience changes similar to menopause. Quite serious complications are visual impairment, as well as vascular dilatation.

There are a number of unwanted effects that occur in less than 1 percent of patients. Taking the drug can lead to impairment of cognitive activity, attention control, as well as increased seizure activity. Undesirable effects may manifest themselves in the form of:

• Amnesia;
• Hallucinations;
• Tremors;
• Paresthesia.

Representatives of the fairer sex complain about the appearance of disorders in the menstrual cycle. The use of the medicine can lead to disruption of the functioning of the heart and blood vessels:

• orthostatic hypotension;
• cardiovascular collapse;
• palpitations of the heart.

During treatment, patients may experience an increase in muscle tone, a decrease in body weight, and difficulty swallowing.

Instructions for use

The instructions for using Tramadol state that you must strictly adhere to the rules for administering the medicine in order to exclude the possibility of complications.

The use of drug injections is recommended only after the patient reaches 14 years of age. The dosage of the medication should be determined only by the doctor. In this case, the specialist takes into account the severity of the pain syndrome, the individual characteristics and sensitivity of the patient. The duration of treatment is also prescribed by the doctor, the continuation of which is strictly prohibited for the patient.

The medication is administered into the muscles, veins or subcutaneously. The intravenous medication should be administered as slowly as possible. If the patient's age is more than 14 years, then a single dose is 1-2 milliliters of solution, depending on the severity of pain. If there is no appropriate therapeutic effect within an hour, the patient may be prescribed a second dose. To eliminate pain, an adult patient needs 400 milligrams of the drug per day.

If a patient is prescribed a drug for cancer or after surgery, the dosage of the drug may be increased. If the patient has liver or kidney disease, the effect of the medicine may be longer. That is why these categories of patients are recommended to increase the intervals between the administration of solutions. If the patient's age is more than 75 years, then slow elimination of the drug components may be observed. In this case, it is recommended to increase the interval of drug administration.

Although the drug is prohibited for children, exceptions have been observed in medical practice. The dosage of Tramadol for children aged 1 to 4 years is selected according to weight. One kilogram requires 1 to 2 milligrams of the drug. The medicine must be administered to children in the same ways as for adult patients. Tramadol should be administered into a vein in young patients as slowly as possible. The medicine is pre-diluted in an infusion solution. The intervals between drug administration should be at least 4 hours.

Features of overdose

The use of Tramadol must be carried out in strict accordance with the doses prescribed by doctors. Otherwise, quite dangerous symptoms may occur. When administering the drug in an increased dose, the following may occur:

• disturbance of consciousness;
• coma;
• convulsions of central origin;
• hypotension.

If the drug is administered incorrectly or in excessive quantities, it may cause respiratory depression. In some cases, patients' pupils narrow or dilate. A fairly serious complication of overdose is. If there is a significant overdose of the drug, this can cause damage to the central nervous system. Such patients are diagnosed with shallow breathing. To eliminate these symptoms, it is recommended that the patient be administered Naloxone. If seizures occur due to an overdose, treatment is carried out with Diazepam.

In case of an overdose of the drug, the corresponding symptoms are observed in the form of:

• seizures;
• respiratory depression;
• coma;
• collapse;
• nausea and vomiting;
• apnea.

Treatment of the pathological condition should be aimed at ensuring airway patency. Patients are prescribed medications that support respiratory function and the cardiovascular system.

Interaction of Tramadol with other drugs

Use at the same time Tramadol and MAO inhibitors is strictly prohibited. If the drug is combined with drugs that affect the central nervous system, this may lead to a synergistic effect. Their development is also observed with the simultaneous use of medicine and alcoholic beverages. In this case, sedation increases and the analgesic effect also increases.

When taken simultaneously Carbamazepine and Tramadol an increase in the metabolism of the latter is observed. This requires increasing its dosage. If taken simultaneously with Tramadol tricyclic antidepressants, SSRIs, psycholeptics, this can lead to seizures. During the period of taking barbiturates, a decrease in the analgesic effect of Tramadol is observed. Cross-tolerance may occur due to prolonged exposure to barbiturates.

During the period of taking anxiolytics, an increase in the severity of the analgesic effect is observed. Thanks to Naloxone, breathing is activated and analgesia is eliminated. During the period of taking Quinidine, an increase in the plasma concentration of Tramadol is observed.

special instructions

Women during pregnancy and lactation

In the first trimester of pregnancy, women are strictly prohibited from taking the medicine. In the second and third trimester, administration of the drug is allowed if possible risks for the child are minimized. During lactation, the drug is prescribed in accordance with vital indications. During treatment with the drug, women are advised to temporarily stop breastfeeding.

For liver failure

If the patient has a dysfunction of the liver, this may lead to a longer effect of the medicine. That is why, during Tramadol therapy, doctors recommend increasing the intervals between its administration. After pain relief, it is necessary to discontinue the medication. In case of severe liver failure, the use of the solution is strictly prohibited.

The active substances may negatively affect the patient's concentration. That is why during the period of treatment with medication it is recommended to refrain from driving vehicles and operating complex mechanisms. It is also recommended to avoid activities that require rapid psychomotor reactions during this period.

Price of Tramadol ampoules

The drug can be purchased at any pharmacy in the country. Since Tramadol belongs to the category of potent opioid drugs, it can only be purchased with a prescription. The drug is released in ampoules, which are packaged in cardboard boxes. The price of one package of the drug averages 110-320 rubles, depending on the city. Due to the low cost of the drug, its availability is ensured for a wide range of patients.

Storage of the drug

The medicine should be stored in places that are protected from excessive humidity and ultraviolet radiation. During storage of the medicine, it is necessary to ensure that children's access to it is limited. It should be stored at a temperature of 15-25 degrees.

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solution for injection 50 mg/1 ml: amp. 5, 10 or 100 pcs. Reg. No.: P No. 011409/02

Clinical and pharmacological group:

Opioid analgesic with a mixed mechanism of action

Release form, composition and packaging

Injection transparent, colorless, odorless.

Excipients: sodium acetate, water d/i.

1 ml - ampoules (5) - plastic containers (1) - cardboard packs.
1 ml - ampoules (5) - plastic containers (2) - cardboard packs.
1 ml - ampoules (5) - plastic containers (20) - cardboard packs.

Description of the active components of the drug " Tramadol»

pharmachologic effect

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

Tramadol is an opioid synthetic analgesic that has a central effect and an effect on the spinal cord (promotes the opening of K + and Ca 2+ channels, causes hyperpolarization of membranes and inhibits the conduction of pain impulses), enhances the effect of sedatives. Activates opioid receptors (mu-, delta-, kappa-) on the pre- and postsynaptic membranes of afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

Indications

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

— pain relief during painful diagnostic or therapeutic procedures.

Dosage regimen

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 beyond the period justified from a therapeutic point of view.

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

For adults and teenagers over 14 years old for a single administration of 50-100 mg of tramadol hydrochloride (1-2 ml of solution for injection). If satisfactory analgesia does not occur, a repeat single dose of 50 mg (1 ml) may be prescribed after 30-60 minutes. For severe pain, a higher dose (100 mg tramadol hydrochloride) may be prescribed as an initial dose. In general, 400 mg of tramadol hydrochloride/day is usually sufficient to relieve pain.

For the treatment of pain due to cancer and severe pain in the postoperative period Higher doses may be used.

Children over 1 year of age injection solution can be prescribed in a single dose at the rate of 1-2 mg/kg of the child’s body weight. A daily dose of 4-8 mg/kg body weight is usually sufficient. Tramadol is diluted with water for injection. Dilute Tramadol with water to obtain final concentration.

1 ml of the drug contains 50 mg of tramadol
Tramadol+water	Concentration
1 ml + 1 ml	25.0 mg/ml
1 ml + 2 ml	16.7 mg/ml
1 ml + 3 ml	12.5 mg/ml
1 ml + 4 ml	10.0 mg/ml
1 ml + 5 ml	8.3 mg/ml
1 ml + 6 ml	7.1 mg/ml
1 ml + 7 ml	6.3 mg/ml
1 ml + 8 ml	5.8 mg/ml
1 ml + 9 ml	5.0 mg/ml
2 ml of the drug contains 100 mg of tramadol
Tramadol+water	Concentration
2 ml + 2 ml	25.0 mg/ml
2 ml + 4 ml	16.7 mg/ml
2 ml + 6 ml	12.5 mg/ml
2 ml + 8 ml	10.0 mg/ml
2 ml + 10 ml	7.1 mg/ml
2 ml + 14 ml	6.3 mg/ml
2 ml + 16 ml	5.8 mg/ml
2 ml + 18 ml	5.0 mg/ml

Example: To administer a dose of 1.5 mg of tramadol hydrochloride per kg of body weight to a child weighing 45 kg, 67.5 mg of tramadol hydrochloride is required. To do this, 2 ml of Tramadol is diluted with 4 ml of water for injection to a final concentration of 16.7 mg of tramadol hydrochloride per milliliter. Then 4 ml of the diluted solution is administered (total dose is approximately 67 mg of tramadol hydrochloride).

It is possible to dilute injection solutions with solutions for infusion for intravenous administration. In this case, 0.9% sodium chloride solution or 5% glucose solution is used for dilution.

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

In patients with kidney and liver diseases Tramadol may last longer. For such patients, the doctor may recommend increasing the interval between single doses.

Tramadol should not be prescribed for longer than therapeutically necessary.

Side effect

From the nervous system: sweating, dizziness, headache, weakness, increased fatigue, lethargy, paradoxical stimulation of the central nervous system (nervousness, agitation, anxiety, tremors, muscle spasms, euphoria, emotional lability, hallucinations), drowsiness, sleep disturbance, confusion, poor coordination of movements, convulsions central origin (with intravenous administration in high doses or with simultaneous administration of antipsychotic drugs), 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 cardiovascular system: tachycardia, orthostatic hypotension, syncope, collapse.

Allergic reactions: urticaria, itching, exanthema, bullous rash.

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

From the senses: disturbance of vision, taste.

From the respiratory system: dyspnea.

Others: menstrual irregularities.

With prolonged use - the development of drug dependence. With abrupt withdrawal - withdrawal syndrome.

Contraindications

- conditions accompanied by respiratory depression or severe depression of the central nervous system (poisoning with alcohol, sleeping pills, narcotic analgesics, psychotropic drugs);

- severe liver and/or renal failure (creatinine clearance less than 10 ml/min);

- simultaneous use of MAO inhibitors (and two weeks after their discontinuation);

- children's age (up to 1 year);

- hypersensitivity to the drug and other opioids.

Carefully: the drug should be used by patients with impaired renal and liver function, with traumatic brain injuries, increased intracranial pressure, patients with epilepsy, as well as persons with drug addiction to opioids, in patients with abdominal pain of unknown origin ("acute abdomen") .

Pregnancy and lactation

During pregnancy and lactation, use is possible only for health reasons; use should be limited to a single dose only.

Use for liver dysfunction

Carefully: The drug should be used in patients with impaired liver function.

Use for renal impairment

Carefully: The drug should be used in patients with impaired renal function.

Use in old age

Tramadol is used at increased intervals in elderly patients.

Application for children

Contraindication: children under 1 year of age.

special instructions

Tramadol is used at increased intervals in elderly patients. Under close medical supervision and in reduced doses, Tramadol should be used against the background of the effects of anesthesia, hypnotics and psychotropic drugs.

It is prohibited to drink alcohol during treatment with Tramadol,

Tramadol in the form of injections can be addictive, so long-term use in this dosage form should be avoided, and if necessary, tolerance, physical and mental dependence on the drug should be assessed.

Impact on the ability to drive vehicles and operate machinery

When using Tramadol, you must refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

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

Treatment: ensuring airway patency. Maintaining breathing and cardiovascular activity, opiate-like effects can be stopped with naloxone, convulsions - with benzodiazepine.

Drug interactions

Conditions for dispensing from pharmacies

On prescription.

Storage conditions and periods

Store at a temperature of 15-25°C, in a dry place, protected from light, out of reach of children. The drug belongs to list No. 1 of potent substances of the Standing Committee for Drug Control of the Ministry of Health of the Russian Federation. Shelf life - 3 years.

Drug interactions

Pharmaceutically incompatible with solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, nitroglycerin, midazolam.

Strengthens the effect of drugs that have a depressant effect on the central nervous system and ethanol.

Inducers of microsomal oxidation (including carbamenzapine, barbiturates) reduce the severity of the 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. Naloxone activates respiration, eliminating analgesia after the use of opioid analgesics. MAO inhibitors, furosalidone, procarbazine, antipsychotics - risk of developing seizures (reduced seizure threshold).

Quinidine increases the plasma concentration of tramadol and reduces the concentration of the M1 metabolite due to competitive inhibition of the CYP 2D6 isoenzyme.